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cobicistat, darunavir, emtricitabine, and tenofovir

Pronunciation: koe BIK i stat, dar UE na vir, EM trye SYE ta been, and ten OF oh vir

Brand: Symtuza

What is the most important information I should know about Symtuza?

This medicine can cause serious liver problems. Call your doctor if you have upper stomach pain, loss of appetite, vomiting, dark urine, or yellowing of the skin or eyes.

Stop taking this medicine and call your doctor right away if you have a severe skin reaction: fever, burning or redness in your eyes, mouth sores, or a skin rash that spreads and causes blistering and peeling.

If you've ever had hepatitis B, it may become active or get worse after you stop using Symtuza. You may need frequent liver function tests for several months.

What is cobicistat, darunavir, emtricitabine, and tenofovir (Symtuza)?

Cobicistat reduces the action of enzymes in your liver that break down certain antiviral medicines. This allows the antiviral medicines to be used more safely and effectively at lower doses.

Darunavir, emtricitabine and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body. HIV can cause acquired immunodeficiency syndrome (AIDS).

Cobicistat, darunavir, emtricitabine, and tenofovir (Symtuza) is a combination medicine used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Symtuza is not a cure for HIV or AIDS.

Cobicistat, darunavir, emtricitabine, and tenofovir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking Symtuza?

You should not use this medicine if you are allergic to cobicistat, darunavir, emtricitabine, or tenofovir.

Some medicines can cause unwanted or dangerous effects when used with darunavir. Your doctor may change your treatment plan if you also use:

  • alfuzosin;
  • cisapride;
  • colchicine (in people with liver or kidney disease);
  • dronedarone;
  • elbasvir and grazoprevir;
  • lovastatin or simvastatin;
  • pimozide, lurasidone;
  • ranolazine;
  • rifampin;
  • sildenafil (Revatio, for pulmonary arterial hypertension);
  • St. John's wort;
  • triazolam or oral midazolam;
  • ergot medicines --dihydroergotamine, ergotamine, methylergonovine; or
  • seizure medicine --carbamazepine, phenytoin, phenobarbital.

Tell your doctor if you have ever had:

  • liver disease (especially cirrhosis, or hepatitis B or C);
  • kidney disease;
  • diabetes;
  • an allergy to sulfa drugs; or
  • a bleeding disorder such as hemophilia.

You should not use Symtuza if you are pregnant. This medicine may be less effective if you take it while you are pregnant. Tell your doctor if you become pregnant. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take Symtuza?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Always take this medicine with food.

If you cannot swallow a tablet whole, you may break the tablet in half. Take both halves right away.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using Symtuza. You may need frequent liver function tests while using this medicine and for several months after your last dose.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Symtuza?

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of Symtuza?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • increased thirst, increased urination;
  • little or no urination;
  • lactic acidosis --unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or
  • liver problems --swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Symtuza affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection --fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • nausea, upset stomach, diarrhea, gas;
  • headache, feeling tired;
  • rash; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Symtuza?

Other drugs may affect Symtuza, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about cobicistat, darunavir, emtricitabine, and tenofovir.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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