Vismodegib

Vismodegib is a prescription medicine used for the treatment of basal cell carcinoma.

• Vismodegib is available under the following different brand names: Erivedge

Common side effects of Vismodegib include:

• nausea, vomiting, decreased appetite;
• diarrhea, constipation;
• tired feeling;
• joint pain, muscle spasms;
• hair loss;
• weight loss; or
• decreased sense of taste.

Serious side effects of Vismodegib include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat, and

Rare side effects of Vismodegib include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 150 mg

Basal Cell Carcinoma

Adult dosage

• 150 mg orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Vismodegib has severe interactions with no other drugs.
• Vismodegib has serious interactions with the following drug:
  • palifermin
• Vismodegib has moderate interactions with at least 21 other drugs.
• Vismodegib has minor interactions with the following drug:
  • levoketoconazole

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vismodegib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vismodegib?”

Cautions

• Can cause fetal harm when administered to pregnant women, or if pregnant women are exposed to vismodegib via seminal fluid
• Patients should not donate blood while taking vismodegib or for at least 24 months after the last dose
• Premature fusion of epiphyses reported in pediatric patients exposed to drug; In some cases, fusion progressed after drug discontinuation
• Advise males not to donate semen during and for 3 months after therapy
• Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, reported during treatment; permanently discontinue in patients with these reactions

Pregnancy and Lactation

• 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
• Can cause fetal harm when administered to a pregnant woman based on its mechanism of action (by either direct exposure or exposure from seminal fluid); see Black Box Warnings
• Shown to be teratogenic, embryotoxic, and fetotoxic in rats at maternal exposures lower than the human exposures at the recommended dose of 150 mg/day; embryo lethal in rats at exposures within the range achieved at the recommended human dose
• Advise females of reproductive potential to use effective contraception during therapy and for 24 months after the final dose; advise male patients to use condoms, even after a vasectomy, to avoid potential drug exposure in pregnant partners and female partners of reproductive potential during therapy and for 3 months after the final dose
• Amenorrhea can occur in females of reproductive potential; the reversibility of amenorrhea is unknown
• Advise males to use condoms, even after a vasectomy, to avoid potential drug exposure in pregnant partners and female partners of reproductive potential during therapy and for 3 months after the final dose; advise male patients not to donate semen during and for 3 months after the final dose
• Lactation
  • Unknown whether distributed in breast milk; because of the potential for serious adverse reactions in breastfed infants from therapy, advise a nursing woman that breastfeeding is not recommended during therapy and for 24 months after the final dose
  • A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother