LENALIDOMIDE

Manufacturer: Zydus Pharmaceuticals USA Inc.

Score: 148.0

Quick Summary

Lenalidomide is an immunomodulatory agent used in combination with dexamethasone for the treatment of multiple myeloma (MM) and as a single agent for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality. It has antiangiogenic and antineoplastic properties, and its mechanism of action involves the targeting of cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. Lenalidomide can cause significant neutropenia and thrombocytopenia, and it has a boxed warning for embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism. The recommended starting dose is 25 mg orally once daily on Days 1 to 21 of repeated 28-day cycles in combination with dexamethasone for MM, and 10 mg daily for MDS.

Key Clinical Findings and Indications

Treatment of multiple myeloma (MM) in combination with dexamethasone
Treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality
Immunomodulatory, antiangiogenic, and antineoplastic properties

Important Safety Information

Warning

Embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism

Contraindications

Pregnancy
Severe hypersensitivity reactions

Adverse Reactions

Neutropenia
Thrombocytopenia
Diarrhea
Fatigue
Anemia
Constipation
Peripheral edema
Insomnia
Muscle cramp/spasms
Abdominal pain
Back pain
Nausea
Asthenia
Pyrexia
Upper respiratory tract infection
Bronchitis
Nasopharyngitis
Gastroenteritis
Cough
Rash
Dyspnea
Dizziness
Decreased appetite
Thrombocytopenia
Tremor

Dosing Recommendations

General Guidance

Dose adjustments should be made based on hematologic and non-hematologic toxicity

Multiple myeloma (MM)

Adult Dose

25 mg orally once daily on Days 1 to 21 of repeated 28-day cycles in combination with dexamethasone

Pediatric Dose

Myelodysplastic syndromes (MDS)

Adult Dose

10 mg daily

Pediatric Dose

Special Population Considerations

Pregnancy

Lenalidomide can cause fetal harm when administered to a pregnant female
Pregnancy exposure registry available to monitor pregnancy outcomes

Nursing Mothers

No information regarding the presence of lenalidomide in human milk
Advise women not to breastfeed during treatment with lenalidomide

Pediatric Use

Safety and effectiveness have not been established in pediatric patients

Geriatric Use

Of the 1613 patients in the NDMM study, 94% were 65 years of age or older
No differences in efficacy were observed between patients over 65 years of age and younger patients
Care should be taken in dose selection for elderly patients due to decreased renal function