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adverse reactions
ADVERSE REACTIONS The safety assessment is based on all safety data from the Studies TMC114-C213 and TMC114-C202 and the TMC114-C215/C208 analysis reported with the recommended dose PREZISTA/rtv 600/100 mg b.i.d. in the 458 subjects who initiated treatment with the recommended dose ( de novo subjects). In Studies TMC114-C213 and TMC114-C202, the mean exposure in weeks for subjects in the PREZISTA/rtv 600/100 mg b.i.d. arm and comparator PI arm was 63.5 and 31.5, respectively. The mean exposure in weeks for subjects in the TMC114-C215/C208 analysis was 23.9. The most common treatment-emergent adverse events (> 10%) reported in the de novo subjects, regardless of causality or frequency, were diarrhea, nausea, headache, and nasopharyngitis. For subjects in the PREZISTA/rtv 600/100 mg b.i.d. arm and the comparator PI arm in the pooled analysis for Studies TMC114-C213 and TMC114-C202, diarrhea was reported in 19.8% and 28.2%, nausea in 18.3% and 12.9%, headache in 15.3% and 20.2%, and nasopharyngitis in 13.7% and 10.5%, of subjects, respectively. In the randomized trials, rates of discontinuation of therapy due to adverse events were 9% in subjects receiving PREZISTA/rtv and in 5% of subjects in the comparator PI arm. Due to the need for co-administration of PREZISTA with 100 mg of ritonavir, please refer to ritonavir prescribing information for ritonavir-associated adverse reactions. Drug-related clinical adverse events of moderate or severe intensity (≥ Grade 2) occurring in ≥ 2% of subjects treated with PREZISTA/rtv for 1 to 96 weeks are presented in Table 12 . Table 12: Percentage of Subjects with Selected Treatment Emergent, Drug-Related^ Adverse Events of at least Moderate Intensity (Grades 2-4) in ≥ 2% of Adult Subjects in Any PREZISTA/rtv Treatment Groups † System Organ Class, Preferred Term, % Randomized Studies TMC114-C213 and TMC114-C202 Non-randomized TMC114-C215/C208 Analysis PREZISTA/rtv 600/100 mg b.i.d. +OBR N = 131 Comparator PI +OBR N = 124 PREZISTA/rtv 600/100 mg b.i.d.+OBR N = 327 ^ Includes adverse events at least possibly, probably, or very likely related to the drug N=total number of subjects per treatment group † Excludes laboratory abnormalities that were reported as Adverse Events (see Table 13: Treatment Emergent Grade 2 to 4 Laboratory Abnormalities Reported in ≥ 2% of Subjects ) Gastrointestinal Disorders Diarrhea 2.3% 3.2% 2.8% Vomiting 1.5% 1.6% 2.4% Abdominal Pain 2.3% 0.8% 1.2% Constipation 2.3% 0.8% 0.6% Nervous System Disorders Headache 3.8% 2.4% 0.9% Treatment-emergent adverse events occurring in less than 2% of de novo subjects (n=458) receiving PREZISTA/rtv, considered at least possibly related to treatment and of at least moderate intensity are listed below by body system: Body as a Whole : folliculitis, asthenia, pyrexia, fatigue, rigors, hyperthermia, peripheral edema Cardiovascular System : myocardial infarction, tachycardia, hypertension Digestive System : flatulence, abdominal distension, dry mouth, dyspepsia, abdominal pain, nausea, constipation Metabolic and Nutritional Disorders : anorexia, hypercholesterolemia, hyperlipidemia, diabetes mellitus, decreased appetite, obesity, fat redistribution, hyponatremia, polydipsia Musculoskeletal System : arthralgia, pain in extremity, myalgia, osteopenia, osteoporosis Nervous System : peripheral neuropathy, hypoesthesia, memory impairment, paresthesia, somnolence, transient ischemic attack, confusional state, disorientation, irritability, altered mood, nightmare, anxiety, headache Respiratory System : dyspnea, cough, hiccups Skin and Appendages : lipoatrophy, night sweats, allergic dermatitis, eczema, toxic skin eruption, alopecia, dermatitis medicamentosa, hyperhidrosis, skin inflammation, maculopapular rash, Special Senses : vertigo Urogenital System : acute renal failure, renal insufficiency, nephrolothiasis, polyuria, gynecomastia