What is the dosage of Epkinly?

Epkinly is available in 2 dosages, including 5 mg/ml Injection 0.8 ml and 60 mg/ml Injection 0.8 ml

What does Epkinly treat?

Epkinly treats Lymphoma, Large B-Cell, Diffuse

What is Epkinly made of?

Epkinly contains epcoritamab which is a Bispecific CD20-directed CD3 T Cell Engager

How is Epkinly administered?

Epkinly is administered as a Injectable

What is Epkinly mechanism of action?

Epkinly mechanism of action is CD20-directed Antibody Interactions, CD3-directed Antibody Interactions, CD3 Receptor Agonists or Cytochrome P450 Inhibitors

Epkinly

(epcoritamab-bysp)

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Dosage & Administration

* For subcutaneous injection only.
* Recommended Dosage:

DLBCL and High-grade B-cell Lymphoma

Cycle of treatment *	Day of treatment	Dose of EPKINLY
* Cycle = 28 days
Cycle 1	1	Step-up dose 1	0.16 mg
	8	Step-up dose 2	0.8 mg
	15	First full dose	48 mg
	22	48 mg
Cycles 2 and 3	1, 8, 15 and 22	48 mg
Cycles 4 to 9	1 and 15	48 mg
Cycle 10 and beyond	1	48 mg

Follicular Lymphoma

Cycle of treatment *	Day of treatment	Dose of EPKINLY
* Cycle = 28 days
Cycle 1	1	Step-up dose 1	0.16 mg
	8	Step-up dose 2	0.8 mg
	15	Step-up dose 3	3 mg
	22	First full dose	48 mg
Cycles 2 and 3	1, 8, 15 and 22	48 mg
Cycles 4 to 9	1 and 15	48 mg
Cycle 10 and beyond	1	48 mg

* Monitor all patients for signs and symptoms of CRS and ICANS.
* Patients with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after administration of the Cycle 1 Day 15 dosage of 48 mg.
* Administer premedications, post-medications, and prophylaxis as recommended.
* Dosages of EPKINLY 0.16 mg and 0.8 mg require dilution prior to administration.
* See Full Prescribing Information for instructions on preparation and administration.

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Epkinly Prescribing Information

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosage schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1, 2.2, 2.6) and Warnings and Precautions (5.1)].

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1, 2.2, 2.6) and Warnings and Precautions (5.2)].

DLBCL and High-grade B-cell Lymphoma

EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.

This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Follicular Lymphoma

EPKINLY is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Dosing Information

Certain doses of EPKINLY require dilution prior to administration. There are 2 available methods to prepare diluted EPKINLY:
- Empty sterile vial method as described in subsection 2.7 [see Dosage and Administration (2.7)], or
- Sterile syringe method as described in subsection 2.8 [see Dosage and Administration (2.8)].
Preparation of 3 mg and 48 mg EPKINLY doses do not require dilution. For preparation, refer to subsection 2.9 [see Dosage and Administration (2.9)].
Administer EPKINLY to well-hydrated patients.
Premedicate before each dose in Cycle 1 [see Dosage and Administration (2.4)].
EPKINLY should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [see Warnings and Precautions (5.1, 5.2)].
Administer EPKINLY subcutaneously according to the step-up dosage schedule in Table 1 for patients with DLBCL or high-grade B-cell Lymphoma, or Table 2 for patients with FL to reduce the incidence and severity of CRS.
Due to the risk of CRS and ICANS, monitor all patients for signs and symptoms [see Dosage and Administration (2.6)].
- For Patients with DLBCL or High-grade B-cell Lymphoma:
  Patients should be hospitalized for 24 hours after administration of the Cycle 1 Day 15 dosage of 48 mg [see Dosage and Administration (2.2) and Warnings and Precautions (5.1, 5.2)].

Recommended Dosage

EPKINLY is for subcutaneous injection only.

