Generic Name: darunavir + cobicistat + tenofovir alafenamide + emtricitabine

Pronunciation: N/A

Abbreviation: DRV/c + FTC + TAF

Other Market Name: N/A

Drug Class: Complete Regimens

Company: Janssen Therapeutics

Approval Status: Approved

Generic Version Available: No

Experimental Code: N/A

Drug Indication

The drugs in Symtuza, when used together, are recommended as initial therapy in certainl clinical situations (i.e., it is effective and tolerable, but may have some disadvantages when compared with DHHS-recommended initial regimens for most people living with HIV). It is recommended for people who need to start HIV treatment rapidly. Visit https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/0 for the full DHHS guidelines.

General Info

Symtuza is a single-tablet regimen for HIV.  It contains a protease inhibitor (darunavir), a boosting agent (cobicistat) and two nucleoside/nucleotide reverse transcriptase inhibitors (tenofovir alafenamide +emtricitabine).

Symtuza was approved by the U.S. Food and Drug Administration in July 2018.

Dosage

Adult Dose: One tablet once a day. Each tablet contains 800 mg darunavir, 150mg cobicistat, 200mg emtricitabine and 10mg tenofovir alafenamide.

Pediatric Dose:

One tablet once a day for individuals 12 years of age and older, who weigh at least 88 lbs (40 kg).

Dosing Info: This is a complete one-pill, once-daily drug regimen; if Symtuza is used by people living with HIV that has developed resistance to other available antiretrovirals, it may be combined with other HIV drugs. It should be taken with food.

Side Effects

Common side effects associated with Symtuza include diarrhea, nausea, fatigue, headache and abdominal pain.

Rash is another common side effect of Symtuza. If a severe rash occurs while taking Symtuza, contact your health care provider immediately. The darunavir in Symtuza is a sulfa-containing drug and should be used with caution in patients with a known sulfa allergy.

Some people may experience increases in their lipid levels (triglycerides and cholesterol) or diabetes risk while being treated with protease inhibitors. These problems are much less common with duranavir-based regimens compared with most other protease inhibitors.

Drug-induced hepatitis (liver injury) has been reported in people taking protease inhibitors. This usually occurred in people who had extremely low CD4 cells, were taking multiple other medications and who were also infected with hepatitis B virus (HBV) or hepatitis C virus (HCV). Lab tests to monitor liver function is an important component of routine follow-up care and important for people using Symtuza.

Symtuza may lead to new or worsening kidney problems. Your healthcare provider may do blood tests to check your kidneys before and during treatment with Symtuza.

Drug Interactions

The following medications should not be taken while you are being treated with Symtuza:

  • alfuzosin
  • carbamazepine 
  • cisapride 
  • colchicine, if you have liver or kidney problems 
  • dronedarone 
  • elbasvir and grazoprevir 
  • ergot-containing medicines, such as: dihydroergotamine ergotamine tartrate methylergonovine 
  • lovastatin or a product that contains lovastatin 
  • lurasidone 
  • midazolam, when taken by mouth 
  • phenobarbital 
  • phenytoin 
  • pimozide 
  • ranolazine 
  • rifampin 
  • sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH) 
  • simvastatin or a product that contains simvastatin 
  • St. John’s wort (Hypericum perforatum), or a product that contains St. John’s Wort
  • triazolam

Symtuza, particularly its cobicistat component, can increase the levels of many other drugs in the body, potentially increasing the risk of serious side effects. Dosage adjustments or substitutions may be necessary if you are prescribed certain medications from any of the following drug classes: antiarrhythmics, antibiotics, cancer chemotherapeutic drugs, anticoagulants, anticonvulsants, antidepressants, antifungals, anti-gout medications, antimalarial drugs, beta-blockers, calcium channel blockers, corticosteroids (oral and inhaled), endothelin receptor antagonists, hepatitis C medications, statins, hormonal contraceptives, immune-suppressants, inhaled beta agonists, narcotic medications (for pain and opioid dependence), neuroleptics/anti-seizure medications, erectile dysfunction drugs, and sedatives/hypnotics. Be sure to let your health care provider know about any other prescription and over-the-counter medications and supplements you are taking. Consult the Symtuza package insert for more details.

Other Info

Before taking this medication, tell your doctor if you have kidney disease or liver disease (including hepatitis B). In addition, tell your doctor if you are pregnant or planning to become pregnant; if you are breast feeding, and all your medical conditions, including all prescription and over-the-counter medications and supplements you are taking.

For More Info: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SYMTUZA-pi.pdf

Last Reviewed: April 14, 2019