Monday, September 19, 2016

nelfinavir


Generic Name: nelfinavir (nel FIN a veer)

Brand Names: Viracept


What is nelfinavir?

Nelfinavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Nelfinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.


Nelfinavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Nelfinavir is not a cure for HIV or AIDS.


Nelfinavir may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about nelfinavir?


A European version of nelfinavir was found to have high levels of an impurity known to cause cancer in animals. Nelfinavir in the U.S. was found to have lower levels of the impurity, which is created during the manufacturing process but can be minimized.

It is not known whether this impurity has caused harm to anyone taking nelfinavir, and it is important to keep treating your condition. Children and pregnant women should not take nelfinavir as a "first-line" treatment. If you already take nelfinavir your doctor may recommend that you keep taking it. Do not stop taking nelfinavir or change your dose without your doctor's advice.


Do not take nelfinavir with amiodarone (Cordarone, Pacerone), quinidine (Quinaglute, Quinidex), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, or Methergine. These drugs can cause life-threatening side effects if you use them while you are taking nelfinavir.

There are many other medicines that can interact with nelfinavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.


Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex.


What should I discuss with my healthcare provider before taking nelfinavir?


You should not take this medication if you are allergic to nelfinavir, or if you have severe liver or kidney disease.


Do not take nelfinavir with amiodarone (Cordarone, Pacerone), quinidine (Quinaglute, Quinidex), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, or Methergine. These medications can cause life-threatening side effects if you use them while you are taking nelfinavir.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take nelfinavir.


  • liver disease;

  • kidney disease;


  • diabetes;




  • a bleeding disorder such as hemophilia; or




  • high cholesterol or triglycerides.




FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant. Nelfinavir can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking nelfinavir.

If you are pregnant, your name may need to be listed on an antiviral pregnancy registry when you start using this medication.


You should not breast-feed while you are using nelfinavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk. Do not give this medication to a child younger than 2 years old.

The powder form of nelfinavir may contain phenylalanine. Talk to your doctor before using this form of nelfinavir if you have phenylketonuria (PKU).


How should I take nelfinavir?


A European version of nelfinavir was found to have high levels of an impurity known to cause cancer in animals. This impurity is created during the manufacturing process but can be minimized. Nelfinavir in the U.S. is not made by the same manufacturer as the European version, and the U.S. version was found to have lower levels of the impurity.

It is not known whether this impurity has caused harm to anyone taking nelfinavir, and it is important to keep treating your condition. Children and pregnant women should not take nelfinavir as a "first-line" treatment. If you already take nelfinavir your doctor may recommend that you keep taking it. Do not stop taking nelfinavir or change your dose without your doctor's advice.


Take nelfinavir exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.


This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


Take nelfinavir with a full glass (8 ounces) of water. Nelfinavir works best if you take it with food.

Swallow the nelfinavir tablet whole.


If you cannot swallow a whole tablet, dissolve it in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.


A dose of nelfinavir powder must be mixed with liquid. You may use water, milk, formula, soy formula, soy milk, or a dietary supplement. Do not mix the powder with apple juice, orange juice, or other acidic juices or foods. Do not add the liquid directly to the bottle of nelfinavir powder.


Drink the mixture right away. If the mixture is not used right away, it may be stored in a refrigerator for up to 6 hours.


It is important to use nelfinavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.


To be sure nelfinavir is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.


Store nelfinavir at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a nelfinavir overdose are not known.

What should I avoid while taking nelfinavir?


If you also take didanosine, take it 1 hour before or 2 hours after you take nelfinavir.


Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Nelfinavir side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking nelfinavir and call your doctor at once if you have any of these serious side effects:

  • increased urination or extreme thirst;




  • easy bruising or bleeding; or




  • signs of a new infection, such as fever or chills, cough, or flu symptoms.



Less serious side effects may include:



  • nausea, vomiting, diarrhea, stomach pain, bloating, loss of appetite;




  • tired feeling;




  • headache, mood changes; or




  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Nelfinavir Dosing Information


Usual Adult Dose for HIV Infection:

1250 mg orally every 12 hours (preferred regimen) or 750 mg every 8 hours

Usual Adult Dose for Nonoccupational Exposure:

1250 mg orally every 12 hours (preferred regimen) or 750 mg every 8 hours

Duration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.

