Reyataz Adverse Reactions



Bristol-Myers Squibb


Full Prescribing Info
Adverse Reactions
Clinical Trial Experiences: Body System List of Events: Reyataz has been evaluated for safety and tolerability in combination therapy with other antiretroviral medications in controlled clinical trials in adult patients, receiving Reyataz 400 mg once daily or Reyataz 300 mg once daily plus ritonavir 100 mg once daily.
The more frequent adverse events of any severity with at least a possible relationship to regimens containing Reyataz and ≥1 NRTIs were nausea (20%), jaundice (13%) and diarrhea (10%). Jaundice was reported within a few days to a few months after the initiation of treatment and resulted in discontinuation of treatment in <1% of patients.
Lipodystrophy, of moderate intensity or greater, was reported in regimens containing Reyataz and ≥1 NRTIs, as at least possibly related to the regimen, in 5% of patients.
The following adverse reactions of moderate intensity or greater with at least a possible relationship to regimens containing Reyataz and ≥1 NRTIs have been reported: Cardiac Disorders: Uncommon: Syncope. Rare: Oedema, palpitation.
Nervous System Disorders: Common: Headache. Uncommon: Peripheral neurologic symptoms, amnesia, somnolence, dizziness, dysgeusia.
Eye Disorders: Common: Scleral icterus.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Dyspnea.
Gastrointestinal Disorders: Common: Abdominal pain, diarrhoea, dyspepsia, nausea, vomiting. Uncommon: Dry mouth, flatulence, gastritis, pancreatitis, aphthous stomatitis, abdominal distention.
Renal and Urinary Disorders: Uncommon: Hematuria, pollakiuria, proteinuria, nephrolithiasis. Rare: Kidney pain.
Skin and Subcutaneous Tissue Disorders: Common: Rash. Uncommon: Alopecia, pruritus, urticaria. Rare: Vasodilatation, vesiculobullous rash, eczema.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Arthralgia, muscle atrophy, myalgia. Rare: Myopathy.
Metabolism and Nutrition Disorders: Uncommon: Anorexia, increased appetite, decreased weight, weight gain.
Vascular Disorders: Uncommon: Hypertension.
General Disorders and Administration Site Conditions: Common: Asthenia, fatigue. Uncommon: Chest pain, fever, malaise, gait disturbance.
Immune System Disorders: Uncommon: Allergic reaction.
Hepatobiliary Disorders: Common: Jaundice. Uncommon: Hepatitis. Rare: Hepatosplenomegaly.
Reproductive System and Breast Disorders: Uncommon: Gynecomastia.
Psychiatric Disorders: Uncommon: Anxiety, depression, sleep disorder, insomnia, abnormal dream, disorientation.
Patients Co-infected with Hepatitis B and/or C Virus: The frequency of treatment-emergent hepatitis or transaminase elevations in co-infected patients was comparable between Reyataz and comparator regimens. No differences in frequency of bilirubin elevations were observed.
Laboratory Findings: Adult Patients: The most frequently reported laboratory abnormality in patients receiving regimens containing Reyataz and ≥1 NRTIs was elevated total bilirubin reported predominantly as elevated indirect (unconjugated) bilirubin (87% Grade 1, 2, 3 or 4). Grade 3 or 4 elevation of total bilirubin was noted in 37% (6% Grade 4).
Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥2% of patients receiving regimens containing Reyataz and ≥1 NRTIs included: Elevated creatinine kinase (CK) (7%), elevated ALT/SGPT (5%), low neutrophils (5%), elevated AST/SGOT (3%) and elevated lipase (3%).
In clinical studies, the observed magnitude of dyslipidemia was less with Reyataz than with comparators.
Post-marketing Experience: The following events have been identified during post-approval use of Reyataz. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to the seriousness, frequency of reporting or causal connection to Reyataz or a combination of these factors.
Cardiac and Vascular Disorders: Second- and third-degree atrioventicular block, QTc prolongation, torsades de pointes.
Metabolism and Nutrition Disorders: Hyperglycemia, diabetes mellitus.
Renal and Urinary Disorders: Nephrolithiasis.
Hepatobiliary Disorders: Cholelithiasis, cholecystitis, cholestasis.
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