Viracept

Yes

Nelfinavir is an antiviral medication that 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 purposes not listed in this medication guide.

You should not use nelfinavir if you have moderate to severe liver disease.

Serious drug interactions can occur when certain medicines are used together with nelfinavir. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

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

Some medicines can cause unwanted or dangerous effects when used with nelfinavir. Your doctor may need to change your treatment plan if you use any of the following drugs:

• alfuzosin;
• pimozide;
• rifampin;
• sildenafil (Revatio for pulmonary arterial hypertension);
• St. John's wort;
• lovastatin or simvastatin;
• dihydroergotamine, ergotamine, ergonovine, or methylergonovine;
• amiodarone or quinidine; or
• oral midazolam, or triazolam.

To make sure nelfinavir is safe for you, tell your doctor if you have:

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

This medication is not expected to be harmful to an unborn baby, but HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of nelfinavir on the baby.

Nelfinavir can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

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.

Nelfinavir is not approved for use by anyone younger than 2 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Nelfinavir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with nelfinavir. Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
• cold sores, sores on your genital or anal area;
• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

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

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.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Viracept 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 Viracept:

• 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 Viracept. They may reduce the levels of Viracept 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 Viracept 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 Viracept levels and lead to increased viral load and possible resistance to Viracept.

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

Do not take Viracept 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 Viracept.

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 Viracept.
• There is also an increased risk of drug interactions between Viracept 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 Viracept.
• Before you take PDE5 Inhibitors, such as Viagra (sildenafil), Levitra (vardenafil) or Cialis (tadalafil) with Viracept, talk to your healthcare provider about possible drug interactions and side effects. If you take these types of drugs and Viracept 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 Viracept, talk to your healthcare provider since Viracept may increase the amount of tadalafil in your blood.
• Before you take Tracleer (bosentan) with Viracept, talk to your healthcare provider since Viracept may increase the amount of bosentan in your blood.
• Before you take colchicine with Viracept, talk to your healthcare provider since Viracept may increase the amount of colchicine in your blood.
• Before you take warfarin (Coumadin) with Viracept, talk to your healthcare provider since Viracept may affect the amount of warfarin in your blood.
  • If you are taking both didanosine (Videx) and Viracept:
  • You should take Viracept 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 Viracept may reduce the effectiveness of oral contraceptives.
  • Non-nucleoside reverse transcriptase inhibitors (NNRTIs): Rescriptor (delavirdine) may increase the amount of Viracept in your blood and Viracept may lower the amount of Rescriptor in your blood.
  • Protease Inhibitors (PIs): Viracept 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 Viracept or one of these other medicines or monitor certain lab tests if Viracept 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.

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

• Keep Viracept and all other medicines out of the reach of children.
• Keep bottle closed and store at room temperature (between 59°F and 86°F) away from sources of moisture such as a sink or other damp place. Heat and moisture may reduce the effectiveness of Viracept.
• Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, it is out of the reach of children.
• Store in original container.

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

Some medicines can cause unwanted or dangerous effects when used with nelfinavir. Your doctor may need to change your treatment plan if you use any of the following drugs:

• alfuzosin;

• pimozide;

• rifampin;

• sildenafil (Revatio for pulmonary arterial hypertension);

• St. John's wort;

• lovastatin or simvastatin;

• dihydroergotamine, ergotamine, ergonovine, or methylergonovine;

• amiodarone or quinidine; or

• oral midazolam, or triazolam.

To make sure nelfinavir is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease;

• diabetes;

• a bleeding disorder such as hemophilia; or

• high cholesterol or triglycerides.

This medication is not expected to be harmful to an unborn baby, but HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of nelfinavir on the baby.

Nelfinavir can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

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.

