Dolutegravir and rilpivirine is a combination antiviral medicine used to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS). dolutegravir and rilpivirine is not a cure for HIV or AIDS.

Dolutegravir and rilpivirine is for use only in people who have been successfully treated with other antiviral medications for at least 6 months.

Dolutegravir and rilpivirine may also be used for purposes not listed in this medication guide.

Taking dolutegravir during the first trimester of pregnancy may cause birth defects. Use effective birth control to prevent pregnancy while you are using dolutegravir.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Always take this medicine with food, not with a meal replacement drink.

You will need frequent blood tests.

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.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with any packet or canister of moisture-absorbing preservative.

Usual Adult Dose for HIV Infection:

1 tablet orally once a day with a meal

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

You should not use dolutegravir and rilpivirine if you are allergic to dolutegravir or rilpivirine.

Some medicines can cause unwanted or dangerous effects when used with dolutegravir and rilpivirine. Your doctor may change your treatment plan if you also use:

• dofetilide (can cause serious medical problems or death when taken with dolutegravir and rilpivirine);

• St John's wort;

• more than one dose of dexamethasone;

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin;

• rifampin, rifapentine; or

• esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.

Tell your doctor if you have ever had:

• liver problems;

• mental illness;

• a severe skin rash or allergic reaction to dolutegravir or rilpivirine; or

• if you also take rifabutin.

You may need to have a negative pregnancy test before starting this treatment.

Dolutegravir and rilpivirine may harm an unborn baby if you take the medicine at the time of conception or during the first 12 weeks of pregnancy. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

HIV can be passed to your baby if the virus is not controlled during pregnancy. If you are pregnant, your name may be listed on a registry to track any effects of antiviral medicine on the baby. Use your medications properly to control HIV.

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 medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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

Using dolutegravir and rilpivirine will not prevent your disease from spreading. 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 signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Dolutegravir and rilpivirine may cause serious side effects. Call your doctor at once if you have:

• thoughts about suicide or hurting yourself;

• anxiety, sadness, feeling hopeless;

• depression--mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself; or

• liver problems--nausea, vomiting, loss of appetite, right-sided upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Dolutegravir and rilpivirine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of dolutegravir and rilpivirine may include:

• headache; or

• nausea, diarrhea.

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.

Some medicines can make dolutegravir and rilpivirine less effective when taken at the same time. If you take any of the following medicines, take your dolutegravir and rilpivirine dose at least 4 hours before or 6 hours after you take the other medicine.

• antacids or laxatives that contain calcium, magnesium, or aluminum (such as Maalox, Milk of Magnesia, Mylanta, Rolaids, Tums, and others), or the ulcer medicine sucralfate (Carafate);

• buffered medicine; or

• vitamin or mineral supplements that contain calcium or iron (but if you take dolutegravir and rilpivirine with food, you can take these supplements at the same time).

Take dolutegravir and rilpivirine dose at least 4 hours before or 12 hours after you take famotidine, cimetidine, nizatidine, or ranitidine.

Many drugs can affect dolutegravir and rilpivirine, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.