Uses

What is Symtuza used for?

Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) is used to treat human immunodeficiency virus (HIV).

Learn more about treating HIV with Symtuza.

Symtuza may also be used for other conditions as determined by your healthcare provider.

How does Symtuza work (mechanism of action)?

Symtuza contains four medicines: darunavir, cobicistat, emtricitabine, and tenofovir alafenamide. They work together to stop the spread of human immunodeficiency virus (HIV) in your body. 

How is Symtuza supplied (dosage forms)?

Symtuza is available as 800 mg/150 mg/200 mg/10 mg oral tablets that are taken by mouth.

How should I store Symtuza?

Symtuza should be stored in the original container at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep the Symtuza bottle tightly closed in the original container after you open it. This is because it has a desiccant that will protect the medicine from moisture and keep it dry. Do not remove the desiccant from the bottle.

Side Effects

What are the most common side effects of Symtuza?

The most common side effects of Symtuza are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Nausea and diarrhea
  • Rash
  • Tiredness
  • Headache
  • Stomach discomfort
  • Gas

There may be other side effects of Symtuza that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Symtuza?

While less common, the most serious side effects of Symtuza are described below, along with what to do if they happen.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Symtuza. This can cause serious liver problems that can lead to death. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Severe Skin Reactions. Symtuza can cause severe skin reactions called Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) that can lead to death if not treated. If you develop a rash, stop Symtuza and call your healthcare provider right away. Get emergency help right away if you have any of the following symptoms of SJS or TEN.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes

Immune System Changes. When you start Symtuza, your immune system might get stronger and start fighting infections that have been hiding inside your body for a long time. The type of symptoms you may have will depend on the infection. Tell your healthcare provider right away if you notice any of the following new symptoms of infection. 

  • Fever, sweats, chills, or muscle aches
  • Swollen lymph nodes
  • Vision problems
  • Confusion, problems talking, or headache
  • Skin problems such as a painful rash or warts
  • Cough or coughing up blood
  • Weakness or coordination problems 

Kidney Damage. Kidney damage can happen when taking Symtuza. Call your healthcare provider right away if you have any of the following symptoms of kidney damage.

  • Reduced need to pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • Difficulty catching your breath or chest pain/pressure
  • Confusion
  • Nausea
  • Seizures

Lactic Acidosis. Symtuza may cause lactic acidosis (a buildup of lactic acid in your blood), which can be serious. Stop taking Symtuza and get help right away if you have any of the following symptoms of lactic acidosis.

  • General ill feeling
  • Muscle pain
  • Difficulty breathing
  • Drowsiness
  • Stomach pain

New or Worsening Diabetes. Symtuza may cause some people to develop diabetes or for people with diabetes to have higher blood sugar. This may lead to diabetic ketoacidosis (DKA), which can be life threatening. Stop taking Symtuza and get help right away if you have any of the following symptoms of diabetic ketoacidosis.

  • Nausea or vomiting
  • Stomach pain
  • Feeling very tired, woozy, or confused
  • Difficulty breathing
  • Your breath smells fruity or sweet
  • Very high blood sugar levels (>300 mg/dL) 

Fat Redistribution. Some people taking Symtuza have changes in how their body stores fat. This can include getting more fat around the belly, a larger upper back (buffalo hump), losing fat in the arms, legs, and face, or getting bigger breasts.

Severe Allergic Reactions. Symtuza may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for Drug Reaction with Eosinophilia and Systemic Symptoms. It is also sometimes called multiorgan hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking Symtuza and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Swelling in your feet, ankles, or legs
  • Shortness of breath, trouble swallowing, or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Warnings & Precautions

Who should not use Symtuza?

Allergies to Ingredients. People who are allergic to any of the following should not take Symtuza.

  • Symtuza
  • Darunavir
  • Cobicistat
  • Emtricitabine
  • Tenofovir alafenamide
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Symtuza.

Drug Interactions. Symtuza should not be taken while you are using certain other medicines. Before taking Symtuza, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about Symtuza before using it?

Do not take Symtuza unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Take each dose of Symtuza with food. 

Do not share Symtuza with other people, even if they have the same condition as you. It may harm them.

Keep Symtuza out of the reach of children.

While Symtuza can help keep the HIV infection under control, it does not cure it. Also, Symtuza does not help protect against or prevent the spread of sexually transmitted infections (STIs), like herpes, gonorrhea, or chlamydia.

