MYLAN-EFAVIRENZ 600 MG

What is MYLAN-EFAVIRENZ?

MYLAN-EFAVIRENZ 600 MG contains EFAVIRENZ : 600 MG. It is listed in the Health Canada Drug Product Database under DIN 02381524, held by MYLAN PHARMACEUTICALS ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 30-Jul-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 MYLAN-EFAVIRENZ used for?

Mylan-Efavirenz (efavirenz) is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.

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 dosage of Mylan-Efavirenz tablets in combination with other antiretroviral agents is 600 mg orally, once daily. It is recommended that Mylan-Efavirenz be taken on an empty stomach, preferably at bedtime. The increased efavirenz concentrations observed following administration of Mylan-Efavirenz with food may lead to an increase in frequency of adverse events. Dosing at bedtime may improve the tolerability of nervous system symptoms. For pediatric patients weighing greater than 40 kg, the recommended dosage is 600 mg, once daily. Mylan-Efavirenz tablets are not recommended for children weighing less than 40 kg because no appropriate dose adjustment can be made. If a dose is missed, patients should take the dose as soon as possible and then return to their normal schedule. However, if a dose is skipped, the patient should not double the next dose.

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

How is it stored and handled?

Mylan-Efavirenz (efavirenz tablets) should be stored between 15°C and 30°C.

How is it supplied?

Tablets 600 mg are yellow, film coated, capsule shaped, biconvex tablets, debossed with “M” on one side of the tablet and “EZ6” on the other side. Available in bottles containing 30 tablets and 100 tablets.

Contraindications

Mylan-Efavirenz (efavirenz) is contraindicated in patients with clinically significant hypersensitivity to any of its components. Mylan-Efavirenz must not be administered concurrently with cisapride, midazolam, triazolam, pimozide or ergot derivatives because competition for CYP3A4 by efavirenz could result in inhibition of metabolism of these drugs and create the potential for serious and/or life-threatening adverse events (e.g., cardiac arrhythmias, prolonged sedation or respiratory depression). Coadministration of efavirenz with elbasvir, grazoprevir, or voriconazole is contraindicated, due to the potential for significant decreases in plasma concentrations of elbasvir, grazoprevir, or voriconazole. This effect is due to an induction of CYP3A4 by efavirenz, and may result in loss of therapeutic effect. Herbal preparations containing St. John's wort (Hypericum perforatum) must not be used while taking Mylan-Efavirenz due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz.

Warnings and precautions

Coadministration of Mylan-Efavirenz with ATRIPLA, a fixed-dose combination tablet containing efavirenz, emtricitabine and tenofovir disoproxil fumarate, is not recommended. Mylan-Efavirenz may cause dizziness, impaired concentration, and/or drowsiness. Patients should be instructed that, if they experience these symptoms, they should avoid potentially hazardous tasks such as driving or operating machinery. QTc prolongation has been observed with the use of efavirenz. Consider alternatives to Mylan-Efavirenz when coadministered with a drug with a known risk of Torsade de Pointes or when administered to patients at higher risk of Torsade de Pointes. Serum lipid and blood glucose levels may increase during antiretroviral therapy (ART). Postmarketing reports of hepatic failure have occurred including some cases in patients without pre-existing hepatic disease or other identifiable risk factors. Elevated triglycerides have been reported in patients receiving efavirenz, in some cases to levels which can predispose a patient to pancreatitis. Immune Reconstitution Inflammatory Syndrome has been reported in patients treated with combination antiretroviral therapy, including efavirenz. Autoimmune disorders have also been reported. Caution should be taken in any patient with a history of seizures. Convulsions have been observed infrequently in patients receiving efavirenz, generally in the presence of known medical history of seizures. Serious psychiatric adverse experiences have been reported in patients treated with efavirenz. Mylan-Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen. Efavirenz is not recommended for patients who have had a life-threatening cutaneous reaction (e.g., Stevens-Johnson syndrome). Mylan-Efavirenz should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever. Efavirenz may cause fetal harm when administered during the first trimester to a pregnant woman. Pregnancy should be avoided in women receiving Mylan-Efavirenz and for 12 weeks after discontinuation. Barrier contraception must always be used in combination with other methods of contraception. It is recommended that women living with HIV do not breast-feed their infants in order to avoid transmission of HIV. Efavirenz has been shown to be excreted in human milk.

What can be used instead?

Other Canadian products sharing ATC code J05AG03 EFAVIRENZ. 3 of 8 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies EFAVIRENZ worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. EFAVIRENZ appears in 49 registered pack listings across 9 markets, published on 7 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.