Daily Dosage Bottles Chosen for Victrelis
In May, FDA approved Merck’s new treatment for chronic hepatitis C (CHC), Victrelis (boceprevir). The drug is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, according to Merck.
Victrelis is packaged in daily dosage bottles, with each bottle containing 12 capsules. “For Victrelis, as the medicine will be prescribed as a one-month supply, packaging in daily dosage bottles helps to keep track of product usage,” explained Mark Egan, project leader, Merck Manufacturing, to PMP News. “According to the product prescribing information, Victrelis must be administered in combination with peginterferon alfa and ribavirin. The dose of Victrelis is 800 mg (four 200-mg capsules) three times daily (every 7-9 hours) with food [a meal or light snack].”
Victrelis capsules are shipped and stored refrigerated, Egan explained. “For patient use, refrigerated capsules can remain stable until the expiration date printed on the label. Victrelis can also be stored at room temperature up to 25°C (77°F) for 3 months. The container should stay tightly closed.”
Merck’s manufacturing facilities handled all launch production, which was performed using existing bottle filling, labeling, and packaging technology, Egan said. “Through close coordination of regulatory approvals needed to import product to our finishing site, Merck was ready to package, print labels, and ship to distribution centers within hours of the FDA approval,” he reported.
Merck began shipping Victrelis to pharmacies within a week of approval. The launch also included distribution of coupons to help eligible patients with medication cost along with other support.