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APO-ABACAVIR 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: …..................................................................................................................... 4 1.1 Pediatrics.......................................................................................................................... 4 1.2 Geriatrics…
Verbatim from this product's HC label. Tap a section to expand.
” APO-ABACAVIR is available as an oral solution for use in children and for those patients for whom tablets are inappropriate. APO-ABACAVIR can be taken with or without food. 2 Recommended Dose and Dosage Adjustment Adults weighing at least 25 kg The recommended oral dose of APO-ABACAVIR for adults, is 600 mg daily administered as either 300 mg twice daily or 600 mg once daily.
APO-ABACAVIR (Abacavir Tablets) Page 6 of 41 Adolescents and children weighing at least 25 kg The recommended dose of APO-ABACAVIR can be administered as 300 mg (1 tablet) twice daily.
Pediatrics (≥ three months of age) and weighing less than 25 kg:
The recommended dose of APO-ABACAVIR is 8 mg/kg twice daily (up to a maximum of 300 mg twice daily). Scored Tablets APO-ABACAVIR is also available as a scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate.
Before prescribing APO-ABACAVIR tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow APO-ABACAVIR tablets, the oral solution formulation should be prescribed. The recommended oral dosage of APO-ABACAVIR tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1 - Dosing Recommendations for APO-ABACAVIR Tablets in Pediatric Patients Weight (kg) Twice-Daily dosing Total Daily Dose AM Dose PM Dose 14 to <20 ½ tablet (150 mg) ½ tablet (150 mg) 300 mg ≥20 to <25 ½ tablet (150 mg) 1 tablet (300 mg) 450 mg ≥25 1 tablet (300 mg) 1 tablet (300 mg) 600 mg a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment (see 14 CLINICAL TRIALS).
Pediatrics (< three months of age):
The safety and efficacy of abacavir in pediatric patients less than 3 months of age have not been established; therefore, Health Canada has not authorized an indication for pediatric use in patients less than 3 months of age. Renal Impairment No dosage adjustment of APO-ABACAVIR is necessary in patients with renal dysfunction.
The use of abacavir 600 mg once daily has not been studied in patients with renal impairment (see 7 WARNINGS AND PRECAUTIONS, Renal Impairment). Hepatic Impairment Abacavir is primarily metabolized by the liver. The recommended dose of APO-ABACAVIR in patients with mild hepatic impairment (Child-Pugh Score A) who have confirmed cirrhosis is 200 mg twice a day.
6 Description of Abacavir Hypersensitivity Adverse Reactions). The symptoms related to this HSR worsen with continued therapy and can be life-threatening. These symptoms usually resolve upon APO-ABACAVIR (Abacavir Tablets) Page 10 of 41 discontinuation of abacavir.
A warning card with information for the patient about this hypersensitivity reaction is included in the APO-ABACAVIR outer pack label (see a copy of this card on the last page). Carcinogenesis and Mutagenesis Carcinogenicity studies with abacavir in mice and rats showed an increase in malignant tumours in the preputial gland of males and the clitoral gland of females of both species, and in the liver, urinary bladder, lymph nodes and subcutis of female rats.
The majority of these tumours occurred at exposures equivalent to 24 to 33 times the expected systemic exposure in humans (see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity). Abacavir was not mutagenic in a bacterial mutagenicity assay but induced chromosomal aberrations in vitro and was mutagenic in the absence of metabolic activation in an L5178Y mouse lymphoma assay.
In an in vivo mouse bone marrow micronucleus assay, abacavir was clastogenic in males at exposures ~9X higher than those in humans at the therapeutic dose (see 16 NON- CLINICAL TOXICOLOGY, Mutagenicity). Cardiovascular Several observational and epidemiological studies have reported an association with abacavir use and the risk of myocardial infarction.
Meta-analyses of randomised controlled trials have observed no excess risk of myocardial infarction with abacavir use. To date, there is no established biological mechanism to explain a potential increase in risk. Overall, the available data from the observational studies and from controlled clinical trials show inconsistency and therefore the evidence for a causal relationship between abacavir treatment and the risk of myocardial infarction is inconclusive.
, General 04/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS….....................................................................................................................
1 Pediatrics.......................................................................................................................... 2 Geriatrics ..........................................................................................................................
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 .....................................................................................................................
7 5 OVERDOSAGE.. .................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................................... 7 7 WARNINGS AND PRECAUTIONS ...........................................................................................
APO-ABACAVIR tablets are 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 to abacavir, or products containing abacavir, regardless of HLA- B*5701 status. Fatal hypersensitivity reactions have been associated with rechallenge of abacavir (see 7 WARNINGS AND PRECAUTIONS).
• with moderate or severe hepatic impairment since the pharmacokinetics have not been studied in this patient group.
