Tecvayli

(Teclistamab)

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Dosage & Administration

Dosing Schedule Day Dose

All Patients

Step-up Dosing Schedule

Day 1

Step-up dose 1

0.06 mg/kg

Day 4

Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions. Step-up dose 2 0.3 mg/kg

Day 7

First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions. First treatment dose 1.5 mg/kg

Weekly Dosing Schedule

One week after first treatment dose and weekly thereafter

Subsequent treatment doses

1.5 mg/kg once weekly

Patients who have achieved and maintained a complete response or better for a minimum of 6 months

Biweekly (every two weeks) dosing schedule

The dosing frequency may be decreased to 1.5 mg/kg every two weeks

* For subcutaneous injection only. (

2.1 Recommended Dosage

For subcutaneous injection only.

The recommended dosing schedule for TECVAYLI is provided in Table 1. The recommended dosage of TECVAYLI is step-up doses of 0.06 mg/kg and 0.3 mg/kg followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity. In patients who have achieved and maintained a complete response or better for a minimum of 6 months, the dosing frequency may be decreased to 1.5 mg/kg every two weeks until disease progression or unacceptable toxicity.

Administer pretreatment medications prior to each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Table 1

[see Dosage and Administration (2.2)]

Administer TECVAYLI subcutaneously according to the step-up dosing schedule in Table 1 to reduce the incidence and severity of cytokine release syndrome (CRS). Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule

[see Dosage and Administration (2.4)and Warnings and Precautions (5.1, 5.2)]

Table 1: TECVAYLI Dosing Schedule
Dosing schedule	Day	Dose
All Patients
Step-up dosing scheduleSee Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].	Day 1	Step-up dose 1	0.06 mg/kg
	Day 4Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.	Step-up dose 2	0.3 mg/kg
	Day 7First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.	First treatment dose	1.5 mg/kg
Weekly dosing schedule	One week after first treatment dose and weekly thereafter	Subsequent treatment doses	1.5 mg/kg once weekly
Patients who have achieved and maintained a complete response or better for a minimum of 6 months
Biweekly (every two weeks) dosing schedule	The dosing frequency may be decreased to 1.5 mg/kg every two weeks.

Refer to Tables 7, 8, and 9 to determine the dosage based on predetermined weight ranges

[see Dosage and Administration (2.5)]

)

* Patients should be hospitalized for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule. (

2.1 Recommended Dosage

For subcutaneous injection only.

Administer pretreatment medications prior to each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Table 1

[see Dosage and Administration (2.2)]

[see Dosage and Administration (2.4)and Warnings and Precautions (5.1, 5.2)]

Table 1: TECVAYLI Dosing Schedule
Dosing schedule	Day	Dose
All Patients
Step-up dosing scheduleSee Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].	Day 1	Step-up dose 1	0.06 mg/kg
	Day 4Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.	Step-up dose 2	0.3 mg/kg
	Day 7First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.	First treatment dose	1.5 mg/kg
Weekly dosing schedule	One week after first treatment dose and weekly thereafter	Subsequent treatment doses	1.5 mg/kg once weekly
Patients who have achieved and maintained a complete response or better for a minimum of 6 months
Biweekly (every two weeks) dosing schedule	The dosing frequency may be decreased to 1.5 mg/kg every two weeks.

Refer to Tables 7, 8, and 9 to determine the dosage based on predetermined weight ranges

[see Dosage and Administration (2.5)]

)

* Administer pretreatment medications as recommended. (

2.2 Recommended Pretreatment Medications

Administer the following pretreatment medications 1 to 3 hours before each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose (see Table 1), to reduce the risk of CRS

[see Warnings and Precautions (5.1)and Adverse Reactions (6.1)]

* Corticosteroid (oral or intravenous dexamethasone 16 mg)
* Histamine-1 (H1) receptor antagonist (oral or intravenous diphenhydramine 50 mg or equivalent)
* Antipyretics (oral or intravenous acetaminophen 650 mg to 1,000 mg or equivalent)

Administration of pretreatment medications may be required prior to administration of subsequent doses of TECVAYLI in the following patients:

* Patients who repeat doses within the TECVAYLI step-up dosing schedule following a dose delay

[see Dosage and Administration (2.3)].

* Patients who experienced CRS following the prior dose of TECVAYLI

[see Dosage and Administration (2.4)].

Prophylaxis for Herpes Zoster Reactivation

Prior to starting treatment with TECVAYLI, consider initiation of antiviral prophylaxis to prevent herpes zoster reactivation per guidelines.

)

* Refer to Tables 7, 8, and 9 to determine the dosage based on predetermined weight ranges. (

2.5 Preparation and Administration

TECVAYLI is intended for subcutaneous use by a healthcare provider only.

TECVAYLI should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and ICANS

[see Warnings and Precautions (5.1, 5.2)]

TECVAYLI is a clear to slightly opalescent, colorless to light yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is discolored, or cloudy, or if foreign particles are present.

TECVAYLI 30 mg/3 mL (10 mg/mL) vial and TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial are supplied as ready-to-use solution that do not need dilution prior to administration.

Do not combine TECVAYLI vials of different concentrations to achieve treatment dose.

Use aseptic technique to prepare and administer TECVAYLI.

Preparation of TECVAYLI

Refer to the following reference tables for the preparation of TECVAYLI.

Refer to Tables 7, 8, and 9 below to determine the dosage based on predetermined weight ranges.

Use Table 7 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 1 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.

Table 7: Step-up Dose 1 (0.06 mg/kg) Injection Volumes using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=3 mL)
35 to 39	2.2	0.22	1
40 to 44	2.5	0.25	1
45 to 49	2.8	0.28	1
50 to 59	3.3	0.33	1
60 to 69	3.9	0.39	1
70 to 79	4.5	0.45	1
80 to 89	5.1	0.51	1
90 to 99	5.7	0.57	1
100 to 109	6.3	0.63	1
110 to 119	6.9	0.69	1
120 to 129	7.5	0.75	1
130 to 139	8.1	0.81	1
140 to 149	8.7	0.87	1
150 to 160	9.3	0.93	1

Use Table 8 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 2 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.

Table 8: Step-up Dose 2 (0.3 mg/kg) Injection Volumes using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=3 mL)
35 to 39	11	1.1	1
40 to 44	13	1.3	1
45 to 49	14	1.4	1
50 to 59	16	1.6	1
60 to 69	19	1.9	1
70 to 79	22	2.2	1
80 to 89	25	2.5	1
90 to 99	28	2.8	1
100 to 109	31	3.1	2
110 to 119	34	3.4	2
120 to 129	37	3.7	2
130 to 139	40	4	2
140 to 149	43	4.3	2
150 to 160	47	4.7	2

Use Table 9 to determine total dose, injection volume and number of vials required based on patient's actual body weight for the treatment dose using TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial.

Table 9: Treatment Dose (1.5 mg/kg) Injection Volumes using TECVAYLI 153 mg/1.7 mL (90 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=1.7 mL)
35 to 39	56	0.62	1
40 to 44	63	0.7	1
45 to 49	70	0.78	1
50 to 59	82	0.91	1
60 to 69	99	1.1	1
70 to 79	108	1.2	1
80 to 89	126	1.4	1
90 to 99	144	1.6	1
100 to 109	153	1.7	1
110 to 119	171	1.9	2
120 to 129	189	2.1	2
130 to 139	198	2.2	2
140 to 149	216	2.4	2
150 to 160	234	2.6	2

Remove the appropriate strength TECVAYLI vial from refrigerated storage [2 °C to 8 °C (36 °F to 46 °F)].

