vismodegib (Rx)

Brand and Other Names:Erivedge
  • Print

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule

  • 150mg

Basal Cell Carcinoma

Indicated for 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 or radiation

150 mg PO qDay

Continue until disease progression or unacceptable toxicity

Dosage Modifications

Hepatic and renal impairment: No dosage adjustment necessary

Intolerable adverse reactions

  • Withhold treatment for ≤8 weeks for intolerable adverse reactions until improvement or resolution
  • Treatment durations <8 weeks prior to interruptions have not been studied

Safety and efficacy not established

Clinical trials did not include sufficient numbers of patient 65 years or older to evaluate if a different dose is required

Next:

Interactions

Interaction Checker

and vismodegib

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • palifermin

                palifermin increases toxicity of vismodegib by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              Monitor Closely (19)

              • aluminum hydroxide

                aluminum hydroxide will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • aluminum hydroxide/magnesium carbonate

                aluminum hydroxide/magnesium carbonate will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • aluminum hydroxide/magnesium trisilicate

                aluminum hydroxide/magnesium trisilicate will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • aspirin/citric acid/sodium bicarbonate

                aspirin/citric acid/sodium bicarbonate will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • calcium carbonate

                calcium carbonate will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • cimetidine

                cimetidine will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • dexlansoprazole

                dexlansoprazole will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • dichlorphenamide

                dichlorphenamide and vismodegib both decrease serum potassium. Use Caution/Monitor.

              • esomeprazole

                esomeprazole will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • famotidine

                famotidine will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • ibuprofen/famotidine

                ibuprofen/famotidine will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • lansoprazole

                lansoprazole will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • magnesium hydroxide

                magnesium hydroxide will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • magnesium oxide

                magnesium oxide will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • nizatidine

                nizatidine will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • omeprazole

                omeprazole will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • pantoprazole

                pantoprazole will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • rabeprazole

                rabeprazole will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • siponimod

                siponimod and vismodegib both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              Minor (0)

                Previous
                Next:

                Adverse Effects

                >10%

                Muscle spasms (71.7%)

                Alopecia (63.8%)

                Dysgeusia (55.1%)

                Weight loss (44.9%)

                Fatigue (39.9%)

                Nausea (30.4%)

                Diarrhea (29%)

                Decreased appetite (25.4%)

                Constipation (21%)

                Arthralgias (15.9%)

                Vomiting (13.8%)

                Ageusia (10.9%)

                1-10%

                Hyponatremia (4%)

                Azotemia (2%)

                Hypokalemia (1%)

                Frequency Not Defined

                Amenorrhea

                Premature fusion of epiphyses

                Increased blood creatinine phosphokinase

                Postmarketing Reports

                Drug-induced liver injury

                Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms

                Previous
                Next:

                Warnings

                Black Box Warnings

                Embryo-fetal toxicity

                • Can cause fetal harm when administered to a pregnant woman based on its mechanism of action
                • Shown to be embryotoxic, fetotoxic, and teratogenic in animals
                • Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations
                • Verify pregnancy status of females of reproductive potential ≤7 days before initiating therapy
                • Advise male and female patients of the risks of embryo-fetal death and severe birth defects and the need for contraception during and after treatment
                • Advise males of the potential risk of drug exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential
                • Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant
                • Report exposure during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555

                Contraindications

                None

                Cautions

                Can cause fetal harm when administered to pregnant women, or if pregnant women are exposed to vismodegib via seminal fluid

                Patient should not donate blood while taking vismodegib or for at least 24 months after 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

                Previous
                Next:

                Pregnancy & Lactation

                Pregnancy

                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; embryolethal 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 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; 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 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 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

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

                Previous
                Next:

                Pharmacology

                Mechanism of Action

                Hedgehog (Hh) pathway inhibitor; the Hedgehog signaling pathway is important in embryogenesis, but in adults, it is mostly inactive; signaling is relayed by key proteins including Smoothened (SMO)

                Hh ligand-expressing cancerous epithelial cells that are activated by the Hh signaling pathway may cause growth-promotion; vismodegib binds to and inhibits SMO, a transmembrane protein involved in Hedgehog signal transduction

                Absorption

                Bioavailability: 31.8%

                Steady-state achieved within 7 days

                Distribution

                Protein Bound: >99%, binds to both albumin and alpha-1-acid glycoprotein

                Vd: 16.4-26.6 L

                Metabolism

                >98% of total circulating drug components are the parent drug

                Minimally metabolized by oxidation, glucuronidation, and pyridine ring cleavage

                Minor substrate of CYP2C9 and CYP3A4

                Minor inhibitor of CYP2C8, CYP2C9, and CYP2C19

                An inhibitor of BCRP transporter

                Elimination

                Half-life: 4 days (at steady-state); 12 days (single-dose)

                Excretion: Feces 82%, urine 4.4%

                Previous
                Next:

                Administration

                Oral Administration

                May take with or without food

                Swallow capsules whole; do not open or crush capsules

                If a dose missed, resume with the next scheduled dose

                Storage

                Capsules: Store at room temperature 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

                Previous
                Next:

                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Erivedge oral
                -
                150 mg capsule

                Copyright © 2010 First DataBank, Inc.

                Previous
                Next:

                Patient Handout

                Patient Education
                vismodegib oral

                VISMODEGIB - ORAL

                (VIS-moe-DEG-ib)

                COMMON BRAND NAME(S): Erivedge

                WARNING: Vismodegib must not be used during pregnancy because it may cause serious harm (possibly death) to an unborn baby. Women of childbearing age must have a negative pregnancy test within 7 days before starting this medication. They must also use a reliable form of birth control before starting vismodegib, while taking it, and for 2 years after the last dose of vismodegib.Vismodegib passes into semen. Men taking vismodegib, even men who have had a vasectomy, must use condoms with spermicide during sex with women who are pregnant or of childbearing age, both during treatment with vismodegib and for 3 months after the last dose of this medication. Men should also not donate sperm during this time.If you or your partner become pregnant or think you may be pregnant, tell your doctor right away.

                USES: This medication is used to treat adults with a certain type of skin cancer (basal cell carcinoma).

                HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking vismodegib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the capsules whole. Do not crush or chew the capsules.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Tell your doctor if your condition persists or worsens.Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the contents of the capsules.

                SIDE EFFECTS: Muscle spasms, hair loss, taste changes/loss, weight loss, tiredness, nausea, diarrhea, loss of appetite, constipation, vomiting, or joint pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: missed periods.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before taking vismodegib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Do not donate blood while taking this drug and for 2 years after stopping treatment. This will prevent the possibility of your blood being given to a pregnant woman.This medication may stop normal bone growth and affect final height, or bring on early puberty, if it is used by children/young adults. Ask your doctor for more details.This medication must not be used during pregnancy. It may harm an unborn baby. Men and women must use an effective form of birth control (such as condoms with spermicide and birth control pills) while taking this medication. Consult your doctor for more details and to discuss reliable forms of birth control. (See also Warning section.)It is unknown if this medication passes into breast milk. Because of the potential harm to a nursing infant, breast-feeding while using this drug and for 2 years after your last dose of this medication is not recommended. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as a pregnancy test) must be performed before starting vismodegib and periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

                Previous
                Next:

                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                Additional Offers
                Email to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Email Forms to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Previous
                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.