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MYLAN-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.
Used for: PrMYLAN-ATAZANAVIR (Atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients 6 years of age and older weighing at least 20 kg. This indication is based on analyses of plasma HIV-1 RNA levels…
Verbatim from this product's HC label. Tap a section to expand.
, 7 WARNINGS AND PRECAUTIONS, 15 MICROBIOLOGY - Resistance). 1 Pediatrics Pediatrics (from 6 to <18 years of age and weighing at least 20 kg): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Atazanavir sulfate capsules in pediatric patients have been established.
3 Pediatrics, 14 CLINICAL TRIALS). Dosage is based on body weight not to exceed the adult dose (see 4 DOSAGE AND ADMINISTRATION). There are no dosing recommendations for pediatric patients less than 6 years of age. 2 Geriatrics Geriatrics (≥ 65 years of age): Clinical studies of atazanavir sulfate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
In general, dose selection for an elderly patient should reflect the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. , Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any component of the product or container, including atazanavir.
For a complete listing see
). 5 Post-Market Adverse Reactions).
Immune Immune Reconstitution Inflammatory Syndrome:
Immune reconstitution inflammatory syndrome has been reported in patients treated with combination antiretroviral therapy, including MYLAN- ATAZANAVIR. 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 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.
MYLAN-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.
, 15 MICROBIOLOGY - Resistance). 1 Pediatrics Pediatrics (from 6 to <18 years of age and weighing at least 20 kg): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Atazanavir sulfate capsules in pediatric patients have been established.
3 Pediatrics, 14 CLINICAL TRIALS). Dosage is based on body weight not to exceed the adult dose (see 4 DOSAGE AND ADMINISTRATION). There are no dosing recommendations for pediatric patients less than 6 years of age. 2 Geriatrics Geriatrics (≥ 65 years of age): Clinical studies of atazanavir sulfate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
In general, dose selection for an elderly patient should reflect the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. , Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any component of the product or container, including atazanavir.
For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Coadministration of MYLAN-ATAZANAVIR is contraindicated with drugs that are highly dependent on CYP3A4 and/or UGT1A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events, and with drugs that are strong inducers of CYP3A due to the potential for loss of therapeutic effect and development of possible resistance.
Therefore, coadministration is contraindicated with drugs listed in Table 1. Table 1 includes, but is not limited to, a list of drugs within a class for which co-administration with MYLAN-ATAZANAVIR is CONTRAINDICATED. MYLAN-ATAZANAVIR (Atazanavir sulfate capsules) Page 5 of 87 Unclassified / Non classifié Table 1 Drugs That Are Contraindicated with MYLAN-ATAZANAVIRa Drug Class Drugs within class that are contraindicated with MYLAN-ATAZANAVIR Alpha 1-Adrenoreceptor Antagonists alfuzosin Antianginals ranolazine (when used with ritonavir) Antiarrhythmics amiodarone (when used with ritonavir), dronedarone (when used with ritonavir) flecainide (when used with ritonavir), propafenone (when used with ritonavir), quinidine Anticoagulants: Direct-acting oral anticoagulants (DOACs) apixaban, rivaroxaban (when used with ritonavir)b Anticonvulsants carbamazepine, phenobarbital, phenytoin Antigout colchicine (when used with ritonavir) Antimycobacterials rifampin Antineoplastics apalutamide, encorafenib, irinotecan, neratinib (when used with ritonavir), venetoclax (when used with ritonavir).
, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any component of the product or container, including atazanavir. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Coadministration of MYLAN-ATAZANAVIR is contraindicated with drugs that are highly dependent on CYP3A4 and/or UGT1A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events, and with drugs that are strong inducers of CYP3A due to the potential for loss of therapeutic effect and development of possible resistance.
Therefore, coadministration is contraindicated with drugs listed in Table 1. Table 1 includes, but is not limited to, a list of drugs within a class for which co-administration with MYLAN-ATAZANAVIR is CONTRAINDICATED. MYLAN-ATAZANAVIR (Atazanavir sulfate capsules) Page 5 of 87 Unclassified / Non classifié Table 1 Drugs That Are Contraindicated with MYLAN-ATAZANAVIRa Drug Class Drugs within class that are contraindicated with MYLAN-ATAZANAVIR Alpha 1-Adrenoreceptor Antagonists alfuzosin Antianginals ranolazine (when used with ritonavir) Antiarrhythmics amiodarone (when used with ritonavir), dronedarone (when used with ritonavir) flecainide (when used with ritonavir), propafenone (when used with ritonavir), quinidine Anticoagulants: Direct-acting oral anticoagulants (DOACs) apixaban, rivaroxaban (when used with ritonavir)b Anticonvulsants carbamazepine, phenobarbital, phenytoin Antigout colchicine (when used with ritonavir) Antimycobacterials rifampin Antineoplastics apalutamide, encorafenib, irinotecan, neratinib (when used with ritonavir), venetoclax (when used with ritonavir).
