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 | 0.3 mg/kg | |
| Day 7 † | 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 | ||
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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 Dosage and Administration (2.1, 2.4) and Warnings and Precautions (5.1)] .
Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life-threatening 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 Dosage and Administration (2.4) and Warnings and Precautions (5.2)] .
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 Warnings and Precautions (5.3)] .
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 Clinical Studies (14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
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)] .
| 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 | 0.3 mg/kg | |
| Day 7 ‡ | 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)] .
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.
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)].
| 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). * |
| 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. |
| More than 28 days † | 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). * | |
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 5 for recommended actions for adverse reactions of CRS, neurologic toxicity, and ICANS. See Table 6 for 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.
| Grade * | Presenting Symptoms | Actions |
|---|---|---|
| ||
| Grade 1 | Temperature ≥100.4°F (38°C) † |
|
| 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 cannula §or blow-by. |
|
| 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:
|
Recurrent Grade 3 CRS or Grade 3 CRS with Duration 48 Hours or Longer:
| ||
| 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). |
|
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.
| Adverse Reaction | Severity * | Actions |
|---|---|---|
| ||
| Neurologic Toxicity *(excluding ICANS) | Grade 1 |
|
| Grade 2 Grade 3 (First occurrence) |
| |
| Grade 3 (Recurrent) Grade 4 |
| |
| Grade * | Presenting Symptoms † | Actions |
|---|---|---|
| ||
| Grade 1 | ICE score 7–9 ‡, or depressed level of consciousness §: awakens spontaneously. |
|
| Grade 2 | ICE score 3–6 ‡, or depressed level of consciousness §: awakens to voice. |
|
| Grade 3 | ICE score 0–2 ‡, or depressed level of consciousness §: awakens only to tactile stimulus, or seizures §, either:
| First Occurrence of Grade 3 ICANS:
|
Recurrent Grade 3 ICANS:
| ||
| Grade 4 | ICE score 0 ‡, or depressed level of consciousness §: either:
|
|
| Adverse Reactions | Severity | Actions |
|---|---|---|
| ||
| Infections *[see Warnings and Precautions (5.5)] | All Grades |
|
| Grade 3 |
| |
| Grade 4 |
| |
| Hematologic Toxicities [see Warnings and Precautions (5.6) and Adverse Reactions (6.1)] | Absolute neutrophil count less than 0.5 × 10 9/L |
|
| Febrile neutropenia |
| |
| Hemoglobin less than 8 g/dL |
| |
| Platelet count less than 25,000/mcL Platelet count between 25,000/mcL and 50,000/mcL with bleeding |
| |
| Other Non-Hematologic Adverse Reactions * [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)] | Grade 3 |
|
| Grade 4 |
| |
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.
| 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.
| 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.
| 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)] .
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.
Pregnancy
Risk Summary
Based on the mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data on the use of TECVAYLI in pregnant women to evaluate for a drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with TECVAYLI. Teclistamab-cqyv causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus.
TECVAYLI is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with TECVAYLI should be considered.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
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.
Females and Males of Reproductive Potential
TECVAYLI may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] .
Pregnancy Testing
Verify pregnancy status of females of reproductive potential prior to initiating TECVAYLI.
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose of TECVAYLI.
Pediatric Use
The safety and efficacy of TECVAYLI have not been established in pediatric patients.
Geriatric Use
Of the 165 patients with relapsed or refractory multiple myeloma treated with TECVAYLI in MajesTEC-1 at the recommended dosage, 48% were 65 years of age or older, and 15% were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients 65 to 74 years of age compared to younger patients. There is an insufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness.
None.