VOTRIENT® is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
DOSAGE AND ADMINISTRATION
The recommended dose of VOTRIENT is 800 mg orally once daily without food (at least1 hour before or 2 hours after a meal) [see CLINICAL PHARMACOLOGY]. The dose of VOTRIENT should not exceed 800 mg.
Do not crush tablets due to the potential for increased rate of absorption which may affect systemic exposure. [See CLINICAL PHARMACOLOGY.] If a dose is missed, it should not be taken if it is less than 12 hours until the next dose.
Dose Modification Guidelines
Initial dose reduction should be 400 mg, and additional dose decrease or increase should be in 200 mg steps based on individual tolerability. The dose of VOTRIENT should not exceed 800 mg.
No dose adjustment is required in patients with mild hepatic impairment. In patients with moderate hepatic impairment, alternatives to VOTRIENT should be considered. If VOTRIENT is used in patients with moderate hepatic impairment, the dose should be reduced to 200 mg per day. VOTRIENT is not recommended in patients with severe hepatic impairment. [See Use in Specific Populations and CLINICAL PHARMACOLOGY.]
Concomitant Strong CYP3A4 Inhibitors
The concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) may increase pazopanib concentrations and should be avoided. If coadministration of a strong CYP3A4 inhibitor is warranted, reduce the dose of VOTRIENT to 400 mg. Further dose reductions may be needed if adverse effects occur during therapy. This dose is predicted to adjust the pazopanib AUC to the range observed without inhibitors. However, there are no clinical data with this dose adjustment in patients receiving strong CYP3A4 inhibitors. [See DRUG INTERACTIONS.]
Concomitant Strong CYP3A4 Inducer
The concomitant use of strong CYP3A4 inducers (e.g., rifampin) may decrease pazopanib concentrations and should be avoided.
VOTRIENT should not be used in patients who can not avoid chronic use of strong CYP3A4 inducers. [See DRUG INTERACTIONS.]
Dosage Forms And Strengths
200 mg tablets of VOTRIENT — modified capsule-shaped, gray, film-coated with GS JT debossed on one side. Each tablet contains 216.7 mg of pazopanib hydrochloride equivalent to 200 mg of pazopanib.
Storage And Handling
The 200 mg tablets of VOTRIENT are modified capsule-shaped, gray, film-coated with GS JT debossed on one side and are available in:
Bottles of 120 tablets: NDC 0173-0804-09
Store at room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
GlaxoSmithKline, Research Triangle Park, NC 27709. March 2012
Last reviewed on RxList: 4/4/2012
This monograph has been modified to include the generic and brand name in many instances.
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