stribild

Stribild contains 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 drugs that prevent HIV (human immunodeficiency virus) cells from multiplying in the body. HIV causes acquired immunodeficiency syndrome (AIDS).

Stribild 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.

Important information

Stribild 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.

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

Many drugs can interact with cobicistat, elvitegravir, emtricitabine, and tenofovir and some should not be used at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any you start or stop using.

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.

Before taking this medicine

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

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.

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.

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.

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.

Stribild is not approved for use by anyone younger than 18 years old.

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.

Take with food.

Use Stribild regularly to get the most benefit. 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.

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.

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.

Stribild dosing information

Usual Adult Dose for HIV Infection:

1 tablet orally once a day with food

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

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 Stribild?

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.

Taking Stribild 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.

Stribild side effects

Get emergency medical help if you have signs of an allergic reaction to Stribild: 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 urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

• liver problems - nausea, upper stomach pain, itching, tired feeling, 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 Stribild 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.

See also: Side effects (in more detail)

What other drugs will affect Stribild?

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 other drugs can interact with Stribild. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• atorvastatin;

• colchicine;

• dexamethasone;

• digoxin;

• salmeterol;

• warfarin (Coumadin, Jantoven);

• an antibiotic such as clarithromycin;

• an antidepressant or antipsychotic medication;

• hormonal contraception (birth control pills or skin patches);

• medicine to prevent organ transplant rejection;

• a sedative or sleep medication, such as Valium, Ambien, and others;

• sildenafil (Viagra) or other erectile dysfunction medicines;

• antifungal medicine - itraconazole, ketoconazole, voriconazole;

• heart rhythm medicine - amiodarone, disopyramide, flecainide, mexiletine, propafenone, quinidine, and others;

• seizure medicine - carbamazepine, clonazepam, ethosuximide, oxcarbazepine, phenytoin; 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.