Treatment-emergent adverse events occurring in less than 2% of de novo subjects (n=458) receiving PREZISTA/rtv, considered at least possibly related to treatment and of at least moderate intensity are listed below by body system: Body as a Whole : folliculitis, asthenia, pyrexia, fatigue, rigors, hyperthermia, peripheral edema Cardiovascular System : myocardial infarction, tachycardia, hypertension Digestive System : flatulence, abdominal distension, dry mouth, dyspepsia, abdominal pain, nausea, constipation Metabolic and Nutritional Disorders : anorexia, hypercholesterolemia, hyperlipidemia, diabetes mellitus, decreased appetite, obesity, fat redistribution, hyponatremia, polydipsia Musculoskeletal System : arthralgia, pain in extremity, myalgia, osteopenia, osteoporosis Nervous System : peripheral neuropathy, hypoesthesia, memory impairment, paresthesia, somnolence, transient ischemic attack, confusional state, disorientation, irritability, altered mood, nightmare, anxiety, headache Respiratory System : dyspnea, cough, hiccups Skin and Appendages : lipoatrophy, night sweats, allergic dermatitis, eczema, toxic skin eruption, alopecia, dermatitis medicamentosa, hyperhidrosis, skin inflammation, maculopapular rash, Special Senses : vertigo Urogenital System : acute renal failure, renal insufficiency, nephrolothiasis, polyuria, gynecomastia Laboratory abnormalities The percentages of adult subjects treated with PREZISTA/rtv 600/100 mg b.i.d. with treatment-emergent Grade 2 to 4 laboratory abnormalities are presented in Table 13 . The percentages of adult subjects treated with PREZISTA/rtv 600/100 mg b.i.d. with treatment-emergent Grade 2 to 4 laboratory abnormalities are presented in Table 13 . Table 13: Treatment Emergent Grade 2 to 4 Laboratory Abnormalities Reported in ≥ 2% of Subjects Randomized Studies TMC114-C213 and TMC114-C202 Non-randomized TMC114-C215/C208 Analysis Laboratory Parameter Preferred Term, % Limit PREZISTA/rtv 600/100 mg b.i.d. + OBR N = 131 Comparator PI + OBR N = 124 PREZISTA/rtv 600/100 mg b.i.d. N = 327 Biochemistry Aspartate Aminotransferase > 2.5 X ULN 10.0% 13.0% 5.3% Alanine Aminotransferase > 2.5 X ULN 6.9% 9.8% 5.6% Gamma Glutamyl Transferase > 2.5 X ULN 9.2% 8.9% 8.4% Hyperbilirubinemia > 1.5 X ULN 2.3% 15.4% 0.9% Alkaline Phosphatase > 2.5 X ULN 4.6% 0% 2.8% Pancreatic Amylase > 1.5 X ULN 16.9% 8.9% 10.8% Pancreatic Lipase > 1.5 X ULN 8.5% 4.1% 6.2% Hyperglycemia ≥ 161 mg/dL 2.3% 8.1% 5.9% Hypoglycemia ≤ 54 mg/dL 1.5% 1.6% 3.7% Total Cholesterol ≥ 240 mg/dL 9.2% 3.3% 8.0% Triglycerides > 400 mg/dL 25.4% 26.0% 18.9% Hypoalbuminemia < 3 g/dL 3.1% 1.6% 4.3% Hyperuricemia ≥ 9.9 mg/dL 6.9% 6.5% 2.2% Bicarbonate < 15 mmol/L 3.1% 4.1% 3.4% Hypocalcemia ≤ 7.8 mg/dL 0% 0.8% 4.0% Hyponatremia ≤ 129 meq/L 0.8% 0% 2.5% Hypernatremia ≥ 151 meq/L 2.3% 0% 0% Hematology White Blood Cell Count decrease < 3000 count/mm 3 15.4% 18.7% 13.0% Total Absolute Neutrophil Count decrease ≤ 999 mm 3 6.9% 9.8% 11.5% Lymphocytes decrease < 1000 count/mm 3 4.6% 19.5% 10.9% Partial Thromboplastin Time increase > 1.66 X ULN 7.8% 4.1% 4.3% Plasma Prothrombin Time increase > 1.25 X ULN 3.9% 0.8% 0.6% Platelet Count decrease < 75,000/mm 3 3.1% 1.6% 2.8% Additional adverse reactions identified in clinical studies, occurring in less than 1% of the patients, are listed below by body system: Hepatobiliary System : hepatitis Skin and Appendages : erythema multiforme, Stevens-Johnson Syndrome Patients co-infected with hepatitis B and/or hepatitis C virus In subjects co-infected with hepatitis B or C virus receiving PREZISTA/rtv, the incidence of adverse events and clinical chemistry abnormalities was not higher than in subjects receiving PREZISTA/rtv who were not co-infected, except for increased hepatic enzymes. The pharmacokinetic exposure in co-infected subjects was comparable to that in subjects without co-infection. Standard clinical monitoring of patients with hepatitis co-infectionis considered adequate.