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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 TABLETS (abacavir sulfate / lamivudine) 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 sulfate / lamivudine has been established in adolescents and…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations 02/2023 7 WARNINGS AND PRECAUTIONS, Clinical Management of Abacavir HSRs 02/2023 7 WARNINGS AND PRECAUTIONS, Immune 02/2023 7 WARNINGS AND PRECAUTIONS, General, Renal Insufficiency 02/2023 7 WARNINGS AND PRECAUTIONS, General 01/2024 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 ..................................................................................................................
1 Pediatrics (< 18 years of age) ........................................................................................... 2 Geriatrics (≥ 65 years of age) ...........................................................................................
4 2 CONTRAINDICATIONS ..................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX................................................................. 5 4 DOSAGE AND ADMINISTRATION .....................................................................................
1 Dosing Considerations...................................................................................................... 2 Recommended Dose and Dosage Adjustment ................................................................ 5 Missed Dose .....................................................................................................................
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. d. d. plus Lamivudine plus Efavirenz (n = 386) 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 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 02/2023 7 WARNINGS AND PRECAUTIONS, Immune 02/2023 7 WARNINGS AND PRECAUTIONS, General, Renal Insufficiency 02/2023 7 WARNINGS AND PRECAUTIONS, General 01/2024 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 ..................................................................................................................
1 Pediatrics (< 18 years of age) ........................................................................................... 2 Geriatrics (≥ 65 years of age) ...........................................................................................
4 2 CONTRAINDICATIONS ..................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX................................................................. 5 4 DOSAGE AND ADMINISTRATION .....................................................................................
1 Dosing Considerations...................................................................................................... 2 Recommended Dose and Dosage Adjustment ................................................................ 5 Missed Dose .....................................................................................................................
7 5 OVERDOSAGE ................................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 7 7 WARNINGS AND PRECAUTIONS ......................................................................................
APO-ABACAVIR-LAMIVUDINE TABLETS 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 TABLETS 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.
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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 sulfate/lamivudine. 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 APO-ABACAVIR-LAMIVUDINE TABLETS (abacavir sulfate and lamivudine tablets) Page 17 of 51 Laboratory abnormalities (Grades 3 to 4) in therapy-naive adults during therapy with ZIAGEN 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 3TC 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 sulfate/lamivudine.
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, […]
1 Special Populations ........................................................................................................ 1 Pregnant Women ...........................................................................................................
2 Breast-feeding ................................................................................................................ 3 Pediatrics (< 18 years of age) .........................................................................................
4 Geriatrics (≥ 65 years of age) ......................................................................................... 14 8 ADVERSE REACTIONS ....................................................................................................
1 Adverse Reaction Overview ........................................................................................... 2 Clinical Trial Adverse Reactions......................................................................................
1 Clinical Trial Adverse Reactions - Pediatrics................................................................... 3 Less Common Clinical Trial Adverse Reactions .............................................................. 5 Post-Market Adverse Reactions .....................................................................................
17 9 DRUG INTERACTIONS.................................................................................................... 2 Drug Interactions Overview ...........................................................................................
4 Drug-Drug Interactions................................................................................................... 5 Drug-Food Interactions ..................................................................................................
6 Drug-Herb Interactions .................................................................................................. 7 Drug-Laboratory Test Interactions .................................................................................
23 10 CLINICAL PHARMACOLOGY ........................................................................................... 1 Mechanism of Action .....................................................................................................
3 Pharmacokinetics ........................................................................................................... 24 11 STORAGE, STABILITY AND DISPOSAL .............................................................................
27 PART II: SCIENTIFIC INFORMATION ...................................................................................... 28 13 PHARMACEUTICAL INFORMATION ................................................................................
28 14 CLINICAL TRIALS............................................................................................................ 1 Clinical Trials by Indication .............................................................................................
2 Comparative Bioavailability Studies ............................................................................... 31 15 MICROBIOLOGY ............................................................................................................
33 16 NON-CLINICAL TOXICOLOGY ......................................................................................... 36 17 SUPPORTING PRODUCT MONOGRAPHS ........................................................................ 41 PATIENT […]