Nelfinavir

Nelfinavir is a prescription medication used to treat human immunodeficiency virus (HIV) infection. Nelfinavir is in a class of medicines called HIV protease inhibitors. Nelfinavir works by blocking HIV protease (a protein-cutting enzyme), which is required for HIV to multiply.

This medication comes in tablet and powder forms. It is usually taken 2 to 3 times daily, with food.

Common side effects include diarrhea and nausea.

Nelfinavir is a prescription medicine used to treat HIV infection. HIV is the virus that causes AIDS (acquired immune deficiency syndrome).

• Nelfinavir is always used in combination with other antiretroviral drugs in the treatment of people with HIV infection.
• Nelfinavir is for adults and for children 2 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Adults

The recommended adult dose of nelfinavir is 1250 mg (five 250 mg tablets or two 625 mg tablets) taken two times a day or 750 mg (three 250 mg tablets) taken three times a day. Each dose should always be taken with a meal to help achieve higher nelfinavir levels. Nelfinavir tablets are film-coated to help make the tablets easier to swallow.

Children

Dosing in children 2 years of age and older: The nelfinavir dose in children depends on their weight. The recommended oral dose of nelfinavir oral powder or 250 mg tablets is 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily. All doses should be taken with a meal. Children who cannot swallow tablets may take nelfinavir oral powder or crushed tablets.

Serious side effects may occur:

• Diabetes and high blood sugar (hyperglycemia) occur in patients taking protease inhibitors such as Nelfinavir. Some patients had diabetes before starting protease inhibitors, others did not. Some patients needed changes in their diabetes medicine. Others needed new diabetes medicine after starting their Nelfinavir medicine.
• Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
• Some patients with hemophilia have increased bleeding with protease inhibitors.
• There were other side effects, some of them serious, noted in clinical studies that occurred in less than 2% of patients receiving Nelfinavir. However, these side effects may have been due to other drugs that patients were taking or to the illness itself. Except for diarrhea, there were not many differences in side effects in patients who took Nelfinavir along with other drugs compared with those who took only the other drugs.

Do not take Nelfinavir if you are allergic to any ingredient in it.

Most of the side effects experienced with nelfinavir have been mild to moderate. Some serious side effects may occur. See "Drug Precautions" section.

Common side effects include:

• diarrhea
• nausea
• gas
• rash

This is not a complete list of side effects. Ask your doctor or pharmacist for more information.

Nelfinavir may interact with other drugs, including those you take without a prescription. You must tell your healthcare provider about all medicines you are taking or planning to take including prescription and non-prescription medicines, herbal remedies and supplements and street drugs.

Do not take the following drugs because they can cause serious problems or death if taken with Nelfinavir:

• Cordarone (amiodarone) (for irregular heartbeat)
• Orap (pimozide) 
• Quinidine (for irregular heartbeat), also known as Quinaglute, Cardioquin, Quinidex, and others
• D.H.E. 45 Injection, Ergomar, Migranal, Wigraine and Cafergot (for migraine headaches) and Methergine (for bleeding after childbirth)
• Halcion (triazolam) (for sleep problem)
• Versed (midazolam) (sedative hypnotic)
• Revatio (sildenafil) (for treatment of pulmonary arterial hypertension)
• Alfuzosin (for treatment of benign prostate enlargement)

Do not take the following medicines when you take Nelfinavir. They may reduce the levels of Nelfinavir in the blood and make it less effective. Talk with your healthcare provider if you are currently taking these medicines because other medicines may have to be given to take their place:

• Prilosec (omeprazole) (for stomach acid reduction)
• Rifampin (also known as Rimactane, Rifadin, Rifater, or Rifamate) (for tuberculosis)
• Phenobarbital (for seizures)
• Tegretol (carbamazepine) (for seizures)

Do not take Nelfinavir with St. John's wort (hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John's wort. Talk with your healthcare provider if you are taking or planning to take St. John's wort. Taking St. John's wort may decrease Nelfinavir levels and lead to increased viral load and possible resistance to Nelfinavir.

