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MYLAN-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: MYLAN-ABACAVIR/LAMIVUDINE (abacavir sulfate/lamivudine) is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults. 1.1 Pediatrics (< 18 years of age) MYLAN-ABACAVIR/LAMIVUDINE is not indicated in antiretroviral combination therapy for the treatment…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations 09/2023 7 WARNINGS AND PRECAUTIONS, General 09/2023 7 WARNINGS AND PRECAUTIONS, Clinical Management of Abacavir HSRs 09/2023 7 WARNINGS AND PRECAUTIONS, Renal Insufficiency 09/2023 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 ................................................................................................................
1 Pediatrics (< 18 years of age) ................................................................................... 2 Geriatrics (≥ 65 years of age) ...................................................................................
4 2 CONTRAINDICATIONS .................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 4 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................ 5 Missed Dose ............................................................................................................
6 5 OVERDOSAGE............................................................................................................... 6
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 drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Therapy-Naïve 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) 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).
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.
, General 09/2023 7 WARNINGS AND PRECAUTIONS, Clinical Management of Abacavir HSRs 09/2023 7 WARNINGS AND PRECAUTIONS, Renal Insufficiency 09/2023 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 ................................................................................................................
1 Pediatrics (< 18 years of age) ................................................................................... 2 Geriatrics (≥ 65 years of age) ...................................................................................
4 2 CONTRAINDICATIONS .................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 4 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................ 5 Missed Dose ............................................................................................................
6 5 OVERDOSAGE............................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 7 7 WARNINGS AND PRECAUTIONS ...................................................................................
MYLAN-ABACAVIR/LAMIVUDINE (abacavir sulfate/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 the 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 MYLAN-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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4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Laboratory abnormalities (Grades 3-4) 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 1% <1% MYLAN-ABACAVIR/LAMIVUDINE (Abacavir (as Abacavir Sulfate)/Lamivudine) Page 15 of 44 Grade 3/4 Laboratory Abnormalities ZIAGEN plus Lamivudine plus Efavirenz (n = 324) Zidovudine plus Lamivudine plus Efavirenz (n = 325) <50,000/mm3) Leukopenia (WBC ≤1,500/mm3) <1% 2% ULN = upper limit of normal.
ANC = absolute neutrophil count. 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 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 System: Immune Reconstitution Inflammatory Syndrome (see 7 WARNINGS AND PRECAUTIONS, Immune) Skin: rash, erythema multiforme, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (primarily in combination with medications known to be associated with SJS and TEN, respectively).
Because of the overlap of the clinical signs and symptoms between hypersensitivity to abacavir, SJS and TEN and the possibility of multiple […]
1 Special Populations................................................................................................ 1 Pregnant Women ............................................................................................ 2 Breast-feeding .................................................................................................
3 Pediatrics (< 18 years of age) ........................................................................... 4 Geriatrics (≥ 65 years of age) ........................................................................... 12 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ......................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings .......................................................................... 5 Post-Market Adverse Reactions ............................................................................
15 9 DRUG INTERACTIONS ................................................................................................. 2 Drug Interactions Overview ...................................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions.......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions......................................................................... 20 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action .......................................................................................
3 Pharmacokinetics ............................................................................................ 21 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 23 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................
23 PART II: SCIENTIFIC INFORMATION ........................................................................................ 24 13 PHARMACEUTICAL INFORMATION .............................................................................
24 14 CLINICAL TRIALS ......................................................................................................... 1 Clinical Trials by Indication ..............................................................................
2 Comparative Bioavailability Studies................................................................. 27 15 MICROBIOLOGY ......................................................................................................... 28 16 NON-CLINICAL TOXICOLOGY ......................................................................................
30 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 35 PATIENT MEDICATION INFORMATION ................................................................................... 36 MYLAN-ABACAVIR/LAMIVUDINE (Abacavir (as Abacavir Sulfate)/Lamivudine) Page 4 of 44 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS MYLAN-ABACAVIR/LAMIVUDINE (abacavir […]