Once removed from refrigerated storage, equilibrate TECVAYLI to ambient temperature [15 °C to 30 °C (59 °F to 86 °F)] for at least 15 minutes. Do not warm TECVAYLI in any other way.

Once equilibrated, gently swirl the vial for approximately 10 seconds to mix. Do not shake.

Withdraw the required injection volume of TECVAYLI from the vial(s) into an appropriately sized syringe using a transfer needle.

Each injection volume should not exceed 2 mL. Divide doses requiring greater than 2 mL equally into multiple syringes.

TECVAYLI is compatible with stainless steel injection needles and polypropylene or polycarbonate syringe material.

Replace the transfer needle with an appropriately sized needle for injection.

Administration of TECVAYLI

Inject the required volume of TECVAYLI into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, TECVAYLI may be injected into the subcutaneous tissue at other sites (e.g., thigh). If multiple injections are required, TECVAYLI injections should be at least 2 cm apart.

Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.

Any unused product or waste material should be disposed in accordance with local requirements.

Storage

If the prepared dosing syringe(s) of TECVAYLI is not used immediately, store syringe(s) at 2 °C to 8 °C (36 °F to 46 °F) or at ambient temperature 15 °C to 30 °C (59 °F to 86 °F) for a maximum of 20 hours. Discard syringe(s) after 20 hours, if not used.

Monitoring

Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule

[see Dosage and Administration (2.1)and Warnings and Precautions (5.1, 5.2)]

)

* See Full Prescribing Information for instructions on preparation and administration. (

2.5 Preparation and Administration

TECVAYLI is intended for subcutaneous use by a healthcare provider only.

TECVAYLI should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and ICANS

[see Warnings and Precautions (5.1, 5.2)]

TECVAYLI 30 mg/3 mL (10 mg/mL) vial and TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial are supplied as ready-to-use solution that do not need dilution prior to administration.

Do not combine TECVAYLI vials of different concentrations to achieve treatment dose.

Use aseptic technique to prepare and administer TECVAYLI.

Preparation of TECVAYLI

Refer to the following reference tables for the preparation of TECVAYLI.

Refer to Tables 7, 8, and 9 below to determine the dosage based on predetermined weight ranges.

Use Table 7 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 1 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.

Table 7: Step-up Dose 1 (0.06 mg/kg) Injection Volumes using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=3 mL)
35 to 39	2.2	0.22	1
40 to 44	2.5	0.25	1
45 to 49	2.8	0.28	1
50 to 59	3.3	0.33	1
60 to 69	3.9	0.39	1
70 to 79	4.5	0.45	1
80 to 89	5.1	0.51	1
90 to 99	5.7	0.57	1
100 to 109	6.3	0.63	1
110 to 119	6.9	0.69	1
120 to 129	7.5	0.75	1
130 to 139	8.1	0.81	1
140 to 149	8.7	0.87	1
150 to 160	9.3	0.93	1

Use Table 8 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 2 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.

Table 8: Step-up Dose 2 (0.3 mg/kg) Injection Volumes using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=3 mL)
35 to 39	11	1.1	1
40 to 44	13	1.3	1
45 to 49	14	1.4	1
50 to 59	16	1.6	1
60 to 69	19	1.9	1
70 to 79	22	2.2	1
80 to 89	25	2.5	1
90 to 99	28	2.8	1
100 to 109	31	3.1	2
110 to 119	34	3.4	2
120 to 129	37	3.7	2
130 to 139	40	4	2
140 to 149	43	4.3	2
150 to 160	47	4.7	2

Use Table 9 to determine total dose, injection volume and number of vials required based on patient's actual body weight for the treatment dose using TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial.

Table 9: Treatment Dose (1.5 mg/kg) Injection Volumes using TECVAYLI 153 mg/1.7 mL (90 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=1.7 mL)
35 to 39	56	0.62	1
40 to 44	63	0.7	1
45 to 49	70	0.78	1
50 to 59	82	0.91	1
60 to 69	99	1.1	1
70 to 79	108	1.2	1
80 to 89	126	1.4	1
90 to 99	144	1.6	1
100 to 109	153	1.7	1
110 to 119	171	1.9	2
120 to 129	189	2.1	2
130 to 139	198	2.2	2
140 to 149	216	2.4	2
150 to 160	234	2.6	2

Remove the appropriate strength TECVAYLI vial from refrigerated storage [2 °C to 8 °C (36 °F to 46 °F)].

Once removed from refrigerated storage, equilibrate TECVAYLI to ambient temperature [15 °C to 30 °C (59 °F to 86 °F)] for at least 15 minutes. Do not warm TECVAYLI in any other way.

Once equilibrated, gently swirl the vial for approximately 10 seconds to mix. Do not shake.

Withdraw the required injection volume of TECVAYLI from the vial(s) into an appropriately sized syringe using a transfer needle.

Each injection volume should not exceed 2 mL. Divide doses requiring greater than 2 mL equally into multiple syringes.

TECVAYLI is compatible with stainless steel injection needles and polypropylene or polycarbonate syringe material.

Replace the transfer needle with an appropriately sized needle for injection.

Administration of TECVAYLI

Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.

Any unused product or waste material should be disposed in accordance with local requirements.

Storage

Monitoring

Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule

[see Dosage and Administration (2.1)and Warnings and Precautions (5.1, 5.2)]

)

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Tecvayli Prescribing Information

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity

[see

2.1 Recommended Dosage

For subcutaneous injection only.

Administer pretreatment medications prior to each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Table 1

[see Dosage and Administration (2.2)]

[see Dosage and Administration (2.4)and Warnings and Precautions (5.1, 5.2)]

Table 1: TECVAYLI Dosing Schedule
Dosing schedule	Day	Dose
All Patients
Step-up dosing scheduleSee Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].	Day 1	Step-up dose 1	0.06 mg/kg
	Day 4Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.	Step-up dose 2	0.3 mg/kg
	Day 7First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.	First treatment dose	1.5 mg/kg
Weekly dosing schedule	One week after first treatment dose and weekly thereafter	Subsequent treatment doses	1.5 mg/kg once weekly
Patients who have achieved and maintained a complete response or better for a minimum of 6 months
Biweekly (every two weeks) dosing schedule	The dosing frequency may be decreased to 1.5 mg/kg every two weeks.

Refer to Tables 7, 8, and 9 to determine the dosage based on predetermined weight ranges

[see Dosage and Administration (2.5)]

2.4 Dosage Modifications for Adverse Reactions

Dosage reductions of TECVAYLI are not recommended.

Dosage delays may be required to manage toxicities related to TECVAYLI

[see Warnings and Precautions (5)].

See Tables 3, 4, and 5for recommended actions for adverse reactions of CRS, neurologic toxicity, and ICANS. See Table 6for recommended actions for other adverse reactions following administration of TECVAYLI.

Management of CRS, Neurologic Toxicity and ICANS

Cytokine Release Syndrome (CRS)

Management recommendations for CRS are summarized in Table 3.