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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To enable dose reduction abacavir oral solution should be used for the treatment of these patients. Abacavir is contraindicated in patients with moderate or severe hepatic impairment, as the pharmacokinetics have not been studied in these patient groups.
(See 2 APO-ABACAVIR (Abacavir Tablets) Page 7 of 41 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Hepatic Impairment). Pharmacokinetic and safety data on the use of abacavir in patients with moderate and severe hepatic impairment are not available.
Therefore the use of APO-ABACAVIR is contraindicated in patients with moderate or severe hepatic impairment. Once daily abacavir 600 mg dosing has not been studied in the patients with impaired hepatic function. 5 Missed Dose If the patient forgets to take their medicine, they should take it as soon as they remember.
Then continue as before. Patients should not take a double dose to make up for forgotten individual doses. If a patient stops therapy with APO-ABACAVIR because of side effects or illness, they must check with their healthcare professional before restarting therapy to make sure that symptoms of a hypersensitivity reaction have not been missed.
g. hypertension, hyperlipidemia, diabetes mellitus and smoking). Endocrine and Metabolism Serum lipids and blood glucose Serum lipid and blood glucose levels may increase during antiretroviral therapy. Disease control and lifestyle changes may also be contributing factors.
Consideration should be given to the measurement of serum lipids and blood glucose. Lipid disorders and blood glucose elevations should be managed as clinically appropriate. APO-ABACAVIR (Abacavir Tablets) Page 11 of 41 Hepatic/Biliary/Pancreatic Lactic Acidosis/Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues either alone or in combination, including abacavir and other antiretrovirals.
A majority of these cases have been in women. Clinical features which may be indicative of the development of lactic acidosis include generalised weakness, anorexia and sudden unexplained weight loss, gastrointestinal symptoms and respiratory symptoms (dyspnea and tachypnea).
Female sex and obesity may be risk factors. Caution should be exercised when administering APO- ABACAVIR or other nucleoside analogues, particularly to those with known risk factors for liver disease. However, cases have also been reported in patients with no known risk factors.
Treatment with APO-ABACAVIR should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis with or without hepatitis, which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations.
Hepatic Impairment Abacavir is contraindicated in patients with moderate to severe hepatic impairment and dose reduction is required in patients with mild hepatic impairment. Abacavir is metabolized primarily by the liver. The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh Score A) who had confirmed cirrhosis.
58 fold in the half life of abacavir. The AUCs of the metabolites were not modified by the liver disease. However, the rates of formation and elimination of these were decreased. The pharmacokinetics have not been studied in patients with moderate or severe hepatic impairment; therefore abacavir is contraindicated in these patient groups.
Immune Immune Reconstitution Inflammatory Syndrome During the initial phase of treatment, patients responding to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (such as MAC, CMV, PCP and TB), which may necessitate further evaluation and treatment.
Autoimmune disorders (such as Graves’ disease, polymyositis, autoimmune hepatitis and Guillain- Barre syndrome) have also been reported to occur in the setting of immune reconstitution, however the time to onset is more variable, and can occur many months after initiation of treatment and sometimes can be an atypical presentation.
APO-ABACAVIR (Abacavir Tablets) Page 12 of 41 Renal Impairment Preliminary data from a single dose pharmacokinetic study of abacavir in 6 end-stage renal disease patients has demonstrated that abacavir concentrations were similar to those with normal renal function.
The two major metabolites (5'-glucuronide and 5'-carboxylate metabolites) are likely to accumulate but are considered inactive. No dosing modification of abacavir is recommended in patients with renal impairment. 1 Pregnant Women Abacavir has not been studied in pregnant women.
Therefore, APO-ABACAVIR should not be used in pregnant women unless the potential benefits outweigh the potential risk to the fetus. There have been reports of developmental delay, seizures and other neurological disease. However, a causal […]
1 Special Populations ........................................................................................................ 1 Pregnant Women .........................................................................................................
2 Breast-Feeding ............................................................................................................. 3 Pediatrics .....................................................................................................................
4 Geriatrics ...................................................................................................................... 13 8 ADVERSE REACTIONS .......................................................................................................
1 Adverse Reaction Overview ........................................................................................... 2 Clinical Trial Adverse Reactions ......................................................................................
1 Clinical Trials Adverse Reactions - Pediatrics ................................................................ 3 Less Common Clinical Trial Adverse Reactions ............................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative APO-ABACAVIR (Abacavir Tablets) Page 3 of 41 Data ................................................................................................................................
5 Post-Market Adverse Reactions ...................................................................................... 6 Description of Abacavir Hypersensitivity Adverse Reactions ........................................... 17 9 DRUG INTERACTIONS .......................................................................................................
2 Drug Interaction 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 ............................................................................................ 29 […]