Erivedge

Erivedge

vismodegib

Manufacturer:

Roche

Distributor:

Firma Chun Cheong
/
DKSH
Concise Prescribing Info
Contents
Vismodegib
Indications/Uses
For adult patients w/ symptomatic metastatic basal cell carcinoma & locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy.
Dosage/Direction for Use
Administration
May be taken with or without food: Swallow whole w/ water, do not open the cap.
Contraindications
Hypersensitivity. Concomitant use w/ St. John's wort. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
May cause embryo-foetal death or severe birth defects when administered to a pregnant woman. Male & female patients should use recommended contraception during treatment. Perform medically supervised pregnancy test w/in 7 days prior to initiating treatment & mthly during treatment. Potential risk for short stature & tooth deformities to infants & childn. Do not donate blood while on treatment & for 24 mth after the final dose. Do not donate semen while on treatment & for 2 mth after the final dose. Monitor routinely for cutaneous squamous cell carcinoma. Rare hereditary problem of galactose intolerance, primary hypolactasia or glucose-galactose malabsorption. Concomitant treatment w/ strong CYP inducers.
Adverse Reactions
Muscle spasms. Alopecia, pruritus. Dysgeusia, ageusia. Weight decreased, fatigue. Nausea, diarrhoea, constipation, vomiting. Decreased appetite. Amenorrhea.
Drug Interactions
May have altered solubility & reduced bioavailability w/ PPIs, H2-receptor antagonists & antacids. May have increased systemic exposure w/ inhibitors of P-gp (eg, clarithromycin, erythromycin, azithromycin, verapamil, cyclosporin), CYP2C9 (amiodarone, fluconazole or miconazole) or CYP3A4 (boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin or voriconazole). May have decreased exposure w/ CYP inducers (rifampicin, carbamazepine, phenytoin, St. John's wort). May give rise to increased exposure of medicinal products transported by breast cancer resistance protein eg, rosuvastatin, topotecan & sulfasalazin. Caution w/ contraceptive steroids.
ATC Classification
L01XX43 - vismodegib ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Erivedge hard cap 150 mg
Packing/Price
28's
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