Identify CRS based on clinical presentation

[see Warnings and Precautions (5.1)].

Evaluate and treat other causes of fever, hypoxia, and hypotension.

If CRS is suspected, withhold TECVAYLI until CRS resolves. Manage according to the recommendations in Table 3 and consider further management per current practice guidelines. Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS. Consider laboratory testing to monitor for disseminated intravascular coagulation (DIC), hematology parameters, as well as pulmonary, cardiac, renal, and hepatic function.

Table 3: Recommendations for Management of Cytokine Release Syndrome
GradeBased on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS.	Presenting Symptoms	Actions
Grade 1	Temperature ≥100.4 °F (38 °C)Attributed to CRS. Fever may not always be present concurrently with hypotension or hypoxia as it may be masked by interventions such as antipyretics or anticytokine therapy.	Withhold TECVAYLI until CRS resolves. Administer pretreatment medications prior to next dose of TECVAYLI.See Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].
Grade 2	Temperature ≥100.4 °F (38 °C) with: Hypotension responsive to fluids and not requiring vasopressors, and/or, Oxygen requirement of low-flow nasal cannulaLow-flow nasal cannula is ≤6 L/min, and high-flow nasal cannula is >6 L/min.or blow-by.	Withhold TECVAYLI until CRS resolves. Administer pretreatment medications prior to next dose of TECVAYLI. Patients should be hospitalized for 48 hours following the next dose of TECVAYLI [see Dosage and Administration (2.1)].
Grade 3	Temperature ≥100.4 °F (38 °C) with: Hypotension requiring one vasopressor with or without vasopressin, and/or, Oxygen requirement of high-flow nasal cannula , facemask, non-rebreather mask, or Venturi mask.	First Occurrence of Grade 3 CRS with Duration Less than 48 Hours: Withhold TECVAYLI until CRS resolves. Provide supportive therapy, which may include intensive care. Administer pretreatment medications prior to next dose of TECVAYLI. Patients should be hospitalized for 48 hours following the next dose of TECVAYLI [see Dosage and Administration (2.1)].
Grade 3		Recurrent Grade 3 CRS or Grade 3 CRS with Duration 48 Hours or Longer: Permanently discontinue TECVAYLI. Provide supportive therapy, which may include intensive care.
Grade 4	Temperature ≥100.4 °F (38 °C) with: Hypotension requiring multiple vasopressors (excluding vasopressin), and/or, Oxygen requirement of positive pressure (e.g., continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), intubation, and mechanical ventilation).	Permanently discontinue TECVAYLI. Provide supportive therapy, which may include intensive care.

Neurologic Toxicity and ICANS

Management recommendations for neurologic toxicity and ICANS are summarized in Tables 4 and 5.

At the first sign of neurologic toxicity, including ICANS, withhold TECVAYLI and consider neurology evaluation. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care, for severe or life-threatening neurologic toxicities, including ICANS

[see Warnings and Precautions (5.2)]

. Manage ICANS according to the recommendations in Table 5 and consider further management per current practice guidelines.

Table 4: Recommendations for Management of Neurologic Toxicity (excluding ICANS)
Adverse Reaction	SeverityBased on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.	Actions
Neurologic Toxicity (excluding ICANS)	Grade 1	Withhold TECVAYLI until neurologic toxicity symptoms resolve or stabilize.See Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].
	Grade 2 Grade 3 (First occurrence)	Withhold TECVAYLI until neurologic toxicity symptoms improve to Grade 1 or less. Provide supportive therapy.
	Grade 3 (Recurrent) Grade 4	Permanently discontinue TECVAYLI. Provide supportive therapy, which may include intensive care.

Table 5: Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome
GradeBased on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS.	Presenting SymptomsManagement is determined by the most severe event, not attributable to any other cause.	Actions
Grade 1	ICE score 7–9If patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) Assessment, assess: Orientation (oriented to year, month, city, hospital = 4 points); Naming (name 3 objects, e.g., point to clock, pen, button = 3 points); Following Commands (e.g., "show me 2 fingers" or "close your eyes and stick out your tongue" = 1 point); Writing (ability to write a standard sentence = 1 point; and Attention (count backwards from 100 by ten = 1 point). If patient is unarousable and unable to perform ICE Assessment (Grade 4 ICANS) = 0 points., or depressed level of consciousnessNot attributable to any other cause.: awakens spontaneously.	Withhold TECVAYLI until ICANS resolves.See Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)]. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis.
Grade 2	ICE score 3–6 , or depressed level of consciousness : awakens to voice.	Withhold TECVAYLI until ICANS resolves. Administer dexamethasoneAll references to dexamethasone administration are dexamethasone or equivalent.10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less then taper. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis. Patients should be hospitalized for 48 hours following the next dose of TECVAYLI [see Dosage and Administration (2.1)] .
Grade 3	ICE score 0–2 , or depressed level of consciousness : awakens only to tactile stimulus, or seizures , either: any clinical seizure, focal or generalized, that resolves rapidly, or non-convulsive seizures on electroencephalogram (EEG) that resolve with intervention, or raised intracranial pressure: focal/local edema on neuroimaging .	First Occurrence of Grade 3 ICANS: Withhold TECVAYLI until ICANS resolves. Administer dexamethasone 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis. Provide supportive therapy, which may include intensive care. Patients should be hospitalized for 48 hours following the next dose of TECVAYLI [see Dosage and Administration (2.1)] .
Grade 3		Recurrent Grade 3 ICANS: Permanently discontinue TECVAYLI Administer dexamethasone 10 mg intravenously and repeat dose every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis. Provide supportive therapy, which may include intensive care.
Grade 4	ICE score 0 , or depressed level of consciousness : either: patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse, or stupor or coma, or seizures , either: life-threatening prolonged seizure (>5 minutes), or repetitive clinical or electrical seizures without return to baseline in between, or motor findings : deep focal motor weakness such as hemiparesis or paraparesis, or raised intracranial pressure/cerebral edema , with signs/symptoms such as: diffuse cerebral edema on neuroimaging, or decerebrate or decorticate posturing, or cranial nerve VI palsy, or papilledema, or Cushing's triad.	Permanently discontinue TECVAYLI. Administer dexamethasone 10 mg intravenously and repeat dose every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. Alternatively, consider administration of methylprednisolone 1,000 mg per day intravenously and continue methylprednisolone 1,000 mg per day intravenously for 2 or more days. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis. Provide supportive therapy, which may include intensive care.

