Press room ... 1998 archive

Ritonavir Capsule Alert

July 27, 1998

San Francisco, CA—Abbott Laboratories announced today that they are experiencing manufacturing difficulties with ritonavir (Norvir) capsules. The production difficulties apply only to the capsules. They do not apply to the ritonavir oral solution. The concern that prompted the announcement is the development of a crystalline structure during production of the capsules. The crystalline structure influences how the drug gets absorbed in the body. Ultimately, it failed to meet quality assurance specifications for the drug. The source of the problem has not yet been identified. The crystalline structure has not been identified in any of the capsules currently on the market. Anyone taking ritonavir capsules should be advised that a shortage of the drug will likely happen in mid-August when the existing pharmaceutical supply of capsules will be depleted. Anyone who has difficulty obtaining ritonavir capsules can replace their capsule formulation with the ritonavir oral solution. The following information on ritonavir oral solution should be followed closely to optimize the use of the drug: The liquid should not be refrigerated and should be stored at room temperature, ideally between 68 - 77°F. It should be taken with food, and it can be taken with chocolate milk, Ensure, and Advera to minimize the unpleasant taste. To reduce the risk of crystal formation, shake the liquid well and use the oral solution within 30 days of obtaining the drug from the pharmacy. The oral solution can be used in the same manner as the capsule formulation, i.e., in combination with other drugs. The drug interaction profile between the oral solution and the capsule formulation should be identical. The only major difference between the two formulations is that the oral solution contains a higher alcohol content. Ritonavir oral solution comes with a measuring cap that is scored to measure doses of 400mg and 600mg. Project Inform will continue to provide up-to-date information regarding this development with ritonavir as it becomes available. For more information on supplies of ritonavir and implications of the manufacturing difficulties, consult Abbott Laboratories toll-free at 800-637-2400 from 7am to 7pm EST.