If you have HIV and hepatitis B, stopping Symtuza can cause a serious flare-up, or worsening, of your hepatitis B. Your healthcare provider will test you for hepatitis B before or when starting this medicine. Do not run out of Symtuza or stop taking it without talking to your healthcare provider first. If you have HIV and hepatitis B and stop taking Symtuza, keep all appointments for blood work so your healthcare provider can check the health of your liver. 

What should I tell my healthcare provider before using Symtuza?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Symtuza is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Medical Conditions. Tell your healthcare provider if you have any of the following.

  • Kidney problems
  • Liver problems, including hepatitis B or hepatitis C
  • Diabetes
  • Hemophilia (a problem where bleeding takes longer to stop than usual)

Sulfa Allergy. Some people who have a sulfa allergy may also be allergic to Symtuza. A sulfa allergy is a rash or more serious reaction to sulfa, or sulfonamide, medicines. Sulfa medicines include sulfamethoxazole, sulfadiazine silver, or sulfasalazine. Tell your healthcare provider if you have any allergies to medicines. Your healthcare provider can help you decide if it is safe for you to take Symtuza.

Pregnancy. Symtuza is not recommended during pregnancy because it may not work as well to treat HIV. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant while taking Symtuza, you can register for the Antiretroviral Pregnancy Registry by visiting www.apregistry.com. This registry collects safety information about the use of HIV medicines during pregnancy.

Breastfeeding. Do not breastfeed while you are taking Symtuza. Symtuza passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. There may be risks with breastfeeding while taking Symtuza and having HIV.

How can I get more information about Symtuza?

For more information about Symtuza, you can visit the manufacturer’s website at www.symtuza.com or call them at 800-526-7736.

Interactions

Does Symtuza interact with foods or drinks?

There are no known interactions between Symtuza and foods or drinks.

It is unknown if drinking alcohol will affect Symtuza.

Does Symtuza interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Symtuza.

  • Alfuzosin, which is a medicine that may be used for high blood pressure and/or difficulty peeing due to an enlarged prostate
  • Any medicine for seizures, such as carbamazepine, phenytoin, or phenobarbital
  • Colchicine, which is a medicine used for gout flares
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis 
  • Lurasidone or pimozide, which is a medicine for certain mental health conditions
  • Dronedarone, which is a medicine used to control your heart rate or rhythm (antiarrhythmic) 
  • Ranolazine, which is a medicine used for chest pain
  • Ivabradine, which is a medicine used for heart failure
  • An ergot, such as ergotamine (Ergomar) or dihydroergotamine (Migranal or Trudhesa), which is a medicine used to treat migraine
  • St. John’s wort, which is a supplement that may be used to treat depression
  • Zepatier (elbasvir/grazoprevir), which is a medicine used for hepatitis
  • Lomitapide, which is a medicine used to lower cholesterol levels
  • A statin, such as lovastatin or simvastatin, which is a medicine to lower cholesterol 
  • Naloxegol, which is a medicine used for opioid-induced constipation 
  • A type of medicine called a phosphodiesterase-5 (PDE-5) inhibitor, such as avanafil (Stendra), sildenafil (Viagra, Revatio, and others), tadalafil (Cialis and others), or vardenafil (Levitra, Staxyn), which are used for erectile dysfunction and pulmonary arterial hypertension (PAH)
  • Clonazepam, midazolam, or triazolam, which is a sedating medicine
  • A selective serotonin reuptake inhibitor (SSRI), which is a medicine commonly used for anxiety and depression 
  • A tricyclic antidepressant, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression 
  • Any other medicine for HIV or AIDS
  • Any medicine for treating a viral infection
  • Any aminoglycoside antibiotic, such as amikacin or gentamicin, which is given by injection to treat infections
  • A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which are contained in many prescription and OTC products for pain, swelling, and fever

Many other medicines may alter the blood levels of Symtuza, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Symtuza. Always check with your healthcare provider.

Does Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) interact with other drugs you are taking?
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Overdose/Missed Dose

What should I do if I accidentally use too much Symtuza?

If you or someone else has used too much Symtuza, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Symtuza?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

Missing doses of Symtuza can cause it to not work as well over time. So it is important not to miss or skip doses.

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