June 26, 2016
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Erivedge

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Erivedge

ERIVEDGE®
(vismodegib) Capsule for Oral Use




WARNING

EMBRYO-FETAL TOXICITY

ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations.

Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE therapy. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE therapy. Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. Advise pregnant women of the potential risks to a fetus. [See WARNINGS AND PRECAUTIONS, Use in Specific Populations].

DRUG DESCRIPTION

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:

ERIVEDGE® (vismodegib) Structural Formula Illustration

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
  • decreased...

Read All Potential Side Effects and See Pictures of Erivedge »

Last reviewed on RxList: 4/27/2016
This monograph has been modified to include the generic and brand name in many instances.

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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