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Nelfinavir

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IMPORTANT WARNING:

Posted 09/10/2007 Pfizer issued a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate (EMS), a process-related impurity in nelfinavir (Viracept) and to provide guidance on the use of nelfinavir in pregnant women and pediatric patients. EMS is a potential human carcinogen. Data from animal studies indicate EMS is teratogenic, mutagenic and carcinogenic; however, no data from humans exist. FDA has asked Pfizer to implement new specifications to limit the presence of EMS in Pfizer-manufactured nelfinavir products marked in the United States.

For pediatric patients who are stable on nelfinavir-containing regimens, FDA and Pfizer agree that the benefit-risk ratio remains favorable and those patients may continue to receive nelfinavir. Pediatric patients who need to begin HIV treatment should not start regimens containing nelfinavir until further notice. Pregnant women who need to begin antiretroviral therapy should not be offered regimens containing nelfinavir until further notice. As a precautionary measure, pregnant women currently receiving nelfinavir should be switched to an alternative antiretroviral therapy while Pfizer and FDA work to implement the long term EMS specification for nelfinavir. For pregnant women with no alternative treatment options, FDA and Pfizer agree that the risk-benefit ratio remains favorable for the continued use of nelfinavir.

IMPORTANT WARNING:

The effect of nelfinavir on the clinical progression of HIV infection, including the effect on the incidence of opportunistic infections or on overall survival, remains to be established.

Why is this medication prescribed?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Nelfinavir is used in combination with other drugs, such as zidovudine (AZT), to treat human immunodeficiency virus (HIV) infections in patients with or without acquired immunodeficiency syndrome (AIDS). Nelfinavir is one of a class of drugs called protease (pro' tee ace) inhibitors, which slow the spread of HIV infection in the body.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Nelfinavir comes as a tablet and a powder to take by mouth. It usually is taken three times a day with a meal or light snack. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nelfinavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Nelfinavir powder may be added to water, milk, formula, soy milk, or dietary supplements. Your prescription label tells you how many scoops of powder to add to the liquid. Drink the entire mixture to get the full dose.

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). After nelfinavir powder has been added to liquid, the mixture may be kept at room temperature for up to 6 hours. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Nelfinavir is not a cure and does not prevent the spread of HIV infection to other people, so use precautions to avoid the spread of this infection.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to nelfinavir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

Viracept®

Viracept® Oral Powder

Notes:

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EditText of this page (last edited February 28, 2008)