October 2015

New Product - Viekira Pak-RBV Combination Therapy Pack

Viekira Pak‑RBV Combination Therapy Pack ((paritaprevir/ritonavir/ombitasvir), dasabuvir, ribavirin) combines ribavirin with three direct acting hepatitis C virus antiviral agents with distinct mechanisms of action and nonoverlapping resistance profiles to target HCV at multiple steps in the viral lifecycle. Viekira Pak-RBV is indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis. Viekira Pak‑RBV is contraindicated in the following: severe hepatic impairment (Child-Pugh C); use of ethinyloestradiol containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings; drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events; drugs that are moderate or strong inducers of CYP3A and strong inducers of CYP2C8 and may lead to reduced efficacy of Viekira Pak; and drugs that are strong inhibitors of CYP2C8 and may increase dasabuvir plasma concentrations and the risk of QT prolongation. Viekira Pak‑RBV use is also contraindicated with the following drugs: alfuzosin, amiodarone, quinidine, carbamazepine, phenytoin, phenobarbitone, astemizole, terfenadine, cisapride, colchicine (in renal/ hepatic impairment), gemfibrozil, rifampicin, blonanserin, ergotamine, dihydroergotamine, ergonovine, methylergonovine, St John's wort, lovastatin, simvastatin, salmeterol, pimozide, efavirenz, sildenafil (in PAH), ticagrelor, triazolam, oral midazolam, fusidic acid, mitotane and enzalutamide. Viekira Pak-RBV Combination Therapy Pack is available as a composite pack containing paritaprevir 75 mg/ ritonavir 50 mg/ ombitasvir 12.5 mg tablets in packs of 56 tablets, dasabuvir 250 mg tablets in packs of 56 tablets, and ribavirin tablets (available as RBV 200 (168 tablets of ribavirin 200 mg), RBV 400 (56 tablets of ribavirin 400 mg), RBV 1000 (28 tablets of ribavirin 600 mg + 28 tablets of ribavirin 400 mg), or RBV 1200 (56 tablets of ribavirin 600 mg)). Viekira Pak‑RBV is dispensed in a monthly carton for a total of 28 days of therapy.

This list is a summary of only some of the changes that have occurred over the last month. Before prescribing, always refer to the full product information.

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