Table 6: Recommended Dosage Modifications for Other Adverse Reactions
Adverse Reactions	Severity	Actions
InfectionsBased on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. [see Warnings and Precautions (5.5)]	All Grades	Withhold TECVAYLI in patients with active infection during the step-up dosing schedule.See Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].
	Grade 3	Withhold subsequent treatment doses of TECVAYLI (i.e., doses administered after TECVAYLI step-up dosing schedule) until infection improves to Grade 1 or less.
	Grade 4	Consider permanent discontinuation of TECVAYLI. If TECVAYLI is not permanently discontinued, withhold subsequent treatment doses of TECVAYLI (i.e., doses administered after TECVAYLI step-up dosing schedule) until infection improves to Grade 1 or less.
Hematologic Toxicities [see Warnings and Precautions (5.6)and Adverse Reactions (6.1)]	Absolute neutrophil count less than 0.5 × 10⁹/L	Withhold TECVAYLI until absolute neutrophil count is 0.5 × 10⁹/L or higher.
	Febrile neutropenia	Withhold TECVAYLI until absolute neutrophil count is 1 × 10⁹/L or higher and fever resolves.
	Hemoglobin less than 8 g/dL	Withhold TECVAYLI until hemoglobin is 8 g/dL or higher.
	Platelet count less than 25,000/mcL Platelet count between 25,000/mcL and 50,000/mcL with bleeding	Withhold TECVAYLI until platelet count is 25,000/mcL or higher and no evidence of bleeding.
Other Non-Hematologic Adverse Reactions [see Warnings and Precautions (5.4)and Adverse Reactions (6.1)]	Grade 3	Withhold TECVAYLI until adverse reaction improves to Grade 1 or less.
	Grade 4	Consider permanent discontinuation of TECVAYLI. If TECVAYLI is not permanently discontinued, withhold subsequent treatment doses of TECVAYLI (i.e., doses administered after TECVAYLI step-up dosing schedule) until adverse reaction improves to Grade 1 or less.

and

5.1 Cytokine Release Syndrome

TECVAYLI can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions

[see Adverse Reactions (6.1)]

In the clinical trial, CRS occurred in 72% of patients who received TECVAYLI at the recommended dose, with Grade 1 CRS occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%. Recurrent CRS occurred in 33% of patients. Most patients experienced CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the initial treatment dose (24%). Less than 3% of patients developed first occurrence of CRS following subsequent doses of TECVAYLI. The median time to onset of CRS was 2 (range: 1 to 6) days after the most recent dose with a median duration of 2 (range: 1 to 9) days.

Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation).

Initiate therapy according to TECVAYLI step-up dosing schedule to reduce risk of CRS

[see Dosage and Administration (2.1, 2.4)]

. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI accordingly

[see Dosage and Administration (2.2, 2.4)]

At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold or permanently discontinue TECVAYLI based on severity

[see Dosage and Administration (2.4)]

TECVAYLI is available only through a restricted program under a REMS

[see Warnings and Precautions (5.3)].

]

Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur with TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity

[see

2.4 Dosage Modifications for Adverse Reactions

Dosage reductions of TECVAYLI are not recommended.

Dosage delays may be required to manage toxicities related to TECVAYLI

[see Warnings and Precautions (5)].

Management of CRS, Neurologic Toxicity and ICANS

Cytokine Release Syndrome (CRS)

Management recommendations for CRS are summarized in Table 3.

Identify CRS based on clinical presentation

[see Warnings and Precautions (5.1)].

Evaluate and treat other causes of fever, hypoxia, and hypotension.

Table 3: Recommendations for Management of Cytokine Release Syndrome
GradeBased on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS.	Presenting Symptoms	Actions
Grade 1	Temperature ≥100.4 °F (38 °C)Attributed to CRS. Fever may not always be present concurrently with hypotension or hypoxia as it may be masked by interventions such as antipyretics or anticytokine therapy.	Withhold TECVAYLI until CRS resolves. Administer pretreatment medications prior to next dose of TECVAYLI.See Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].
Grade 2	Temperature ≥100.4 °F (38 °C) with: Hypotension responsive to fluids and not requiring vasopressors, and/or, Oxygen requirement of low-flow nasal cannulaLow-flow nasal cannula is ≤6 L/min, and high-flow nasal cannula is >6 L/min.or blow-by.	Withhold TECVAYLI until CRS resolves. Administer pretreatment medications prior to next dose of TECVAYLI. Patients should be hospitalized for 48 hours following the next dose of TECVAYLI [see Dosage and Administration (2.1)].
Grade 3	Temperature ≥100.4 °F (38 °C) with: Hypotension requiring one vasopressor with or without vasopressin, and/or, Oxygen requirement of high-flow nasal cannula , facemask, non-rebreather mask, or Venturi mask.	First Occurrence of Grade 3 CRS with Duration Less than 48 Hours: Withhold TECVAYLI until CRS resolves. Provide supportive therapy, which may include intensive care. Administer pretreatment medications prior to next dose of TECVAYLI. Patients should be hospitalized for 48 hours following the next dose of TECVAYLI [see Dosage and Administration (2.1)].
Grade 3		Recurrent Grade 3 CRS or Grade 3 CRS with Duration 48 Hours or Longer: Permanently discontinue TECVAYLI. Provide supportive therapy, which may include intensive care.
Grade 4	Temperature ≥100.4 °F (38 °C) with: Hypotension requiring multiple vasopressors (excluding vasopressin), and/or, Oxygen requirement of positive pressure (e.g., continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), intubation, and mechanical ventilation).	Permanently discontinue TECVAYLI. Provide supportive therapy, which may include intensive care.

Neurologic Toxicity and ICANS

Management recommendations for neurologic toxicity and ICANS are summarized in Tables 4 and 5.

[see Warnings and Precautions (5.2)]

. Manage ICANS according to the recommendations in Table 5 and consider further management per current practice guidelines.

Table 4: Recommendations for Management of Neurologic Toxicity (excluding ICANS)
Adverse Reaction	SeverityBased on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.	Actions
Neurologic Toxicity (excluding ICANS)	Grade 1	Withhold TECVAYLI until neurologic toxicity symptoms resolve or stabilize.See Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].
	Grade 2 Grade 3 (First occurrence)	Withhold TECVAYLI until neurologic toxicity symptoms improve to Grade 1 or less. Provide supportive therapy.
	Grade 3 (Recurrent) Grade 4	Permanently discontinue TECVAYLI. Provide supportive therapy, which may include intensive care.

Table 5: Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome
GradeBased on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS.	Presenting SymptomsManagement is determined by the most severe event, not attributable to any other cause.	Actions
Grade 1	ICE score 7–9If patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) Assessment, assess: Orientation (oriented to year, month, city, hospital = 4 points); Naming (name 3 objects, e.g., point to clock, pen, button = 3 points); Following Commands (e.g., "show me 2 fingers" or "close your eyes and stick out your tongue" = 1 point); Writing (ability to write a standard sentence = 1 point; and Attention (count backwards from 100 by ten = 1 point). If patient is unarousable and unable to perform ICE Assessment (Grade 4 ICANS) = 0 points., or depressed level of consciousnessNot attributable to any other cause.: awakens spontaneously.	Withhold TECVAYLI until ICANS resolves.See Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)]. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis.
Grade 2	ICE score 3–6 , or depressed level of consciousness : awakens to voice.	Withhold TECVAYLI until ICANS resolves. Administer dexamethasoneAll references to dexamethasone administration are dexamethasone or equivalent.10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less then taper. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis. Patients should be hospitalized for 48 hours following the next dose of TECVAYLI [see Dosage and Administration (2.1)] .
Grade 3	ICE score 0–2 , or depressed level of consciousness : awakens only to tactile stimulus, or seizures , either: any clinical seizure, focal or generalized, that resolves rapidly, or non-convulsive seizures on electroencephalogram (EEG) that resolve with intervention, or raised intracranial pressure: focal/local edema on neuroimaging .	First Occurrence of Grade 3 ICANS: Withhold TECVAYLI until ICANS resolves. Administer dexamethasone 10 mg intravenously every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis. Provide supportive therapy, which may include intensive care. Patients should be hospitalized for 48 hours following the next dose of TECVAYLI [see Dosage and Administration (2.1)] .
Grade 3		Recurrent Grade 3 ICANS: Permanently discontinue TECVAYLI Administer dexamethasone 10 mg intravenously and repeat dose every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis. Provide supportive therapy, which may include intensive care.
Grade 4	ICE score 0 , or depressed level of consciousness : either: patient is unarousable or requires vigorous or repetitive tactile stimuli to arouse, or stupor or coma, or seizures , either: life-threatening prolonged seizure (>5 minutes), or repetitive clinical or electrical seizures without return to baseline in between, or motor findings : deep focal motor weakness such as hemiparesis or paraparesis, or raised intracranial pressure/cerebral edema , with signs/symptoms such as: diffuse cerebral edema on neuroimaging, or decerebrate or decorticate posturing, or cranial nerve VI palsy, or papilledema, or Cushing's triad.	Permanently discontinue TECVAYLI. Administer dexamethasone 10 mg intravenously and repeat dose every 6 hours. Continue dexamethasone use until resolution to Grade 1 or less, then taper. Alternatively, consider administration of methylprednisolone 1,000 mg per day intravenously and continue methylprednisolone 1,000 mg per day intravenously for 2 or more days. Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management, including consideration for starting non-sedating, anti-seizure medicines for seizure prophylaxis. Provide supportive therapy, which may include intensive care.

