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Genvoya

Generic Name: cobicistat, elvitegravir, emtricitabine, and tenofovir (koe BIK i stat, EL vi TEG ra vir, EM trye SYE ta been, and ten OF oh vir)
Brand Names: Genvoya, Stribild

What is Genvoya?

Genvoya is a tablet containing a combination of 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).

Genvoya is a combination medicine used to treat HIV in adults and children who weigh at least 55 pounds (25 kilograms).

Genvoya is not a cure for HIV or AIDS.

Important information

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

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

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.

Genvoya 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.

Before taking this medicine

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

Some medicines can interact with Genvoya 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 or simvastatin;

  • oral midazolam, or triazolam;

  • rifampin;

  • sildenafil (Revatio, for treating pulmonary arterial hypertension);

  • St. John's wort;

  • antipsychotic medicine - lurasidone, pimozide;

  • ergot medicine - dihydroergotamine, ergotamine, methylergonovine; or

  • seizure medicine - carbamazepine, phenobarbital, phenytoin.

Genvoya 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 Genvoya is safe for you, tell your doctor if you have ever had:

  • hepatitis B or other liver problems; or

  • kidney disease.

Some people taking Genvoya 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.

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 Genvoya 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.

Genvoya is not approved for use by a child who weighs less than 55 pounds.

How should I take Genvoya?

Genvoya 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 Genvoya with food.

Use Genvoya 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 kidney or liver function may also need to be tested.

Store Genvoya 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.

Genvoya dosing information

Usual Adult Dose of Genvoya for HIV Infection:

1 tablet orally once a day with food

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate (DF).

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

Usual Pediatric Dose of Genvoya for HIV Infection:

12 years or older and at least 35 kg:
-Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide: 1 tablet orally once a day with food

Comments:
-Patients should be tested for HBV infection before starting this drug.
-In all patients, estimated CrCl, urine glucose, and urine protein should be assessed before starting cobicistat/elvitegravir/emtricitabine/tenofovir DF.

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of this drug

Dosage Information (in more detail)

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 Genvoya?

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

Taking Genvoya 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.

Genvoya side effects

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

Call your doctor at once if you have:

  • kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

  • lactic acidosis - muscle pain or weakness, numbness or cold feeling in your arms and legs, trouble breathing, fast or irregular heartbeats, dizziness, 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).

Genvoya 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 Genvoya 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.

Side effects (in more detail)

What other drugs will affect Genvoya?

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 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 your current medicines and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Genvoya.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Genvoya only for the indication prescribed.
  • Disclaimer: 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 1996-2017 Cerner Multum, Inc. Version: 3.01.

Date modified: November 07, 2017
Last reviewed: September 28, 2017

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