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ATAZANAVIR SANDOZ is a brand name for Atazanavir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Atazanavir capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1-infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2). Based on available virological and clinical data from adult patients, no…
Verbatim from this product's MHRA label. Tap a section to expand.
Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Adults The recommended dose of Atazanavir capsules is 300 mg once daily taken with ritonavir 100 mg once daily and with food. 1). (See also section
Summary of the safety profile Atazanavir has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving atazanavir 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or atazanavir 300 mg with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration).
Adverse reactions were consistent between patients who received atazanavir 400 mg once daily and patients who received atazanavir 300 mg with ritonavir 100 mg once daily, except that jaundice and elevated total bilirubin levels were reported more frequently with atazanavir plus ritonavir.
Among patients who received atazanavir 400 mg once daily or atazanavir 300 mg with ritonavir 100 mg once daily, the only adverse reactions of any severity reported very commonly with at least a possible relationship to regimens containing atazanavir and one or more NRTIs were nausea (20%), diarrhoea (10%), and jaundice (13%).
Among patients receiving atazanavir 300 mg with ritonavir 100 mg, the frequency of jaundice was 19%. 4). Chronic kidney disease in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance.
A large prospective observational study has shown an association between an increased incidence of chronic kidney disease and cumulative exposure to atazanavir/ritonavir-containing regimen in HIV-infected patients with an initially normal eGFR.
This association was observed independently of exposure to tenofovir disoproxil. 4). Tabulated list of adverse reactions Assessment of adverse reactions for atazanavir is based on safety data from clinical studies and post-marketing experience.
Frequency is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
4 Withdrawal of ritonavir only under restrictive conditions). Paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) The dose of atazanavir capsules for paediatric patients is based on body weight as shown in Table 1 and should not exceed the recommended adult dose.
Atazanavir capsules must be taken with ritonavir and have to be taken with food.
Table 1:
Dose for paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) for Atazanavir capsules with ritonavir Body Weight (kg) Atazanavir once daily dose ritonavir once daily dosea 15 to less than 35 200 mg 100 mg at least 35 300 mg 100 mg a Ritonavir capsules, tablets or oral solution.
Paediatric patients (at least 3 months of age and weighing at least 5 kg):
Other formulations of atazanavir may be available for paediatric patients at least 3 months of age and weighing at least 5 kg (see relevant Summary of Product Characteristics for alternative forms). Switching to capsules from other formulations is encouraged as soon as patients are able to consistently swallow capsules.
When transitioning between formulations, a change in dose may be needed. Consult the dosing table for the specific formulation (see relevant Summary of Product Characteristics). Special populations Renal impairment No dosage adjustment is needed.
2). Hepatic impairment Atazanavir with ritonavir has not been studied in patients with hepatic impairment. Atazanavir with ritonavir should be used with caution in patients with mild hepatic impairment. 2). 2). Unboosted Atazanavir must not be used in patients with severe hepatic impairment.
Pregnancy and Postpartum During the second and third trimesters of pregnancy:
1. 2). 2). 5). 5). 4 and
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Immune system disorders: uncommon: hypersensitivity Metabolism and nutrition disorders: uncommon: weight decreased, weight gain, anorexia, appetite increased Psychiatric disorders: uncommon: depression, disorientation, anxiety, insomnia, sleep disorder, abnormal dream Nervous system disorders: common: headache; uncommon: peripheral neuropathy, syncope, amnesia, dizziness, somnolence, dysgeusia Eye disorders: common: ocular icterus Cardiac disorders: uncommon: torsades de pointesa rare: QTc prolongationa, oedema, palpitation Vascular disorders: uncommon: hypertension Respiratory, thoracic and mediastinal disorders: uncommon: dyspnoea Gastrointestinal disorders: common: vomiting, diarrhoea, abdominal pain, nausea, dyspepsia; uncommon: pancreatitis, gastritis, abdominal distension, stomatitis aphthous, flatulence, dry mouth Hepatobiliary disorders: common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitisa Skin and subcutaneous tissue disorders: common: rash; uncommon: erythemia multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia, pruritus; rare: Stevens-Johnson syndromea,b, vesiculobullous rash, eczema, vasodilatation Musculoskeletal and connective tissue disorders: uncommon: muscle atrophy, arthralgia, myalgia; rare: myopathy Renal and urinary disorders: uncommon: nephrolithiasisa, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney diseasea; rare: kidney pain Reproductive system and breast disorders: uncommon: gynaecomastia General disorders and administration site conditions: common: fatigue; uncommon: chest pain, malaise, pyrexia, asthenia; rare: gait disturbance a These adverse reactions were identified through post-marketing surveillance, however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to atazanavir in randomised controlled and other available clinical trials (n = 2321).
b See description of selected adverse reactions for more details. Description of selected adverse reactions In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
4). Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART). 4). 4). Rash and associated syndromes Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with atazanavir.
4). Laboratory abnormalities The most frequently reported laboratory abnormality in patients receiving regimens containing atazanavir and one or more NRTIs was elevated total bilirubin reported predominantly as elevated indirect [unconjugated] bilirubin (87% Grade 1, 2, 3, or 4).
Grade 3 or 4 […]
Atazanavir 300 mg with ritonavir 100 mg may not provide sufficient exposure to atazanavir, especially when the activity of atazanavir or the whole regimen may be compromised due to drug resistance. Since there are limited data available and due to inter-patient variability during pregnancy, Therapeutic Drug Monitoring (TDM) may be considered to ensure adequate exposure.
, tenofovir disoproxil or H2-receptor antagonists). 2). • It is not recommended to use Atazanavir with ritonavir for pregnant patients who are receiving both tenofovir disoproxil and an H2-receptor antagonist. 4 Withdrawal of ritonavir only under restrictive conditions).
2). Therefore, postpartum patients should be closely monitored for adverse reactions. 5). Paediatric patients (less than 3 months of age) Atazanavir should not be used in children less than 3 months because of safety concerns especially taking into account the potential risk of kernicterus.
Method of administration:
For oral use. The capsules should be swallowed whole. 1. 2). 2). 5). 5). 4 and