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Erivedge (vismodegib)

Indicated for the treatment of adults with metastatic basal cell cancer, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

An inhibitor of the Hedgehog (Hh) signaling pathway.

Binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

Single dose bioavailability is 31.8%, and absorption is not affected by food.

Has a plasma protein binding of greater then 99%.

This drug and its metabolites are eliminated primarily by the hepatic route with 82% of the drug recovered in the feces and 4.4% in the urine.

Objective response rate in metastatic basal cell carcinoma is 30.3%, all of which was partial responses with a median response duration of 7.6 months.

Objective response rate in the locally advanced basal cell carcinoma was 42.9%, with 20.6% complete responses, and 22.2%, partial responses.

21% of the patients treated in the single international study involving 104 patients had Gorlin syndrome.

Side effects include nausea 30%, diarrhea 29%, constipation 21%, and vomiting, 13.8%, fatigue 40%, weight loss 45%, anorexia 25.4%, muscle spasms 71.7%, arthralgias 16% dysgeusia 55%, ageusia 11%, and alopecia 63.8%.

150 mg orally daily.

Excreted predominantly as an unchanged drug.

Adverse events and systemic exposure may be increased by drugs that inhibit P-glycoprotein, such as clarithromycin, erythromycin, and azithromycin.

Can result in embryo-fetal death and severe birth defects.

Patients should not donate blood or blood products while receiving this drug or for at least 7 months after the last dose.

Used to treat adults with basal cell carcinoma that has spread to other parts of the body or has recurred after surgery or for lesions that cannot be treated with surgery or radiation.

Requires a pregnancy test before taking Erivedge.

Erivedge is present in semen.

 

Most common side effects are:

Muscle spasms

Hair loss

Change in how things taste or loss of taste

Weight loss

Tiredness

Nausea

Diarrhea

Decreased appetite

Constipation

Joint pain

Vomiting

Can cause amenorrhea in females who are able to become pregnant.

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