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EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS
ERIVEDGE (vismodegib) capsule can result in embryo-fetal death or severe birth defects. ERIVEDGE is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations.
Verify pregnancy status prior to the initiation of ERIVEDGE. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of ERIVEDGE exposure through semen [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].
Vismodegib is an inhibitor of the hedgehog (Hh) signaling
pathway, which is described chemically as 2-Chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide.
The molecular formula is C19H14Cl2N2O3S.
The molecular weight is 421.30 g/mol and the structural formula is:
Vismodegib is a crystalline free base with a pKa (pyridinium cation) of 3.8, appearing as a white to tan powder. The solubility of vismodegib is pH dependent with 0.1 μg/mL at pH 7 and 0.99 mg/mL at pH 1. The partition coefficient (log P) is 2.7.
Each ERIVEDGE (vismodegib) capsule for oral administration contains 150 mg vismodegib and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone, sodium starch glycolate, talc, and magnesium stearate (non-bovine). The capsule shell contains gelatin, titanium dioxide, red iron oxide, and black iron oxide. The black printing ink contains shellac and black iron oxide.
What are the possible side effects of vismodegib (Erivedge)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you miss a menstrual period. This could be a side effect, or it may be a sign that you are pregnant.
Less serious side effects may include:
- nausea, vomiting, decreased appetite;
- diarrhea, constipation;
- tired feeling;
- joint pain, muscle spasms;
- hair loss;
- weight loss;
- unusual or unpleasant taste in your mouth; or
Last reviewed on RxList: 2/2/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Erivedge Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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