Dosage & Administration
The recommended dosage is 150 mg orally once daily.
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Erivedge Prescribing Information
- 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 [see Warnings and Precautions (5.1), Use in Specific Populations (8.1)].
- Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE [see Dosage and Administration (2.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].
- 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 [see Warnings and Precautions (5.1), Use in Specific Populations (8.3)].
ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, 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.
Important Safety Information
Verify pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE [see Use in Specific Populations (8.1, 8.3)].
Recommended Dosage
The recommended dosage of ERIVEDGE is 150 mg taken orally once daily, with or without food, until disease progression or until unacceptable toxicity.
Swallow capsules whole. Do not open or crush capsules.
If a dose of ERIVEDGE is missed, resume dosing with the next scheduled dose.
Dosage Modifications for Adverse Reactions
Withhold ERIVEDGE for up to 8 weeks for intolerable adverse reactions until improvement or resolution. Treatment durations shorter than 8 weeks prior to interruptions have not been studied.
Permanently discontinue ERIVEDGE if patients experience severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS) [see Warnings and Precautions (5.2)].
Interrupt ERIVEDGE for severe or intolerable musculoskeletal adverse reactions. Permanently discontinue ERIVEDGE for recurrent, severe or intolerable musculoskeletal adverse reactions [see Warnings and Precautions (5.3)].
Capsules: 150 mg with "150 mg" printed on pink opaque body and "VISMO" printed on grey opaque cap in black ink.
Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ERIVEDGE during pregnancy. Report pregnancies to Genentech at 1-888-835-2555.
Risk Summary
Based on its mechanism of action and findings from animal reproduction studies, ERIVEDGE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. In animal reproduction studies, oral administration of vismodegib during organogenesis at doses below the 150 mg clinical dose resulted in embryotoxicity, fetotoxicity, and teratogenicity in rats (see Data). There are no human data on the use of ERIVEDGE in pregnant women. Advise pregnant women of the potential risk to a fetus.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data
Animal Data
In an embryo-fetal toxicity study, pregnant rats were administered vismodegib orally at doses of 10, 60, or 300 mg/kg/day during the period of organogenesis. Pre- and post-implantation loss were increased at doses of ≥ 60 mg/kg/day [approximately 2 times the human exposure at the 150 mg clinical dose based on area under the curve (AUC)], which included early resorption of 100% of the fetuses. A dose of 10 mg/kg/day [approximately 0.2 times the human exposure (AUC) at the recommended 150 mg clinical dose] resulted in malformations (including missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (including dilated renal pelvis, dilated ureter, and incompletely or unossified sternal elements, centra of vertebrae, or proximal phalanges and claws).
Lactation
No data are available regarding the presence of vismodegib in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Because of the potential for serious adverse reactions in breastfed infants from ERIVEDGE, advise women that breastfeeding is not recommended during therapy with ERIVEDGE and for 24 months after the final dose.
Females and Males of Reproductive Potential
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE.
Contraception
Based on its mechanism of action and animal data, ERIVEDGE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].
Females
Advise females of reproductive potential to use effective contraception during therapy with ERIVEDGE and for 24 months after the final dose.
Males
Vismodegib is present in semen [see Clinical Pharmacology (12.3)]. It is not known if the amount of vismodegib in semen can cause embryo-fetal harm. Advise male patients to use condoms, even after a vasectomy, to avoid drug exposure to pregnant partners and female partners of reproductive potential during therapy with and for 3 months after the final dose of ERIVEDGE. Advise males of the potential risk to an embryo or fetus if a female partner of reproductive potential is exposed to ERIVEDGE. Advise males not to donate semen during therapy with ERIVEDGE and for 3 months after the final dose.
Infertility
Females
Amenorrhea can occur in females of reproductive potential. Reversibility of amenorrhea is unknown [see Adverse Reactions (6.1)].
Pediatric Use
The safety and effectiveness of ERIVEDGE have not been established in pediatric patients.
Premature fusion of the epiphyses [see Warnings and Precautions (5.3)] and precocious puberty have been reported in pediatric patients exposed to ERIVEDGE. In some cases, epiphyseal fusion progressed after drug discontinuation.
Juvenile Animal Toxicity Data
In repeat-dose toxicology studies in rats, administration of oral vismodegib resulted in toxicities in bone and teeth. Effects on bone consisted of closure of the epiphyseal growth plate when oral vismodegib was administered for 26 weeks at ≥ 50 mg/kg/day (approximately ≥ 0.4 times the human exposure (AUC) at the 150 mg clinical dose). Abnormalities in growing incisor teeth (including degeneration/necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and hemorrhage resulting in breakage or loss of teeth) were observed after administration of oral vismodegib at ≥ 15 mg/kg/day (approximately ≥ 0.2 times the human exposure (AUC) at the 150 mg clinical dose).
Geriatric Use
Clinical studies of ERIVEDGE did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Hepatic Impairment
No dose adjustment is required in patients with hepatic impairment [see Clinical Pharmacology (12.3)].
Renal Impairment
No dose adjustment is required in patients with renal impairment [see Clinical Pharmacology (12.3)].
None.