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APO-ATAZANAVIR is a brand name for Atazanavir, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 09/2024 7 WARNINGS AND PRECAUTIONS, General 09/2024 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 ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment .......................................................
4 Administration ....................................................................................................... 5 Missed Dose...........................................................................................................
9 5 OVERDOSAGE ............................................................................................................... 9
). 5 Post-Market Adverse Reactions). Immune APO-ATAZANAVIR (Atazanavir Capsules) Page 14 of 97 Immune Reconstitution Inflammatory Syndrome: Immune reconstitution inflammatory syndrome has been reported in patients treated with combination antiretroviral therapy, including atazanavir capsules.
During the initial phase of treatment, a patient whose immune system responds to 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) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
5 Post-Market Adverse Reactions).
Renal Renal Impairment:
In healthy subjects, approximately 7 % of the dose of atazanavir is eliminated unchanged in the urine. Atazanavir capsules has been studied in adult subjects with severe renal impairment (n = 20), including those on hemodialysis, at multiple doses of 400 mg once daily.
The impact of renal impairment on atazanavir elimination for patients without hemodialysis is anticipated to be low. Moderate increases in atazanavir clearance and decreased exposure levels were seen in patients managed with hemodialysis.
APO-ATAZANAVIR should not be administered to HIV-treatment-experienced patients with end stage renal disease managed with hemodialysis (see 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY).
Chronic kidney disease:
Chronic kidney disease (CKD) has been reported in patients treated with atazanavir, with or without ritonavir, during post-marketing surveillance. Some resulted in fatal outcomes in patients with pre-existing CKD, and some resulted in the need for hemodialysis in patients with or without pre-existing CKD.
, General 09/2024 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 ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................... 1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment .......................................................
4 Administration ....................................................................................................... 5 Missed Dose...........................................................................................................
9 5 OVERDOSAGE ............................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 10 7 WARNINGS AND PRECAUTIONS ..................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Atazanavir in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
APO-ATAZANAVIR should be used with caution, particularly in those patients with other risk factors for chronic kidney disease. Prescribers should consider the risk-benefit in continuing APO-ATAZANAVIR therapy if patients develop signs and symptoms of CKD.
Nephrolithiasis and Cholelithiasis:
Cases of nephrolithiasis and/or cholelithiasis were reported during post-marketing surveillance in HIV-infected patients receiving atazanavir therapy. Some patients required hospitalization for additional management, and some had complications.
Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made. If signs or symptoms of nephrolithiasis and/or cholelithiasis occur, temporary interruption or discontinuation of therapy may be considered.
Reproductive Health:
Female and Male Potential Fertility APO-ATAZANAVIR (Atazanavir Capsules) Page 15 of 97 In a fertility and early embryonic development study in rats, atazanavir altered estrus cycling with no effects on mating, fertility, or early embryonic development.
Systemic drug exposure levels were equal (in male rats) or two times (in female rats) those at the human clinical dose (400 mg/day). Sensitivity/Resistance Resistance In vitro HIV-1 isolates with a decreased susceptibility to ATV have been selected in vitro and obtained from patients treated with ATV or atazanavir/ritonavir (ATV/RTV).
HIV-1 isolates that were 93- to 183-fold resistant to ATV from three different viral strains were selected in vitro by 5 months. The mutations in these HIV-1 viruses that contributed to ATV resistance included I50L, N88S, I84V, A71V, and M46I.
Changes were also observed at the protease cleavage sites following drug selection. Recombinant viruses containing the I50L mutation were growth impaired and displayed increased in vitro susceptibility to other protease inhibitors (PIs) (amprenavir, lopinavir, nelfinavir, ritonavir, and saquinavir).
The I50L and I50V substitutions yielded selective resistance to ATV and amprenavir, respectively, and did not appear to be cross-resistant. Both genotypic and phenotypic resistances have developed during clinical studies (see 15 MICROBIOLOGY, Resistance).
Cross Resistance Cross-resistance among PIs has been observed. Baseline phenotypic and genotypic analyses of clinical isolates from ATV clinical trials of PI-experienced subjects showed that isolates cross- resistant to multiple PIs were cross-resistant to ATV.
Greater than 90 % of the isolates with mutations that included I84V or G48V were resistant to ATV. Greater than 60 % of isolates containing L90M, G73S/T/C, A71V/T, I54V, M46I/L, or a change at V82 were resistant to ATV, and 38 % of isolates containing a D30N mutation in addition to other changes were resistant to ATV.
Isolates resistant to ATV were also cross-resistant to other PIs with > 90 % of the isolates resistant to lopinavir, nelfinavir, ritonavir, and saquinavir, and 80 % resistant to amprenavir. In treatment-experienced patients, PI-resistant viral isolates that developed the I50L mutation in addition to other PI resistance-associated mutations were also cross-resistant to other PIs.
Genotypic and/or phenotypic analysis of baseline virus may aid in determining ATV susceptibility before initiation of ATV/RTV therapy. Overall, both the number and type of baseline PI mutations affected response rates in treatment-experienced patients (see 15 MICROBIOLOGY, Cross-Resistance).
Skin APO-ATAZANAVIR (Atazanavir Capsules) Page 16 of 97 Rash:
In controlled clinical trials, rash (all grades, regardless of causality) occurred in approximately 20 % of patients treated with atazanavir capsules. 4 weeks. […]
1 Special Populations .............................................................................................. 1 Pregnant Women ................................................................................................. 2 Breast-feeding .....................................................................................................
3 Pediatrics ............................................................................................................. 4 Geriatrics .............................................................................................................
17 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..................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................
5 Post-Market Adverse Reactions ........................................................................... 29 9 DRUG INTERACTIONS .................................................................................................. 1 Serious Drug Interactions.....................................................................................
2 Drug Interactions Overview ................................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................
6 Drug-Herb Interactions ........................................................................................ 62 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action ...........................................................................................
2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics ................................................................................................. 62 11 STORAGE, STABILITY AND DISPOSAL ...........................................................................
67 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 68 PART II: SCIENTIFIC INFORMATION ........................................................................................
69 13 PHARMACEUTICAL INFORMATION .............................................................................. 69 14 CLINICAL TRIALS ..........................................................................................................
1 Clinical Trials by Indication ................................................................................... 2 Comparative Bioavailability Studies ..................................................................... 80 15 MICROBIOLOGY ..........................................................................................................
81 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 84 17 SUPPORTING PRODUCT MONOGRAPHS ...................................................................... 86 PATIENT MEDICATION INFORMATION ...................................................................................
87 APO-ATAZANAVIR […]