Epkinly Dosage
Generic name: epcoritamab 48mg in 0.8mL
Dosage form: injection, solution
Drug class: Bispecific T-cell engagers (BiTE)
Medically reviewed by Drugs.com. Last updated on Jul 26, 2024.
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, or
- Sterile syringe method as described in subsection 2.8.
- Preparation of 3 mg and 48 mg EPKINLY doses do not require dilution. For preparation, refer to subsection 2.9.
- Administer EPKINLY to well-hydrated patients.
- Premedicate before each dose in Cycle 1.
- 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).
- 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.
- 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.
- For Patients with DLBCL or High-grade B-cell Lymphoma:
Recommended Dosage
EPKINLY is for subcutaneous injection only.
Administer EPKINLY in 28-day cycles until disease progression or unacceptable toxicity.
Indication | Cycle of treatment* | Day of treatment | Dose of EPKINLY | |
---|---|---|---|---|
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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 |
Indication | Cycle of treatment* | Day of treatment | Dose of EPKINLY | |
---|---|---|---|---|
|
||||
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.
Last Dose Administered | Time Since the Last Dose Administered | Action for Next Dose(s)* |
---|---|---|
|
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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. |
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. |
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. |
Last Dose Administered | Time Since the Last Dose Administered | Action for Next Dose(s)* |
---|---|---|
|
||
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. |
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. |
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. |
Recommended Pre- and Post-Administration Medications
Administer pre- and post-administration medications as outlined in Table 5 to reduce the risk of CRS.
Cycle | Patients requiring medication | Medication | Administration |
---|---|---|---|
Cycle 1 | All patients |
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Cycle 2+ | Patients who experienced Grade 2 or 3† CRS with previous dose |
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Recommended Prophylaxis
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. 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.
Grade* | Presenting Symptoms | Actions |
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Grade 1 | Temperature ≥ 100.4°F (38°C)† |
|
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. |
|
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. |
|
Recurrent Grade 3 CRS
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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). |
|
Immune Effector Cell-Associated Neurological Toxicity Syndrome (ICANS)
Monitor patients for signs and symptoms of ICANS. 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. Manage ICANS according to the recommendations in Table 7 and consider further management per current practice guidelines.
Grade* | Presenting Symptoms† | Actions |
---|---|---|
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Grade 1 | ICE score 7-9‡, Or depressed level of consciousness§: awakens spontaneously. |
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Grade 2 | ICE score 3-6‡, Or depressed level of consciousness§: awakens to voice. |
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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
|
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Grade 4 | ICE score 0‡, Or depressed level of consciousness§: either:
|
|
Adverse Reaction* | Severity* | Action |
---|---|---|
Infections | Grades 1-4 |
|
Neutropenia | Absolute neutrophil count less than 0.5 × 109/L |
|
Thrombocytopenia | Platelet count less than 50 × 109/L |
|
Other Adverse Reactions | Grade 3 or higher |
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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.
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
|
2. Perform first dilution
|
3. Perform second dilution
|
4. Withdraw dose
|
5. Label syringe
|
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
|
2. Perform dilution
|
3. Withdraw dose
|
4. Label syringe
|
Discard the vial containing unused EPKINLY.
Preparation of Diluted EPKINLY using the Syringe 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.
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) – Sterile Syringe Method
Use an appropriately sized syringe and needle for each transfer step.
1. Prepare EPKINLY vial
|
2. Perform first dilution
|
3. Perform second dilution
|
4. Withdraw dose
|
5. Label syringe
|
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
|
2. Perform first dilution
|
3. Withdraw dose
|
4. Label syringe
|
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.
1. Prepare EPKINLY vial
|
DO NOT invert, vortex, or vigorously shake the vial. |
2. Withdraw dose
|
3. Label syringe
|
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
|
DO NOT invert, vortex, or vigorously shake the vial. |
2. Withdraw dose
|
3. Label syringe
|
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.
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