Administer EPKINLY in 28-day cycles until disease progression or unacceptable toxicity.

Table 1: EPKINLY 2-step up Dosage Schedule for Patients with DLBCL or High-grade B-cell Lymphoma
Indication	Cycle of treatment *	Day of treatment	Dose of EPKINLY
* Cycle = 28 days
DLBCL or High-grade B-cell Lymphoma	Cycle 1	1	Step-up dose 1	0.16 mg
		8	Step-up dose 2	0.8 mg
		15	First full dose	48 mg
		22	48 mg
	Cycles 2 and 3	1, 8, 15 and 22	48 mg
	Cycles 4 to 9	1 and 15	48 mg
	Cycle 10 and beyond	1	48 mg

Table 2: EPKINLY 3-step up Dosage Schedule for Patients with FL
Indication	Cycle of treatment *	Day of treatment	Dose of EPKINLY
* Cycle = 28 days
Follicular Lymphoma	Cycle 1	1	Step-up dose 1	0.16 mg
		8	Step-up dose 2	0.8 mg
		15	Step-up dose 3	3 mg
		22	First full dose	48 mg
	Cycles 2 and 3	1, 8, 15 and 22	48 mg
	Cycles 4 to 9	1 and 15	48 mg
	Cycle 10 and beyond	1	48 mg

Restarting EPKINLY after Dosage Delay

If a dose of EPKINLY is delayed, restart therapy based on the recommendations made in Table 3 for patients with DLBCL or high-grade B-cell lymphoma, or Table 4 for patients with FL [see Dosage and Administration (2.2)].

Table 3: Recommendations for Restarting Therapy with EPKINLY After Dosage Delay for Patients with DLBCL or High-grade B-cell Lymphoma
Last Dose Administered	Time Since the Last Dose Administered	Action for Next Dose(s) *
* Administer pretreatment medication prior to EPKINLY dose and monitor patients accordingly [see Dosage and Administration (2.4, 2.6)].
0.16 mg (e.g., on Cycle 1 Day 1)	More than 8 days	Repeat Cycle 1 schedule starting at step-up dose 1 (0.16 mg). Following the repeat of Cycle 1 schedule, resume the planned treatment schedule.
0.8 mg (e.g., on Cycle 1 Day 8)	14 days or less	Administer 48 mg, then resume the planned treatment schedule.
0.8 mg (e.g., on Cycle 1 Day 8)	More than 14 days	Repeat Cycle 1 schedule starting at step-up dose 1 (0.16 mg). Following the repeat of Cycle 1 schedule, resume the planned treatment schedule.
48 mg (e.g., on Cycle 1 Day 15 onwards)	6 weeks or less	Administer 48 mg, then resume the planned treatment schedule.
48 mg (e.g., on Cycle 1 Day 15 onwards)	More than 6 weeks	Repeat Cycle 1 schedule starting at step-up dose 1 (0.16 mg). Following the repeat of Cycle 1 schedule, resume the planned treatment schedule.

Table 4: Recommendations for Restarting Therapy with EPKINLY After Dosage Delay for Patients with FL
Last Dose Administered	Time Since the Last Dose Administered	Action for Next Dose(s) *
* Administer pretreatment medication prior to EPKINLY dose and monitor patients accordingly [see Dosage and Administration (2.4, 2.6)].
0.16 mg (e.g., on Cycle 1 Day 1)	More than 8 days	Repeat Cycle 1 schedule starting at step-up dose 1 (0.16 mg). Following the repeat of Cycle 1 schedule, resume the planned treatment schedule.
0.8 mg (e.g., on Cycle 1 Day 8)	More than 8 days	Repeat Cycle 1 schedule starting at step-up dose 1 (0.16 mg). Following the repeat of Cycle 1 schedule, resume the planned treatment schedule.
3 mg (e.g., on Cycle 1 Day 15)	14 days or less	Administer 48 mg, then resume the planned treatment schedule.
3 mg (e.g., on Cycle 1 Day 15)	More than 14 days	Repeat Cycle 1 schedule starting at step-up dose 1 (0.16 mg). Following the repeat of Cycle 1 schedule, resume the planned treatment schedule.
48 mg (e.g., on Cycle 1 Day 22 onwards)	6 weeks or less	Administer 48 mg, then resume the planned treatment schedule.
48 mg (e.g., on Cycle 1 Day 22 onwards)	More than 6 weeks	Repeat Cycle 1 schedule starting at step-up dose 1 (0.16 mg). Following the repeat of Cycle 1 schedule, resume the planned treatment schedule.

