These highlights do not include all the information needed to use DARUNAVIR TABLETS safely and effectively. See full prescribing information for DARUNAVIR TABLETS.
DARUNAVIR tablets, for oral use
Initial U.S. Approval: 2006
RECENT MAJOR CHANGES
Contraindications (4) 4/2022
INDICATIONS AND USAGE
Darunavir tablets are a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. Darunavir tablets must be co-administered with ritonavir (darunavir/ritonavir) and with other antiretroviral agents. (1)
DOSAGE AND ADMINISTRATION
Testing:
In treatment-experienced patients, treatment history genotypic and/or phenotypic testing is recommended prior to initiation of therapy with darunavir tablets/ritonavir to assess drug susceptibility of the HIV-1 virus (2.1, 12.4)
Monitor serum liver chemistry tests before and during therapy with darunavir tablets/ritonavir. (2.1, 2.2, 5.2)
Treatment-naïve adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions: 800 mg (one 800 mg tablet) taken with ritonavir 100 mg once daily and with food. (2.3)
Treatment-experienced adult patients with at least one darunavir resistance associated substitution: 600 mg (one 600 mg tablet) taken with ritonavir 100 mg twice daily and with food. (2.3)
Pregnant patients: 600 mg (one 600 mg tablet) taken with ritonavir 100 mg twice daily and with food. (2.4)
Pediatric patients (3 to less than 18 years of age and weighing at least 10 kg): dosage of darunavir and ritonavir is based on body weight and should not exceed the adult dose. Darunavir tablets should be taken with ritonavir and with food. (2.5)
Darunavir tablets/ritonavir is not recommended for use in patients with severe hepatic impairment. (2.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg (3)
CONTRAINDICATIONS
Co-administration of darunavir/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). (4)
WARNINGS AND PRECAUTIONS
Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with darunavir/ritonavir. Monitor liver function before and during therapy, especially in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases. Postmarketing cases of liver injury, including some fatalities, have been reported. (5.2)
Skin reactions ranging from mild to severe, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms and acute generalized exanthematous pustulosis, have been reported. Discontinue treatment if severe reaction develops. (5.3)
Use with caution in patients with a known sulfonamide allergy. (5.4)
Patients may develop new onset diabetes mellitus or hyperglycemia. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. (5.6)
Patients may develop redistribution/accumulation of body fat or immune reconstitution syndrome. (5.7, 5.8)
Patients with hemophilia may develop increased bleeding events. (5.9)
Darunavir/ritonavir is not recommended in pediatric patients below 3 years of age in view of toxicity and mortality observed in juvenile rats dosed with darunavir up to days 23 to 26 of age. (5.10)
ADVERSE REACTIONS
The most common clinical adverse drug reactions to darunavir/ritonavir (incidence greater than or equal to 5%) of at least moderate intensity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain and vomiting. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Co-administration of darunavir/ritonavir with other drugs can alter the concentrations of other drugs and other drugs may alter the concentrations of darunavir. The potential drug-drug interactions must be considered prior to and during therapy. (4, 5.5, 7, 12.3).
USE IN SPECIFIC POPULATIONS
Pregnancy: Total darunavir exposures were generally lower during pregnancy compared to postpartum period. The reduction in darunavir exposures during pregnancy were greater for once daily dosing compared to the twice daily dosing regimen. (8.1, 12.3)
Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission. (8.2)
Pediatrics: Not recommended for patients less than 3 years of age. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2023
