Viracept Side Effects

Please note - some side effects for Viracept may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Viracept - for the Consumer

Viracept

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Viracept:

Diarrhea; gas; loss of appetite; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever, chills, or sore throat; mental or mood changes; suicidal thoughts or actions; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); unusual bleeding or bruising.

Viracept Powder

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Viracept Powder:

Diarrhea; gas; loss of appetite; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever, chills, or sore throat; mental or mood changes; suicidal thoughts or actions; symptoms of high blood sugar (eg, confusion; flushed face; fruit-like breath odor; increased thirst, hunger, or urination; unusual drowsiness); unusual bleeding or bruising.

Viracept Side Effects - for the Professional

Viracept

The safety of Viracept was studied in over 5000 patients who received drug either alone or in combination with nucleoside analogues. The majority of adverse events were of mild intensity. The most frequently reported adverse event among patients receiving Viracept was diarrhea, which was generally of mild to moderate intensity.

Drug-related clinical adverse experiences of moderate or severe intensity in ≥ 2% of patients treated with Viracept coadministered with d4T and 3TC (Study 542) for up to 48 weeks or with ZDV plus 3TC (Study 511) for up to 24 weeks are presented in Table 12.

Adverse events occurring in less than 2% of patients receiving Viracept in all phase II/III clinical trials and considered at least possibly related or of unknown relationship to treatment and of at least moderate severity are listed below.

Body as a Whole: abdominal pain, accidental injury, allergic reaction, asthenia, back pain, fever, headache, malaise, pain, and redistribution/accumulation of body fat.

Digestive System: anorexia, dyspepsia, epigastric pain, gastrointestinal bleeding, hepatitis, mouth ulceration, pancreatitis and vomiting.

Hemic/Lymphatic System: anemia, leukopenia and thrombocytopenia.

Metabolic/Nutritional System: increases in alkaline phosphatase, amylase, creatine phosphokinase, lactic dehydrogenase, SGOT, SGPT and gamma glutamyl transpeptidase; hyperlipemia, hyperuricemia, hyperglycemia, hypoglycemia, dehydration, and liver function tests abnormal.

Musculoskeletal System: arthralgia, arthritis, cramps, myalgia, myasthenia and myopathy.

Nervous System: anxiety, depression, dizziness, emotional lability, hyperkinesia, insomnia, migraine, paresthesia, seizures, sleep disorder, somnolence and suicide ideation.

Respiratory System: dyspnea, pharyngitis, rhinitis, and sinusitis.

Skin/Appendages: dermatitis, folliculitis, fungal dermatitis, maculopapular rash, pruritus, sweating, and urticaria.

Special Senses: acute iritis and eye disorder.

Urogenital System: kidney calculus, sexual dysfunction and urine abnormality.

Post-Marketing Experience

The following additional adverse experiences have been reported from postmarketing surveillance as at least possibly related or of unknown relationship to Viracept:

Body as a Whole: hypersensitivity reactions (including bronchospasm, moderate to severe rash, fever and edema).

Cardiovascular System: QTc prolongation, torsades de pointes.

Digestive System: jaundice.

Metabolic/Nutritional System: bilirubinemia, metabolic acidosis.

Laboratory Abnormalities

The percentage of patients with marked laboratory abnormalities in Studies 542 and 511 are presented in Table 13. Marked laboratory abnormalities are defined as a Grade 3 or 4 abnormality in a patient with a normal baseline value or a Grade 4 abnormality in a patient with a Grade 1 abnormality at baseline.

Pediatric Population

Viracept has been studied in approximately 400 pediatric patients in clinical trials from birth to 13 years of age. The adverse event profile seen during pediatric clinical trials was similar to that for adults.

The most commonly reported drug-related, treatment-emergent adverse events reported in the pediatric studies included: diarrhea, leukopenia/neutropenia, rash, anorexia and abdominal pain. Diarrhea, regardless of assigned relationship to study drug, was reported in 39% to 47% of pediatric patients receiving Viracept in 2 of the larger treatment trials. Leukopenia/neutropenia was the laboratory abnormality most commonly reported as a significant event across the pediatric studies.

Side Effects by Body System

General

Nelfinavir is generally well-tolerated with most adverse effects regarded as mild to moderate in severity.

Gastrointestinal

Gastrointestinal side effects have included diarrhea as the most frequent side effect. The incidence ranges from 14% to 32% depending on dose and concomitant antiretroviral therapy. Diarrhea was reported in 39% to 47% of pediatric patients in clinical trials. Nausea (3% to 7%), flatulence (3% to 8%), abdominal pain (up to 4%), anorexia, dyspepsia, epigastric pain, gastrointestinal bleeding, mouth ulceration, pancreatitis, and vomiting have also been reported.

Nervous system

Nervous system adverse effects have included dizziness, hyperkinesia, insomnia, migraine, paresthesia, seizures, sleep disorder, and somnolence in less than 2% of patients.

Hematologic

Hematologic side effects have included neutropenia, anemia, leukopenia, and thrombocytopenia in less than 2% of patients.

Hematologic side effects associated with protease inhibitors have included spontaneous bleeding in patients with hemophilia A and B. 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.

Hepatic

Hepatic side effects have included elevations in AST (SGOT), ALT (SGPT), and GGT, hepatitis, and jaundice.

Endocrine

Endocrine side effects have included new onset and exacerbation of preexisting diabetes mellitus during postmarketing surveillance in patients receiving protease inhibitor therapy. Careful monitoring of blood glucose levels should be done and either initiation or dose adjustments of insulin or oral hypoglycemic agents may be needed.

Other

Other side effects have included redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, breast enlargement, and "cushingoid appearance" in patients receiving protease inhibitors. The mechanism and long-term consequences of these events are currently unknown and a causal relationship has not been established.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, cramps, myalgia, myasthenia, and myopathy in less than 2% of patients.

Respiratory

Respiratory side effects have included dyspnea, pharyngitis, rhinitis, and sinusitis in less than 2% of patients.

Dermatologic

Dermatologic side effects have included rash in up to 4% of patients. Dermatitis, folliculitis, fungal dermatitis, maculopapular rash, pruritus, sweating, and urticaria have been reported in less than 2% of patients.

Cardiovascular

Cardiovascular side effects have included postmarketing reports of QTc prolongation and torsades de pointes.

Metabolic

Metabolic side effects occurring in less than 2% of patients have included increases in alkaline phosphatase, amylase, creatine phosphokinase, lactic dehydrogenase; hyperlipidemia, hyperuricemia, hyperglycemia, hypoglycemia, dehydration, bilirubinemia, and metabolic acidosis.

Hypersensitivity

Hypersensitivity reactions including bronchospasm, moderate to severe rash, fever, and edema have been reported.

Other

Side effects affecting the body as a whole have included abdominal pain, accidental injury, asthenia, back pain, fever, headache, malaise, and pain in less than 2% of patients.

Ocular

Ocular side effects have included acute iritis and eye disorder in less than 2% of patients.

Genitourinary

Genitourinary side effects have included kidney calculus, sexual dysfunction, and urine abnormality in less than 2% of patients.

Psychiatric

Psychiatric side effects have included anxiety, depression, emotional lability, and suicidal ideation in less than 2% of patients.

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