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Atazanavir

    Brands

    DEA Class; Rx

    Common Brand Names; Reyataz

    • HIV, Protease Inhibitors; 
    • Antiretroviral Agents

    Protease inhibitor
    Used for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents
    Advantages include a unique resistance profile and fewer lipid abnormalities compared to other PIs

    Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection

    Previously demonstrated hypersensitivity including Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions

    Treatment-experienced patients with ESRD receiving hemodialysis

    Severe hepatic impairment (Child-Pugh Class C); hepatic impairment and concomitant ritonavir

    Indinavir; both atazanavir and indinavir are associated with indirect hyperbilirubinemia

    • Incidence based on combination therapy
    • Total bilirubin increased (35-49%)
    • Fever (19%)
    • Rash (3-21%)
    • Cholesterol is increased (6-25%)
    • Nausea (4-14%)
    • CPK increased (6-11%)
    • Cough (21%)
    • Diarrhea (3-11%)
    • Neutrophils decrease (6-10%)
    • Jaundice (5-9%)
    • Headache (1-7%)
    • Peripheral neuropathy (1-4%)
    • Insomnia (1-3%)
    • Fever (2%)
    • Vomiting (3-7%)
    • Dizziness (1-2%)
    • Myalgia (4%)
    • Abdominal pain (2-4%)
    • Depression (1-2%)

    Do not use proton-pump inhibitors in treatment-experienced patients

    Discontinue if severe rash; Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions reported, including drug rash, eosinophilia, and systemic symptoms (DRESS) syndrome; discontinue if severe rash develops

    Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy

    Spontaneous bleeding may occur and additional factor VIII may be required

    PR interval prolongation may occur in some patients; ECG monitoring should be considered in patients with preexisting conduction system disease or when administered with other drugs that may prolong the PR interval; because of limited clinical experience with preexisting conduction system disease (eg, marked first-degree AV block or second- or third-degree AV block), ECG monitoring should be considered

    Most patients experience asymptomatic increases in indirect bilirubin, which is reversible upon discontinuation; do not dose reduce; if concomitant transaminase increase occurs, evaluate for alternative etiologies

    Atazanavir has been evaluated in a limited number of women during pregnancy; available human and animal data suggest that atazanavir does not increase risk of major birth defects overall compared to background rate

    Therapy must be administered with ritonavir in pregnant women

    The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed infants to avoid risking postnatal transmission of HIV-1

    Adults

    300 mg/day PO with ritonavir and 400 mg/day PO without ritonavir for oral capsules; 300 mg/day PO for oral powder. 

    Geriatric

    300 mg/day PO with ritonavir and 400 mg/day PO without ritonavir for oral capsules; 300 mg/day PO for oral powder. 

    Adolescents

    40 kg or more: 300 mg/day PO with ritonavir and 400 mg/day PO without ritonavir for oral capsules; 300 mg/day PO for oral powder.
    35 to 39 kg: 300 mg/day PO for oral capsules and oral powder.
    25 to 34 kg: 200 mg/day PO for oral capsules; 300 mg/day PO for oral powder.

    Children

    Oral capsules
    6 to 12 years weighing 35 kg or more: 300 mg/day PO.
    6 to 12 years weighing 15 to 34 kg: 200 mg/day PO.
    1 to 5 years or weighing less than 15 kg: Safety and efficacy have not been established.
     
    Oral powder
    25 kg or more: 300 mg/day PO.
    15 to 24 kg: 250 mg/day PO.
    5 to 14 kg: 200 mg/day PO.

    Infants

    3 to 11 months weighing 5 to 14 kg: 200 mg/day PO for oral powder.
    3 to 11 months weighing less than 5 kg: Safety and efficacy have not been established.
    1 to 2 months: Not recommended due to the risk of hyperbilirubinemia.

    Neonates

    Not recommended due to the risk of hyperbilirubinemia.

    Atazanavir

    capsule

    • 100mg
    • 150mg
    • 200mg
    • 300mg