Juluca contains a combination of dolutegravir and rilpivirine. Dolutegravir and rilpivirine are antiviral medicines that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Juluca is used to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS).

Juluca is not a cure for HIV or AIDS.

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

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

Before taking this medicine

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

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

• dofetilide (can cause serious medical problems or death when taken with Juluca);

• St John's wort;

• more than one dose of dexamethasone;

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin;

• rifampin, rifapentine; or

• esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.

To make sure Juluca is safe for you, 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.

Juluca 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 Juluca exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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.

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

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 of Juluca 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 Juluca if you are allergic to dolutegravir or rilpivirine.

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

• dofetilide (can cause serious medical problems or death when taken with Juluca);

• St John's wort;

• more than one dose of dexamethasone;

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin;

• rifampin, rifapentine; or

• esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.

To make sure Juluca is safe for you, 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.

Juluca 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 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.

This 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.

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to Juluca: 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.

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 Juluca side effects 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 Juluca less effective when taken at the same time. If you take any of the following medicines, take your 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 your Juluca dose at least 4 hours before or 12 hours after you take famotidine, cimetidine, nizatidine, or ranitidine.

Many drugs can interact with dolutegravir and rilpivirine, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.