Symtuza (Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide) - Oral

What Is Symtuza?

Symtuza is a combination drug that comes in a single-tablet regimen used to treat HIV infection. It is an antiretroviral made up of the drug classes of protease inhibitors, nucleoside reverse transcriptase inhibitors, and cytochrome P450 (CYP450 )inhibitors.

This drug contains the following as active ingredients: 

• Darunavir
• Cobicistat
• Emtricitabine
• Tenofovir alafenamide

Darunavir, a protease inhibitor, targets and attaches to a specific part of the HIV protease, inhibiting its activity and stopping the maturation of HIV cells. This reduces the amount of HIV in the blood.

Cobicistat is a CYP450 inhibitor. It works as a boosting agent, as it lowers the viral load by boosting darunavir levels in your body. Emtricitabine and tenofovir alafenamide are nucleoside reverse transcriptase inhibitors. They stop the virus from multiplying.

This combination drug is available by prescription as a tablet to be taken by mouth.

What Is Symtuza Used For?

Symtuza is a once-daily drug that treats HIV infection. It is used in adults and children weighing 40 kilograms (about 88 pounds) or more. It is not recommended in people with severe kidney or severe liver problems.

Additionally, Symtuza should not be used in children under 3 years old, weighing less than 10 kilograms (about 22 pounds), due to an increased risk of death.

How to Take Symtuza

Take once daily with food, as taking it with a meal will help your body better absorb it.

You may break the pill in half with a pill cutter for children or others who cannot swallow the tablet whole. However, you must take the entire dose once broken in half; do not save one half for later.

Keep taking your medication as prescribed, even if you feel better. Do not miss or skip any doses. Stopping Symtuza can cause an existing hepatitis B infection to worsen, so you should always consult with your healthcare provider before ending treatment.

Storage

It is recommended to store Symtuza at room temperature (68 F to 77 F) in a dry place away from moisture. However, you may keep it between cool and mildly hot temperatures (59 F to 86 F) temporarily. Do not store it in your bathroom.

Leave this drug tightly closed in its original container. Also, do not remove the anti-moisture packet inside the container. Keep it out of reach of children and pets.

Toss unused and expired drugs. Do not flush them down the toilet or pour them down the drain unless otherwise instructed. Ask your pharmacist about the best ways to dispose of medications. Check out drug disposal programs in your area.

What Are the Side Effects of Symtuza?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Symtuza may or may not cause side effects in some people. Contact your healthcare provider immediately if your side effects do not go away or become irritating. The following are some common side effects of Symtuza:

• Gas (flatulence)
• Headache
• Upset stomach
• Rash
• Diarrhea
• Feeling tired or weak

Severe Side Effects

Immediately inform your healthcare provider if you experience any serious adverse effects. Call 911 if you have any life-threatening symptoms that may require emergency medical attention.

Severe side effects of Symtuza include:

• Swollen gland
• Change in body fat
• Joint or muscle pain
• Signs of infection like a sore throat, cough, and fever
• Signs of lactic acidosis (too much lactic acid in the blood) like feeling cold, fast breathing, abnormal heartbeat, and muscle pain or cramps
• Signs of high blood sugar like confusion, excessive thirst, and breath that smells like fruit
• Fat redistribution, including Cushingoid appearance, central obesity, facial wasting, peripheral wasting, buffalo hump, or breast enlargement
• Signs of kidney problems like excessive weight gain, a change in how much urine is passed, and blood in the urine
• Signs of liver problems like upset stomach or stomach pain, light-colored stools, and yellow skin or eyes (jaundice)
• Signs of an allergic reaction can include hives, wheezing, and trouble breathing, talking, or swallowing 
• Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) 
• Immune reconstitution syndrome
• Decrease in bone mineral density

Dosage: How Much of Symtuza Should I Take?

Modifications

Symtuza is not recommended in people with severe kidney disease. During dialysis, 30% to 54% of this medicine is removed from your system within a three-hour period. It is best to take your medicine after dialysis.

This medication is not recommended for use during pregnancy. This is because darunavir and cobicistat, two components of Symtuza, are substantially less effective in pregnant people. If you become pregnant while on this drug, your healthcare provider may consider switching you to an alternative treatment.

Missed Dose

Try not to miss or skip a dose while taking this drug. However, if you do, take the missed dose as soon as you remember. Skip the missed dose if it is too close to your next dose and return to your regular dosing schedule. Do not take extra doses or two doses at a time.

Stopping Symtuza suddenly can cause hepatitis B flare-ups in people who are already infected. Call your healthcare provider if you miss a dose and are unsure what to do.

Overdose: What Happens If I Use Too Much Symtuza?

Human data on Symtuza overdoses are limited. If you have taken too much Symtuza, immediately contact your healthcare provider or the Poison Control Center for the next steps. You may need to receive supportive treatment.

Precautions

What Are Reasons I Shouldn't Take Symtuza?

Do not take Symtuza if you are hypersensitive to darunavir, cobicistat, emtricitabine, and tenofovir alafenamide, or any part of its formulation.

Do not take this drug if you are using certain substances, including but not limited to:

• Revatio (sildenafil)
• St John’s wort
• Zocor (simvastatin)

What Other Medications Interact With Symtuza?

Certain medications may alter the effects of either darunavir, cobicistat, emtricitabine, or tenofovir alafenamide or vice versa. These drugs include:

• Uroxatral (alfuzosin)
• Multaq (dronedarone)
• Corlanor (ivabradine)
• Addyi (flibanserin)
• Flonase Allergy Relief (fluticasone)
• Dilantin (phenytoin)
• Altoprev (lovastatin)
• Latuda (lurasidone)
• Versed (midazolam)
• Movantik (naloxegol)
• Pimozide
• Trileptal (oxcarbazepine)
• Ranexa (ranolazine)
• Revatio (sildenafil)
• Rifampin
• Serevent (salmeterol)
• Zocor (simvastatin)
• Halcion (triazolam)
• Vincristine

Symtuza also interacts with:

• St. John's wort
• Red yeast rice
• Garlic

Additionally, since Symtuza is a complete treatment regimen for HIV, it is not recommended to take other antiretroviral medications simultaneously.

This is not a complete list of drug interactions. Talk to your healthcare provider before starting any new medication, including over-the-counter (OTC) medicines, vitamins, and herbal supplements.

What Medications Are Similar?

Medications similar to Symtuza that may be used to treat HIV infection include:

• Truvada (emtricitabine and tenofovir disoproxil fumarate)
• Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)
• Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate)

This is a list of drugs also prescribed to treat HIV infection. It is NOT a list of medicines recommended to take with Symtuza. Do not take these drugs together unless instructed by your healthcare provider.

How Can I Stay Healthy While Taking Symtuza?

Staying healthy is possible while living with HIV. Symtuza reduces the amount of HIV in your body; however, you must keep taking it as directed for it to continue working. Do not stop this medication suddenly without consulting your healthcare provider.

Although Symtuza helps lower viral levels in the body, it does not stop the spread of HIV entirely. Continue to take precautions to prevent transmission, including safer sex practices and not sharing needles, razors, or anything that may expose someone to bodily fluids.