Table 6: Recommended Dosage Modifications for Other Adverse Reactions
Adverse Reactions	Severity	Actions
InfectionsBased on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. [see Warnings and Precautions (5.5)]	All Grades	Withhold TECVAYLI in patients with active infection during the step-up dosing schedule.See Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].
	Grade 3	Withhold subsequent treatment doses of TECVAYLI (i.e., doses administered after TECVAYLI step-up dosing schedule) until infection improves to Grade 1 or less.
	Grade 4	Consider permanent discontinuation of TECVAYLI. If TECVAYLI is not permanently discontinued, withhold subsequent treatment doses of TECVAYLI (i.e., doses administered after TECVAYLI step-up dosing schedule) until infection improves to Grade 1 or less.
Hematologic Toxicities [see Warnings and Precautions (5.6)and Adverse Reactions (6.1)]	Absolute neutrophil count less than 0.5 × 10⁹/L	Withhold TECVAYLI until absolute neutrophil count is 0.5 × 10⁹/L or higher.
	Febrile neutropenia	Withhold TECVAYLI until absolute neutrophil count is 1 × 10⁹/L or higher and fever resolves.
	Hemoglobin less than 8 g/dL	Withhold TECVAYLI until hemoglobin is 8 g/dL or higher.
	Platelet count less than 25,000/mcL Platelet count between 25,000/mcL and 50,000/mcL with bleeding	Withhold TECVAYLI until platelet count is 25,000/mcL or higher and no evidence of bleeding.
Other Non-Hematologic Adverse Reactions [see Warnings and Precautions (5.4)and Adverse Reactions (6.1)]	Grade 3	Withhold TECVAYLI until adverse reaction improves to Grade 1 or less.
	Grade 4	Consider permanent discontinuation of TECVAYLI. If TECVAYLI is not permanently discontinued, withhold subsequent treatment doses of TECVAYLI (i.e., doses administered after TECVAYLI step-up dosing schedule) until adverse reaction improves to Grade 1 or less.

and

5.2 Neurologic Toxicity including ICANS

TECVAYLI can cause serious, life-threatening or fatal neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

[see Adverse Reactions (6.1)]

In the clinical trial, neurologic toxicity occurred in 57% of patients who received TECVAYLI at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 2.4% of patients. The most frequent neurologic toxicities were headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%).

With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI.

In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI at the recommended dose

[see Adverse Reactions (6.1)]

. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent doses of TECVAYLI. The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or permanently discontinue TECVAYLI based on severity per recommendations and consider further management per current practice guidelines

[see Dosage and Administration (2.4)]

Due to the potential for neurologic toxicity, patients receiving TECVAYLI are at risk of depressed level of consciousness

[see Adverse Reactions (6.1)]

. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves

[see Dosage and Administration (2.1)]

TECVAYLI is available only through a restricted program under a REMS

[see Warnings and Precautions (5.3)].

]

Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS

[see

5.3 TECVAYLI and TALVEY REMS

TECVAYLI is available only through a restricted program under a REMS called the TECVAYLI and TALVEY REMS because of the risks of CRS and neurologic toxicity, including ICANS

[see Warnings and Precautions (5.1, 5.2)].

Notable requirements of the TECVAYLI and TALVEY REMS include the following:

Prescribers must be certified with the program by enrolling and completing training.
Prescribers must counsel patients receiving TECVAYLI about the risk of CRS and neurologic toxicity, including ICANS, and provide patients with Patient Wallet Card.
Pharmacies and healthcare settings that dispense TECVAYLI must be certified with the TECVAYLI and TALVEY REMS program and must verify prescribers are certified through the TECVAYLI and TALVEY REMS program.
Wholesalers and distributers must only distribute TECVAYLI to certified pharmacies or healthcare settings.

Further information about the TECVAYLI and TALVEY REMS program is available at www.TEC-TALREMS.com or by telephone at 1-855-810-8064.

]

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

[see Dosage and Administration (2.1

2.4)and Warnings and Precautions (5.1)]

[see Dosage and Administration (2.4)and Warnings and Precautions (5.2)]

[see Warnings and Precautions (5.3)]

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

See full prescribing information for complete boxed warning.

Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity.

TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS).

8/2025

Dosage and Administration, Recommended Dosage (

2.1 Recommended Dosage

For subcutaneous injection only.

Administer pretreatment medications prior to each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Table 1

[see Dosage and Administration (2.2)]

[see Dosage and Administration (2.4)and Warnings and Precautions (5.1, 5.2)]

Table 1: TECVAYLI Dosing Schedule
Dosing schedule	Day	Dose
All Patients
Step-up dosing scheduleSee Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].	Day 1	Step-up dose 1	0.06 mg/kg
	Day 4Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.	Step-up dose 2	0.3 mg/kg
	Day 7First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.	First treatment dose	1.5 mg/kg
Weekly dosing schedule	One week after first treatment dose and weekly thereafter	Subsequent treatment doses	1.5 mg/kg once weekly
Patients who have achieved and maintained a complete response or better for a minimum of 6 months
Biweekly (every two weeks) dosing schedule	The dosing frequency may be decreased to 1.5 mg/kg every two weeks.

Refer to Tables 7, 8, and 9 to determine the dosage based on predetermined weight ranges

[see Dosage and Administration (2.5)]

)

2/2024

Dosage and Administration, Restarting TECVAYLI after Dosage Delay (

2.3 Restarting TECVAYLI after Dosage Delay

If a dose of TECVAYLI is delayed, restart therapy based on the recommendations in Table 2 and resume the treatment schedule accordingly

[see Dosage and Administration (2.1)]

. Administer pretreatment medications as indicated in Table 2

Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule

[see Dosage and Administration (2.4)and Warnings and Precautions (5.1, 5.2)].

