nel-FIN-a-veer
Brand Name: Viracept
Other Name(s): Mesilato de nelfinavir, NFV, Nelfinavir mesylate
AdvertisementDrug Class: Protease Inhibitors
Nelfinavir, also known as Viracept, is a type of medicine called a protease inhibitor (PI). Nelfinavir works by blocking protease, an enzyme that HIV needs to make more copies of itself.
During the normal HIV life cycle, an HIV enzyme called protease cuts long chains of HIV proteins into smaller proteins. As the smaller HIV proteins come together, a new virus particle is assembled. When nelfinavir is present, however, it binds to the HIV protease enzyme. This process prevents the protease enzyme from working, thereby preventing the formation of mature virus particles.
Indications and Usage
Nelfinavir was approved by the U.S. Food and Drug Administration (FDA) on March 14, 1997, for use with other antiretroviral agents in the treatment of HIV infection in adults and children 2 years of age or older. It is also used for the prevention of HIV infection in individuals who have been exposed to the virus.
In June 2007, high levels of ethyl methanesulfonate (EMS), a chemical used during the making of nelfinavir, were detected in European-made nelfinavir by the European manufacturer Roche Ltd. The U.S. manufacturer Pfizer released a statement in September 2007 to inform doctors that some amounts of EMS have been detected in nelfinavir manufactured in the United States. EMS may cause cancer in humans; in animals, EMS has caused birth defects and cancer. Effective March 31, 2008, Pfizer and FDA agreed upon a limit for EMS and agreed that nelfinavir is now safe for use in all patient populations including pregnant females and children.
Nelfinavir does not cure HIV infection or AIDS and does not reduce the risk of passing the virus to other people.
Dosage Form/Administration
Always take this medication as your doctor instructs. Nelfinavir is taken by mouth, with food (or with a meal), and it always must be taken with other anti-HIV medications.
Dosage forms and strengths:
- Tablets: 250 mg or 625 mg
- Oral powder: 50 mg/gram (50 mg per each level scoopful)
What storage conditions are needed for this medicine?
- Store nelfinavir tablets and oral powder at room temperature (between 59°F and 86°F) away from moisture and heat.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Throw away any medication that is outdated or no longer needed.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?
- Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
- It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Recommended Daily Dose
FDA Dosing Recommendations for Adults
- Nelfinavir 1250 mg (five 250 mg tablets or two 625 mg tablets) taken twice daily by mouth and with a meal OR nelfinavir 750 mg (three 250 mg tablets) taken three times daily by mouth and with a meal.
FDA Dosing Recommendations for Pediatric Patients (2 to 13 years of age)
- The nelfinavir dose in children is based on their weight.
- The dose of nelfinavir oral powder or 250 mg tablets is 45 to 55 mg/kg taken twice daily by mouth and with a meal OR 25 to 35 mg/kg taken three times daily by mouth and with a meal.
Note:
- Your doctor or healthcare provider will assess the appropriate dosage form and dose for each patient. It is important to take your medicine exactly as prescribed.
- If you or your child is unable to swallow tablets, dissolve tablets in a small amount of water. Once dissolved, mix well and drink this mixture immediately. Refill the glass with some water and drink again to make sure the entire dose has been consumed.
- Nelfinavir oral powder may be mixed with a small amount of water, milk, formula, soy formula, soy milk, dietary supplements, or dairy foods (such as pudding or ice cream). Once mixed, the entire amount must be taken immediately. If the mixture is not taken immediately, it must be refrigerated and can be stored for up to 6 hours. Do not heat mixture.
- To avoid a bitter taste, it is not recommended to mix oral powder with acidic foods or juices, such as orange or grapefruit juice, apple or apple sauce.
- Do not add water to original containers of nelfinavir oral powder. Nelfinavir oral powder is supplied with a scoop for measuring.
- Nelfinavir oral powder contains aspartame and should not be taken by children with phenylketonuria (PKU).
- Nelfinavir should not be used in patients with moderate or severe hepatic (liver) disease.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose of nelfinavir to make up for a missed dose.
Contraindications
What special precautions should I follow?
Before taking nelfinavir,
- Tell your doctor and pharmacist if you are allergic to nelfinavir or any other medications.