Nelfinavir is not approved for use by anyone younger than 2 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Antiretroviral; HIV protease inhibitor (PI).1 2 3 4 7 8

Metabolized by CYP3A and CYP2C19.1 80 83

Inhibits CYP3A; does not inhibit CYP2D6, CYP2C9, CYP2C19, CYP2C8, CYP1A2, or CYP2E1.1 80 83

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors, inducers, or substrates of CYP3A or CYP2C19 with possible alteration in metabolism of nelfinavir and/or other drug.1

Specific Drugs

• Critical nature of compliance with HIV therapy and importance of remaining under the care of a clinician.1 Importance of taking as prescribed; do not alter or discontinue antiretroviral regimen without consulting clinician.1

• Importance of using in conjunction with other antiretroviralsnot for monotherapy.1

• Antiretroviral therapy is not a cure for HIV infection; opportunistic infections and other complications associated with HIV disease may still occur.1 Sustained decreases in plasma HIV RNA have been associated with reduced risk of progression to AIDS and death.1

• Advise patients that effective antiretroviral regimens can decrease HIV concentrations in blood and genital secretions and strict adherence to such regimens in conjunction with risk-reduction measures may decrease, but cannot absolutely eliminate, the risk of secondary transmission of HIV to others.200 Importance of continuing to practice safer sex (e.g., using latex or polyurethane condoms to minimize sexual contact with body fluids), never sharing personal items that can have blood or body fluids on them (e.g., toothbrushes, razor blades), and never reusing or sharing needles.1 200

• Importance of reading patient information provided by the manufacturer.1

• Importance of taking with food.1

• If a dose is missed, it should be taken as soon as it is remembered and the next dose taken at the regularly scheduled time.1 If a dose is skipped, do not administer a double dose to make up for the missed dose.1

• Redistribution/accumulation of body fat may occur, with as yet unknown long-term health effects.1

• Advise patients that diarrhea is the most frequent adverse effect and can usually be controlled with OTC drugs such as loperamide.1

• Advise patients receiving selective phosphodiesterase type 5 (PDE5) inhibitors (e.g., avanafil, sildenafil, tadalafil, vardenafil) that they may be at increased risk of PDE5 inhibitor-associated adverse effects (e.g., hypotension, visual changes, priapism) and that any symptoms should be promptly reported to clinician.1 188 Should not be used in patients receiving avanafil for treatment of erectile dysfunction188 or sildenafil for treatment of PAH.1

• If using oral contraceptives, need for alternative or concomitant nonhormonal contraceptive measures.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Advise HIV-infected women not to breast-feed.1

• Importance of advising patients of other important precautionary information.1 (See Cautions.)

ALERT: Find out about medicines that should not be taken with Viracept. This statement is included on the product's bottle label.

Risk of Serious Adverse Reactions Due to Drug Interactions

Initiation of Viracept, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving Viracept, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of Viracept, respectively. These interactions may lead to:

• Clinically significant adverse reactions, potentially leading to severe, life threatening, or fatal events from greater exposures of concomitant medications.
• Clinically significant adverse reactions from greater exposures of Viracept.
• Loss of therapeutic effect of Viracept and possible development of resistance.

See Table 6 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations [see Drug Interactions (7)]. Consider the potential for drug interactions prior to and during Viracept therapy; review concomitant medications during Viracept therapy; and monitor for the adverse reactions associated with the concomitant medications [see Contraindications (4) and Drug Interactions (7)].

Hepatic Impairment

Viracept should not be used in patients with either moderate or severe hepatic impairment (Child-Pugh B or C, score greater than or equal to 7) [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)].

Phenylketonurics

Viracept Oral Powder contains phenylalanine, a component of aspartame. Each gram of Viracept powder contains 11.2 mg phenylalanine. Phenylalanine can be harmful to patients with phenylketonuria.

Diabetes Mellitus/Hyperglycemia

New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported during post-marketing surveillance in HIV-infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. In some cases diabetic ketoacidosis has occurred. In those patients who discontinued protease inhibitor therapy, hyperglycemia persisted in some cases. Because these events have been reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between protease inhibitor therapy and these events has not been established.

