Vitekta is an antiviral medication that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Vitekta is used with other antiviral medications to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS). Elvitegravir is not a cure for HIV or AIDS.

Vitekta is usually given after other HIV medicines have been tried without success.

You should not use Vitekta if you are also taking dofetilide (Tikosyn).

Vitekta 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.

Vitekta must be taken together with ritonavir (Norvir) and one other HIV medicine. Your doctor may prescribe one of the following:

• atazanavir (Reyataz);

• darunavir (Prezista);

• fosamprenavir (Lexiva);

• lopinavir/ritonavir combination (Kaletra); or

• tipranavir (Aptivus).

If you are switched from one of these medicines to another, your Vitekta dose needs may change. Carefully follow your doctor's dosing instructions.

While using Vitekta, you may need frequent blood tests.

Use all medicines as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Use your medicines regularly to get the most benefit. Get your prescriptions refilled before you run out of medicine completely.

Store Vitekta in the original container at room temperature away from moisture and heat.

Usual Adult Dose of Vitekta for HIV Infection:

With once-daily atazanavir/ritonavir or twice-daily lopinavir-ritonavir: 85 mg orally once a day with food
With twice-daily darunavir/ritonavir, fosamprenavir/ritonavir, or tipranavir/ritonavir: 150 mg orally once a day with food

Comments:
-The manufacturer product information should be consulted for the recommended dosing regimen for atazanavir/ritonavir, lopinavir-ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, or tipranavir/ritonavir; this drug should not be used with other dose regimens or HIV-1 protease inhibitors.
-This drug should not be used with cobicistat and protease inhibitors.

Use: In combination with a ritonavir-boosted HIV protease inhibitor and at least 1 other antiretroviral drug, for the treatment of HIV-1 infection in antiretroviral therapy-experienced patients

You should not use Vitekta if you are allergic to elvitegravir or if you are also taking cobicistat (Stribild, Tybost) or any other medicines that contain elvitegravir.

To make sure Vitekta is safe for you, tell your doctor if you have:

• liver disease, especially hepatitis B or C.

Vitekta is not expected to harm an unborn baby. However, HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant and 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 Vitekta 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.

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.

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

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

Taking HIV medication 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.

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

Vitekta 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 Vitekta. 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 Vitekta side effects may include:

• diarrhea;

• nausea; or

• headache.

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.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Vitekta, especially:

• bosentan;

• buprenorphine, naloxone;

• dexamethasone;

• ketoconazole;

• methadone;

• St. John's wort;

• hepatitis C medications - boceprevir or telaprevir;

• hormonal birth control - ills, injections, implants, skin patches, vaginal rings;

• other HIV or AIDS medicines - didanosine, efavirenz, nevirapine;

• seizure medication - carbamazepine, oxcarbazepine, phenobarbital, phenytoin; or

• tuberculosis medicine - rifabutin, rifampin, rifapentine.

This list is not complete. Other drugs may interact with elvitegravir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.