Table 2: Recommendations for Restarting Therapy with TECVAYLI After Dose Delay
Last dose administered	Time since the last dose administered	Action
Step-up dose 1	More than 7 days	Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).Administer pretreatment medications prior to TECVAYLI dose and monitor patients accordingly [see Dosage and Administration (2.2, 2.5)].
Step-up dose 2	8 days to 28 days	Repeat step-up dose 2 (0.3 mg/kg) and continue TECVAYLI step-up dosing schedule.
Step-up dose 2	More than 28 daysConsider benefit-risk of restarting TECVAYLI in patients who require a dose delay of more than 28 days due to an adverse reaction.	Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).
Any weekly treatment dose	28 days or less	Continue TECVAYLI at last treatment dose in weekly schedule (1.5 mg/kg once weekly; see Table 1).
	29 days to 56 days	Restart TECVAYLI step-up dosing schedule at step-up dose 2 (0.3 mg/kg).
	More than 56 days	Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).
Any biweekly (every two weeks) treatment dose	63 days or less	Continue TECVAYLI at last treatment dose in biweekly schedule (1.5 mg/kg every two weeks; see Table 1).
	64 days to 112 days	Restart TECVAYLI step-up dosing schedule at step up dose 2 (0.3 mg/kg).
	More than 112 days	Restart TECVAYLI step-up dosing schedule at step-up dose 1 (0.06 mg/kg).

)

11/2024

Dosage and Administration, Preparation and Administration (

2.5 Preparation and Administration

TECVAYLI is intended for subcutaneous use by a healthcare provider only.

TECVAYLI should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and ICANS

[see Warnings and Precautions (5.1, 5.2)]

TECVAYLI 30 mg/3 mL (10 mg/mL) vial and TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial are supplied as ready-to-use solution that do not need dilution prior to administration.

Do not combine TECVAYLI vials of different concentrations to achieve treatment dose.

Use aseptic technique to prepare and administer TECVAYLI.

Preparation of TECVAYLI

Refer to the following reference tables for the preparation of TECVAYLI.

Refer to Tables 7, 8, and 9 below to determine the dosage based on predetermined weight ranges.

Use Table 7 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 1 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.

Table 7: Step-up Dose 1 (0.06 mg/kg) Injection Volumes using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=3 mL)
35 to 39	2.2	0.22	1
40 to 44	2.5	0.25	1
45 to 49	2.8	0.28	1
50 to 59	3.3	0.33	1
60 to 69	3.9	0.39	1
70 to 79	4.5	0.45	1
80 to 89	5.1	0.51	1
90 to 99	5.7	0.57	1
100 to 109	6.3	0.63	1
110 to 119	6.9	0.69	1
120 to 129	7.5	0.75	1
130 to 139	8.1	0.81	1
140 to 149	8.7	0.87	1
150 to 160	9.3	0.93	1

Use Table 8 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 2 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.

Table 8: Step-up Dose 2 (0.3 mg/kg) Injection Volumes using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=3 mL)
35 to 39	11	1.1	1
40 to 44	13	1.3	1
45 to 49	14	1.4	1
50 to 59	16	1.6	1
60 to 69	19	1.9	1
70 to 79	22	2.2	1
80 to 89	25	2.5	1
90 to 99	28	2.8	1
100 to 109	31	3.1	2
110 to 119	34	3.4	2
120 to 129	37	3.7	2
130 to 139	40	4	2
140 to 149	43	4.3	2
150 to 160	47	4.7	2

Use Table 9 to determine total dose, injection volume and number of vials required based on patient's actual body weight for the treatment dose using TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial.

Table 9: Treatment Dose (1.5 mg/kg) Injection Volumes using TECVAYLI 153 mg/1.7 mL (90 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=1.7 mL)
35 to 39	56	0.62	1
40 to 44	63	0.7	1
45 to 49	70	0.78	1
50 to 59	82	0.91	1
60 to 69	99	1.1	1
70 to 79	108	1.2	1
80 to 89	126	1.4	1
90 to 99	144	1.6	1
100 to 109	153	1.7	1
110 to 119	171	1.9	2
120 to 129	189	2.1	2
130 to 139	198	2.2	2
140 to 149	216	2.4	2
150 to 160	234	2.6	2

Remove the appropriate strength TECVAYLI vial from refrigerated storage [2 °C to 8 °C (36 °F to 46 °F)].

Once removed from refrigerated storage, equilibrate TECVAYLI to ambient temperature [15 °C to 30 °C (59 °F to 86 °F)] for at least 15 minutes. Do not warm TECVAYLI in any other way.

Once equilibrated, gently swirl the vial for approximately 10 seconds to mix. Do not shake.

Withdraw the required injection volume of TECVAYLI from the vial(s) into an appropriately sized syringe using a transfer needle.

Each injection volume should not exceed 2 mL. Divide doses requiring greater than 2 mL equally into multiple syringes.

TECVAYLI is compatible with stainless steel injection needles and polypropylene or polycarbonate syringe material.

Replace the transfer needle with an appropriately sized needle for injection.

Administration of TECVAYLI

Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.

Any unused product or waste material should be disposed in accordance with local requirements.

Storage

Monitoring

Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule

[see Dosage and Administration (2.1)and Warnings and Precautions (5.1, 5.2)]

)

2/2024

Warnings and Precautions, Neurologic Toxicity including ICANS (

5.2 Neurologic Toxicity including ICANS

TECVAYLI can cause serious, life-threatening or fatal neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

[see Adverse Reactions (6.1)]

With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI.

In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI at the recommended dose

[see Adverse Reactions (6.1)]

[see Dosage and Administration (2.4)]

Due to the potential for neurologic toxicity, patients receiving TECVAYLI are at risk of depressed level of consciousness

[see Adverse Reactions (6.1)]

[see Dosage and Administration (2.1)]

TECVAYLI is available only through a restricted program under a REMS

[see Warnings and Precautions (5.3)].

)

8/2025

TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate

[see

14 CLINICAL STUDIES

The efficacy of TECVAYLI was evaluated in patients with relapsed or refractory multiple myeloma in a single-arm, open-label, multi-center study (MajesTEC-1, NCT03145181 [Phase 1] and NCT04557098 [Phase 2]). The study included patients who had previously received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The study excluded patients who had stroke, seizure, allogeneic stem cell transplantation within the past 6 months, Eastern Cooperative Oncology Group (ECOG) performance score of 2 or higher, known active CNS involvement or clinical signs of meningeal involvement of multiple myeloma, or active or documented history of autoimmune disease, with the exception of vitiligo, Type 1 diabetes, and prior autoimmune thyroiditis.

Patients received step-up doses of 0.06 mg/kg and 0.3 mg/kg of TECVAYLI followed by TECVAYLI 1.5 mg/kg subcutaneously once weekly thereafter until disease progression or unacceptable toxicity

[see Dosage and Administration (2.1)]

The efficacy population included 110 patients. The median age was 66 (range: 33 to 82) years with 16% of patients 75 years of age or older; 56% were male; 91% were White, 5% were Black or African American, 3% were Asian. The International Staging System (ISS) at study entry was Stage I in 50%, Stage II in 38%, and Stage III in 12% of patients. High-risk cytogenetics (presence of del(17p), t(4;14) and t(14;16)) were present in 25% of patients. Seventeen percent of patients had extramedullary plasmacytomas. Patients with prior BCMA-targeted therapy were not included in the efficacy population.

