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Pazopanib

PAZOPANIB

Manufacturer: Teva Pharmaceuticals, Inc.

Score: 148.0

Quick Summary

Pazopanib is a kinase inhibitor used for the treatment of adults with advanced renal cell carcinoma (RCC) and advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The recommended dosage is 800 mg orally once daily without food, with dose modifications for hepatic impairment and certain concomitant drugs. Pazopanib can cause severe and fatal hepatotoxicity, and monitoring of hepatic function is required. The drug is not recommended in patients with severe hepatic impairment, and its use in pregnancy and nursing mothers should be avoided due to potential fetal harm and lack of data on safety.

Key Clinical Findings and Indications

  • Advanced renal cell carcinoma (RCC)
  • Advanced soft tissue sarcoma (STS) who have received prior chemotherapy

Important Safety Information

Warning

Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended.

Contraindications

  • None

Adverse Reactions

  • Diarrhea
  • Hypertension
  • Hair color changes
  • Nausea
  • Anorexia
  • Vomiting
  • Fatigue
  • Asthenia
  • Abdominal pain
  • Headache

Dosing Recommendations

General Guidance

Dose modifications for hepatic impairment and certain concomitant drugs, including strong CYP3A4 inhibitors and inducers.

Advanced renal cell carcinoma (RCC)

Adult Dose

800 mg orally once daily without food

Pediatric Dose

Advanced soft tissue sarcoma (STS)

Adult Dose

800 mg orally once daily without food

Pediatric Dose

Special Population Considerations

Pregnancy

  • Pazopanib can cause fetal harm when administered to a pregnant woman
  • Advise pregnant women of the potential risk to a fetus

Nursing Mothers

  • Pazopanib can cause fetal harm if administered to a nursing mother
  • Advise nursing mothers to avoid breastfeeding during treatment with pazopanib

Pediatric Use

  • The safety and effectiveness of pazopanib in pediatric patients have not been established
  • Pazopanib caused abnormal organ growth/maturation in juvenile animal studies

Geriatric Use

  • In pooled clinical trials with pazopanib, 30% of 2080 patients were aged ≥ 65 years
  • More patients ≥ 65 years had ALT elevations > 3 × ULN compared to patients < 65 years

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