Table 5: EPKINLY Pre- and Post-Administration Medications
Cycle	Patients requiring medication	Medication	Administration
* Dexamethasone is the preferred corticosteroid when available. † Patients will be permanently discontinued from EPKINLY after Grade 4 CRS.
Cycle 1	All patients	Dexamethasone * (15 mg oral or intravenous) or Prednisolone (100 mg oral or intravenous) or equivalent	30-120 minutes prior to each weekly administration of EPKINLY And for three consecutive days following each weekly administration of EPKINLY in Cycle 1
Diphenhydramine (50 mg oral or intravenous) or equivalent Acetaminophen (650 mg to 1,000 mg oral)	30-120 minutes prior to each weekly administration of EPKINLY
Cycle 2+	Patients who experienced Grade 2 or 3 † CRS with previous dose	Dexamethasone * (15 mg oral or intravenous) or Prednisolone (100 mg oral or intravenous) or equivalent	30-120 minutes prior to next administration of EPKINLY after a Grade 2 or 3 † CRS event And for three consecutive days following the next administration of EPKINLY until EPKINLY is given without subsequent CRS of Grade 2 or higher

Recommended Prophylaxis

Pneumocystis jirovecii pneumonia (PJP)

Provide PJP prophylaxis prior to starting treatment with EPKINLY.

Herpes virus

Consider initiating prophylaxis against herpes virus prior to starting EPKINLY to prevent herpes zoster reactivation.

Dosage Modifications and Management of Adverse Reactions

See Tables 6 and 7 for recommended actions for adverse reactions of CRS and ICANS, respectively. See Table 8 for recommended actions for other adverse reactions following administration of EPKINLY.

Cytokine Release Syndrome (CRS)

Identify CRS based on clinical presentation [see Warnings and Precautions (5.1)]. Evaluate for and treat other causes of fever, hypotension, and hypoxia.

If CRS is suspected, withhold EPKINLY until CRS resolves. Manage according to the recommendations in Table 6 and consider further management per current practice guidelines. Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS.

Table 6: Recommendations for Management of Cytokine Release Syndrome
Grade *	Presenting Symptoms	Actions
* Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS. † Premedication may mask fever, therefore if clinical presentation is consistent with CRS, follow these management guidelines. ‡ Refer to Table 3 or Table 4 for information on restarting EPKINLY after dosage delays [see Dosage and Administration (2.3)]. § Low-flow oxygen defined as oxygen delivered at < 6L/minute; high-flow oxygen defined as oxygen delivered at ≥ 6 L/minute. ¶ If Grade 2 or 3 CRS occurs with the second full dose (48 mg) or beyond, administer CRS pre- and post-administration medications with each subsequent dose until a EPKINLY dose is given without subsequent CRS of Grade 2 or higher. Refer to Table 5 for additional information on pre- and post-administration medications.
Grade 1	Temperature ≥ 100.4°F (38°C) †	Withhold EPKINLY and manage per current practice guidelines. Ensure CRS symptoms are resolved prior to next dose of EPKINLY. ‡
Grade 2	Temperature ≥ 100.4°F (38°C) † with: Hypotension not requiring vasopressors and/or Hypoxia requiring low-flow oxygen § by nasal cannula or blow-by.	Withhold EPKINLY and manage per current practice guidelines. Ensure CRS symptoms are resolved prior to next dose of EPKINLY. ‡ Administer premedication ¶ prior to next dose of EPKINLY. For the next dose of EPKINLY, monitor more frequently and consider hospitalization.
Grade 3	Temperature ≥ 100.4°F (38°C) † with: Hypotension requiring a vasopressor (with or without vasopressin) and/or Hypoxia requiring high-flow oxygen § by nasal cannula, face mask, non-rebreather mask, or Venturi mask.	Withhold EPKINLY and manage per current practice guidelines, which may include intensive care. Ensure CRS symptoms are resolved prior to the next dose of EPKINLY. ‡ Administer premedication ¶ prior to next dose of EPKINLY. Hospitalize for the next dose of EPKINLY.
Grade 3		Recurrent Grade 3 CRS Permanently discontinue EPKINLY. Manage CRS per current practice guidelines and 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 Hypoxia requiring oxygen by positive pressure (e.g., CPAP, BiPAP, intubation and mechanical ventilation).	Permanently discontinue EPKINLY. Manage CRS per current practice guidelines and provide supportive therapy, which may include intensive care.

