Elvitegravir

Elvitegravir is a prescription medication is used to treat HIV infection in patients who have been tried on treatment for HIV before.

Elvitegravir belongs to a group of drugs called (HIV-1) integrase inhibitor. These work by decreasing the amount of HIV in the blood.

This medication comes in tablet form and is taken once daily, with food. Elvitegravir must be given with a protease inhibitor, ritonavir, and with another antiretroviral drug.

Common side effects of elvitegravir include diarrhea and nausea.

Elvitegravir is a prescription medication is used to treat HIV infection in patients who have been tried on treatment for HIV before.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Elvitegravir may be found in some form under the following brand names:

• Vitekta

Serious side effects have been reported with elvitegravir. See the “Elvitegravir Precautions” section.

The most common side effect of elvitegravir is diarrhea.

Tell your healthcare 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 elvitegravir. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

Do not take elvitegravir if you also take:

• cobicistat (TYBOST) with a protease inhibitor 
• other medicines that contain elvitegravir (STRIBILD)

Especially tell your healthcare provider if you take: 

• hormone-based contraceptives (birth control pills and patches) 
• an antacid medicine. Take antacids at least 2 hours before or after you take elvitegravir.
• medicines used to treat seizures
• any of the following medicines:
  • boceprevir (VICTRELIS)
  • bosentan (TRACLEER)
  • didanosine (VIDEX®, VIDEX EC)
  • medicines that contain dexamethasone 
  • efavirenz (SUSTIVA)
  • ketoconazole (EXTINA, NIZORAL, XOLEGEL)
  • nevirapine (VIRAMUNE)
  • rifabutin (MYCOBUTIN)
  • rifampin (RIFADIN, RIFAMATE, RIFATER, RIMACTANE)
  • rifapentine (PRIFTIN)
  • St. John's wort (Hypericum perforatum) or products containing St. John's wort
  • telaprevir (INCIVEK)

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Do not start any new medicines while you are taking elvitegravir without first talking with your healthcare provider or pharmacist.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Elvitegravir may cause serious side effects, including:

• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.

Elvitegravir must be taken with an HIV protease inhibitor medicine along with ritonavir (NORVIR). You must also take other antiretroviral medicines prescribed by your healthcare provider. 

It is not known if elvitegravir is safe and effective in children.

When used with other HIV-1 medicines to treat HIV-1 infection, elvitegravir may:

• Reduce the amount of HIV-1 in your blood. This is called "viral load".
• Increase the count of CD4+ (T) cells in your blood that help fight off other infections. 

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve the immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

Elvitegravir does not cure HIV-1 infections or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses.

Avoid doing things that can spread HIV-1 infection to others.

• Do not share or re-use needles or other injection equipment. 
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. 
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. 

Ask your healthcare provider if you have any questions about how to prevent passing HIV-1 to other people.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of elvitegravir, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take elvitegravir, tell your healthcare provider if you:

• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Elvitegravir falls into category B. There are no well-done studies that have been done in humans with elvitegravir. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Do not breastfeed if you take elvitegravir.

• You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
• It is not known if elvitegravir can pass to your baby in your breast milk. 
• Talk to your healthcare provider about the best way to feed your baby. 

• Take elvitegravir exactly as your healthcare provider tells you.
• Elvitegravir must be taken with a protease inhibitor medicine which may include one of the following:
  • atazanavir (REYATAZ) with ritonavir (NORVIR)
  • darunavir (PREZISTA) with ritonavir (NORVIR)
  • fosamprenavir (LEXIVA) with ritonavir (NORVIR)
  • lopinavir/ritonavir (KALETRA)
  • tipranavir (APTIVUS) with ritonavir (NORVIR)
• Stay under the care of your healthcare provider during treatment with elvitegravir. See your healthcare provider regularly while you take elvitegravir.
• Do not change your dose or stop taking elvitegravir without first talking with your healthcare provider.
• Do not miss a dose of elvitegravir. 
• Take elvitegravir 1 time each day.
• Take elvitegravir with food.
• If you take too much elvitegravir, call your healthcare provider or go to the nearest hospital emergency room right away.
• Do not run out of elvitegravir. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to elvitegravir and become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.

The recommended dosage of elvitegravir is either:

• 85 mg by mouth, once daily, or
• 150 mg by mouth, once daily

Elvitegravir must be administered once daily with food in combination with a protease inhibitor along with ritonavir and another antiretroviral drug.

If you take too much elvitegravir, tell your healthcare provider or seek emergency medical attention.

• Store elvitegravir at room temperature below 86 °F (30 °C).
• Keep elvitegravir in its original container. 
• Do not use elvitegravir if the seal over the bottle opening is broken or missing.

Keep elvitegravir and all medicines out of the reach of children.