| Document Date: 2009-09-18 15:40:59
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Company GlaxoSmithKline / / Currency CYP / pence / / Event FDA Phase / / Facility Laboratory Abnormality / Laboratory Abnormalities Reported / / IndustryTerm food / treatment of HIV / / MedicalCondition inflammatory response / Gastrointestinal Diarrhea / Diabetes/Hyperglycemia New onset diabetes mellitus / HIV / headache / Mycobacterium avium infection / Patients With Hemophilia / Skin disorders / Sulfa Allergy / Subcutaneous Tissue Disorders / nausea / Skin Rash / Oral paresthesia / hepatitis B / Nervous system Headache / Stevens-Johnson syndrome / Lipid disorders / Fatigue / diabetic ketoacidosis / Cardiac Disorders / residual opportunistic infections / clinically significant hypersensitivity / diarrhea / Hypersensitivity / pruritus / Nephrolithiasis / Hemophilia / immune reconstitution syndrome / sulfonamide allergy / Nutrition Disorders / Abdominal pain / pre-existing diabetes mellitus / central obesity / hemolytic anemia / Immune Reconstitution Syndrome Immune reconstitution syndrome / hemophilia A / Nervous System Disorders / Carcinogenesis / hyperglycemia / cardiac arrhythmias / Pneumocystis jirovecii pneumonia / Diabetes/Hyperglycemia / rhabdomyolysis / vomiting / Myocardial infarction / diabetes mellitus / simvastatin myopathy / Angioedema / drug-related vomiting episodes / respiratory depression / infection / Sulfa Allergy LEXIVA / Adverse Reaction Gastrointestinal Diarrhea / rash / Hypercholesterolemia / tuberculosis / / MedicalTreatment antiretroviral treatment / antiretroviral therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / Once-daily administration / / / Position General / / Product simvastatin / triazolam / Oral Suspension / Rifampin / LEXIVA / abacavir / lamivudine / Lovastatin / LEXIVA Oral Suspension / CYP3A4 / / Technology Pharmacokinetics / / URL www.fda.gov/medwatch / /
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----------------------- WARNINGS AND PRECAUTIONS ---------------• Certain drugs should not be coadministered with LEXIVA due to risk of serious or life-threatening adverse reactions. (5.1) • LEXIVA should be discon