The Protective Barrier to Resistance of Darunavir in a Convenient STR1

Dosing & Administration

One tablet, once daily with food.

Not Actual Size

The smallest darunavir coformulation available.
SYMTUZA® is a complete regimen that is smaller than PREZCOBIX®.

If desired, patients have the option to split the pill into 2 pieces. The whole dose should be taken immediately after splitting. When splitting SYMTUZA®, a standard tablet splitter may be used.

Recommended Dosage

SYMTUZA® is a 4-drug fixed-dose combination product containing 800 mg of darunavir (DRV), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of tenofovir alafenamide (TAF).

The recommended dosage of SYMTUZA® is 1 tablet taken orally once daily with food in adults and pediatric patients weighing at least 40 kg. For patients who are unable to swallow the whole tablet, SYMTUZA® may be split into 2 pieces using a tablet splitter, and the entire dose should be consumed immediately after splitting.

 

Not Recommended in Patients With Severe Renal Impairment

SYMTUZA® is not recommended in patients with creatinine clearance below 30 mL per minute.

 

Not Recommended During Pregnancy

SYMTUZA® is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during the second and third trimesters.

 

SYMTUZA® should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with SYMTUZA®.

 

Testing Prior to Initiation of SYMTUZA®

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.

 

Not Recommended in Patients With Severe Hepatic Impairment

SYMTUZA® is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).

 

Not Recommended in Pediatric Patients Weighing <40 kg

The safety and effectiveness of SYMTUZA® have not been established and is not recommended in pediatric patients weighing less than 40 kg.

 

Lactation

The Centers for Disease Control and Prevention recommends that HIV-infected mothers in the United States must not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.

DOSAGE FORMS AND STRENGTHS

 

Each SYMTUZA® tablet contains darunavir ethanolate equivalent to 800 mg of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine (FTC), and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide (TAF). The yellow to yellowish-brown capsule-shaped, film-coated tablet is debossed with "8121" on one side and "JG" on other side.

These recommendations are based on drug interaction trials conducted with the components of SYMTUZA®, as individual agents or in combination, or are predicted interactions. No drug interaction trials have been performed with SYMTUZA® or with all the components administered together.3

Examples of drugs that are contraindicated3

Alpha 1-adrenoreceptor antagonist alfuzosin
Anticonvulsants carbamazepine, phenobarbital, phenytoin
Antigout colchicine in patients with renal and/or hepatic impairment
Antimycobacterial rifampin
Antipsychotics lurasidone, pimozide
Cardiac disorders dronedarone, ivabradine, ranolazine
Ergot derivatives dihydroergotamine, ergotamine, methylergonovine
Hepatitis C direct-acting antivirals elbasvir/grazoprevir
Herbal product St. John’s wort (Hypericum perforatum)
Lipid-modifying agents lomitapide, lovastatin, simvastatin
Opioid antagonist naloxegol
PDE-5 inhibitor sildenafil when used for treatment of pulmonary arterial hypertension
Sedatives/hypnotics midazolam, triazolam

Examples of drugs where coadministration is not recommended3

Anticoagulant rivaroxaban
Anticonvulsants eslicarbazepine, oxcarbazepine
Antifungal voriconazole
Antimycobacterials rifabutin, rifapentine
corticosteroids betamethasone, budesonide, ciclesonide, dexamethasone (systemic), fluticasone, methylprednisolone, mometasone, triamcinolone
Hepatitis C direct-acting antivirals glecaprevir/pibrentasvir
Immunosuppressant/neoplastic everolimus, irinotecan
Inhaled beta agonist salmeterol
PDE-5 inhibitor avanafil
Platelet aggregation inhibitors clopidogrel, ticagrelor

The information presented here is a subset of clinical information in Table 4 of the Prescribing Information; it is not a complete list of all information in Table 4.

PDE-5=phosphodiesterase type 5; STR=single-tablet regimen.

 

Reference: 1. Department of Health and Human Services. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Updated January 20, 2022. Accessed March 8, 2022. https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines
2.
Data on file. Janssen Therapeutics, Division of Janssen Products, LP. 3. SYMTUZA® [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP.4. Crauwels HM, Baugh B, Van Landuyt E, et al. Bioequivalence of the once-daily single-tablet regimen of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide compared to combined intake of the separate agents and the effect of food on bioavailability. Clin Pharmacol Drug Dev. 2019;8(4):480-491.