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cobicistat, elvitegravir, emtricitabine, and tenofovir

Pronunciation: koe BIK i stat, EL vi TEG ra vir, EM trye SYE ta been, and ten OF oh vir

Brand: Stribild

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

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Stribild is a complete treatment and should not be used in combination with other antiviral medications.

Many drugs can interact with Stribild and some should not be used at the same time, especially: alfuzosin, cisapride, lovastatin, simvastatin, oral midazolam, triazolam, pimozide, rifampin, sildenafil (for treating pulmonary arterial hypertension), St. John's wort, or ergot medicine (dihydroergotamine, ergotamine, ergonovine, methylergonovine).

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Stribild can cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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Some people develop lactic acidosis while taking this medicine. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have hepatitis B you may develop liver symptoms after you stop taking Stribild, even months after stopping. Your doctor may want to check your liver function for several months after you stop using this medicine.

What is Stribild (cobicistat, elvitegravir, emtricitabine, and tenofovir)?

Cobicistat, elvitegravir, emtricitabine and tenofovir are antiviral drugs that prevent HIV (human immunodeficiency virus) cells from multiplying in the body. HIV causes acquired immunodeficiency syndrome (AIDS).

Stribild (cobicistat, elvitegravir, emtricitabine, and tenofovir) is a combination medicine used to treat HIV in adults who have never taken HIV medicines before. Stribild is not a cure for HIV or AIDS.

Stribild may also be used for purposes not listed in this medication guide.

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

Stribild is a complete treatment and should not be used in combination with other antiviral medications, especially medicines that contain adefovir, emtricitabine, lamivudine, or tenofovir: Atripla, Combivir, Complera, Emtriva, Epivir, Epzicom, Hepsera, Trizivir, Truvada, or Viread.

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You should not take Stribild if you are allergic to cobicistat, elvitegravir, emtricitabine, or tenofovir.

Some medicines can interact with Stribild and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • alfuzosin;
  • lovastatin, simvastatin;
  • oral midazolam, triazolam;
  • pimozide;
  • rifampin;
  • sildenafil (Revatio, for treating pulmonary arterial hypertension);
  • St. John's wort; or
  • ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine.

To make sure Stribild is safe for you, tell your doctor if you have:

  • liver or kidney disease;
  • osteopenia (low bone mineral density); or
  • if you also have hepatitis B infection.
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Some people taking Stribild develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

FDA pregnancy category B. Stribild is not expected to be harmful to an unborn baby. However, HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Stribild on the baby.

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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.

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Do not give this medication to anyone under 18 years old without medical advice.

How should I take Stribild?

Stribild is usually taken once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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Take with food.

Do not change your dose or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

While using Stribild, your blood may need to be tested often. Your bone density and kidney or liver function may also need to be tested.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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Store in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Stribild.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Stribild?

Taking this medication will not prevent you from passing HIV to other people. 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.

Avoid taking an antacid within 2 hours before or after you take Stribild. Some antacids can make it harder for your body to absorb Stribild.

What are the possible side effects of Stribild?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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Some people develop lactic acidosis while taking Stribild. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

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Call your doctor at once if you have:

  • little or no urinating;
  • swelling, rapid weight gain;
  • increased thirst and urination, loss of appetite, weakness, constipation;
  • signs of liver damage - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Stribild may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Stribild. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
  • cold sores, sores on your genital or anal area;
  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

  • headache, strange dreams;
  • mild diarrhea. mild nausea; 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 cobicistat, elvitegravir, emtricitabine, and tenofovir?

Stribild can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Many drugs can interact with Stribild. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Stribild, especially:

  • atorvastatin;
  • colchicine;
  • dexamethasone;
  • digoxin;
  • salmeterol;
  • an antibiotic such as clarithromycin;
  • an antidepressant;
  • antifungal medication--itraconazole, ketoconazole, voriconazole;
  • hormonal contraception (birth control pills or skin patches);
  • heart rhythm medicine--amiodarone, disopyramide, flecainide, mexiletine, propafenone, quinidine, and others;
  • medicine to prevent organ transplant rejection;
  • a sedative or sleep medication, such as Valium, Ambien, and others;
  • seizure medication--carbamazepine, clonazepam, ethosuximide, oxcarbazepine, phenytoin;
  • sildenafil (Viagra) or other erectile dysfunction medicines; or
  • tuberculosis medication--rifabutin, rifapentine.

This list is not complete and many other drugs can interact with Stribild. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about Stribild (cobicistat, elvitegravir, 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.

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