EDURANT 25 MG — DIN 02370603

What is EDURANT?

EDURANT 25 MG contains RILPIVIRINE (RILPIVIRINE HYDROCHLORIDE) : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02370603, held by JANSSEN INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 09-Sep-2014. 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 EDURANT used for?

EDURANT® (rilpivirine), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult and pediatric patients 12 years of age and older (and weighing ≥35 kg) with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.

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

How is it administered?

Adults: The recommended dose of Edurant is one 25 mg tablet once daily which must be taken with a meal. Pediatric Patients (12 to <18 years of age and weighing ≥35 kg): The recommended dose of Edurant for pediatric patients 12 years to <18 years of age and weighing at least 35 kg is one 25 mg tablet once daily which must be taken with a meal. Pregnancy and Postpartum: The recommended dose of Edurant in pregnant patients is one 25 mg tablet once daily taken with a meal. Lower exposures of rilpivirine were observed during the 2nd and 3rd trimesters of pregnancy, therefore viral load should be monitored closely. Hepatic Impairment: No dose adjustment of Edurant is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Use is not recommended in severe hepatic impairment (Child-Pugh score C). Renal Impairment: No dose adjustment of Edurant is required in patients with mild to moderate renal impairment. Dose adjustment with Rifabutin coadministration: For patients concomitantly receiving rifabutin, the Edurant dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal. When rifabutin co-administration is stopped, the Edurant dose should be decreased to 25 mg once daily, taken with a meal. Administration: Edurant tablets should be swallowed whole with water. Edurant must be taken with a meal. Missed Dose: If the patient misses a dose of Edurant within 12 hours of the time it is usually taken, the patient should take Edurant with a meal as soon as possible, and then take the next dose of Edurant at the regularly scheduled time. If a patient misses a dose of Edurant by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule.

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

Contraindications

Edurant is contraindicated in patients who are hypersensitive to rilpivirine or to any ingredient in the formulation. Co-administration of Edurant is contraindicated with drugs which induce CYP3A enzymes or increase gastric pH as this may result in significant decreases in the plasma concentrations of rilpivirine, a loss of virologic response and possible resistance to Edurant and to the NNRTI class of antiretrovirals. Contraindicated drugs include: Anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin), Antimycobacterials (rifapentine, rifampin), systemic dexamethasone (more than a single dose), Herbal products (St. John's wort (Hypericum perforatum)), and Proton pump inhibitors (esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole).

Warnings and precautions

Transmission of HIV: Patients should be advised that current antiretroviral therapy does not cure HIV. Appropriate precautions to prevent the transmission of HIV should continue to be employed. Virologic failure and development of resistance: More Edurant-treated subjects with baseline HIV-1 RNA >100,000 copies/mL experienced virologic failure. More Edurant-treated subjects with CD4+ cell count less than 200 cells/mm³ at the start of therapy experienced virologic failure. The observed virologic failure rate in Edurant-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class. More subjects treated with Edurant developed tenofovir and lamivudine/emtricitabine associated resistance. Interactions with medicinal products: Caution should be exercised when prescribing Edurant with drugs that may reduce the exposure of rilpivirine. Resistance testing should guide the use of Edurant. Carcinogenesis and Mutagenesis: Rilpivirine induced benign and malignant tumors in the liver of mice and rats, and thyroid follicular cells in rats. These effects are considered rodent-specific. Cardiovascular: Edurant should be administered with caution to patients who are suspected to be at an increased risk of experiencing proarrhythmic conditions such as hypokalemia, clinically significant bradycardia, acute myocardial ischemia, congestive heart failure or congenital prolongation of QTc interval. Edurant has been associated with prolongation of the QT interval. Edurant should be used with caution when co-administered with drugs with a known risk of Torsade de Pointes. Endocrine and Metabolism: Serum lipids and blood glucose may increase during antiretroviral therapy. Lipid disorders and blood glucose elevations should be managed as clinically appropriate. Gastrointestinal: Edurant contains lactose. Not recommended for patients with rare hereditary problems of galactose intolerance (severe lactase deficiency or glucose-galactose malabsorption). Hepatotoxicity: Hepatic adverse events have been reported. Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity is recommended. Immune Reconstitution Inflammatory Syndrome: Has been reported in patients treated with combination antiretroviral therapy, including Edurant. Autoimmune disorders have also been reported. Psychiatric: Depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) have been reported. Patients with severe depressive symptoms should seek immediate medical evaluation. Skin: Severe skin and hypersensitivity reactions, including DRESS, have been reported. Discontinue Edurant immediately if signs or symptoms of severe skin or hypersensitivity reactions develop.