Pazopanib - Pazopanib tablet, Film Coated Prescribing Information
Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended
[see Warnings and Precautions (5.1)].
Pazopanib tablets are kinase inhibitor indicated for the treatment of adults with:
•
advanced renal cell carcinoma (RCC). (1.1)
•
advanced soft tissue sarcoma (STS) who have received prior chemotherapy. (1.2)
Limitations of Use
: The efficacy of pazopanib tablets for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.
•
Recommended Dosage: 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). (2.1)
•
Moderate Hepatic Impairment: 200 mg orally once daily. (2.2)
Tablets: 200 mg, capsule-shaped, grey colored, film-coated debossed with ‘
S7
’ on one side and plain on other side.
•
Lactation
: Advise not to breastfeed. (8.2)
None.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available