Atazanavir

What it is used for

Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg.

Limitations of Use:

• Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus.
• Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions.

Side effects, and when to stop

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• cardiac conduction abnormalities
• rash
• hyperbilirubinemia
• chronic kidney disease
• nephrolithiasis and cholelithiasis [ see Warnings and Precautions ]

Who should not take it

Atazanavir capsules are contraindicated:

• in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules.
• when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening events (see Table 6).
• when coadministered with drugs that are strong inducers of CYP3A due to the potential for loss of therapeutic effect and development of resistance.

Coadministration is contraindicated with, but not limited to, the following drugs listed in Table 6: