cobicistat, elvitegravir, emtricitabine, and tenofovir

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

Brand: Genvoya, Stribild

What is the most important information I should know about this medicine?

Many drugs can interact with this medicine and some should not be used at the same time. Tell your doctor about all the medicines you use.

This medicine may cause a serious condition called lactic acidosis. 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.

This medicine can harm your liver. Call your doctor at once if you have: nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.

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

What is cobicistat, elvitegravir, emtricitabine, and tenofovir?

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.

Elvitegravir, 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, elvitegravir, emtricitabine, and tenofovir is a combination medicine used to treat HIV. This medicine is not a cure for HIV or AIDS.

This medicine is for use in adults and children who are at least 12 years old.

Cobicistat, elvitegravir, 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 this medicine?

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

Some medicines can interact with this medicine 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;
  • rifampin;
  • sildenafil (Revatio, for treating pulmonary arterial hypertension);
  • St. John's wort;
  • antipsychotic medicine --lurasidone, pimozide;
  • ergot medicine --dihydroergotamine, ergotamine, ergonovine, methylergonovine; or
  • seizure medicine --carbamazepine, phenobarbital, phenytoin.

Cobicistat, elvitegravir, emtricitabine, and tenofovir is a complete combination treatment and should not be used with other antiviral medications, especially those that contain adefovir, cobicistat, elvitegravir, emtricitabine, lamivudine, ritonavir, or tenofovir: Atripla, Combivir, Complera, Emtriva, Epivir, Epzicom, Hepsera, Kaletra, Norvir, Triumeq, Trizivir, Truvada, Tybost, Viread, or Viekira.

To make sure cobicistat, elvitegravir, emtricitabine, and tenofovir is safe for you, tell your doctor if you have:

  • liver or kidney disease;
  • osteopenia (low bone mineral density); or
  • a history of hepatitis B or C infection.

Some people taking this medicine 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.

This medicine 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.

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 this 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.

Cobicistat, elvitegravir, emtricitabine, and tenofovir is not approved for use by a child younger than 12 years old or weighing less than 77 pounds.

How should I take this medicine?

This medicine 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.

Take with food.

Use this medicine regularly to get the most benefit. Your disease may become resistant if you miss doses. Do not change your dose or medication schedule without your doctor's advice. Get your prescription refilled before you run out of medicine completely. Every person with HIV or AIDS should remain under the care of a doctor.

Your blood may need to be tested often. Your bone density and kidney or liver function may also need to be tested.

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 medicine, even months after stopping. Your doctor may want to check your liver function for several months after you stop using this medicine.

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?

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

What should I avoid while taking this medicine?

Avoid taking an antacid within 2 hours before or 2 hours after you take cobicistat, elvitegravir, emtricitabine, and tenofovir. Some antacids can make it harder for your body to absorb this medicine.

Taking this medicine 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.

What are the possible side effects of this medicine?

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

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: 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.

Call your doctor at once if you have:

  • kidney problems --little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or
  • liver problems --nausea, swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

This medicine 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. 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:

  • diarrhea;
  • 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?

This medicine 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 cobicistat, elvitegravir, emtricitabine, and tenofovir. Some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this medicine. 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 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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