ERIVEDGE (vismodegib)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Pregnancy

There are 0 moderate contraindications.

There are 8 severe adverse reactions.

More Frequent	Less Frequent
None.	Azotemia Hypokalemia Hyponatremia

Rare/Very Rare
DRESS syndrome Hepatitis Premature epiphyseal closure Stevens-johnson syndrome Toxic epidermal necrolysis

There are 14 less severe adverse reactions.

More Frequent	Less Frequent
Alopecia Anorexia Arthralgia Constipation Diarrhea Dysgeusia Fatigue Loss of taste Muscle spasm Nausea Vomiting Weight loss	Amenorrhea Musculoskeletal pain

Rare/Very Rare
None.

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.