Hemophilia

There have been reports of increased bleeding, including spontaneous skin hematomas and hemarthrosis, in patients with hemophilia type A and B treated with protease inhibitors. In some patients, additional factor VIII was given. In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced. A causal relationship has not been established.

Fat Redistribution

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement ("buffalo hump"), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Viracept. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

Pregnancy

Pregnancy Category B

Viracept 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 Viracept.

There were no effects on fetal development or maternal toxicity when nelfinavir was administered to pregnant rats at systemic exposures (AUC) comparable to human exposure. Administration of nelfinavir to pregnant rabbits resulted in no fetal development effects up to a dose at which a slight decrease in maternal body weight was observed; however, even at the highest dose evaluated, systemic exposure in rabbits was significantly lower than human exposure. Additional studies in rats indicated that exposure to nelfinavir in females from mid-pregnancy through lactation had no effect on the survival, growth, and development of the offspring to weaning. Subsequent reproductive performance of these offspring was also not affected by maternal exposure to nelfinavir.

Antiretroviral Pregnancy Registry (APR): To monitor maternal-fetal outcomes of pregnant women exposed to Viracept and other antiretroviral agents, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling (800) 258-4263.

Nursing Mothers

The Centers for Disease Control and Prevention recommends that HIV-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV. Studies in lactating rats have demonstrated that nelfinavir is excreted in milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they are receiving Viracept.

Pediatric Use

The safety, tolerability, pharmacokinetic profile and efficacy of Viracept were evaluated in HIV infected pediatric patients from 2 to 13 years of age in multicenter clinical trials, Study 556 and PACTG 337 [see Clinical Pharmacology (12.3) and Clinical Studies (14.3)]. In patients less than 2 years of age, Viracept was found to be safe at the doses studied, but a reliably effective dose could not be established [see Dosage and Administration (2.2), Adverse Reactions (6.2), and Clinical Pharmacology (12.3)]. The pharmacokinetic profile, safety and antiviral activity of Viracept in adolescent patients 13 years and older is supported by data from the adult clinical trials where some trials allowed enrolment of subjects 13 years and older. Thus, the data for adolescents and adults were analyzed collectively. [see Adverse Reactions (6.1)].

Geriatric Use

Clinical studies of Viracept did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Hepatic Impairment

Viracept should not be used in patients with either moderate or severe hepatic impairment (Child-Pugh B or C, score greater than or equal to 7) [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. No dose adjustment of Viracept is necessary for patients with mild hepatic impairment (Child-Pugh A, score 5–6).

Renal Impairment

The safety and efficacy of Viracept have not been established in patients with renal impairment.

Viracept® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus type 1 (HIV-1) protease. Viracept Tablets are available for oral administration as a light-blue, capsule-shaped tablet with a clear film coating in 250 mg strength (as nelfinavir-free base) and as a white oval tablet with a clear film coating in 625 mg strength (as nelfinavir-free base). Each tablet contains the following common inactive ingredients: calcium silicate, crospovidone, magnesium stearate, hypromellose, and triacetin. In addition, the 250 mg tablet contains FD&C blue #2 powder and the 625 mg tablet contains colloidal silicon dioxide. Viracept Oral Powder is available for oral administration in a 50 mg/g strength (as nelfinavir-free base) in bottles. The oral powder also contains the following inactive ingredients: microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, crospovidone, hypromellose, aspartame, sucrose palmitate, and natural and artificial flavor. The chemical name for nelfinavir mesylate is [3S-[2(2S*, 3S*), 3α,4aβ,8aβ]]-N-(1,1-dimethylethyl)decahydro-2-[2-hydroxy-3-[(3-hydroxy-2-methylbenzoyl)amino]-4-(phenylthio)butyl]-3-isoquinoline carboxamide mono-methanesulfonate (salt) and the molecular weight is 663.90 (567.79 as the free base). Nelfinavir mesylate has the following structural formula:

Nelfinavir mesylate is a white to off-white amorphous powder, slightly soluble in water at pH ≤4 and freely soluble in methanol, ethanol, 2-propanol and propylene glycol.

