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Venclexta

VENETOCLAX

Manufacturer: AbbVie Inc.

Score: 141.0

Quick Summary

Venclexta (Venetoclax) is a BCL-2 inhibitor used for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The drug has shown significant clinical activity in these indications, but also carries important safety risks, including tumor lysis syndrome, neutropenia, and infections. Dosing recommendations vary by indication and patient population, with a 5-week ramp-up phase for CLL/SLL and a 3- or 4-day ramp-up for AML. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of adult patients with CLL or SLL
  • Treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
  • Significant clinical activity in CLL/SLL and AML

Important Safety Information

Warning

Tumor lysis syndrome, neutropenia, and infections are important safety risks associated with Venclexta

Contraindications

  • Concomitant use with strong CYP3A inhibitors at initiation and during the ramp-up phase in patients with CLL/SLL

Adverse Reactions

  • Neutropenia
  • Thrombocytopenia
  • Anemia
  • Diarrhea
  • Nausea
  • Upper respiratory tract infection
  • Cough
  • Musculoskeletal pain
  • Fatigue
  • Edema

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with neutropenia, thrombocytopenia, or other adverse reactions

CLL/SLL

Adult Dose

20 mg on Week 1, 50 mg on Week 2, 100 mg on Week 3, 200 mg on Week 4, and 400 mg on Week 5 and beyond

Pediatric Dose

AML

Adult Dose

100 mg on Day 1, 200 mg on Day 2, 400 mg on Day 3, and 400 mg or 600 mg on Days 4 and beyond

Pediatric Dose

Special Population Considerations

Pregnancy

  • Venclexta may cause embryo-fetal harm when administered to a pregnant woman

Nursing Mothers

  • It is not known if Venclexta is present in human milk

Pediatric Use

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

Geriatric Use

  • No clinically meaningful differences in safety and effectiveness were observed between older and younger patients in the combination and monotherapy studies