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MINT-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: MINT-ABACAVIR/LAMIVUDINE (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 and lamivudine tablets have been established in children and adolescents…
Verbatim from this product's HC label. Tap a section to expand.
). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Fatal Hypersensitivity Reactions to Abacavir Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of MINT-ABACAVIR/LAMIVUDINE.
Patients who carry the HLA-B*5701 allele are at higher risk of a hypersensitivity reaction to abacavir, although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele (see 7 WARNINGS AND PRECAUTIONS).
MINT-ABACAVIR/LAMIVUDINE (abacavir and lamivudine tablets) Page 5 of 44 MINT-ABACAVIR/LAMIVUDINE is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with MINT-ABACAVIR/LAMIVUDINE or re-initiation of therapy with MINT- ABACAVIR/LAMIVUDINE, unless patients have a previously documented HLA-B*5701 allele assessment.
Discontinue MINT-ABACAVIR/LAMIVUDINE immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible (see 7 WARNINGS AND PRECAUTIONS). Following a hypersensitivity reaction to MINT-ABACAVIR/LAMIVUDINE, NEVER restart MINT- ABACAVIR/LAMIVUDINE or any other abacavir-containing product because more severe symptoms, including death, can occur within hours.
Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity (see 7 WARNINGS AND PRECAUTIONS). • Post-Treatment Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co- infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, one component of MINT-ABACAVIR/LAMIVUDINE.
Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue MINT-ABACAVIR/LAMIVUDINE. If appropriate, initiation of anti-hepatitis B therapy may be warranted (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
1 Dosing Considerations • Screen for HLA-B*5701 Allele Prior to Initiating or Reinitiating Therapy with MINT- ABACAVIR/LAMIVUDINE All patients should be screened for the HLA-B*5701 allele prior to initiating or reinitiating treatment with MINT-ABACAVIR/LAMIVUDINE, unless patients have a previously documented HLA- B*5701 allele assessment.
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% aSubjects 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 MINT-ABACAVIR/LAMIVUDINE (abacavir and lamivudine tablets) Page 14 of 44 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).
). • with hepatic impairment, as MINT-ABACAVIR/LAMIVUDINE is a fixed-dose combination and the dosage of the individual components cannot be adjusted (see 4 DOSAGE AND ADMINISTRATION). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Fatal Hypersensitivity Reactions to Abacavir Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of MINT-ABACAVIR/LAMIVUDINE.
Patients who carry the HLA-B*5701 allele are at higher risk of a hypersensitivity reaction to abacavir, although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele (see 7 WARNINGS AND PRECAUTIONS).
MINT-ABACAVIR/LAMIVUDINE (abacavir and lamivudine tablets) Page 5 of 44 MINT-ABACAVIR/LAMIVUDINE is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with MINT-ABACAVIR/LAMIVUDINE or re-initiation of therapy with MINT- ABACAVIR/LAMIVUDINE, unless patients have a previously documented HLA-B*5701 allele assessment.
Discontinue MINT-ABACAVIR/LAMIVUDINE immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible (see 7 WARNINGS AND PRECAUTIONS). Following a hypersensitivity reaction to MINT-ABACAVIR/LAMIVUDINE, NEVER restart MINT- ABACAVIR/LAMIVUDINE or any other abacavir-containing product because more severe symptoms, including death, can occur within hours.
Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity (see 7 WARNINGS AND PRECAUTIONS). • Post-Treatment Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co- infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, one component of MINT-ABACAVIR/LAMIVUDINE.
MINT-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 MINT-ABACAVIR/LAMIVUDINE is a fixed-dose combination and the dosage of the individual components cannot be adjusted (see
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(see 2 CONTRAINDICATIONS and 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). • MINT-ABACAVIR/LAMIVUDINE can be taken with or without food. • Before prescribing MINT-ABACAVIR/LAMIVUDINE tablets, pediatric patients should be assessed for the ability to swallow tablets.
• Because MINT-ABACAVIR/LAMIVUDINE is a fixed dose tablet it should not be prescribed for patients requiring dosage adjustments, such as: • pediatric patients who weigh less than 40 kg with renal impairment (creatinine clearance < 50 mL/min) • patients who weigh less than 25 kg • patients with renal impairment (creatinine clearance < 30 mL/min) (see 7 WARNINGS AND PRECAUTIONS.
Renal Insufficiency) MINT-ABACAVIR/LAMIVUDINE (abacavir and lamivudine tablets) Page 6 of 44 • patients with mild hepatic impairment • patients experiencing dose-limiting adverse events • Separate preparations of abacavir or lamivudine should be administered in cases where discontinuation or dose adjustment is indicated.