Viracept (nelfinavir) is an antiviral medicine that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Viracept is used to treat HIV, the virus that can cause cause acquired immunodeficiency syndrome (AIDS).

Viracept is not a cure for HIV or AIDS.

You should not use Viracept if you have moderate to severe liver disease.

Life-threatening side effects may occur if you take Viracept with alfuzosin (Uroxatral), amiodarone (Cordarone, Pacerone), lovastatin (Mevacor, Altoprev, Advicor), midazolam (Versed), quinidine (Quin-G), pimozide (Orap), rifampin (Rifadin, Rimactane, Rifater), sildenafil (Revatio for pulmonary arterial hypertension), simvastatin (Zocor, Simcor, Vytorin, Juvisync), St. John's wort, triazolam (Halcion), or an ergot medicine such as Ergomar, Ergotrate, Cafergot, Wigraine, D.H.E. 45, Migranal, or Methergine.

Taking Viracept will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Applies to nelfinavir: oral powder for reconstitution, oral tablet

General

Most side effects were of mild severity. The most common side effect was diarrhea, which was usually of mild to moderate severity.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 20%)
Common (1% to 10%): Nausea, flatulence
Frequency not reported: Abdominal pain, dyspepsia, epigastric pain, gastrointestinal bleeding, increased amylase, mouth ulceration, pancreatitis, vomiting[Ref]

Hematologic

Common (1% to 10%): Decreased lymphocytes, decreased neutrophils, decreased hemoglobin
Frequency not reported: Anemia, leukopenia, thrombocytopenia

HIV protease inhibitor therapy:
-Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacs[Ref]

Increased bleeding (including spontaneous skin hematomas and hemarthrosis) in patients with hemophilia type A and B has been associated with protease inhibitors. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.[Ref]

Hepatic

Common (1% to 10%): Elevated AST, elevated ALT
Frequency not reported: Elevated GGT, abnormal liver function tests, hepatitis
Postmarketing reports: Jaundice, bilirubinemia[Ref]

Musculoskeletal

Common (1% to 10%): Elevated creatine kinase
Frequency not reported: Arthralgia, arthritis, back pain, cramps, increased creatine phosphokinase, myalgia, myasthenia, myopathy[Ref]

Dermatologic

Common (1% to 10%): Rash
Frequency not reported: Dermatitis, folliculitis, fungal dermatitis, maculopapular rash, pruritus, sweating, urticaria[Ref]

Nervous system

Frequency not reported: Dizziness, headache, hyperkinesia, migraine, paresthesia, seizures, somnolence[Ref]

Other

Frequency not reported: Accidental injury, asthenia, fever, malaise, pain[Ref]

Respiratory

Frequency not reported: Dyspnea, pharyngitis, rhinitis, sinusitis[Ref]

Cardiovascular

Postmarketing reports: QTc prolongation, torsades de pointes[Ref]

Metabolic

Frequency not reported: Anorexia, increased alkaline phosphatase, increased LDH, hyperlipidemia, hyperuricemia, hyperglycemia, hypoglycemia, dehydration, redistribution/accumulation of body fat
Postmarketing reports: Metabolic acidosis

Combination antiretroviral therapy:
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")

HIV protease inhibitor therapy:
-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, ketoacidosis[Ref]

Psychiatric

Frequency not reported: Anxiety, depression, emotional lability, insomnia, sleep disorder, suicidal ideation[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction
Postmarketing reports: Hypersensitivity reactions (including bronchospasm, moderate to severe rash, fever, edema)[Ref]

Renal

Frequency not reported: Kidney calculus[Ref]

Genitourinary

Frequency not reported: Sexual dysfunction, urine abnormality[Ref]

Immunologic

Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Ocular

Frequency not reported: Acute iritis, eye disorder[Ref]

Some side effects of Viracept may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.