Antiplatelets ticagrelor Antipsychotics lurasidone (when used with ritonavir), pimozide Benzodiazepines triazolam Long-Acting Beta Andrenoreceptor salmeterol (when used with ritonavir) Ergot Derivatives dihydroergotamine, ergotamine, ergonovine, methylergonovine Hepatitis C Direct-Acting Antivirals glecaprevir/pibrentasvir Herbal Products St.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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MYLAN-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 MYLAN-ATAZANAVIR therapy if patients develop signs and symptoms of CKD.
MYLAN-ATAZANAVIR (Atazanavir sulfate capsules) Page 13 of 87 Unclassified / Non classifié 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 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 MYLAN-ATAZANAVIR (Atazanavir sulfate capsules) Page 14 of 87 Unclassified / Non classifié Rash: In controlled clinical trials, rash (all grades, regardless of causality) occurred in approximately 20 % of patients treated with atazanavir.
3 weeks and the median duration of rash […]
Antiplatelets ticagrelor Antipsychotics lurasidone (when used with ritonavir), pimozide Benzodiazepines triazolam Long-Acting Beta Andrenoreceptor salmeterol (when used with ritonavir) Ergot Derivatives dihydroergotamine, ergotamine, ergonovine, methylergonovine Hepatitis C Direct-Acting Antivirals glecaprevir/pibrentasvir Herbal Products St.
John’s wort (Hypericum perforatum) Lipid-Modifying Agents:
HMG-CoA Reductase Inhibitors Other Lipid-Modifying agents: lovastatin, simvastatin lomitapide Phosphodiesterase Type 5 (PDE5) Inhibitors sildenafilc (when used for the treatment of pulmonary arterial hypertension [PAH]), vardenafil (when used for the treatment of erectile dysfunction) Non-nucleoside Reverse Transcriptase Inhibitors nevirapine a See Table 15 for more detailed information.
b See Table 15 for apixaban and rivaroxaban when co-administered with atazanavir without ritonavir MYLAN-ATAZANAVIR (Atazanavir sulfate capsules) Page 6 of 87 Unclassified / Non classifié c See Table 15 for sildenafil when dosed for erectile dysfunction.
1 Dosing Considerations Concomitant Therapy: (see 7 WARNINGS AND PRECAUTIONS, 9 DRUG INTERACTIONS and 10 CLINICAL PHARMACOLOGY).
Ritonavir:
Efficacy and safety of atazanavir with ritonavir in doses greater than 100 mg once daily have not been established. The use of higher ritonavir doses might alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended.
There are limited safety data from controlled trials for atazanavir plus ritonavir regimens without tenofovir DF (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS).
Efavirenz - Therapy-Naive Patients:
If MYLAN-ATAZANAVIR is combined with efavirenz, MYLAN-ATAZANAVIR 400 mg (two 200 mg capsules) with ritonavir 100 mg should be administered once daily all as a single dose with food, and efavirenz should be administered on an empty stomach, preferably at bedtime.
Efavirenz - Therapy-Experienced Patients:
Do not co-administer MYLAN-ATAZANAVIR with efavirenz in treatment-experienced patients due to decreased atazanavir exposure.
Didanosine:
When co-administered with didanosine buffered formulations, MYLAN-ATAZANAVIR should be given (with food) two hours before or one hour after didanosine.
Tenofovir disoproxil fumarate (DF):
If co-administered with tenofovir DF, it is recommended that 300 mg of MYLAN-ATAZANAVIR and ritonavir 100 mg be given with tenofovir DF 300 mg (together as single daily doses with food). There are limited safety data from controlled trials for atazanavir plus ritonavir regimens without tenofovir DF.
MYLAN-ATAZANAVIR without ritonavir should not be co-administered with tenofovir DF (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). 2 Recommended Dose and Dosage Adjustment Recommended Adult Dose Therapy-Naive Patients • MYLAN-ATAZANAVIR 300 mg once daily taken with ritonavir 100 mg once daily taken with food.
OR • MYLAN-ATAZANAVIR 400 mg (two 200 mg capsules) once daily (without ritonavir) taken with food, for patients who are unable to tolerate ritonavir. Therapy-Experienced Patients • MYLAN-ATAZANAVIR 300 mg once daily taken with ritonavir 100 mg once daily taken with food.
[…]
John’s wort (Hypericum perforatum) Lipid-Modifying Agents:
HMG-CoA Reductase Inhibitors Other Lipid-Modifying agents: lovastatin, simvastatin lomitapide Phosphodiesterase Type 5 (PDE5) Inhibitors sildenafilc (when used for the treatment of pulmonary arterial hypertension [PAH]), vardenafil (when used for the treatment of erectile dysfunction) Non-nucleoside Reverse Transcriptase Inhibitors nevirapine a See Table 15 for more detailed information.
b See Table 15 for apixaban and rivaroxaban when co-administered with atazanavir without ritonavir MYLAN-ATAZANAVIR (Atazanavir sulfate capsules) Page 6 of 87 Unclassified / Non classifié c See Table 15 for sildenafil when dosed for erectile dysfunction.