The median number of prior lines of therapy was 5 (range: 2 to 14); 78% of patients had received at least 4 prior lines of therapy. Eighty-one percent of patients received prior stem cell transplantation. All patients had received prior therapy with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and 76% were triple-class refractory (refractory to a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody).

Efficacy was established based on overall response rate (ORR) as determined by the Independent Review Committee (IRC) assessment using International Myeloma Working Group (IMWG) 2016 criteria (see Table 13).

The median time to first response was 1.2 months (range: 0.2 to 5.5 months). With a median follow-up of 7.4 months among responders, the estimated duration of response (DOR) rate was 90.6% (95% CI: 80.3%, 95.7%) at 6 months and 66.5% (95% CI: 38.8%, 83.9%) at 9 months.

Table 13: Efficacy Results for MajesTEC-1
	N=110
NE=not estimable
Overall response rate (ORR: sCR+CR+VGPR+PR) n(%)	68 (61.8)
95% CI (%)	(52.1, 70.9)
Complete response (CR) or betterComplete response or better = Stringent complete response (sCR) + complete response (CR).	31 (28.2)
Very good partial response (VGPR)	32 (29.1)
Partial response (PR)	5 (4.5)
Duration of Response (DOR) (months)
DOR (Months): Median (95% CI)	NE (9.0, NE)

]

. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Dosing Schedule Day Dose

All Patients

Step-up Dosing Schedule

Day 1

Step-up dose 1

0.06 mg/kg

Day 4

Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions. Step-up dose 2 0.3 mg/kg

Weekly Dosing Schedule

One week after first treatment dose and weekly thereafter

Subsequent treatment doses

1.5 mg/kg once weekly

Patients who have achieved and maintained a complete response or better for a minimum of 6 months

Biweekly (every two weeks) dosing schedule

The dosing frequency may be decreased to 1.5 mg/kg every two weeks

For subcutaneous injection only. (

2.1 Recommended Dosage

For subcutaneous injection only.

Administer pretreatment medications prior to each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Table 1

[see Dosage and Administration (2.2)]

[see Dosage and Administration (2.4)and Warnings and Precautions (5.1, 5.2)]

Table 1: TECVAYLI Dosing Schedule
Dosing schedule	Day	Dose
All Patients
Step-up dosing scheduleSee Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].	Day 1	Step-up dose 1	0.06 mg/kg
	Day 4Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.	Step-up dose 2	0.3 mg/kg
	Day 7First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.	First treatment dose	1.5 mg/kg
Weekly dosing schedule	One week after first treatment dose and weekly thereafter	Subsequent treatment doses	1.5 mg/kg once weekly
Patients who have achieved and maintained a complete response or better for a minimum of 6 months
Biweekly (every two weeks) dosing schedule	The dosing frequency may be decreased to 1.5 mg/kg every two weeks.

Refer to Tables 7, 8, and 9 to determine the dosage based on predetermined weight ranges

[see Dosage and Administration (2.5)]

)

Patients should be hospitalized for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule. (

2.1 Recommended Dosage

For subcutaneous injection only.

Administer pretreatment medications prior to each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose as described in Table 1

[see Dosage and Administration (2.2)]

[see Dosage and Administration (2.4)and Warnings and Precautions (5.1, 5.2)]

Table 1: TECVAYLI Dosing Schedule
Dosing schedule	Day	Dose
All Patients
Step-up dosing scheduleSee Table 2 for recommendations on restarting TECVAYLI after dose delays [see Dosage and Administration (2.3)].	Day 1	Step-up dose 1	0.06 mg/kg
	Day 4Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.	Step-up dose 2	0.3 mg/kg
	Day 7First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.	First treatment dose	1.5 mg/kg
Weekly dosing schedule	One week after first treatment dose and weekly thereafter	Subsequent treatment doses	1.5 mg/kg once weekly
Patients who have achieved and maintained a complete response or better for a minimum of 6 months
Biweekly (every two weeks) dosing schedule	The dosing frequency may be decreased to 1.5 mg/kg every two weeks.

Refer to Tables 7, 8, and 9 to determine the dosage based on predetermined weight ranges

[see Dosage and Administration (2.5)]

)

Administer pretreatment medications as recommended. (
2.2 Recommended Pretreatment Medications
Administer the following pretreatment medications 1 to 3 hours before each dose of the TECVAYLI step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose (see Table 1), to reduce the risk of CRS
[see Warnings and Precautions (5.1)and Adverse Reactions (6.1)]
.
- Corticosteroid (oral or intravenous dexamethasone 16 mg)
- Histamine-1 (H1) receptor antagonist (oral or intravenous diphenhydramine 50 mg or equivalent)
- Antipyretics (oral or intravenous acetaminophen 650 mg to 1,000 mg or equivalent)
Administration of pretreatment medications may be required prior to administration of subsequent doses of TECVAYLI in the following patients:
- Patients who repeat doses within the TECVAYLI step-up dosing schedule following a dose delay
  [see Dosage and Administration (2.3)].
- Patients who experienced CRS following the prior dose of TECVAYLI
  [see Dosage and Administration (2.4)].
Prophylaxis for Herpes Zoster Reactivation
Prior to starting treatment with TECVAYLI, consider initiation of antiviral prophylaxis to prevent herpes zoster reactivation per guidelines.
)

Refer to Tables 7, 8, and 9 to determine the dosage based on predetermined weight ranges. (

2.5 Preparation and Administration

TECVAYLI is intended for subcutaneous use by a healthcare provider only.

TECVAYLI should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and ICANS

[see Warnings and Precautions (5.1, 5.2)]

TECVAYLI 30 mg/3 mL (10 mg/mL) vial and TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial are supplied as ready-to-use solution that do not need dilution prior to administration.

Do not combine TECVAYLI vials of different concentrations to achieve treatment dose.

Use aseptic technique to prepare and administer TECVAYLI.

Preparation of TECVAYLI

Refer to the following reference tables for the preparation of TECVAYLI.

Refer to Tables 7, 8, and 9 below to determine the dosage based on predetermined weight ranges.

Use Table 7 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 1 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.

Table 7: Step-up Dose 1 (0.06 mg/kg) Injection Volumes using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=3 mL)
35 to 39	2.2	0.22	1
40 to 44	2.5	0.25	1
45 to 49	2.8	0.28	1
50 to 59	3.3	0.33	1
60 to 69	3.9	0.39	1
70 to 79	4.5	0.45	1
80 to 89	5.1	0.51	1
90 to 99	5.7	0.57	1
100 to 109	6.3	0.63	1
110 to 119	6.9	0.69	1
120 to 129	7.5	0.75	1
130 to 139	8.1	0.81	1
140 to 149	8.7	0.87	1
150 to 160	9.3	0.93	1

Use Table 8 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 2 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.

Table 8: Step-up Dose 2 (0.3 mg/kg) Injection Volumes using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=3 mL)
35 to 39	11	1.1	1
40 to 44	13	1.3	1
45 to 49	14	1.4	1
50 to 59	16	1.6	1
60 to 69	19	1.9	1
70 to 79	22	2.2	1
80 to 89	25	2.5	1
90 to 99	28	2.8	1
100 to 109	31	3.1	2
110 to 119	34	3.4	2
120 to 129	37	3.7	2
130 to 139	40	4	2
140 to 149	43	4.3	2
150 to 160	47	4.7	2

Use Table 9 to determine total dose, injection volume and number of vials required based on patient's actual body weight for the treatment dose using TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial.

