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Information

An Overview of Stribild (Elvitegravir/Cobicistat/FTC/Tenofovir)

August 15, 2017

Brand Name: Stribild
Other Names: EVG/COBI/FTC/TDF, QUAD
Drug Class: Combination Drugs

Stribild

WARNING:

Stribild can cause serious, life-threatening side effects. These include lactic acidosis (buildup of lactic acid in the blood) and liver problems.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

  • Weakness or tiredness
  • Unusual muscle pain
  • Trouble breathing
  • Stomach pain with nausea and vomiting
  • Feeling cold, especially in your arms and legs
  • Dizziness or lightheadedness
  • Fast or irregular heartbeat

Contact your health care provider right away if you have any of the following symptoms that may signal liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Feeling sick to your stomach (nausea)
  • Pain in the stomach area (abdominal pain)

Stribild is not approved for the treatment of chronic hepatitis B virus (HBV) infection. If you have both HIV and HBV infection and take Stribild, your HBV infection may get worse (flare up) if you stop taking Stribild.

Avoid taking Stribild with other HIV medicines. Certain HIV medicines, if taken with Stribild, may cause serious side effects.

While taking Stribild, it is important to keep all of your appointments with your health care provider.


What Is Stribild?

Stribild is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat HIV infection in adults and children 12 years of age and older who weigh at least 77 lbs (35 kg):

  • who have never taken HIV medicines before; or
  • to replace the HIV medicines currently taken and who:
    • have been on the same HIV medicine regimen for at least 6 months, and
    • have a viral load that is less than 50 copies/mL, and
    • have never had previous HIV treatment that failed, and
    • have no drug resistance mutations associated with any of the HIV medicines in Stribild.

Stribild is a complete regimen for the treatment of HIV infection and should not be used with other HIV medicines.

Stribild contains the following 4 different medicines combined in 1 pill:

  • Elvitegravir -- an HIV medicine called an integrase inhibitor.
  • Cobicistat -- a medicine called a pharmacokinetic enhancer, which is used to increase the effectiveness of elvitegravir.
  • Emtricitabine -- an HIV medicine called a nucleoside reverse transcriptase inhibitor (NRTI).
  • Tenofovir disoproxil fumarate -- another HIV medicine (also an NRTI).
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Integrase inhibitors (such as elvitegravir) block an HIV enzyme called integrase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) NRTIs (such as emtricitabine and tenofovir disoproxil fumarate) block an HIV enzyme called reverse transcriptase. By blocking integrase and reverse transcriptase, the drugs in combination prevent HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.


What Should I Tell My Health Care Provider Before Taking Stribild?

Before taking Stribild, tell your health care provider:

  • If you are allergic to any of the HIV medicines in Stribild (elvitegravir, cobicistat, emtricitabine, or tenofovir disproxil fumarate) or any other medicines.
  • If you have liver problems, including hepatitis B virus (HBV) infection.
  • If you have kidney problems.
  • If you have bone problems.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Whether Stribild can harm an unborn baby is unknown. Stribild should be used during pregnancy only if the potential benefit justifies the potential risk. Talk to your health care provider about possible risks with taking Stribild when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Stribild.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take, including any HIV medicines. Stribild may affect the way other medicines or products work, and other medicines or products may affect how Stribild works. Taking Stribild together with certain medicines or products may cause serious, life-threatening side effects.


How Should I Take Stribild?

Stribild comes in tablet form. Each tablet contains:

  • 150 mg elvitegravir (brand name: Vitekta)
  • 150 mg cobicistat (brand name: Tybost)
  • 200 mg emtricitabine (brand name: Emtriva)
  • 300 mg tenofovir disproxil fumarate (brand name: Viread)

Take Stribild according to your health care provider's instructions.

Take Stribild with food. Do not take Stribild with other HIV medicines.

If you need to take a medicine for indigestion (antacid) that contains aluminum and magnesium hydroxide or calcium carbonate during treatment with Stribild, take it at least 2 hours before or after you take Stribild.

If you take too much Stribild, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take Stribild, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)


What Should I Do If I Forget a Dose?

If you miss a dose of Stribild, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.


What Side Effects Can Stribild Cause?

Stribild may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects from Stribild can be serious. Serious side effects of Stribild include buildup of lactic acid in the blood (lactic acidosis) and liver problems. (See the WARNING box above).

The most common side effects of Stribild include nausea and diarrhea. Other possible side effects of Stribild include:

  • New or worsening kidney problems, including kidney failure.
  • Bone problems (bone pain, softening, or thinning [osteopenia]).
  • Changes in body fat (including gain or loss of fat).
  • Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Stribild. To learn more about possible side effects of Stribild, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at www.accessdata.fda.gov/scripts/medwatch/.


How Should Stribild Be Stored?

  • Store Stribild at room temperature, 68°F to 77°F (20°C to 25°C).
  • Keep Stribild in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
  • Do not use Stribild if the original seal over the container opening is broken or missing.
  • Throw away Stribild that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Stribild and all medicines out of reach of children.


Where Can I Find More Information About Stribild?

More information about Stribild is available:


Manufacturer Information

Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056

The above Patient Version drug summary is based on the following FDA label(s): Tablet.


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This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
 

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