- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of atazanavir sulfate.
HIV infection-combined with other antiretrovirals
Treatment of human immunodeficiency virus (HIV-1) infection in combination with low dose ritonavir and other antiretroviral agents.
The atazanavir capsule should be swallowed whole, taken at the same time as ritonavir, and both taken with food.
If used in combination with ritonavir, consult product information.
300mg once daily.
Atazanavir should be taken with ritonavir 100mg once daily.
Virological and clinical data from adult patients indicates no expected benefit when treating patients with strains resistant to multiple protease inhibitors (4 or more PI mutations).
Children aged 6 to less than 18 years old
The dose for atazanavir is based on the following patient body weights and should not exceed the adult dose:
Bodyweight at least 35kg
300mg atazanavir with 100mg ritonavir once daily.
Bodyweight 15kg to less than 35kg
200mg atazanavir with 100mg ritonavir once daily.
Patients with Hepatic Impairment
Moderate to severe hepatic impairment
Unboosted atazanavir could be maintained in patients with moderate hepatic impairment with a reduced dose of 300mg once daily. Unboosted atazanavir is contraindicated in patients with severe hepatic impairment.
Mild hepatic impairment
Unboosted atazanavir could be maintained at a dose of 400mg.
Additional Dosage Information
Withdrawal of ritonavir is not recommended but may be considered at the dose of 400mg atazanavir once daily and under the following combined restrictive conditions, absence of prior virologic failure, undetectable viral load during the last six months under current regime, viral strains not harbouring HIV resistance associated mutations to current regime.
Atazanavir without ritonavir should not be considered in patients treated with a regime containing tenofovir disoproxil and other concurrent medications which reduce atazanavir concentrations.
Children under 6 years
Children weighing less than 15kg
Long QT syndrome
Moderate hepatic impairment
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Cardiac conduction defects
Chronic hepatic disorder
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Mild hepatic impairment
Correct electrolyte disorders before treatment
Treatment does not prevent risk of transmission of HIV
Advise patient dizziness may affect ability to drive or operate machinery
Must be used in combination with other antiretrovirals
Perform viral resistance testing before initiating therapy
Treatment should be initiated by doctor experienced in HIV management
Advise patient on concurrent use of proton pump inhibitors
Autoimmune disorders can occur many months after initiation of treatment
Blood lipid and glucose levels may increase requiring treatment
Consider monitoring ECG in patients at risk of QT prolongation
May prolong PR interval
Monitor cardiac function in paediatric patients
Monitor closely for skin reactions
Monitor hepatic function in patients with history of hepatic disease
Monitor renal function regularly
Monitor serum electrolytes
Advise patient to seek medical advice if joint aches or pain occur
Advise patient to seek medical advice if movement becomes difficult
Consider discontinuation if symptoms of cholelithiasis occur
Discontinue or interrupt therapy if nephrolithiasis occurs
Inflammatory symptoms should be evaluated and treated appropriately
May cause hyperbilirubinaemia
May develop immune reactivation syndrome
Discontinue if hepatic function deteriorates in pts with hepatic impairment
Discontinue if severe skin reaction occurs
Advise patient not to take St John's wort concurrently
Avoid antacids 1 hour after or 2 hours before dose
Female: Barrier or non-hormonal contraception advised during treatment
Female: Oral contraception may not be adequate during treatment
Advise haemophiliac patients of possibility of increased bleeding
Patients with chronic hepatitis B or C who are treated with combination antiretroviral therapy have an increased risk of developing severe and potentially fatal hepatic adverse effects, and therefore should be closely monitored during treatment. The product literature relating to concurrent treatments for hepatitis B or C should be consulted. If hepatic disease worsens in these patients, interruption or discontinuation of therapy should be considered.
Increased bleeding, including spontaneous skin haematomas and haemarthroses, have been reported in type A and B haemophiliac patients treated with protease inhibitors. Additional factor VIII was required in some patients. In more than half of all reported cases, treatment was continued or reintroduced after discontinuation. Haemophiliac patients should be made aware of the possibility of increased bleeding.
Blood lipid and glucose levels may increase during antiretroviral therapy. This may be linked to disease control and lifestyle. Refer to established HIV treatment guidelines for monitoring and manage lipid and glucose level disorders as appropriate.
Reversible elevations of indirect bilirubin have occurred in patients receiving atazanavir, any rise in hepatic transaminase that occurs with bilirubin elevations should be evaluated for alternative causes.
Alternative antiretroviral therapy should be considered if the patient views jaundice or scleral icterus as unacceptable, a dose reduction of atazanavir is not recommended as a loss of therapeutic effect and development of resistance may occur.
Mild to moderate maculopapular skin eruptions can occur usually within the first 3 weeks of starting therapy with atazanavir. Patients should be monitored closely and advised of the signs and symptoms of more serious rashes. Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome has been reported in patients receiving atazanavir. If the patient develops Stevens-Johnson syndrome or DRESS due to atazanavir, atazanavir must not be restarted.
When combination antiretroviral therapy is initiated in HIV-infected patients with severe immune deficiency, an inflammatory reaction to asymptomatic or residual opportunist pathogens may arise. This can lead to the aggravation of symptoms or other serious clinical conditions such as cytomegalovirus retinitis, mycobacterial infections or Pneumocystis jirovecii pneumonia. These reactions are usually observed within the first few weeks or months after treatment initiation. Any inflammatory symptoms should be evaluated and treated appropriately. Autoimmune disorders such as Graves' disease have also occurred in the context of immune reactivation after initiation of treatment though with a more variable time to onset sometimes after many months of treatment.
Pregnancy and Lactation
Use atazanavir with caution during pregnancy.
The manufacturer recommends that atazanavir may be considered during pregnancy only if the potential benefit justifies the potential risk. At the time of writing, a moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative toxicity of atazanavir. Animal studies do not indicate reproductive toxicity.
Briggs (2015) states that the potential maternal benefit far outweighs any potential embryo-foetal risk. It is unknown if atazanavir crosses the human placenta. The molecular weight and moderately long elimination half-life suggest that it may occur. There is limited data to assess the risk in pregnancy of atazanavir, however the animal data implies a low risk to the foetus.
It is not known if administration of atazanavir to pregnant women will exacerbate physiological hyperbilirubinaemia, which may lead to kernicterus in neonates and infants. In the period immediately before delivery additional monitoring should also be considered.
Atazanavir is contraindicated during breastfeeding.
The manufacturer advises that atazanavir is contraindicated during breastfeeding. It is recommended that HIV infected women should not breastfeed their infants in order to avoid transmission of HIV. Atazanavir has been detected in human breast milk.
Blood lipid changes
Chronic kidney disease
Creatine kinase increased
Drug rash with eosinophilia and systemic symptoms (DRESS)
Elevated serum lipase
Immune Reactivation/Reconstitution Syndrome
Increase in serum ALT/AST
Increased spontaneous bleeding (haemophiliacs)
Increases in hepatic enzymes
Prolongation of PR interval
Prolongation of QT interval
Reduced neutrophil count
Serum bilirubin increased
Torsades de pointes
Toxic skin reaction
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: April 2014
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Atazanavir 150mg Hard Capsules. Zentiva Pharma UK Ltd. Revised June 2020.
Summary of Product Characteristics: Reyataz 100mg 150mg, 200mg and 300mg Hard Capsules. Bristol-Myers Squibb Pharmaceuticals Ltd. Revised February 2019.
The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 January 2022
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Atazanavir. Last revised: September 7, 2013.
Last accessed: March 14, 2014.
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