Prezista Side Effects

Please note - some side effects for Prezista 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 Prezista - for the Consumer

Prezista

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 Prezista:

Diarrhea; headache; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in the amount of urine produced; chest pain; dark urine; fast heartbeat; fever, chills, or persistent sore throat; loss of appetite; pale stools; red, swollen, or blistered skin; severe headache or dizziness; severe or persistent nausea, vomiting, or stomach pain; symptoms of high blood sugar (eg, confusion, flushing, rapid breathing, unusual hunger or thirst); unusual bleeding or bruising; unusual drowsiness, tiredness, or weakness; unusual swelling of the arms or legs; yellowing of the skin or eyes.

Prezista Side Effects - for the Professional

Prezista

• The most common adverse drug reactions to Prezista/rtv (incidence ≥ 5%) of at least moderate intensity (≥ Grade 2) were diarrhea, nausea, headache and abdominal pain. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Tibotec Therapeutics at 1-877-REACH-TT or 1-877-732-2488 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

General

Diarrhea, nausea, headache, rash, abdominal pain, and nasopharyngitis were the most common side effects reported in clinical trials of darunavir in combination with other antiretrovirals, regardless of frequency or causality. Adverse events led to discontinuation of darunavir in 2% and 3.7% of treatment-naive and treatment-experienced subjects, respectively, in randomized trials.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 12%), nausea (up to 7%), vomiting (up to 4%), abdominal pain (up to 5%), and constipation (up to 2.3%), abdominal distension (2%), and dyspepsia (up to 2%). Dry mouth, anorexia, acute pancreatitis, and flatulence have been reported in less than 2% of patients.

Hepatic

Hepatic side effects have included elevations in GGT (greater than 2.5 times ULN; 8.4% to 9.2%), AST (Grade 2: 4% to 6%; Grade 3: 2% to 3%; Grade 4: less than 1%), ALT (Grade 2: 5% to 6%; Grade 3: 2% to 3%; Grade 4: less than 1% to 1%), and alkaline phosphatase (Grade 2: less than 1% to 1%; Grade 3: less than 1%), hypoalbuminemia (less than 3 g/dL; 3.1% to 4.3%), and hyperbilirubinemia (Grade 2: less than 1%; Grade 3: less than 1%; Grade 4: less than 1%). Acute hepatitis (such as acute hepatitis, cytolytic hepatitis, hepatotoxicity) and hyperbilirubinemia were reported in less than 1% of patients.

In patients receiving darunavir/ritonavir, the incidence of adverse events and clinical chemistry abnormalities was not higher in those coinfected with hepatitis B or C virus compared with patients who were not coinfected, with the exception of increased hepatic enzymes.

Hematologic

Hematologic side effects have included decreased white blood cells (less than 3000 count/mm3; 13% to 15.4%), decreased lymphocytes (less than 1000 count/mm3; 4.6% to 10.9%), decreased total neutrophil count (999 mm3 or less; 6.9% to 11.5%), increased partial thromboplastin time (greater than 1.66 times ULN; 4.3% to 7.8%), increased plasma prothrombin time (greater than 1.25 times ULN; 0.6% to 3.9%), and decreased platelet count (less than 75000/mm3; 2.8% to 3.1%). Anemia has also been reported.

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.

Metabolic

Metabolic side effects have included elevated pancreatic lipase (Grade 2: 2%; Grade 3: less than 1% to 2%; Grade 4: less than 1%), elevated pancreatic amylase (Grade 2: 4% to 6%; Grade 3: 3% to 6%), hyperglycemia (Grade 2: 6% to 8%; Grade 3: less than 1%; Grade 4: less than 1%), hypoglycemia (54 mg/dL or less; 1.5% to 3.7%), increased total cholesterol (Grade 2: 12% to 24%; Grade 3: 1% to 8%), increased triglycerides (Grade 2: 2% to 11%; Grade 3: 1% to 7%; Grade 4: less than 1% to 2%), increased low-density lipoprotein cholesterol (Grade 2: 11% to 13%; Grade 3: 2% to 7%) hyperuricemia (9.9 mg/dL or more; 2.2% to 6.9%), decreased bicarbonate (less than 15 mmol/L; 3.1% to 3.4%), hypocalcemia (7.8 mg/dL or less; 4%), hyponatremia (129 mEq/L or less; 0.8% to 2.5%), and hypernatremia (151 mEq/L or more; 2.3%). Other metabolic side effects have included hypercholesterolemia, hyperlipidemia, diabetes mellitus, decreased appetite, obesity, fat redistribution, hyponatremia, and polydipsia in less than 2% of patients. Decreased weight and lipodystrophy have also been reported.

Nervous system

Nervous system side effects have included headache (up to 5%) and peripheral neuropathy, hypoesthesia, paresthesia, somnolence, and transient ischemic attack in less than 2% of patients. Insomnia, dizziness, and progressive multifocal leukoencephalopathy have also been reported.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, myalgia, pain in extremities, osteopenia, and osteoporosis in less than 2% of patients. Rarely, rhabdomyolysis has been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included myocardial infarction, tachycardia, and hypertension in less than 2% of patients.

Other

Other side effects have included asthenia (up to 3%) and vertigo, pyrexia, fatigue, rigors, hyperthermia, and peripheral edema in less than 2% of patients. Herpes simplex infection has also been reported.

Renal

Renal side effects have included acute renal failure, renal insufficiency, nephrolithiasis, and polyuria in less than 2% of patients.

Respiratory

Respiratory side effects have included nasopharyngitis (13.7%). Dyspnea, cough, and hiccups have been reported in less than 2% of patients. Pneumonia and upper respiratory tract infection have also been reported.

Dermatologic

Dermatologic side effects have included rash (up to 6%) and pruritus, folliculitis, lipoatrophy, night sweats, allergic dermatitis, eczema, toxic skin eruption, alopecia, dermatitis medicamentosa, hyperhidrosis, skin inflammation, maculopapular rash, erythema multiforme, and Stevens-Johnson syndrome in less than 2% of patients.

Severe skin rash (including erythema multiforme and Stevens-Johnson syndrome) has been reported during clinical development programs. In some cases, fever and elevations of liver transaminases have accompanied the rash.

Endocrine

Endocrine side effects have included gynecomastia in less than 2% of patients.

Genitourinary

Genitourinary side effects have included acute renal failure, renal insufficiency, nephrolithiasis, polyuria, and gynecomastia in less than 2% of patients.

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