ERIVEDGE 150 MG

What is ERIVEDGE?

ERIVEDGE 150 MG contains VISMODEGIB : 150 MG. It is listed in the Health Canada Drug Product Database under DIN 02409267, held by HOFFMANN-LA ROCHE LIMITED, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 09-Aug-2013. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is ERIVEDGE used for?

ERIVEDGE (vismodegib) is indicated for the treatment of adult patients with histologically confirmed metastatic basal cell carcinoma (BCC) or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy. The indication is granted market authorization based on objective response rate (ORR) demonstrated in a single-arm Phase II trial. Overall survival (OS) benefit in a single-arm trial cannot be confirmed. In the pivotal trial, the majority of the clinical responses occurred within 16 weeks. Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

The recommended dose of ERIVEDGE is 150 mg once daily. ERIVEDGE should be continued until disease progression or until unacceptable toxicity. Because ERIVEDGE is only available as a single 150 mg capsule, dose adjustments are managed by therapy interruptions. ERIVEDGE can be taken without regard to meals. Capsules must be swallowed whole and must not be opened or crushed under any circumstances. If a planned dose of ERIVEDGE is missed, patients should not take the missed dose but resume dosing with the next scheduled dose.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at room temperature (15 - 30 °C). Store in the original package. Keep the bottle tightly closed in order to protect from moisture and heat. Keep out of sight and reach of children. This medicine should not be used after the expiry date (EXP) shown on the pack.

How is it supplied?

ERIVEDGE is supplied in high density polyethylene (HDPE) bottles (28 capsules per bottle).

Contraindications

ERIVEDGE (vismodegib) is contraindicated in: • Female patients who are pregnant and females at risk of becoming pregnant. • Breastfeeding female patients. • Female patients of childbearing potential (FCBP) who do not comply with the ERIVEDGE Pregnancy Prevention Program. • Male patients who do not comply with the contraceptive measures of the ERIVEDGE Pregnancy Prevention Program. • Children and adolescents aged below 18 years. • Patients who are hypersensitive to vismodegib or to any ingredient in the formulation.

Warnings and precautions

ERIVEDGE should be initiated and monitored only under the supervision of a physician qualified in the use of cancer therapies and with a full understanding of the risks of ERIVEDGE therapy and monitoring requirements. ERIVEDGE can cause embryo-fetal death or severe birth defects. ERIVEDGE has not been studied in patients with severe renal impairment. ERIVEDGE is not recommended for use in patients with severe hepatic impairment since limited data are available. ERIVEDGE is available only through a controlled distribution program called the ERIVEDGE Pregnancy Prevention Program (EPPP). ERIVEDGE can cause irreversible premature fusion of the epiphyses in pediatric patients. ERIVEDGE can cause severe cutaneous adverse reactions including Toxic Epidermal Necrolysis (TEN) and Stevens Johnson Syndrome (SJS). Patients experiencing a severe cutaneous adverse reaction should discontinue treatment with ERIVEDGE and seek prompt medical evaluation. ERIVEDGE has been shown to cause severe irreversible changes in the male reproductive systems, growing teeth, and closure of the epiphyseal growth plate in animal species, indicating potential risks for short stature, tooth deformities, and future reproductive problems in infants and children. Patients must not donate blood or blood products while on treatment and for 24 months after treatment discontinuation. Patients with advanced BCC have an increased risk of developing cutaneous squamous cell carcinoma (cuSCC). All patients should be monitored routinely while taking ERIVEDGE. Cardiac-related adverse events such as atrial fibrillation, cardiac flutter, cardiac failure, restrictive cardiomyopathy, angina, myocardial infarction, and left ventricular dysfunction have been observed. Fatal cases of acute myocardial infarction and ischemic stroke were reported. Grade ≥ 3 cardiac adverse events typically occurred in patients with a significant prior history of cardiac disease. Vascular-related disorders include Grade ≥ 3 hypertension and orthostatic hypotension. Thromboembolic events such as thrombosis, deep vein thrombosis, and pulmonary embolism (including a fatal case) have been reported. Hepatotoxicity occurred in patients treated with ERIVEDGE. Serious cases of hepatotoxicity, including cholestasis, hepatitis and hepatocellular injury, have been observed. Pre-existing liver disease, underlying malignancy, concomitant hepatotoxic medications and systemic infections may be risk factors. Renal disorders and cases of renal failure, including a fatal case, have been observed.

Who else supplies VISMODEGIB worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. VISMODEGIB appears in 9 registered pack listings across 9 markets, published on 9 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.