Atazanavir Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

THERAPY-NAIVE PATIENTS:
Atazanavir 300 mg plus ritonavir 100 mg orally once a day
-If unable to tolerate ritonavir: 400 mg orally once a day
-If used with tenofovir: Atazanavir 300 mg plus ritonavir 100 mg orally once a day
-If used with an H2-receptor antagonist: Atazanavir 300 mg plus ritonavir 100 mg orally once a day
-If unable to tolerate ritonavir and used with an H2-receptor antagonist: 400 mg orally once a day
-If used with a proton-pump inhibitor: Atazanavir 300 mg plus ritonavir 100 mg orally once a day
-If used with efavirenz: Atazanavir 400 mg plus ritonavir 100 mg orally once a day

Comments:
-H2-receptor antagonist dose should not exceed a dose comparable to famotidine 40 mg twice a day.
-In patients unable to tolerate ritonavir, H2-receptor antagonist single dose and total daily dose should not exceed doses comparable to famotidine 20 mg and 40 mg, respectively.
-Proton-pump inhibitor dose should not exceed a dose comparable to omeprazole 20 mg.

THERAPY-EXPERIENCED PATIENTS:
Atazanavir 300 mg plus ritonavir 100 mg orally once a day
-If used with an H2-receptor antagonist: Atazanavir 300 mg plus ritonavir 100 mg orally once a day
-If used with an H2-receptor antagonist and tenofovir: Atazanavir 400 mg plus ritonavir 100 mg orally once a day

Comments:
-Therapy-experienced patients should not use atazanavir with proton-pump inhibitors or efavirenz.
-H2-receptor antagonist dose should not exceed a dose comparable to famotidine 20 mg twice a day.

PREGNANCY:
Therapy-experienced patients:
-If used during the second or third trimester with an H2-receptor antagonist or tenofovir: Atazanavir 400 mg plus ritonavir 100 mg orally once a day
-If used with an H2-receptor antagonist and tenofovir: Data not available

Comments:
-Atazanavir without ritonavir should not be used during pregnancy and/or the postpartum period.
-Atazanavir should only be used in pregnant women with HIV-1 strains susceptible to atazanavir.
-No dose adjustment needed for pregnant patients with the above exceptions.
-No dose adjustment needed for postpartum patients; close monitoring for side effects recommended (higher atazanavir exposures possible during first 2 months after delivery).

Approved indication: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure

(Not approved by FDA)

CDC recommendations:
400 mg orally once a day
-If used with tenofovir: Atazanavir 300 mg plus ritonavir 100 mg orally once a day

Duration of therapy: 28 days

Comments:
-Recommended as an alternative regimen for nonoccupational postexposure prophylaxis of HIV
-Atazanavir should be used with (lamivudine or emtricitabine) plus (zidovudine or stavudine or abacavir or didanosine) or (tenofovir plus ritonavir [100 mg/day]); atazanavir should not be used with tenofovir without ritonavir.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.

Usual Pediatric Dose for HIV Infection

6 years to less than 18 years:
15 kg to less than 20 kg: Atazanavir 150 mg plus ritonavir 100 mg orally once a day
20 kg to less than 40 kg: Atazanavir 200 mg plus ritonavir 100 mg orally once a day
40 kg or more: Atazanavir 300 mg plus ritonavir 100 mg orally once a day

Comments:
-The recommended dose for therapy-naive patients at least 13 years of age and weighing at least 40 kg, who are unable to tolerate ritonavir, is atazanavir 400 mg (without ritonavir) orally once a day.
-Patients at least 13 years of age and weighing at least 40 kg receiving concomitant tenofovir, H2-receptor antagonists, or proton-pump inhibitors should not receive atazanavir without ritonavir.

Approved indication: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Panel on Antiretroviral Therapy and Medical Management of HIV-infected Children recommendations:
6 years to less than 18 years:
15 kg to less than 20 kg: Atazanavir 150 mg plus ritonavir 100 mg orally once a day
20 kg to less than 32 kg: Atazanavir 200 mg plus ritonavir 100 mg orally once a day
32 kg to less than 40 kg: Atazanavir 250 mg plus ritonavir 100 mg orally once a day
40 kg or more: Atazanavir 300 mg plus ritonavir 100 mg orally once a day

Comments:
-The 250 mg dose requires 2 different capsule strengths of atazanavir; to avoid dosing errors, additional patient counseling recommended.

Renal Dose Adjustments

Without hemodialysis: No adjustment recommended.

Liver Dose Adjustments

Atazanavir:
-Mild to moderate liver dysfunction: Caution recommended.
-Moderate liver dysfunction (Child-Pugh B) without previous virologic failure: Should consider reducing dose to 300 mg orally once a day
-Severe liver dysfunction (Child-Pugh C): Not recommended.

Atazanavir plus ritonavir: Not recommended.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

End-stage renal disease managed with hemodialysis:
-Therapy-naive patients: Atazanavir 300 mg plus ritonavir 100 mg orally once a day
-Therapy-experienced patients: Not recommended.

Other Comments

Administration advice:
-Take all atazanavir dosing regimens as a single dose with food.
-Atazanavir capsules must not be opened.
-When used with didanosine buffered or enteric-coated formulations: Take atazanavir with food 2 hours before or 1 hour after didanosine.
-When used with an H2-receptor antagonist: Take atazanavir/ritonavir with food at the same time as, and/or at least 10 hours after the H2-receptor antagonist.
-When used with an H2-receptor antagonist without ritonavir: Take atazanavir with food at least 2 hours before and at least 10 hours after the H2-receptor antagonist.
-When used with a proton-pump inhibitor: Take atazanavir/ritonavir with food about 12 hours after the proton-pump inhibitor.
-When used with efavirenz: Take atazanavir/ritonavir with food; take efavirenz on an empty stomach, preferably at bedtime.

General:
-Atazanavir without ritonavir is not recommended for therapy-experienced patients with previous virologic failure.
-Atazanavir with ritonavir in doses greater than 100 mg per day is not recommended.
-The manufacturer's product information for ritonavir should be consulted for further information.
-Atazanavir without ritonavir should not be used with tenofovir.

Monitoring:
-Cardiovascular: ECG with concomitant calcium channel blocker therapy
-General: For side effects in postpartum patients (at least first 2 months after delivery)
-Hematologic: For bleeding in hemophiliacs
-Hepatic: Hepatic laboratory tests in patients with hepatitis B or C or marked transaminase elevations at baseline (before starting and during therapy); for severe hyperbilirubinemia in all infants (first few days of life)
-Metabolic: Blood glucose levels

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