- Certain medicines must not be used if you are taking nelfinavir. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
- Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking nelfinavir, call your doctor. Tell your doctor if you are breastfeeding. You should not breastfeed if you are infected with HIV or if you are taking nelfinavir.
- Tell your doctor about any medical problems you may have, such as liver or kidney disease. Nelfinavir should not be used in patients with moderate or severe liver disease.
Possible Side Effects
Nelfinavir may cause side effects.
The following life-threatening or severe side effects have been reported. Contact your doctor immediately if you experience:
-
Allergic Reaction (Hypersensitivity Reaction). Seek medical attention right away if you develop any of the following symptoms:
- difficulty breathing
- chest pain or tightness
- fast heartbeat
- unusual skin rash or peeling of the skin
- hives
- swelling of tongue or face
-
Liver (Hepatic) Problems. The following signs/symptoms may be associated with liver injury:
- abdominal pain and/or swelling
- unusual tiredness (fatigue)
- fever
- yellowing of the skin or eyes (jaundice)
- loss of appetite
- nausea and vomiting
- dark colored urine
- abnormal liver function blood tests
-
Hemophilia (Bleeding Disorder). In patients with hemophilia, there have been reports of increased bleeding and spontaneous (sudden) bleeding. If you have hemophilia and notice any unusual bleeding, contact your doctor immediately.
-
Diabetes/Hyperglycemia (high blood sugar). This side effect may occur in patients taking protease inhibitors, such as nelfinavir. Some patients, who never had diabetes, may develop diabetes. Some patients, who already have diabetes, may develop worsening of their condition. There have been reports of diabetic ketoacidosis (a serious complication of diabetes). If you develop any of the following symptoms, contact your doctor right away:
- increased thirst
- unexplained weight loss
- increased urination
- fatigue
- unusually dry or itchy skin
- shortness of breath
- difficulty breathing
- increased or decreased appetite
- fruity breath (breath odor)
- abdominal pain
- mental status changes
Some side effects can be serious. The following side effects have occurred:
-
Changes in body fat (fat redistribution/accumulation). Changes in body fat may include increased amount of fat in the upper back and neck (known as "buffalo hump"), breast, and around the trunk. Loss of fat may occur from the legs, arms, and face.
Other less serious side effects have also been reported:
- diarrhea
- nausea
- gas
- mild rash
Nelfinavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the U.S. FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088.
Drug Interactions
Nelfinavir may interact with other medicines. Before taking nelfinavir, it is important to tell your doctor about any prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
The use of certain medicines with nelfinavir can cause life-threatening problems. Do not take nelfinavir if you are taking any of the following medicines:
- alfuzosin
- amiodarone or quinidine
- ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine
- pimozide
- sildenafil (when used for the treatment of pulmonary arterial hypertension)
- midazolam
- triazolam
Other medicines that should not be used with nelfinavir include the following:
- rifampin
- St. John's wort (hypericum perforatum)
- lovastatin
- simvastatin
- omeprazole
- phenobarbital
- carbamazepine
- salmeterol
Medicines that may require dose adjustments or other considerations when taken with nelfinavir:
- lipitor, rosuvastatin, pravastatin, and fluvastatin
- PDE5 inhibitors: sildenafil, vardenafil, and tadalafil
- bosentan
- colchicine
- didanosine
- delavirdine
- indinavir
- ritonavir
- saquinavir
- rifabutin
- phenytoin
- warfarin
- oral contraceptives: If you are taking oral birth control pills to prevent pregnancy, you should use additional or a different type of contraception since nelfinavir may reduce the effectiveness of oral contraceptives.
In addition to the lists above, there are many other medicines that may interact with nelfinavir. For a complete list of all medicines that may interact with nelfinavir, talk with your doctor or pharmacist and check the manufacturer's website for the full prescribing information.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet. Nelfinavir should be taken with food.
Clinical Trials
Click here to search ClinicalTrials.gov for trials that use Nelfinavir.
Manufacturer Information
Nelfinavir
Pfizer Inc
235 East 42nd Street
New York, NY 10017-5755
Phone: 800-438-1985
Viracept
Pfizer Inc
235 East 42nd Street
New York, NY 10017-5755
Phone: 800-438-1985