Erivedge (vismodegib)

The recommended adult dosage for the treatment of metastatic or locally advanced basal cell carcinoma is 150 mg once daily until disease progression or unacceptable toxicity occurs.

If intolerable adverse reactions occur, withhold vismodegib therapy for up to 8 weeks until improvement or resolution. Treatment durations of <8 weeks prior to interruptions have not been studied.

Permanently discontinue vismodegib if patients experience severe cutaneous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS).

Interrupt therapy for severe or intolerable musculokeletal adverse effects. Permanently discontinue therapy for recurrent, severe or intolerable musculoskeletal adverse effects.

Administer vismodegib orally once daily without regard to meals. Swallow capsules whole; do not open or crush capsules. In the event of a missed dose, resume therapy with the next scheduled dose and do not replace the missed dose.

No dosing information is available for this tab.

Vismodegib is minimally metabolized by cytochrome P-450 (CYP) isoenzymes 2C9 and 3A. Vismodegib does not induce CYP isoenzymes 1A2, 2B6, or 3A.

In vitro data indicate that vismodegib is an inhibitor of breast cancer resistance protein (BCRP).

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

• Lactation

• Pregnancy

There are no moderate contraindications for this drug.

Adverse effects reported in >=10% of patients receiving vismodegib include muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgia, vomiting, and ageusia.

Less Frequent

• Azotemia
• Hypokalemia
• Hyponatremia

Rare or Very Rare

• DRESS syndrome
• Hepatitis
• Premature epiphyseal closure
• Stevens-johnson syndrome
• Toxic epidermal necrolysis

More Frequent

• Alopecia
• Anorexia
• Arthralgia
• Constipation
• Diarrhea
• Dysgeusia
• Fatigue
• Loss of taste
• Muscle spasm
• Nausea
• Vomiting
• Weight loss

Less Frequent

• Amenorrhea
• Musculoskeletal pain

No enhanced messaging available.

Safety and efficacy of vismodegib have not been established in pediatric patients.

Vismodegib may cause fetal harm, including death or severe birth defects. Teratogenicity and embryo-fetal toxicity have been demonstrated in animals at exposures lower than those achieved in humans at the recommended daily dosage. There are no human data on the use of vismodegib in pregnant women.

Advise patients of the potential risk to a fetus. A pregnancy registry has been established to monitor pregnancy outcomes in females exposed to vismodegib during pregnancy. Report pregnancies to Genentech at 1-888-835-2555.

It is not known whether vismodegib is distributed into milk; potential effects on the breast-fed infant or on milk production also are not known. Because of the potential for serious adverse reactions to vismodegib in nursing infants, breast-feeding is not recommended during therapy with vismodegib and for 24 months after the final dose.

There is insufficient experience in patients >=65 years of age to determine whether geriatric patients respond differently than younger adults.