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SUTENT (sunitinib capsules) Dosage And Administration

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Dosage And Administration

Recommended Dose for GIST and MRCC
The recommended dose of SUTENT (sunitinib malate) is one 50-mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off.

Recommended Dose for pancreatic NET
The recommended dose of SUTENT for pancreatic neuroendocrine tumours (pancreatic NET) is 37.5 mg taken orally once daily without a scheduled off-treatment period.

SUTENT may be taken with or without food.

Dose Modification

Daily doses should not exceed 50 mg nor be decreased below 25 mg. Dose modification of 12.5- mg is recommended based on individual safety and tolerability.

CYP3A4 Inhibitors: Concurrent administration of sunitinib malate with the CYP3A4 inhibitor, ketoconazole, resulted in 49% and 51% increases in combined (sunitinib + active metabolite) Cmax and AUC0-∞ values, respectively, after a single dose of sunitinib malate in healthy volunteers. Doses of SUTENT may need to be reduced to a minimum of 25 mg daily, and clinical response and tolerability should be carefully monitored, in patients receiving a potent CYP3A4 inhibitor such as ketoconazole (see DRUG INTERACTIONS and ACTION AND CLINICAL PHARMACOLOGY). Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential should be considered. NOTE: This recommendation is based on pharmacokinetic data from healthy volunteers. In clinical trials conducted to date, the safety and efficacy of SUTENT with concomitant use of CYP3A4 inhibitors has not been established. In the 2 cytokine-refractory MRCC studies, 14 of the 169 patients used a potent CYP 3A4 inhibitor concomitantly with SUTENT with no modification of the starting dose of SUTENT.

CYP3A4 Inducers: Concurrent administration of sunitinib malate with the potent CYP3A4 inducer, rifampin, resulted in a more than 23% and 46% reduction in combined (sunitinib + active metabolite) Cmax and AUC0-∞ values, respectively, after a single dose of SUTENT in healthy volunteers. The dose of SUTENT may need to be increased (maximum 50mg), and clinical response and tolerability should be carefully monitored, in patients receiving SUTENT with a potent CYP3A4 inducer, such as rifampin (See DRUG INTERACTIONS and ACTION AND CLINICAL PHARMACOLOGY). Selection of an alternate concomitant medication with no or minimal enzyme induction potential should be considered. NOTE: This recommendation is based on pharmacokinetic data from healthy volunteers. In clinical trials conducted to date, the safety and efficacy of SUTENT with concomitant use of CYP3A4 inducers has not been established. In the two cytokine-refractory MRCC studies, 33 of the 169 patients received a potent CYP3A4 inducer concomitantly with SUTENT with no modification of the starting dose of SUTENT.

Special Populations: No dose adjustment is required on the basis of patient age, body weight, creatinine clearance, race, gender or ECOG score. (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations).

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