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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: Genvoya, Stribild

Stribild

slide 1 of 1, Stribild,

150 mg-150 mg-200 mg-300 mg, capsule, green, imprinted with GSI, LOGO

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

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

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

Do not stop using this medicine without your doctor's advice. Get your prescription refilled before you run out of medicine completely.

If you've ever had hepatitis B, it may become active or get worse after you stop using this medicine. You may need frequent liver function tests 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 in adults and children who are at least 12 years old and who weigh at least 55 pounds (25 kilograms). This medicine is not a cure for HIV or AIDS.

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 cause unwanted or dangerous effects when used with cobicistat, elvitegravir, emtricitabine, and tenofovir. Your doctor may change your treatment plan if you also use:

  • alfuzosin;
  • cisapride;
  • oral midazolam, or triazolam;
  • rifampin;
  • sildenafil (Revatio, for treating pulmonary arterial hypertension);
  • St. John's wort;
  • antipsychotic medicine --lurasidone, pimozide;
  • cholesterol medication --lomitapide, lovastatin, simvastatin;
  • ergot medicine --dihydroergotamine, ergotamine, 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, Biktarvy, Cimduo, Combivir, Complera, Descovy, Epivir, Epzicom, Evotaz, Hepsera, Kaletra, Norvir, Odefsey, Prezcobix, Symfi, Symtuza, Technivie, Triumeq, Trizivir, Tybost, Viekira, and others.

Tell your doctor if you have ever had:

  • hepatitis B or other liver problems;
  • kidney disease; or
  • bone problems.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

This medicine may not work as well if you take it during pregnancy. Do not start taking the medicine if you are pregnant. Tell your doctor right away if you become pregnant.

If you plan to get pregnant, ask your doctor for another antiviral medicine to use during pregnancy. Use all medications properly to control your infection. 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.

If you do not plan to get pregnant, ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy. Cobicistat, elvitegravir, emtricitabine, and tenofovir can increase certain side effects when taken with hormonal birth control (pills, injections, implants, skin patches, vaginal rings).

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 this medicine?

This medicine is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

You will need frequent medical tests. Your kidney function may also need to be checked.

Use this medicine regularly to get the most benefit. Your disease may become resistant if you miss doses. 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 in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using this medicine. 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 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.

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 this medicine?

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

Call your doctor at once if you have:

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

Antiviral medicine 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; or
  • diarrhea.

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?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect cobicistat, elvitegravir, emtricitabine, and tenofovir. Some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

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.

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.

Copyright 1996-2019 Cerner Multum, Inc. Version: 5.01. Revision date: 11/13/2018.

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