Melanoma and other skin cancers:

Indications for: ERIVEDGE

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

Adult Dosage:

Swallow whole. 150mg once daily until disease progression or unacceptable toxicity. Withhold for up to 8 weeks for intolerable reactions until improved or resolved.

Children Dosage:

Not established.

Boxed Warning:

Embryo-fetal toxicity.

ERIVEDGE Warnings/Precautions:

Risk of embryo-fetal death or severe birth defects in pregnant women. Verify pregnancy status within 7 days prior to initiating therapy. Advise females of reproductive potential to use effective contraception during therapy and for 24 months after final dose; male patients should use condoms (even after a vasectomy) during and for 3 months after final dose. Advise patients not to donate blood or blood products during therapy and for 24 months after final dose. Advise male patients not to donate semen during and for 3 months after final dose. Permanently discontinue if severe cutaneous adverse reactions occur (eg, SJS, TEN, DRESS). Obtain baseline serum CPK and creatinine levels, and as clinically indicated. Based on severity, interrupt dose or discontinue if musculoskeletal adverse reactions occur or serum CPK elevation. Premature fusion of the epiphyses (in pediatrics, if exposed). Pregnancy: avoid. Nursing mothers: not recommended (during and for 24 months after final dose).

ERIVEDGE Classification:

Hedgehog pathway inhibitor.

Adverse Reactions:

Muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, vomiting, decreased appetite, constipation, arthralgias, ageusia; amenorrhea.

Note:

Report immediately exposure to Erivedge during pregnancy by contacting the Genentech Adverse Event Line at (888) 835-2555.

Metabolism:

Metabolic pathways include oxidation, glucuronidation, and pyridine ring cleavage. 

The two most abundant oxidative metabolites recovered in feces are produced in vitro by recombinant CYP2C9 and CYP3A.

 

Drug Elimination:

Fecal (82%), renal (4.4%). 

Half-life: 4 days (after continuous once-daily dosing); 12 days (after a single dose).

Generic Drug Availability:

NO

How Supplied:

Caps—28