Monday, December 28, 2020

Indication , Dosage and Description of ERIVEDGE

 ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation.

DOSAGE AND ADMINISTRATION

Important Safety Information

Verify pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE [see Use In Specific Populations].


Recommended Dosage

The recommended dosage of ERIVEDGE is 150 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity.


Swallow the capsules whole. Do not open or crush capsules.


If a dose of ERIVEDGE is missed, resume dosing with the next scheduled dose.


Dosage Modifications For Adverse Reactions

Withhold ERIVEDGE for up to 8 weeks for intolerable adverse reactions until improvement or resolution. Treatment durations shorter than 8 weeks prior to interruptions have not been studied.


HOW SUPPLIED

Dosage Forms And Strengths

Capsules

150 mg with “150 mg” printed on pink opaque body and “VISMO” printed on grey opaque cap in black ink.


Storage And Handling

ERIVEDGE capsules have a pink opaque body and a grey opaque cap with "150 mg" printed on the capsule body and "VISMO" printed on the capsule cap in black ink.


ERIVEDGE capsules are available in bottles of 28 capsules (NDC 50242-140-01).


Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

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