Immune Effector Cell-Associated Neurological Toxicity Syndrome (ICANS)

Monitor patients for signs and symptoms of ICANS [see Warnings and Precautions (5.2)]. At the first sign of ICANS, withhold EPKINLY and consider neurology evaluation. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care, for ICANS [see Warnings and Precautions (5.2)]. Manage ICANS according to the recommendations in Table 7 and consider further management per current practice guidelines.

Table 7: Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome
Grade *	Presenting Symptoms †	Actions
* Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS. † Management is determined by the most severe event, not attributable to any other cause. ‡ If 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 (names 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. § Not attributable to any other cause. ¶ See Table 3 or Table 4 for recommendations on restarting EPKINLY after dosage delays [see Dosage and Administration (2.3)]. # All references to dexamethasone administration are dexamethasone or equivalent.
Grade 1	ICE score 7-9 ‡, Or depressed level of consciousness §: awakens spontaneously.	Withhold EPKINLY until ICANS resolves. ¶ 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 EPKINLY 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.
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 EPKINLY 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.
Grade 3		Recurrent Grade 3 ICANS Permanently discontinue EPKINLY 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.
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 EPKINLY. Administer dexamethasone # 10 mg intravenously 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 8: Recommended Dosage Modifications for Other Adverse Reactions
Adverse Reaction *	Severity *	Action
* Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0. † See Table 3 or Table 4 for recommendations on restarting EPKINLY after dosage delays [see Dosage and Administration (2.3)].
Infections [see Warnings and Precautions (5.3)]	Grades 1-4	Withhold EPKINLY in patients with active infection, until the infection resolves. † For Grade 4, consider permanent discontinuation of EPKINLY.
Neutropenia [see Warnings and Precautions (5.4)]	Absolute neutrophil count less than 0.5 × 109/L	Withhold EPKINLY until absolute neutrophil count is 0.5 × 109/L or higher. †
Thrombocytopenia [see Warnings and Precautions (5.4)]	Platelet count less than 50 × 109/L	Withhold EPKINLY until platelet count is 50 × 109/L or higher. †
Other Adverse Reactions [see Adverse Reactions (6.1)]	Grade 3 or higher	Withhold EPKINLY until the toxicity resolves to Grade 1 or baseline. †

Preparation of Diluted EPKINLY using the Vial Method

Read this entire section carefully before preparation of EPKINLY. Certain doses of EPKINLY require dilution prior to administration. Follow the preparation instructions provided below, as improper preparation may lead to improper dose. This section describes preparation of diluted EPKINLY using empty sterile vial method. For preparation using sterile syringe method, see subsection 2.8 [see Dosage and Administration (2.8)].

