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Black Box Warnings .
Embryo-Fetal Death and Severe Birth Defects
embryotoxic and teratogenic in animals, incl. severe midline defects, missing digits, and other irreversible malformations; verify pregnancy status w/in 7 days of tx start; advise female pts of need for contraception during and after tx; advise male pts of potential exposure risk via semen and need for condoms during and after tx
Adult Dosing .
Dosage forms: 150
Restricted Distribution in US
- [1-888-249-4918 or ErivedgeAccessSolutions.com for more info]
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
basal cell CA, locally advanced or metastatic
- [150 mg PO qd]
- Info: do not open cap
- [no adjustment]
- [no adjustment]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
- hypersens. to drug/class/compon.
- avoid blood donation during tx and x7mo after D/C
- avoid semen donation during tx and x3mo after D/C
Drug Interactions .
hedgehog pathway inhibitor
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
- teratogenicity (animal studies)
- muscle spasms
- weight loss
- appetite decr.
- loss of taste
Pregnancy: N/A, see below
Lactation: Safety Unknown
use effective contraception during tx and x7mo after D/C in women of childbearing potential; use condoms during tx and x3mo after D/C in men w/ partners of childbearing potential; report pregnancies to 1-888-835-2555; may incr. risk of fetal harm based on animal studies and drug's mechanism of action
pregnancy test w/in 7 days of tx start
Metabolism: liver primarily; CYP450: minimal
Excretion: feces 82% (primarily unchanged), urine 4.4%; Half-life: 12 days (single dose), 4 days (continuous daily dosing)
Subclass: Other Oncologics
Mechanism of Action
binds and inhibits the Smoothened receptor, leading to hedgehog signaling pathway inhibition and decreased tumor cell proliferation
Manufacturer: Genentech, Inc.
Approximate Retail Price
- 150 mg (30 ea): $9,016.07
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