For: HIV Infection
Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide) is a once daily, single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-na�ve and certain virologically suppressed adults. SYMTUZA (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets are supplied as yellow to yellowish-brown, capsule-shaped, film-coated tablets debossed with "8121" on one side and "JG" on the other side.
SYMTUZA is packaged in bottles of 30 tablets (NDC 59676-800-30), with a silica gel desiccant and child-resistant closure.
Storage:
Store at 20�C�25�C (between 68�F�77�F); with excursions permitted to 15�C�30�C (59�F�86�F).
Dispense only in the original container. Keep container tightly closed with desiccant inside to protect from moisture. These highlights do not include all the information needed to use SYMTUZA safely and effectively. See full prescribing information for SYMTUZA.
SYMTUZA� (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets, for oral use
Initial U.S. Approval: 2018
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
See full prescribing information for complete boxed warning.
Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of SYMTUZA. Hepatic function should be monitored closely in these patients. If appropriate, anti-hepatitis B therapy may be warranted. (5.1)
RECENT MAJOR CHANGES
Contraindications (4) 05/2019
Warnings and Precautions,
Immune Reconstitution Syndrome (5.5) 05/2019
INDICATIONS AND USAGE
SYMTUZA is a four-drug combination of darunavir (DRV), a human immunodeficiency virus (HIV-1) protease inhibitor, cobicistat (COBI), a CYP3A inhibitor, and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated as a complete regimen for the treatment of HIV-1 infection in adults:
who have no prior antiretroviral treatment history or
who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir. (1)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating SYMTUZA, test patients for HBV infection.
Prior to or when initiating SYMTUZA, and during treatment with SYMTUZA, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. (2.1)
Recommended dosage: One tablet taken once daily with food. (2.2)
Renal Impairment: SYMTUZA is not recommended in patients with estimated creatinine clearance below 30 mL/min. (2.3)
Hepatic Impairment: SYMTUZA is not recommended in patients with severe hepatic impairment. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 800 mg of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide (equivalent to 11.2 mg of tenofovir alafenamide fumarate). (3)
CONTRAINDICATIONS
SYMTUZA is contraindicated to be co-administered with certain drugs for which altered plasma concentrations are associated with serious and/or life-threatening events or which may lead to loss of therapeutic effect of SYMTUZA and development of resistance. (4)
WARNINGS AND PRECAUTIONS
Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) including some fatalities can occur with SYMTUZA. 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. (5.2)
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis may occur with SYMTUZA. Discontinue treatment if severe skin reaction develops. (5.3)
Patients receiving SYMTUZA may develop new onset or exacerbations of immune reconstitution syndrome. (5.5)
Monitor in patients with a known sulfonamide allergy. (5.7)
Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. (5.8)
Patients receiving SYMTUZA may develop new onset or exacerbation of diabetes mellitus/hyperglycemia and redistribution/accumulation of body fat. (5.9, 5.10)
Patients with hemophilia may develop increase bleeding events. (5.11)
ADVERSE REACTIONS
The most common adverse reactions (all grades, incidence greater than or equal to 2%) were diarrhea, rash, nausea, fatigue, headache, abdominal discomfort, and flatulence. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Co-administration of SYMTUZA with other drugs can alter the concentration of other drugs and other drugs may alter the concentrations of SYMTUZA components. Consult the full prescribing information prior to and during treatment for potential drug interactions. (4, 5.4, 7, 12.3)
USE IN SPECIFIC POPULATIONS
Pregnancy: SYMTUZA is not recommended during pregnancy due to substantially lower exposures of darunavir and cobicistat during pregnancy. (2.5, 8.1, 12.3)
Lactation: Breastfeeding is not recommended. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2019
