Dósis e Intreracción

WELIREG offers convenient, once-daily, oral dosing

The recommended dose of WELIREG is 120 mg (three 40-mg tablets) once daily, with or without food.

Not actual size.

1x daily

• Advise patients to swallow tablets whole.
• If a dose of WELIREG is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for WELIREG the next day. Extra tablets should not be taken to make up for the missed dose.
• If vomiting occurs any time after taking WELIREG, do not retake the dose. The next dose should be taken on the next day.
• Treatment should continue until disease progression or unacceptable toxicity occurs.

No dose adjustment recommended for:

• Mild and moderate renal impairment.
• Mild hepatic impairment.

WELIREG has not been studied in patients with severe renal impairment or moderate or severe hepatic impairment.

Additional dosing information:

• Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.
• Females of reproductive potential should be advised to use highly effective contraception during treatment with WELIREG and for at least 1 week after the last dose. Use of WELIREG may reduce the efficacy of hormonal contraceptives.
• Patients using hormonal contraceptives should be advised to use an alternative non-hormonal contraceptive method or have their male partner use a condom during treatment with WELIREG.
• Advise males with female partners of reproductive potential to use highly effective contraception during treatment with WELIREG and for at least 1 week after the last dose.

Dosing & drug interactions:

• WELIREG is metabolized by UGT2B17 and CYP2C19.
• WELIREG is a CYP3A4 inducer.
• Coadministration of WELIREG with CYP3A4 substrates, including hormonal contraceptives, decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates. The magnitude of this decrease may be more pronounced in patients who are dual UGT2B17 and CYP2C19 poor metabolizers.
• Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding.
• Coadministration with inhibitors of UGT2B17 or CYP2C19 is expected to increase plasma exposures of belzutifan. Dose adjustment is not required on coadministration with inhibitors of UGT2B17 or CYP2C19. Drugs that induce CYP2C19 are expected to reduce plasma exposures of WELIREG.
• Dizziness and fatigue may occur following administration of belzutifan. Patients should be advised not to drive and use machines, until they are reasonably certain belzutifan therapy does not affect them adversely.

Anti–PD-1/L1 = anti–PD-1 or anti–PD-L1; PD-1 = programmed death receptor-1; PD-L1 = programmed death ligand 1; VEGF-TKI = vascular endothelial growth factor tyrosine kinase inhibitor.

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