Erivedge (Vismodegib)

Description

Erivedge (vismodegib) is an oral hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma (BCC) or with locally advanced BCC that has recurred following surgery or who are not candidates for surgery or radiation. Vismodegib selectively inhibits Smoothened (SMO), a transmembrane protein that plays a critical role in the aberrant activation of the hedgehog signaling pathway—a key driver of BCC tumorigenesis. Inhibition of SMO suppresses the growth and survival of basal cell carcinoma cells.

Directions

Erivedge is administered orally at a recommended dose of 150 mg once daily, with or without food. Capsules should be swallowed whole and not opened, crushed, or chewed. Treatment should continue until disease progression or unacceptable toxicity occurs. Dose interruptions or discontinuation may be required for significant adverse events, but dose reduction is not recommended due to the fixed capsule strength.

Ingredients

Each Erivedge capsule contains:

• Vismodegib 150 mg

• Lactose monohydrate

• Microcrystalline cellulose

• Sodium starch glycolate

• Povidone

• Sodium lauryl sulfate

• Magnesium stearate

• Gelatin capsule with titanium dioxide and red iron oxide

Contraindications

Erivedge is contraindicated in:

• Pregnant women, due to embryo-fetal death and severe birth defects

• Women who may become pregnant and are not using effective contraception

• Co-administration with St. John's Wort (may reduce vismodegib levels)

Cautions

Erivedge carries a boxed warning for embryo-fetal toxicity. It is teratogenic and contraindicated in pregnancy. Women of reproductive potential must use highly effective contraception during treatment and for 24 months after the last dose. Male patients must use contraception during treatment and for 3 months after the last dose, as vismodegib is present in semen. Blood donation is prohibited during and for 7 months after therapy. Avoid co-administration with strong CYP inducers or inhibitors without medical oversight.

Side Effects

Common side effects of Erivedge include:

• Muscle spasms

• Alopecia

• Dysgeusia (altered taste)

• Weight loss

• Fatigue

• Nausea

• Diarrhea

• Decreased appetite

• Arthralgia

• Constipation

Serious adverse effects may include:

• Severe birth defects or fetal death

• Amenorrhea (which may persist after discontinuation)

• Electrolyte imbalances

• Hepatotoxicity (rare)

• Severe skin reactions (rare)

Product Code : 14599