Important Information for Prescribers on Viracept (Nelfinavir)
The HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission and the HHS Panel on Pediatric Antiretroviral Therapy and Management Guidelines want to bring the below May 6, 2008 letter from Pfizer to your attention regarding use of Viracept (nelfinavir mesylate) in pregnant HIV-infected women and HIV-infected children:
On September 10, 2007, Pfizer informed prescribers of potential concerns related to the presence of ethyl methane sulfonate (EMS) in Viracept (nelfinavir) and provided guidance on the use of Viracept (nelfinavir) in pregnant women and pediatric patients. At that time, the Food and Drug Administration (FDA) asked Pfizer to implement an interim specification to limit the presence of EMS in nelfinavir mesylate used in Viracept while working toward a long-term specification. Health care providers were advised not to initiate antiretroviral regimens containing Viracept (nelfinavir) in their pregnant female or new pediatric patients and to switch pregnant patients receiving Viracept (nelfinavir) to alternative therapy unless no alternative was available. For pediatric patients who were stable on Viracept (nelfinavir), the FDA and Pfizer agreed the benefit-risk ratio remained favorable and those patients could continue to receive the drug. No limits were placed on use of Viracept (nelfinavir) in other patient populations.
As of March 31, 2008, all Viracept (nelfinavir) manufactured and released by Pfizer now meets the new final EMS limits established by the FDA for prescribing to all patient populations, including pregnant women and pediatric patients. The Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection are in the process of being revised to reflect this change in recommendation. The Panels would like to bring to providers' attention that Viracept (nelfinavir) may now be prescribed for pregnant women and for new pediatric patients.
- Full Dear Healthcare Provider Letter - PDF
- AIDSinfo: Nelfinavir drug fact sheet
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