Epcoritamab Dosage

Medically reviewed by Drugs.com. Last updated on Nov 17, 2023.

Usual Adult Dose for B-Cell Lymphoma

Recommended dosing schedule:
Administer in 28-day cycles until disease progression or unacceptable toxicity.
Cycle 1:

• Day 1 of treatment (step-up dose 1): 0.16 mg subcutaneously
• Day 8 of treatment (step-up dose 2): 0.8 mg subcutaneously
• Day 15 of treatment (first full dose): 48 mg subcutaneously
• Day 22 of treatment: 48 mg subcutaneously

Cycles 2 and 3:

• Days 1, 8, 15, and 22 of treatment: 48 mg subcutaneously

Cycles 4 to 9:

• Days 1 and 15 of treatment: 48 mg subcutaneously

Cycle 10 and beyond:

• Day 1 of treatment: 48 mg subcutaneously

Restarting schedule after dosage delay:

• If the last dose administered was 0.16 mg on Cycle 1 Day 1 and more than 8 days since the last dose:
• Repeat 0.16 mg, then administer 0.8 mg the following week, followed by two weekly doses of 48 mg. Then resume the planned dosage schedule beginning with Day 1 of the subsequent cycle.

• If the last dose administered was 0.8 mg on Cycle 1 Day 8 and 14 days or less since the last dose:
• Administer 48 mg then resume the recommended dosage schedule.
• If the last dose administered was 0.8 mg on Cycle 1 Day 8 and more than 14 days since the last dose:
• Repeat 0.16 mg, then administer 0.8 mg the following week, followed by two weekly doses of 48 mg. Then resume the planned dosage schedule beginning with Day 1 of the subsequent cycle.

• If the last dose administered was 48 mg on Cycle 1 Day 15 onwards and 6 weeks or less since the last dose:
• Administer 48 mg then resume the recommended dosage schedule.
• If the last dose administered was 48 mg on Cycle 1 Day 15 onwards and more than 6 weeks since the last dose:
• Repeat 0.16 mg, then administer 0.8 mg the following week, followed by two weekly doses of 48 mg. Then resume the planned dosage schedule beginning with Day 1 of the subsequent cycle.

Recommended Premedications:
Cycle 1 (all patients require premedication):

• Prednisolone (100 mg oral or intravenous) or Dexamethasone (15 mg oral or intravenous) or equivalent. This should be taken 30 to 120 minutes prior to each week and for three consecutive days following each weekly administration of this drug.
• Diphenhydramine (50 mg oral or intravenous) or equivalent OR acetaminophen (650 mg to 1000 mg oral). This should be taken 30 to 120 minutes prior to each weekly administration of epcoritamab.

Cycle 2 and onwards (patients who experienced Grade 2 or 3 cytokine release syndrome (CRS) with the previous dose:

• Prednisolone (100 mg oral or intravenous) or Dexamethasone (15 mg oral or intravenous) or equivalent. This should be taken 30 to 120 minutes prior to the next administration and for three consecutive days following the next administration of epcoritamab until no subsequent CRS of grade 2 or higher occurs.

Comments:

• A cycle is 28 days.
• Premedicate before each dose in Cycle 1.
• Patient should be hospitalized for 24 hours after administration of the Cycle 1 Day 15 dosage due to the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

Uses: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

See manufacturer prescribing information for the management of CRS and ICANS.
Recommended dose adjustments for other adverse reactions:

• Infections (Grades 1-4): Withhold therapy in patients with active infections until resolved. For Grade 4, consider permanent discontinuation of therapy.
• Neutropenia (absolute neutrophil count less than 0.5 x 10(9)/L): Withhold therapy until the absolute neutrophil count is 0.5 x 10(9)/L or higher.
• Thrombocytopenia (platelet count less than 50 x 10(9)/L): Withhold therapy until platelet count is 50 x 10(9)/L or higher.
• Other Adverse Reactions (Grade 3 or higher): Withhold therapy until the toxicity resolves to grade 1 or baseline.

Precautions

US BOXED WARNING(S):

• CYTOKINE RELEASE SYNDROME (CRS): CRS, including serious or life-threatening reactions, can occur in patients receiving this drug. Administer this drug using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold therapy until CRS resolves or permanently discontinue based on severity.
• IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS): ICANS, including life-threatening and fatal reactions, can occur while on this drug. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold therapy until ICANS resolves or permanently discontinue based on severity.

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous injection only.
• Administer to well-hydrated patients.
• Patients should be hospitalized for 24 hours after administration of the Cycle 1 Day 15 dose.
• Administer premedication and prophylaxis as recommended.
• 0.16 mg and 0.8 mg doses require dilution prior to administration.

Storage requirements:

• Refrigerate at 2C to 8C (36F to 46F). Do not freeze.
• Keep in the original carton to protect from light.
• Do not shake.

Reconstitution/preparation techniques:

• The manufacturer's product information should be consulted for detailed dilution and preparation instructions.

Patient advice:

• Read Patient Information Leaflet.
• Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception during treatment and for 4 months after the last dose. Advise them to inform their healthcare professional if they are pregnant or become pregnant while in treatment.
• Breastfeeding is not recommended during treatment with this drug and for 4 months after the last dose.
• Signs and symptoms associated with cytopenias should be reported.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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