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EMPLICITI

ELOTUZUMAB

Manufacturer: E.R. Squibb & Sons, L.L.C.

Score: 141.0

Quick Summary

EMPLICITI (elotuzumab) is a humanized monoclonal antibody used in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies, and in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. The recommended dosage is 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity. Premedication with dexamethasone, diphenhydramine, ranitidine, and acetaminophen is required. The most common adverse reactions include fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia.

Key Clinical Findings and Indications

  • Used in combination with lenalidomide and dexamethasone for multiple myeloma patients who have received one to three prior therapies
  • Used in combination with pomalidomide and dexamethasone for multiple myeloma patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor

Important Safety Information

Warning

No specific warning mentioned

Contraindications

  • None

Adverse Reactions

  • Infusion reactions
  • Infections
  • Second primary malignancies
  • Hepatotoxicity
  • Interference with determination of complete response

Dosing Recommendations

General Guidance

Dose delays and modifications for dexamethasone, pomalidomide, and lenalidomide should be performed as recommended in their Prescribing Information

Multiple myeloma

Adult Dose

10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • There are no available data on EMPLICITI use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage

Nursing Mothers

  • Not mentioned

Pediatric Use

  • Safety and effectiveness have not been established in pediatric patients

Geriatric Use

  • No overall differences in efficacy or safety were observed between patients 65 years or older and younger patients