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APO-ABACAVIR-LAMIVUDINE is a brand name for Abacavir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-ABACAVIR-LAMIVUDINE (abacavir and lamivudine tablets) is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection. 1.1 Pediatrics (< 18 years of age) The safety and efficacy of abacavir and lamivudine tablets has been established in adolescents and children…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations 03/2023 7 WARNINGS AND PRECAUTIONS, Clinical Management of Abacavir HSRs 03/2023 7 WARNINGS AND PRECAUTIONS, Immune 03/2023 7 WARNINGS AND PRECAUTIONS, General, Renal Insufficiency 03/2023 7 WARNINGS AND PRECAUTIONS, General 10/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ........................................................................................ 2 TABLE OF CONTENTS ..........................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................. 4 1 INDICATIONS ...........................................................................................................
4 2 CONTRAINDICATIONS ............................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 5 4 DOSAGE AND ADMINISTRATION .............................................................................
7 5 OVERDOSAGE.......................................................................................................... 7
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Therapy-Naive Adults Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a ≥5% frequency during therapy with abacavir 600 mg once daily or abacavir 300 mg twice daily, both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily, are listed in Table 2.
d. d. plus Lamivudine plus Efavirenz (n = 386) Drug hypersensitivitya 9% 7% Insomnia 7% 9% Depression/Depressed mood 7% 7% Headache/Migraine 5% 5% Fatigue/Malaise 5% 8% Dizziness/Vertigo 5% 5% Nausea 5% 6% Diarrheaa 5% 6% Rash 5% 5% Pyrexia 5% 3% Abnormal dreams 4% 5% Anxiety 3% 5% a Subjects receiving abacavir 600 mg once daily, experienced a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea compared with subjects who APO-ABACAVIR-LAMIVUDINE (abacavir and lamivudine tablets) Page 16 of 50 received abacavir 300 mg twice daily.
Five percent (5%) of subjects receiving abacavir 600 mg once daily had severe drug hypersensitivity reactions compared with 2% of subjects receiving abacavir 300 mg twice daily. Two percent (2%) of subjects receiving abacavir 600 mg once daily had severe diarrhea while none of the subjects receiving abacavir 300 mg twice daily had this event.
Other adverse reactions observed in clinical studies include neutropenia, anemia, thrombocytopenia, anorexia, hyperlactatemia, lactic acidosis, vomiting, pancreatitis, erythema multiforme, upper abdominal pain, transient rise in liver enzymes (AST, ALT, GGT), Stevens- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).
, Clinical Management of Abacavir HSRs 03/2023 7 WARNINGS AND PRECAUTIONS, Immune 03/2023 7 WARNINGS AND PRECAUTIONS, General, Renal Insufficiency 03/2023 7 WARNINGS AND PRECAUTIONS, General 10/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ........................................................................................ 2 TABLE OF CONTENTS ..........................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................. 4 1 INDICATIONS ...........................................................................................................
4 2 CONTRAINDICATIONS ............................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 5 4 DOSAGE AND ADMINISTRATION .............................................................................
7 5 OVERDOSAGE.......................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................. 7 7 WARNINGS AND PRECAUTIONS ..............................................................................
14 8 ADVERSE REACTIONS ............................................................................................ 17 9 DRUG INTERACTIONS ............................................................................................ 23 10 CLINICAL PHARMACOLOGY ...................................................................................
24 11 STORAGE, STABILITY AND DISPOSAL ..................................................................... 26 PART II: SCIENTIFIC INFORMATION ................................................................................... 27 13 PHARMACEUTICAL INFORMATION ........................................................................
APO-ABACAVIR-LAMIVUDINE is contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
• who are positive for the HLA-B*5701 allele and patients with a prior history of a hypersensitivity reaction (HSR) to abacavir, or products containing abacavir, regardless of HLA-B*5701 status. Fatal HSRs have been associated with rechallenge of abacavir (see 7 WARNINGS AND PRECAUTIONS).
• with hepatic impairment, as APO-ABACAVIR-LAMIVUDINE is a fixed-dose combination and the dosage of the individual components cannot be adjusted (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Abacavir in Canada.
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1 Clinical Trial Adverse Reactions - Pediatrics The safety of once daily compared with twice daily dosing of abacavir and lamivudine was assessed in the ARROW study (COL105677). No additional safety issues were identified in pediatric patients (n=669) receiving abacavir and lamivudine either once (n=336) or twice daily dosing compared to adults.
Within this population, 104 pediatric patients weighing at least 25 kg received abacavir and lamivudine once daily as abacavir and lamivudine tablets. 3 Less Common Clinical Trial Adverse Reactions One event of Grade 4 hepatitis in the once daily cohort was considered as uncertain causality by the investigator and all other Grade 3 or 4 adverse events were considered not related by the investigator.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Laboratory abnormalities (Grades 3 to 4) in therapy-naive adults during therapy with abacavir sulfate 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily compared with zidovudine 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily from CNA30024 are listed in Table 3.
Additional laboratory abnormalities observed in clinical trials of lamivudine were thrombocytopenia and elevated levels of bilirubin, amylase, and lipase. 9 gm/dL) <1% 2% Thrombocytopenia (Platelets <50,000/mm3) 1% <1% Leukopenia (WBC ≤1,500/mm3) <1% 2% ULN = Upper limit of normal.
n = Number of subjects assessed. In addition to the adverse events included from clinical trial data, the following adverse events listed below have been identified during post-approval use of abacavir and lamivudine, and/or abacavir and lamivudine tablets.
5 Post-Market Adverse Reactions These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to abacavir and lamivudine, or a combination of these factors. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Abacavir Endocrine/Metabolic: lactic acidosis (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic), hepatic steatosis Digestive: pancreatitis Immune […]
27 14 CLINICAL TRIALS .................................................................................................... 31 15 MICROBIOLOGY ....................................................................................................
32 16 NON-CLINICAL TOXICOLOGY ................................................................................. 35 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................ 40 PATIENT MEDICATION INFORMATION ..............................................................................
41 APO-ABACAVIR-LAMIVUDINE (abacavir and lamivudine tablets) Page 4 of 50 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-ABACAVIR-LAMIVUDINE (abacavir and lamivudine tablets) is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.
1 Pediatrics (< 18 years of age) The safety […]