EPKINLY is prepared and administered by a healthcare provider as a subcutaneous injection. The administration of EPKINLY takes place over the course of 28-day cycles, following the step-up dosage schedule in Section 2.2.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Use aseptic technique to prepare EPKINLY. Filtration of the diluted solution is not required.

0.16 mg Dose Preparation Instructions (2 dilutions required) – Empty Sterile Vial Method

Use an appropriately sized syringe, vial, and needle for each transfer step.

1. Prepare EPKINLY vial

a.: Retrieve one 4 mg/0.8 mL EPKINLY vial from the refrigerator.
b.: Allow the vial to come to room temperature for no more than 1 hour.
c.: Gently swirl the EPKINLY vial.

DO NOT invert, vortex, or vigorously shake the vial.

2. Perform first dilution

a.: Label an appropriately sized empty vial as "Dilution A."
b.: Transfer 0.8 mL of EPKINLY into the Dilution A vial.
c.: Transfer 4.2 mL of 0.9% Sodium Chloride Injection into the Dilution A vial.
The initially diluted solution contains 0.8 mg/mL of EPKINLY.
d.: Gently swirl the Dilution A vial for 30 to 45 seconds.

3. Perform second dilution

a.: Label an appropriately sized empty vial as "Dilution B."
b.: Transfer 2 mL of solution from the Dilution A vial into the Dilution B vial. The Dilution A vial is no longer needed.
c.: Transfer 8 mL of 0.9% Sodium Chloride Injection into the Dilution B vial to make a final concentration of 0.16 mg/mL.
d.: Gently swirl the Dilution B vial for 30 to 45 seconds.

4. Withdraw dose

a.: Withdraw 1 mL of the diluted EPKINLY from the Dilution B vial into a syringe.

5. Label syringe

a.: Label the syringe with the dose strength (0.16 mg) and the time of day.

Discard the vial containing unused EPKINLY.

0.8 mg Dose Preparation Instructions (1 dilution required) – Empty Sterile Vial Method

Use an appropriately sized syringe, vial, and needle for each transfer step.

1. Prepare EPKINLY vial

a.: Retrieve one 4 mg/0.8 mL EPKINLY vial from the refrigerator.
b.: Allow the vial to come to room temperature for no more than 1 hour.
c.: Gently swirl the EPKINLY vial.

DO NOT invert, vortex, or vigorously shake the vial.

2. Perform dilution

a.: Label an appropriately sized empty vial as "Dilution A".
b.: Transfer 0.8 mL of EPKINLY into the Dilution A vial.
c.: Transfer 4.2 mL of 0.9% Sodium Chloride Injection into the Dilution A vial to make a final concentration of 0.8 mg/mL.
d.: Gently swirl the Dilution A vial for 30 to 45 seconds.

3. Withdraw dose

a.: Withdraw 1 mL of the diluted EPKINLY from the Dilution A vial into a syringe.

4. Label syringe

a.: Label the syringe with the dose strength (0.8 mg) and the time of day.

Discard the vial containing unused EPKINLY.

Preparation of Diluted EPKINLY using the Syringe Method

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Use aseptic technique to prepare EPKINLY. Filtration of the diluted solution is not required.

0.16 mg Dose Preparation Instructions (2 dilutions required) – Sterile Syringe Method

Use an appropriately sized syringe and needle for each transfer step.

1. Prepare EPKINLY vial

a.: Retrieve one 4 mg/0.8 mL EPKINLY vial from the refrigerator.
b.: Allow the vial to come to room temperature for no more than 1 hour.
c.: Gently swirl the EPKINLY vial.

DO NOT invert, vortex, or vigorously shake the vial.

2. Perform first dilution

a.: Label an appropriately sized syringe as "Dilution A."
b.: Withdraw 4.2 mL of 0.9% Sodium Chloride Injection into the Dilution A syringe. Include approximately 0.2 mL air in the syringe.
c.: In a new syringe labeled as "Syringe 1", withdraw 0.8 mL of EPKINLY.
d.: Connect the two syringes and push the 0.8 mL of EPKINLY into the Dilution A syringe. The initially diluted solution contains 0.8 mg/mL of EPKINLY
e.: Gently mix by inverting the connected syringes 180 degrees 5 times.
f.: Disconnect the syringes and discard Syringe 1.

