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Pomalyst

POMALIDOMIDE

Manufacturer: Celgene Corporation

Score: 144.0

Quick Summary

Pomalyst (Pomalidomide) is a thalidomide analogue used for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, and for the treatment of AIDS-related Kaposi's sarcoma. The drug has immunomodulatory, antiangiogenic, and antineoplastic properties. It is available in 1mg, 2mg, 3mg, and 4mg capsules for oral administration. Pomalyst can cause severe birth defects and is contraindicated in pregnancy. The recommended dosage is 4mg once daily for multiple myeloma and 5mg once daily for Kaposi's sarcoma. Special considerations are needed for patients with renal or hepatic impairment, and for pediatric and geriatric patients.

Key Clinical Findings and Indications

  • Treatment of multiple myeloma in patients who have received at least two prior therapies
  • Treatment of AIDS-related Kaposi's sarcoma
  • Immunomodulatory, antiangiogenic, and antineoplastic properties

Important Safety Information

Warning

Pomalyst can cause severe birth defects and is contraindicated in pregnancy

Contraindications

  • Pregnancy
  • Hypersensitivity to pomalidomide or any of the excipients

Adverse Reactions

  • Neutropenia
  • Anemia
  • Thrombocytopenia
  • Fatigue
  • Constipation
  • Nausea
  • Diarrhea
  • Dyspnea
  • Upper respiratory tract infections
  • Back pain
  • Pyrexia

Dosing Recommendations

General Guidance

Dose adjustments are needed for patients with renal or hepatic impairment

Multiple Myeloma

Adult Dose

4mg once daily

Pediatric Dose

Not established

Kaposi's Sarcoma

Adult Dose

5mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Pomalyst is contraindicated in pregnancy
  • Can cause severe birth defects

Nursing Mothers

  • It is not known if pomalidomide is excreted in human milk
  • Caution should be exercised when administering pomalidomide to a nursing woman

Pediatric Use

  • The safety and effectiveness of pomalidomide have not been established in pediatric patients

Geriatric Use

  • Of the total number of patients in clinical studies of pomalidomide, 44% were aged older than 65 years
  • No overall differences in effectiveness were observed between these patients and younger patients