Nelfinavir

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 until further notice. If you already take nelfinavir your doctor may recommend that you keep taking it. Do not change any of your medications without your doctor's advice.

Do not take nelfinavir with amiodarone (Cordarone, Pacerone), quinidine (Quinaglute, Quinidex), cisapride (Propulsid), 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. 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.

Taking nelfinavir will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

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 should I discuss with my healthcare provider before taking nelfinavir?

Do not take this medication if you are allergic to nelfinavir.

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

Before taking nelfinavir, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• diabetes;
• a bleeding disorder such as hemophilia; or
• high cholesterol or triglycerides.

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

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.

Do not give this medication to a child younger than 2 years old.

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.

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 unacceptably high levels of an impurity that is 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. It is believed that the benefits of treating HIV or AIDS still outweigh the risk of cancer from exposure to this impurity in most people. However, children and pregnant women should not take nelfinavir if they have never been treated with any prior HIV medication.

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.

Taking nelfinavir will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of nelfinavir?

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. Tell your doctor about any unusual or bothersome side effect.

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);
• lopinavir/ritonavir (Kaletra);
• methadone (Dolophine, Methadose);
• omeprazole (Prilosec);
• St. John's wort;
• antibiotics such as itraconazole (Sporanox), ketoconazole (Nizoral), rifabutin (Mycobutin), or rifampin (Rifadin, Rimactane, Rifater);
• 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), 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.

Where can I get more information?

Your pharmacist can provide more information about nelfinavir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 9.03. Revision date: 10/18/2007.