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Evotaz is a brand name for Atazanavir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EVOTAZ is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Therapy should be initiated by a physician experienced in the management of HIV infection. 2). Advice on missed doses If EVOTAZ is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of EVOTAZ with food as soon as possible.
If this is noticed later than 12 hours of the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule. Special populations Renal impairment Based on the very limited renal elimination of cobicistat and atazanavir, no special precautions or dose adjustments of EVOTAZ are required for patients with renal impairment.
2). Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. g. 2). 3 Hepatic impairment There are no pharmacokinetic data regarding the use of EVOTAZ in patients with hepatic impairment.
Atazanavir and cobicistat are metabolised by the hepatic system. Atazanavir should be used with caution in patients with mild (Child-Pugh Class A) hepatic impairment. However, atazanavir must not be used in patients with moderate (Child-Pugh Class B) to severe (Child-Pugh Class C) hepatic impairment.
No dose adjustment of cobicistat is required in patients with mild or moderate hepatic impairment. Cobicistat has not been studied in patients with severe hepatic impairment and is not recommended in these patients. EVOTAZ should be used with caution in patients with mild hepatic impairment.
3). Paediatric population Children from birth to 3 months of age EVOTAZ should not be used in children less than 3 months of age because of safety concerns especially taking into account the potential risk of kernicterus associated with the atazanavir component.
Children from 3 months to < 12 years of age or weighing < 35 kg The safety and efficacy of EVOTAZ in children less than 12 years of age or weighing less than 35 kg have not been established. 2, but no recommendation on a posology can be made.
Pregnancy and postpartum Treatment with EVOTAZ during pregnancy results in low atazanavir exposure. 6). 2). The film-coated tablet should be swallowed whole and must not be chewed, broken, cut or crushed.
Summary of the safety profile The overall safety profile of EVOTAZ is based on available data from clinical trials conducted with atazanavir, atazanavir boosted with either cobicistat or ritonavir, and post-marketing data. As EVOTAZ contains atazanavir and cobicistat, the adverse reactions associated with each of the individual components may be expected.
In a Phase III study (GS-US-216-0114), the most frequently reported adverse reactions in the atazanavir boosted with cobicistat group were associated with elevated bilirubin levels (see Table 2). In two controlled clinical trials, where subjects received atazanavir alone (400 mg once daily) or atazanavir (300 mg daily) boosted with ritonavir (100 mg daily), the most frequently reported adverse reactions were nausea, diarrhoea and jaundice.
4). 4). Tabulated list of adverse reactions Adverse reactions are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to 1/1,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
34 Table 2: Tabulated summary of adverse reactions System Organ Class Frequency Adverse Reactions Immune system disorders uncommon hypersensitivity Metabolism and nutrition disorders common increased appetite uncommon weight decreased, weight gain, anorexia Psychiatric disorders common insomnia, abnormal dreams uncommon depression, sleep disorder, disorientation, anxiety Nervous system disorders common headache, dizziness, somnolence, dysgeusia uncommon peripheral neuropathy, syncope, amnesia Eye disorders very 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 very common nausea common vomiting, diarrhoea, dyspepsia, abdominal pain, abdominal distension, flatulence, dry mouth uncommon pancreatitis, gastritis, stomatitis aphthous Hepatobiliary disorders very common jaundice common hyperbilirubinaemia uncommon hepatitis, cholelithiasisa, cholestasisa rare hepatosplenomegaly, cholecystitisa Skin and subcutaneous tissue disorders common rash uncommon pruritus, erythema multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia rare Stevens-Johnson syndromea,b, vesiculobullous rash, eczema, vasodilatation Musculoskeletal and connective tissue disorders uncommon myalgia, muscle atrophy, arthralgia rare myopathy Renal and urinary disorders uncommon nephrolithiasisa, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney diseasea rare kidney pain 35 System Organ Class Frequency Adverse Reactions Reproductive system and breast disorders uncommon gynaecomastia General disorders and administration site conditions common fatigue uncommon pyrexia, asthenia, chest pain, malaise 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 (with and without ritonavir) in randomised controlled and other available clinical trials (n = 2321).
1). Pregnancy Treatment with atazanavir/cobicistat 300/150 mg during the second and third trimester has been shown to result in low atazanavir exposure. Cobicistat levels decrease and may not provide sufficient boosting. The substantial reduction in atazanavir exposure may result in virological failure and an increased risk of mother to child transmission of HIV infection.
6). Patients with co-existing conditions Hepatic impairment The use of EVOTAZ is contraindicated in patients with moderate to severe hepatic impairment. 2). 2). The safety and efficacy of atazanavir have not been established in patients with significant underlying liver disorders.
8). In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products. Patients with previous liver dysfunction or patients with chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. 5 Cobicistat Cobicistat has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
2). Effects on estimated creatinine clearance Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine. This effect on serum creatinine, leading to a decrease in the estimated creatine clearance, should be taken into consideration when EVOTAZ is administered to patients in whom the estimated creatinine clearance is used to guide aspects of their clinical management, including adjusting doses of co-administered medicinal products.
For more information consult the cobicistat Summary of Product Characteristics. g. 2). 2). There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat.
1. g. 5). Moderate to severe hepatic impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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b See section Description of selected adverse reactions for more details. Description of selected adverse reactions Immune reactivation syndrome and autoimmune disorders 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). Osteonecrosis Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to 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). Renal impairment Cobicistat, a component of EVOTAZ, has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine. 4 mg/dL. In study GS-US-216-0114, decreases in estimated creatinine clearance occurred early in treatment with cobicistat, after which they stabilised.
8 mL/min in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir DF fixed-dose combination group. 7% in the atazanavir boosted with […]
QT prolongation Dose related asymptomatic prolongations in PR interval with atazanavir, a component of EVOTAZ have been observed in clinical studies. Caution should be used with medicinal products known to induce PR prolongations. 1).
3). Haemophiliac patients There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors. In some patients additional factor VIII was given.
In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued. A causal relationship has been suggested, although the mechanism of action has not been elucidated.
Haemophiliac patients should, therefore, be made aware of the possibility of increased bleeding. Weight and metabolic parameters An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Such changes may in part be linked to the disease control and life style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
For monitoring of blood lipids and glucose, reference is made to established HIV treatment guidelines. Lipid disorders should be managed as clinically appropriate. In clinical studies, atazanavir has been shown to induce dyslipidaemia to a lesser extent than comparators.
8). Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving EVOTAZ should be evaluated for alternative aetiologies. Alternative antiretroviral therapy to EVOTAZ may be considered if jaundice or scleral icterus is unacceptable to a patient.
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