Table 9: Treatment Dose (1.5 mg/kg) Injection Volumes using TECVAYLI 153 mg/1.7 mL (90 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=1.7 mL)
35 to 39	56	0.62	1
40 to 44	63	0.7	1
45 to 49	70	0.78	1
50 to 59	82	0.91	1
60 to 69	99	1.1	1
70 to 79	108	1.2	1
80 to 89	126	1.4	1
90 to 99	144	1.6	1
100 to 109	153	1.7	1
110 to 119	171	1.9	2
120 to 129	189	2.1	2
130 to 139	198	2.2	2
140 to 149	216	2.4	2
150 to 160	234	2.6	2

Remove the appropriate strength TECVAYLI vial from refrigerated storage [2 °C to 8 °C (36 °F to 46 °F)].

Once removed from refrigerated storage, equilibrate TECVAYLI to ambient temperature [15 °C to 30 °C (59 °F to 86 °F)] for at least 15 minutes. Do not warm TECVAYLI in any other way.

Once equilibrated, gently swirl the vial for approximately 10 seconds to mix. Do not shake.

Withdraw the required injection volume of TECVAYLI from the vial(s) into an appropriately sized syringe using a transfer needle.

Each injection volume should not exceed 2 mL. Divide doses requiring greater than 2 mL equally into multiple syringes.

TECVAYLI is compatible with stainless steel injection needles and polypropylene or polycarbonate syringe material.

Replace the transfer needle with an appropriately sized needle for injection.

Administration of TECVAYLI

Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.

Any unused product or waste material should be disposed in accordance with local requirements.

Storage

Monitoring

Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule

[see Dosage and Administration (2.1)and Warnings and Precautions (5.1, 5.2)]

)

See Full Prescribing Information for instructions on preparation and administration. (

2.5 Preparation and Administration

TECVAYLI is intended for subcutaneous use by a healthcare provider only.

TECVAYLI should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and ICANS

[see Warnings and Precautions (5.1, 5.2)]

TECVAYLI 30 mg/3 mL (10 mg/mL) vial and TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial are supplied as ready-to-use solution that do not need dilution prior to administration.

Do not combine TECVAYLI vials of different concentrations to achieve treatment dose.

Use aseptic technique to prepare and administer TECVAYLI.

Preparation of TECVAYLI

Refer to the following reference tables for the preparation of TECVAYLI.

Refer to Tables 7, 8, and 9 below to determine the dosage based on predetermined weight ranges.

Use Table 7 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 1 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.

Table 7: Step-up Dose 1 (0.06 mg/kg) Injection Volumes using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=3 mL)
35 to 39	2.2	0.22	1
40 to 44	2.5	0.25	1
45 to 49	2.8	0.28	1
50 to 59	3.3	0.33	1
60 to 69	3.9	0.39	1
70 to 79	4.5	0.45	1
80 to 89	5.1	0.51	1
90 to 99	5.7	0.57	1
100 to 109	6.3	0.63	1
110 to 119	6.9	0.69	1
120 to 129	7.5	0.75	1
130 to 139	8.1	0.81	1
140 to 149	8.7	0.87	1
150 to 160	9.3	0.93	1

Use Table 8 to determine total dose, injection volume and number of vials required based on patient's actual body weight for step-up dose 2 using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.

Table 8: Step-up Dose 2 (0.3 mg/kg) Injection Volumes using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=3 mL)
35 to 39	11	1.1	1
40 to 44	13	1.3	1
45 to 49	14	1.4	1
50 to 59	16	1.6	1
60 to 69	19	1.9	1
70 to 79	22	2.2	1
80 to 89	25	2.5	1
90 to 99	28	2.8	1
100 to 109	31	3.1	2
110 to 119	34	3.4	2
120 to 129	37	3.7	2
130 to 139	40	4	2
140 to 149	43	4.3	2
150 to 160	47	4.7	2

Use Table 9 to determine total dose, injection volume and number of vials required based on patient's actual body weight for the treatment dose using TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial.

Table 9: Treatment Dose (1.5 mg/kg) Injection Volumes using TECVAYLI 153 mg/1.7 mL (90 mg/mL) Vial
Patient Body Weight (kg)	Total Dose (mg)	Volume of Injection (mL)	Number of Vials (1 vial=1.7 mL)
35 to 39	56	0.62	1
40 to 44	63	0.7	1
45 to 49	70	0.78	1
50 to 59	82	0.91	1
60 to 69	99	1.1	1
70 to 79	108	1.2	1
80 to 89	126	1.4	1
90 to 99	144	1.6	1
100 to 109	153	1.7	1
110 to 119	171	1.9	2
120 to 129	189	2.1	2
130 to 139	198	2.2	2
140 to 149	216	2.4	2
150 to 160	234	2.6	2

Remove the appropriate strength TECVAYLI vial from refrigerated storage [2 °C to 8 °C (36 °F to 46 °F)].

Once removed from refrigerated storage, equilibrate TECVAYLI to ambient temperature [15 °C to 30 °C (59 °F to 86 °F)] for at least 15 minutes. Do not warm TECVAYLI in any other way.

Once equilibrated, gently swirl the vial for approximately 10 seconds to mix. Do not shake.

Withdraw the required injection volume of TECVAYLI from the vial(s) into an appropriately sized syringe using a transfer needle.

Each injection volume should not exceed 2 mL. Divide doses requiring greater than 2 mL equally into multiple syringes.

TECVAYLI is compatible with stainless steel injection needles and polypropylene or polycarbonate syringe material.

Replace the transfer needle with an appropriately sized needle for injection.

Administration of TECVAYLI

Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.

Any unused product or waste material should be disposed in accordance with local requirements.

Storage

Monitoring

Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TECVAYLI step-up dosing schedule

[see Dosage and Administration (2.1)and Warnings and Precautions (5.1, 5.2)]

)

Injection

30 mg/3 mL (10 mg/mL) in a single-dose vial (
3 DOSAGE FORMS AND STRENGTHS
Injection
30 mg/3 mL (10 mg/mL) in a single-dose vial
153 mg/1.7 mL (90 mg/mL) in a single-dose vial
Injection
30 mg/3 mL (10 mg/mL) clear to slightly opalescent, colorless to light yellow solution in a single-dose vial.
153 mg/1.7 mL (90 mg/mL) clear to slightly opalescent, colorless to light yellow solution in a single-dose vial.
)
153 mg/1.7 mL (90 mg/mL) in a single-dose vial (
3 DOSAGE FORMS AND STRENGTHS
Injection
30 mg/3 mL (10 mg/mL) in a single-dose vial
153 mg/1.7 mL (90 mg/mL) in a single-dose vial
Injection
30 mg/3 mL (10 mg/mL) clear to slightly opalescent, colorless to light yellow solution in a single-dose vial.
153 mg/1.7 mL (90 mg/mL) clear to slightly opalescent, colorless to light yellow solution in a single-dose vial.
)

Lactation

: Advise not to breastfeed. (

8.2 Lactation

Risk Summary

There are no data on the presence of teclistamab-cqyv in human milk, the effect on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to TECVAYLI are unknown. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with TECVAYLI and for 5 months after the last dose.

Tecvayli

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Tecvayli Prescribing Information

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