3. Perform second dilution

a.: Label an appropriately sized syringe as "Dilution B."
b.: Withdraw 8 mL of 0.9% Sodium Chloride Injection into the Dilution B syringe. Include approximately 0.2 mL air in the syringe.
c.: Label another appropriately sized syringe as "Syringe 2."
d.: Connect Syringe 2 to the Dilution A syringe and transfer 2 mL of solution into Syringe 2. The Dilution A syringe is no longer needed.
e.: Connect Syringe 2 to the Dilution B syringe and push the 2 mL of solution into the Dilution B syringe to make a final concentration of 0.16 mg/mL.
f.: Gently mix by inverting the connected syringes 180 degrees 5 times.
g.: Disconnect the syringes and discard Syringe 2.

4. Withdraw dose

a.: Connect and transfer 1 mL of the diluted EPKINLY from the Dilution B syringe into a new syringe. The Dilution B syringe is no longer needed

5. Label syringe

a.: Label the syringe with the dose strength (0.16 mg) and the time of day.

Discard the vial containing unused EPKINLY.

0.8 mg Dose Preparation Instructions (1 dilution required) – Sterile Syringe Method

Use an appropriately sized syringe and needle for each transfer step.

1. Prepare EPKINLY vial

a.: Retrieve one 4 mg/0.8 mL EPKINLY vial from the refrigerator.
b.: Allow the vial to come to room temperature for no more than 1 hour.
c.: Gently swirl the EPKINLY vial.

DO NOT invert, vortex, or vigorously shake the vial.

2. Perform first dilution

a.: Label an appropriately sized syringe as "Dilution A."
b.: Withdraw 4.2 mL of 0.9% Sodium Chloride Injection into the Dilution A syringe. Include approximately 0.2 mL air in the syringe.
c.: In a new syringe labeled as "Syringe 1", withdraw 0.8 mL of EPKINLY.
d.: Connect the two syringes and push the 0.8 mL of EPKINLY into the Dilution A syringe to make a final concentration of 0.8 mg/mL.
e.: Gently mix by inverting the connected syringes 180 degrees 5 times.
f.: Disconnect the syringes and discard Syringe 1.

3. Withdraw dose

a.: Connect a new syringe to the Dilution A syringe and transfer 1 mL of the diluted EPKINLY into the new syringe. The Dilution A syringe is no longer needed.

4. Label syringe

a.: Label the syringe with the dose strength (0.8 mg) and the time of day.

Discard the vial containing unused EPKINLY.

Preparation of 3 mg and 48 mg EPKINLY Doses

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Use aseptic technique to prepare EPKINLY.

3 mg Dose Preparation Instructions (No dilution required)

EPKINLY 3 mg dose is required for patients with FL only [see Dosage and Administration (2.2)].

1. Prepare EPKINLY vial

a.: Retrieve one 4 mg/0.8 mL EPKINLY vial from the refrigerator.
b.: Allow the vial to come to room temperature for no more than 1 hour.
c.: Gently swirl the EPKINLY vial.

DO NOT invert, vortex, or vigorously shake the vial.

2. Withdraw dose

a.: Withdraw 0.6 mL of EPKINLY into a syringe.

3. Label syringe

a.: Label the syringe with the dose strength (3 mg) and the time of day.

Discard the vial containing unused EPKINLY.

48 mg Dose Preparation Instructions (No dilution required)

EPKINLY 48 mg/0.8 mL vial is supplied as ready-to-use solution that does not need dilution prior to administration.

