Elranatamab Dosage

Medically reviewed by Drugs.com. Last updated on Jan 8, 2024.

Usual Adult Dose for Multiple Myeloma

Recommended dosing schedule:
Step-up:

• Day 1 of treatment (step-up dose 1): 12 mg subcutaneously
• Day 4 of treatment (step-up dose 2; minimum of 2 days after dose 1): 32 mg subcutaneously
• Day 8 of treatment (first treatment dose; minimum of 3 days after dose 2): 76 mg subcutaneously

Weekly:

• One week after the first treatment dose and weekly thereafter (a minimum of 6 days between treatments) through week 24: 76 mg subcutaneously

Biweekly (only for patients who have achieved partial response or better and maintained response for at least 2 months):

• Week 25 and every 2 weeks thereafter: 76 mg subcutaneously

Recommended Pretreatment medications:
Administer approximately 1 hour before the first three doses in the step-up dosing schedule:

• Acetaminophen (or equivalent) 650 mg orally
• Dexamethasone (or equivalent) 20 mg orally or intravenously
• Diphenhydramine (or equivalent) 25 mg orally

Restarting schedule after dosage delay:
Step-up dose 1 (12 mg):

• If the last dose administered was 12 mg and 14 days or less since the last dose:
• Restart treatment at 32 mg; if tolerated, increase to 76 mg 4 days later.
• If the last dose administered was 12 mg and more than 14 days since the last dose:
• Restart treatment at 12 mg.

Step-up dose 2 (32 mg):

• If the last dose administered was 32 mg and 14 days or less since the last dose:
• Restart treatment at 76 mg.
• If the last dose administered was 32 mg and greater than 2 weeks but 4 weeks or less since the last dose:
• Restart treatment at 32 mg; if tolerated, increase to 76 mg 1 week later.
• If the last dose administered was 32 mg and more than 28 days since the last dose:
• Restart treatment at 12 mg.

Any treatment dose (76 mg):

• If the last dose administered was 76 mg and 42 days or less since the last dose:
• Restart treatment at 76 mg.
• If the last dose administered was 76 mg and greater than 6 weeks but 12 weeks or less since the last dose:
• Restart treatment at 32 mg; if tolerated, increase to 76 mg 1 week later.
• If the last dose administered was 76 mg and more than 84 days since the last dose:
• Restart treatment at 12 mg.

Use: 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.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

See manufacturer prescribing information for the management of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

Recommended dose adjustments for other adverse reactions:

• 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.
• Febrile neutropenia: Withhold therapy until the absolute neutrophil count is 1 times 10(9)/L or higher and the fever resolves.
• Hemoglobin less than 8 g/dL: Withhold therapy until hemoglobin is 8 g/dL or higher.
• Platelet count less than 25,000/mcL or between 25,000 and 50,000/mcL with bleeding: Withhold therapy until the platelet count is 25,000/mcL or higher, and no evidence of bleeding.
• Infections and other non-hematologic adverse reactions:
• Grade 3: Withhold therapy until adverse reaction improves to Grade 1 or less or baseline.
• Grade 4: Consider permanent discontinuation of therapy or withhold treatment until adverse reaction improves to Grade 1 or less.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for elranatamab. It includes a communication plan, elements to assure safe use and an implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US FDA requires a medication guide to ensure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

US BOXED WARNINGS:

• Cytokine Release Syndrome (CRS), including life-threatening or fatal reactions, can occur in patients taking this drug. Initiate treatment following a step-up dosing schedule to reduce the risk of CRS. Withhold treatment until CRS resolves or permanently discontinue based on severity.
• Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening reactions, can occur in patients receiving this drug. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold treatment until the neurologic toxicity resolves or permanently discontinue based on severity.
• This drug is available only through a restricted program called the Risk Evaluation and Mitigation Strategy (REMS).

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, preferably in the subcutaneous tissues of the abdomen and alternatively at other sites.
• This therapy should only be administered by a qualified healthcare professional with appropriate medical support to manage cytokine release syndrome (CRS) and neurologic toxicity.
• Follow the recommended dosing schedule to reduce the incidence and severity of CRS.
• Administer premedication and prophylaxis as recommended.
• Patients should be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after the second step-up dose.

Storage requirements:

• Refrigerate at 2C to 8C (36F to 46F). Do not freeze.
• Store prepared dosing syringe not used immediately between 2C to 30C (36F to 86F) for a maximum of 4 hours.
• Keep in the original carton to protect from light.
• Do not shake the vial or carton.

Reconstitution/preparation techniques:

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

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• 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 of adverse reactions 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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