In general, the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis include nelfinavir as part of a protease inhibitor (PI)-based regimens.

Usual Adult Dose for Occupational Exposure:

1250 mg orally every 12 hours (preferred regimen) or 750 mg every 8 hours

Duration: Therapy should begin promptly, preferably within 1 to 2 hours postexposure and continued for 4 weeks. However, the exact duration of therapy may differ based the institution's protocol.

Usual Pediatric Dose for HIV Infection:

2 to 13 years of age: 45 to 55 mg/kg orally every 12 hours or 25 to 35 mg/kg every 8 hours
Maximum dose: 2500 mg/day

Oral powder (50 mg/g):
9 to less than 10.5 kg: 2.5 teaspoons (tsp) (10 scoops) orally every 12 hours or 1.5 tsp (6 scoops) every 8 hours
10.5 to less than 12 kg: 2.75 tsp (11 scoops) orally every 12 hours or 1.75 tsp (7 scoops) every 8 hours
12 to less than 14 kg: 3.25 tsp (13 scoops) orally every 12 hours or 2 tsp (8 scoops) every 8 hours
14 to less than 16 kg: 3.75 tsp (15 scoops) orally every 12 hours or 2.25 tsp (9 scoops) every 8 hours
16 to less than 18 kg: 2.5 tsp (10 scoops) orally every 8 hours
18 to less than 23 kg: 3 tsp (12 scoops) orally every 8 hours
23 kg or more: 3.75 tsp (15 scoops) orally every 8 hours
For twice daily dosing, nelfinavir tablets are recommended for children weighing 16 kg or more.

Crushed 250 mg tablets may be used instead of powder.

Tablets (250 mg):
10 to 12 kg: 500 mg orally every 12 hours or 250 mg every 8 hours
13 to 18 kg: 750 mg orally every 12 hours or 500 mg every 8 hours
19 to 20 kg: 1000 mg orally every 12 hours or 500 mg every 8 hours
21 kg or more: 1000 to 1250 mg orally every 12 hours or 750 mg every 8 hours


What other drugs will affect nelfinavir?


Before taking nelfinavir, tell your doctor if you are using any of the following drugs:

  • fluticasone (Advair, Flonase, Flovent);




  • itraconazole (Sporanox) or ketoconazole (Nizoral);




  • lopinavir/ritonavir (Kaletra);




  • methadone (Dolophine, Methadose);




  • omeprazole (Prilosec);




  • rifabutin (Mycobutin, or rifampin (Rifadin, Rimactane, Rifater);




  • St. John's wort;




  • antidepressants such as trazodone (Desyrel) and others;




  • a calcium channel blocker such as amlodipine (Caduet, Lotrel, Norvasc), diltiazem (Tiazac, Cartia, Dilacor), felodipine (Plendil), nifedipine (Procardia, Adalat), or verapamil (Calan, Covera, Isoptin, Verelan);




  • cholesterol-lowering medicine such as atorvastatin (Lipitor), lovastatin (Mevacor, Altocor), rosuvastatin (Crestor), or simvastatin (Zocor);




  • drugs that weaken the immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);




  • insulin or diabetes medication you take by mouth;




  • medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra); or




  • seizure medications such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin).



This list is not complete and there are many other medicines that can interact with nelfinavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.



More nelfinavir resources


  • Nelfinavir Side Effects (in more detail)
  • Nelfinavir Use in Pregnancy & Breastfeeding
  • Nelfinavir Drug Interactions
  • Nelfinavir Support Group
  • 0 Reviews for Nelfinavir - Add your own review/rating


  • nelfinavir Advanced Consumer (Micromedex) - Includes Dosage Information

  • Nelfinavir MedFacts Consumer Leaflet (Wolters Kluwer)

  • Nelfinavir Mesylate Monograph (AHFS DI)

  • Viracept Prescribing Information (FDA)

  • Viracept Consumer Overview



Compare nelfinavir with other medications


  • HIV Infection
  • Nonoccupational Exposure
  • Occupational Exposure


Where can I get more information?


  • Your pharmacist can provide more information about nelfinavir.

See also: nelfinavir side effects (in more detail)


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