Nelfinavir

Nelfinavir is a prescription medication used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection.

• Nelfinavir is available under the following different brand name: Viracept

Common side effects of Nelfinavir include:

• diarrhea
• nausea
• stomach pain
• loss of appetite
• gas
• skin rash or changes in the shape or location of body fat (especially in the arms, legs, face, neck, breasts, and trunk)

Serious side effects of Nelfinavir include:

• signs of a new infection
• high blood sugar
• rapid heart rate
• unusual bleeding or weakness

Rare side effects of Nelfinavir include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 250 mg
• 625 mg

HIV Infection

Adult dosage

• 750 mg orally every 8 hours or
• 1250 mg orally every 12 hours

Pediatric dosage

• Children younger than 2 years: Safety and efficacy not established
• Children aged between 2 and 13 years: 45 to 55 mg/kg orally every 12 hours or 25 to 35 mg/kg orally every 8 hours  
• Not to exceed the adult dose of 2,500 mg/day (every 12 hours dosing) or 1,875 mg/day (every 8 hours dosing)
• Adolescents: 1,250 mg orally every 12 hours, or 750 mg orally every 8 hours

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Nelfinavir has severe interactions with at least 42 other drugs
• Nelfinavir has serious interactions with at least 147 other drugs
• Nelfinavir has moderate interactions with at least 326 other drugs
• Nelfinavir has minor interactions with at least 55 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Coadministration with major CYP3A4 substrates and/or inducers
• Drugs that are contraindicated with nelfinavir include alpha1-adrenoreceptor agonists (eg, alfuzosin), antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, quinidine), rifampin, voriconazole, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), cisapride, St. John’s wort, lovastatin, simvastatin, lurasidone, pimozide, sildenafil (when used for PAH), midazolam, and triazolam

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nelfinavir?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nelfinavir?”

Cautions

• Risk to pregnant/pediatric patients: EMS (ethyl methanesulfonate) impurity shown to be teratogenic, mutagenic, and carcinogenic in animal studies
• Oral powder contains 11.2 mg of phenylalanine per gram of powder
• Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs
• Caution in patients with hemophilia A or B (risk of bleeding); increased bleeding, including spontaneous skin hematomas and hemarthrosis reported with protease inhibitors; in more than half of cases, administration of protease inhibitors was continued or reintroduced
• Increased risks of fat redistribution, hemolytic anemia, and hyperbilirubinemia if used in combination with other antiretroviral drugs
• Increases risk of developing new-onset diabetes mellitus (DM): exacerbation of DM and hyperglycemia
• Not for use in patients with moderate to severe hepatic impairment
• In pediatrics, drug exposure is highly variable

Pregnancy and Lactation

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drugs during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263
• Published reports of hepatic adverse events ranging from elevated liver enzymes to hepatic failure in pregnant patients exposed to drug and as part of combination treatment of HIV-1 infection reported; overall adverse event profile, including hepatic adverse events, and literature reports of decreased exposures in second and third trimesters, consider alternative antiretroviral drugs during pregnancy; if drug is used during pregnancy, clinical monitoring recommended
• Therapy may reduce the efficacy of estrogen-based oral contraceptives; advise patients to use alternative or additional contraceptive measures when oral contraceptives containing ethinyl estradiol or norethindrone and nelfinavir are coadministered
• Lactation
  • The CDC recommend that HIV-1-infected patients in the U.S. not breastfeed their infants to avoid risking potential transmission of HIV-1 infection
  • Based on limited published data, the drug is present in low levels in human milk, and adverse effects in infants exposed to Nelfinavir have been reported; because of the potential for HIV-1 transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants), and the potential for serious adverse reactions in breastfed infants similar to those seen in adults, instruct mothers not to breastfeed if they are receiving therapy