Do not take Nelfinavir with cholesterol-lowering medicines Mevacor (lovastatin) or Zocor (simvastatin) because of possible serious reactions.

Do not take Nelfinavir with Serevent (salmeterol) because of possible serious reactions.

Talk to your healthcare provider before you start taking any new prescription or non-prescription medicines or herbal supplements with Nelfinavir.

Medicines that require dose adjustments:

• It is possible that your healthcare provider may need to increase or decrease the dose of other medicines when you are also taking Nelfinavir.
• There is also an increased risk of drug interactions between Nelfinavir and Lipitor (atorvastatin), Crestor (rosuvastatin), Pravachol (pravastatin) and Lescol (fluvastatin); talk to your healthcare provider before you take any of these cholesterol-reducing medicines with Nelfinavir.
• Before you take PDE5 Inhibitors, such as Viagra (sildenafil), Levitra (vardenafil) or Cialis (tadalafil) with Nelfinavir, talk to your healthcare provider about possible drug interactions and side effects. If you take these types of drugs and Nelfinavir together, you may be at increased risk of side effects of these drugs such as low blood pressure, visual changes, and penile erection lasting more than 4 hours. If an erection lasts longer than 4 hours, you should seek immediate medical assistance to avoid permanent damage to your penis. Your healthcare provider can explain these symptoms to you.
• Before you take Adcirca (tadalafil) with Nelfinavir, talk to your healthcare provider since Nelfinavir may increase the amount of tadalafil in your blood.
• Before you take Tracleer (bosentan) with Nelfinavir, talk to your healthcare provider since Nelfinavir may increase the amount of bosentan in your blood.
• Before you take colchicine with Nelfinavir, talk to your healthcare provider since Nelfinavir may increase the amount of colchicine in your blood.
• Before you take warfarin (Coumadin) with Nelfinavir, talk to your healthcare provider since Nelfinavir may affect the amount of warfarin in your blood.
  • If you are taking both didanosine (Videx) and Nelfinavir:
  • You should take Nelfinavir with food one hour after or more than two hours before you take Videx buffered tablets.
  • If you are taking oral contraceptives ("the pill") to prevent pregnancy, you should use an additional or different type of contraception since Nelfinavir may reduce the effectiveness of oral contraceptives.
  • Non-nucleoside reverse transcriptase inhibitors (NNRTIs): Rescriptor (delavirdine) may increase the amount of Nelfinavir in your blood and Nelfinavir may lower the amount of Rescriptor in your blood.
  • Protease Inhibitors (PIs): Nelfinavir may increase the amount of Crixivan (indinavir), Norvir (ritonavir), and Invirase or Fortovase (saquinavir) in your blood. As a result, your healthcare provider may choose to lower the dose of Nelfinavir or one of these other medicines or monitor certain lab tests if Nelfinavir is taken in combination with one or more of these other medicines.
  • If you are taking Mycobutin (rifabutin), your healthcare provider may lower the dose of Mycobutin.
  • If you are taking Dilantin (phenytoin), your healthcare provider will need to monitor the levels of phenytoin in your blood and may need to adjust the dose of phenytoin.

Nelfinavir Oral Powder contains aspartame, a low-calorie sweetener, and therefore should not be taken by children with phenylketonuria (PKU).

Tell your healthcare provider if you are pregnant or plan to become pregnant.

Pregnancy Category B

Nelfinavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women taking nelfinavir.

The effects of nelfinavir on pregnant women or their unborn babies are not known.

Tell your healthcare provider if you are breastfeeding, it is very important that you speak with your healthcare provider about the best way to feed your baby. If your baby does not already have HIV, there is a chance that it can be transmitted through breast-feeding. The Centers for Disease Control and Prevention recommends that women with HIV do not breastfeed.