Classes
DEA Class; Rx
Common Brand Names; Reyataz
- HIV, Protease Inhibitors;
- Antiretroviral Agents
Description
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
Indications
Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection
Contraindications
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
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
300 mg/day PO with ritonavir and 400 mg/day PO without ritonavir for oral capsules; 300 mg/day PO for oral powder.
300 mg/day PO with ritonavir and 400 mg/day PO without ritonavir for oral capsules; 300 mg/day PO for oral powder.
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.
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.
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.
Not recommended due to the risk of hyperbilirubinemia.
How supplied
Atazanavir
capsule
- 100mg
- 150mg
- 200mg
- 300mg