2 Recommended Dose and Dosage Adjustment Adults, adolescents and children weighing at least 25 kg The recommended dose of MINT-ABACAVIR/LAMIVUDINE in adults, adolescents and children weighing at least 25 kg is one tablet once daily.
One tablet contains 600 mg abacavir (as abacavir sulfate) and 300 mg lamivudine. Pediatrics (<18 years of age and weighing less than 25 kg) MINT-ABACAVIR/LAMIVUDINE is not recommended for the treatment of children and adolescents weighing less than 25 kg as the necessary dose adjustment cannot be made.
Geriatrics (≥ 65 years of age) There are limited data available on the use of abacavir and lamivudine in patients aged 65 years and older. However, there is no evidence that elderly patients would differ in their response from adult patients less than 65 years of age.
Missed Dose It is important to take MINT-ABACAVIR/LAMIVUDINE as prescribed to ensure the patient gets maximum benefit. If the patient forgets to take a dose, they should take it as soon as they remember, and then continue as before.
Patients must not take more than one tablet to make up for forgotten individual doses.
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 3-4) in therapy-naïve adults during therapy with abacavir 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% MINT-ABACAVIR/LAMIVUDINE (abacavir and lamivudine tablets) Page 15 of 44 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 System: Immune Reconstitution Inflammatory Syndrome (see 7 WARNINGS AND PRECAUTIONS, Immune) Skin: rash, erythema multiforme, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) […]
Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue MINT-ABACAVIR/LAMIVUDINE. If appropriate, initiation of anti-hepatitis B therapy may be warranted (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
1 Dosing Considerations • Screen for HLA-B*5701 Allele Prior to Initiating or Reinitiating Therapy with MINT- ABACAVIR/LAMIVUDINE All patients should be screened for the HLA-B*5701 allele prior to initiating or reinitiating treatment with MINT-ABACAVIR/LAMIVUDINE, unless patients have a previously documented HLA- B*5701 allele assessment.
(see 2 CONTRAINDICATIONS and 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). • MINT-ABACAVIR/LAMIVUDINE can be taken with or without food. • Before prescribing MINT-ABACAVIR/LAMIVUDINE tablets, pediatric patients should be assessed for the ability to swallow tablets.
• Because MINT-ABACAVIR/LAMIVUDINE is a fixed dose tablet it should not be prescribed for patients requiring dosage adjustments, such as: • pediatric patients who weigh less than 40 kg with renal impairment (creatinine clearance < 50 mL/min) • patients who weigh less than 25 kg • patients with renal impairment (creatinine clearance < 30 mL/min) (see 7 WARNINGS AND PRECAUTIONS.
Renal Insufficiency) MINT-ABACAVIR/LAMIVUDINE (abacavir and lamivudine tablets) Page 6 of 44 • patients with mild hepatic impairment • patients experiencing dose-limiting adverse events • Separate preparations of abacavir or lamivudine should be administered in cases where discontinuation or dose adjustment is indicated.
2 Recommended Dose and Dosage Adjustment Adults, adolescents and children weighing at least 25 kg The recommended dose of MINT-ABACAVIR/LAMIVUDINE in adults, adolescents and children weighing at least 25 kg is one tablet once daily.
One tablet contains 600 mg abacavir (as abacavir sulfate) and 300 mg lamivudine. Pediatrics (<18 years of age and weighing less than 25 kg) MINT-ABACAVIR/LAMIVUDINE is not recommended for the treatment of children and adolescents weighing less than 25 kg as the necessary dose adjustment cannot be made.
Geriatrics (≥ 65 years of age) There are limited data available on the use of abacavir and lamivudine in patients aged 65 years and older. However, there is no evidence that elderly patients would differ in their response from adult patients less than 65 years of age.
Missed Dose It is important to take MINT-ABACAVIR/LAMIVUDINE as prescribed to ensure the patient gets maximum benefit. If the patient forgets to take a dose, they should take it as soon as they remember, and then continue as before.
Patients must not take more than one tablet to make up for forgotten individual doses. 5 OVERDOSAGE If overdosage occurs, the patient should be monitored, and standard supportive treatment applied as required. Administration of activated charcoal may also be used to aid in the removal of unabsorbed active substance.
General supportive measures are recommended. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis. Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied.
Limited data are available on the consequences of ingestion of acute overdoses in humans. No fatalities occurred, and the patients recovered. Single doses up to 1,200 mg and daily doses up to 1,800 mg of abacavir sulfate have been administered to patients in clinical studies.
No unexpected adverse reactions were reported. The effects of higher doses are not known. No specific signs or symptoms have been […]