Prezista Side Effects

Generic name: darunavir

Note: This document contains side effect information about darunavir. Some of the dosage forms listed on this page may not apply to the brand name Prezista.

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

For the Consumer

Applies to darunavir: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking darunavir (the active ingredient contained in Prezista) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using darunavir and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Darunavir 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 darunavir. Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, diarrhea, 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:

• vomiting, mild stomach pain;

• headache;

• mild skin 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.

For Healthcare Professionals

Applies to darunavir: oral suspension, oral tablet

General

The majority of side effects reported during treatment with darunavir (the active ingredient contained in Prezista) plus ritonavir were mild in severity. The most common side effects of at least moderate intensity were diarrhea, nausea, vomiting, headache, rash, and abdominal pain. Adverse events led to discontinuation of darunavir in 2.3% and 4.7% of treatment-naive and treatment-experienced subjects, respectively, in randomized trials.

Gastrointestinal

Gastrointestinal side effects of at least moderate intensity have included diarrhea (up to 14%), nausea (up to 7%), vomiting (up to 5%), abdominal pain (up to 6%), anorexia (2%), abdominal distension (2%), dyspepsia (up to 2%), acute pancreatitis (less than 2%), and flatulence (less than 2%). Dry mouth and constipation have been reported.

Hepatic

Hepatic side effects of at least moderate intensity have included acute hepatitis (e.g., acute hepatitis, cytolytic hepatitis, hepatotoxicity; less than 2%) and increased hepatic enzyme. Hyperbilirubinemia (Grade 2: less than 1%; Grade 3: less than 1%; Grade 4: less than 1%), hypoalbuminemia, and elevated aspartate aminotransferase (Grade 2: up to 7%; Grade 3: up to 4%; Grade 4: up to 1%), alanine aminotransferase (Grade 2: up to 9%; Grade 3: up to 3%; Grade 4: up to 1%), alkaline phosphatase (Grade 2: up to 1%; Grade 3: less than 1%), and gamma glutamyl transferase have been reported. In patients receiving darunavir (the active ingredient contained in Prezista) 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 cell count, lymphocytes, total absolute neutrophil count, and platelets; increased partial thromboplastin time and plasma prothrombin time; and anemia. 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 of at least moderate intensity have included diabetes mellitus (up to 2%), hypercholesterolemia, hyperglycemia, hypertriglyceridemia, increased low density lipoprotein, and increased pancreatic enzyme. Elevated pancreatic lipase (Grade 2: 3%; Grade 3: up to 2%; Grade 4: less than 1%), pancreatic amylase (Grade 2: up to 6%; Grade 3: up to 7%), glucose levels (Grade 2: up to 11%; Grade 3: up to 1%; Grade 4: less than 1%), total cholesterol (Grade 2: up to 25%; Grade 3: up to 10%), triglycerides (Grade 2: up to 10%; Grade 3: up to 7%; Grade 4: up to 3%), and low-density lipoprotein cholesterol (Grade 2: 14%; Grade 3: up to 9%) have been reported. Hypoglycemia, hyperuricemia, decreased bicarbonate, hypocalcemia, hyponatremia, hypernatremia, hyperlipidemia, decreased appetite, obesity, hyponatremia, polydipsia, decreased weight, and lipodystrophy have also been reported. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. Redistribution of body fat has been reported during postmarketing experience. New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, and ketoacidosis have been reported during postmarketing experience in patients receiving protease inhibitors.

Nervous system

Nervous system side effects of at least moderate intensity have included headache (up to 7%). Peripheral neuropathy, hypoesthesia, paresthesia, somnolence, transient ischemic attack, insomnia, dizziness, and progressive multifocal leukoencephalopathy have been reported.

Psychiatric

Psychiatric side effects of at least moderate intensity have included abnormal dreams (less than 2%). Memory impairment, confusion state, disorientation, irritability, altered mood, nightmare, and anxiety have been reported.

Musculoskeletal

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

Cardiovascular

Cardiovascular side effects have included myocardial infarction, tachycardia, and hypertension.

Other

Other side effects of at least moderate intensity have included asthenia (up to 3%) and fatigue (up to 2%). Vertigo, pyrexia, rigors, hyperthermia, peripheral edema, and herpes simplex infection have been reported.

Renal

Renal side effects have included acute renal failure, renal insufficiency, nephrolithiasis, and polyuria.

Respiratory

Respiratory side effects have included nasopharyngitis, dyspnea, cough, hiccups, pneumonia, and upper respiratory tract infection.

Dermatologic

Dermatologic side effects of at least moderate intensity have included rash (up to 7%), and angioedema, pruritus, urticaria, and Stevens-Johnson syndrome in less than 2% of patients. Folliculitis, lipoatrophy, night sweats, allergic dermatitis, eczema, toxic skin eruption, alopecia, dermatitis medicamentosa, hyperhidrosis, skin inflammation, maculopapular rash, and erythema multiforme have been reported. Severe skin reactions (in some cases accompanied by fever and/or elevations of transaminases) have been reported during clinical development programs. Rarely, toxic epidermal necrolysis and acute generalized exanthematous pustulosis have been reported during postmarketing experience.

Endocrine

Endocrine side effects have included gynecomastia.

Genitourinary

Genitourinary side effects have included acute renal failure, renal insufficiency, nephrolithiasis, polyuria, and gynecomastia.

Immunologic

Immunologic side effects of at least moderate intensity have included immune reconstitution syndrome (less than 2%). Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution.

Hypersensitivity

Hypersensitivity side effects of at least moderate intensity have included drug hypersensitivity (less than 2%). Facial edema has been reported.

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