1. Prepare EPKINLY vial

a.: Retrieve one 48 mg/0.8 mL EPKINLY vial from the refrigerator.
b.: Allow the vial to come to room temperature for no more than 1 hour.
c.: Gently swirl the EPKINLY vial.

DO NOT invert, vortex, or vigorously shake the vial.

2. Withdraw dose

a.: Withdraw 0.8 mL of EPKINLY into a syringe.

3. Label syringe

a.: Label the syringe with the dose strength (48 mg) and the time of day.

Discard the vial containing unused EPKINLY.

Storage and Administration

Storage of EPKINLY Solution in the Syringe

Use EPKINLY solution in the syringe immediately. If not used immediately, store the solution refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours or at room temperature at 20°C to 25°C (68°F to 77°F) for up to 12 hours. The total storage time from the start of dose preparation to administration should not exceed 24 hours. Protect from direct sunlight. Discard unused EPKINLY solution beyond the allowable storage time.

Administration of EPKINLY

To minimize injection pain, allow EPKINLY solution to equilibrate to room temperature for no more than 1 hour before administration. Inject the required volume of EPKINLY into the subcutaneous tissue of the lower part of the abdomen (preferred injection site) or the thigh.

Change of injection site from the left or right side or vice versa is recommended, especially during the weekly administrations (Cycles 1 to 3). Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard, or not intact.

Pregnancy

Risk Summary

Based on the mechanism of action, EPKINLY may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on the use of EPKINLY in pregnant women to evaluate for a drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with epcoritamab-bysp.

Epcoritamab-bysp causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD20 on B-cells and the finding of B-cell depletion in non-pregnant animals, epcoritamab-bysp can cause B-cell lymphocytopenia in infants exposed to epcoritamab-bysp in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, EPKINLY has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus.

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 is no information regarding the presence of epcoritamab-bysp in human milk, the effect on the breastfed child, or milk production. Because maternal IgG is present in human milk, and there is potential for epcoritamab-bysp absorption leading to serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with EPKINLY and for 4 months after the last dose.

Females and Males of Reproductive Potential

EPKINLY may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating EPKINLY.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with EPKINLY and for 4 months after the last dose.

Pediatric Use

The safety and efficacy of EPKINLY in pediatric patients have not been established.

Geriatric Use

LBCL

In patients with relapsed or refractory LBCL who received EPKINLY in EPCORE NHL-1, 77 (49%) were 65 years of age and older, and 29 (19%) were 75 years of age or older. No clinically meaningful differences in safety or efficacy were observed between patients with relapsed or refractory LBCL who were 65 years of age and older compared with younger adult patients

In patients with relapsed or refractory FL who received EPKINLY in EPCORE NHL-1, 66 (52%) were 65 years of age or older, and 16 (13%) were 75 years of age and older.

In patients with relapsed or refractory FL, there was a higher rate of fatal adverse reactions, primarily infections, including COVID-19, in patients older than 65 years of age compared to younger adult patients. No overall difference in efficacy was observed in patients with relapsed or refractory FL who were 65 years of age and older compared with younger adult patients.

Epkinly

Dosage & Administration

Epkinly Prescribing Information

DLBCL and High-grade B-cell Lymphoma

Follicular Lymphoma

Important Dosing Information

Recommended Dosage

Restarting EPKINLY after Dosage Delay

Recommended Pre- and Post-Administration Medications

Recommended Prophylaxis

Dosage Modifications and Management of Adverse Reactions

Preparation of Diluted EPKINLY using the Vial Method

Preparation of Diluted EPKINLY using the Syringe Method

Preparation of 3 mg and 48 mg EPKINLY Doses

Storage and Administration

Pregnancy

Lactation

Females and Males of Reproductive Potential

Pediatric Use

Geriatric Use

Epkinly Prior Authorization Resources

Most recent Epkinly prior authorization forms

Most recent state uniform prior authorization forms

Brand Resources

Benefits investigation

Epkinly PubMed™ News

Epkinly Patient Education

Patient toolkit