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ERIVEDGE is a brand name for Vismodegib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions ERIVEDGE (vismodegib) 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 (see WARNINGS AND PRECAUTIONS, Special Populations). ERIVEDGE has not been studied in patients with severe renal impairment (see WARNINGS AND PRECAUTIONS). ERIVEDGE is not recommended for use in patients with severe hepatic impairment since limited data are available in these patients (see WARNINGS AND PRECAUTIONS).
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 (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Effects on Post- Natal Development and Pediatrics and ADVERSE REACTIONS, Post-Market Adverse Events and TOXICOLOGY).
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 (see WARNINGS AND PRECAUTIONS, Skin and ADVERSE REACTIONS, Post-Market Adverse Events).
General Embryo-fetal death or severe birth defects ERIVEDGE may cause embryo-fetal death or severe birth defects when administered to a female who is pregnant (see CONTRAINDICATIONS). Hedgehog pathway inhibitors, such as vismodegib, have been demonstrated to be embryotoxic, fetotoxic and/or teratogenic in multiple animal species at exposures lower than the human exposures at the recommended dose of 150 mg/day (see TOXICOLOGY, Teratogenicity).
ERIVEDGE can cause severe malformations, including craniofacial anomalies, midline defects and limb defects (see TOXICOLOGY). ERIVEDGE must not be used during pregnancy. Effects on Post-Natal Development Irreversible premature fusion of the epiphyses (EPF) and precocious puberty have been reported in pediatric patients exposed to ERIVEDGE.
In some cases of EPF, fusion progressed after drug discontinuation (see INDICATIONS AND CLINICAL USE and WARNINGS AND PRECAUTIONS, Special Populations). ERIVEDGE® Product Monograph Page 6 of 37 In animal species, ERIVEDGE has been shown to cause severe irreversible changes in the male reproductive systems (not reversible after a 4-week recovery period), growing teeth (degeneration/necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and hemorrhage) and closure of the epiphyseal growth plate.
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These findings occurred at clinically relevant doses and indicate a potential risk for short stature, tooth deformities and future reproductive problems in infants and children (see WARNINGS AND PRECAUTIONS, Sexual Function/Reproduction and TOXICOLOGY).
Blood Donation Patients must not donate blood or blood products while on treatment (including dose interruptions) and for 24 months after treatment discontinuation. The safety of ERIVEDGE is based on single-arm clinical trials of patients with advanced BCC (aBCC).
Due to the nature of the design of the trials, it is not always possible to assign, nor to exclude, causality to a particular adverse event. As such, the following sections below describe reported adverse events based on clinical trial experience, irrespective of relatedness to ERIVEDGE (except where noted).
Carcinogenesis and Mutagenesis ERIVEDGE tested negative in a battery of in vitro and in vivo genotoxicity assays, and formal carcinogenicity studies of vismodegib have not been completed. However, pilomatricoma (a benign subcutaneous neoplasm) was observed at clinically relevant exposures in rats administered vismodegib.
Pilomatricoma has not been reported in clinical trials with vismodegib, and the relevance of this finding to patients is therefore uncertain (see DETAILED PHARMACOLOGY and TOXICOLOGY). Patients with advanced BCC have an increased risk of developing cutaneous squamous cell carcinoma (cuSCC).
Cases of cuSCC have been reported in advanced BCC patients (aBCC) treated with ERIVEDGE. Therefore, all patients should be monitored routinely while taking ERIVEDGE. Cardiovascular Cardiac-related adverse events such as atrial fibrillation, cardiac flutter, cardiac failure, restrictive cardiomyopathy, angina, myocardial infarction, and left ventricular dysfunction have been observed in aBCC patients treated with ERIVEDGE.
Fatal cases of acute myocardial infarction and ischemic stroke were reported. Typically, Grade ≥ 3 cardiac adverse events occurred in patients with a significant prior history of cardiac disease. In addition, vascular- related disorders observed include Grade ≥ 3 hypertension and orthostatic hypotension (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).
Thromboembolic events such as thrombosis, deep vein thrombosis, and pulmonary embolism (including a fatal case) have been reported (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions). ERIVEDGE® Product Monograph Page 7 of 37 Endocrine and Metabolism Decreased appetite and dehydration are considered related to treatment with ERIVEDGE.
4%) patients at 12-months post-treatment discontinuation. Electrolyte abnormalities have been observed in aBCC patients treated with ERIVEDGE including Grade 3/Grade 4 hyponatremia, and Grade 3 hypokalemia (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).
Gastrointestinal Nausea, vomiting, diarrhea, constipation, and abdominal pain are all considered related to treatment with ERIVEDGE. In addition, cases of Grade 3/Grade 4 and a fatal case of gastrointestinal hemorrhage, small intestinal obstruction, and aphagia were observed in patients treated with ERIVEDGE (see ADVERSE REACTIONS, Clinical Trial Adverse Drug […]