Dolutegravir (doe-loo-TEG-ra-vir), Rilpivirine (ril-pi-VIR-een)

Treats HIV infection. This medicine does not cure HIV or AIDS, but it may slow the progress of the disease.

Brand Name(s):

Juluca

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is low so you do not run out.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in its original bottle. Keep it tightly closed.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also taking dexamethasone, dofetilide, St John's wort, seizure medicine (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin), medicine to treat tuberculosis (including rifampin, rifapentine), or stomach medicine (including esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole).
• Some medicines can affect how dolutegravir/rilpivirine works. Tell your doctor if you are using dalfampridine, metformin, methadone, rifabutin, or medicine to treat an infection (including clarithromycin, erythromycin, telithromycin).
• Take this medicine at least 4 hours before or 6 hours after you take antacids, laxatives, or other medicine that contains aluminum, calcium carbonate, magnesium, or buffered medicines.
• Take this medicine at least 4 hours before or 12 hours after you take stomach medicine for heartburn or ulcers (including cimetidine, famotidine, nizatidine, ranitidine).
• You may take iron or calcium supplements at the same time that you take this medicine with food. If you do not take these supplements together with this medicine and with food, take this medicine at least 4 hours before or 6 hours after you take these supplements.

Warnings While Using This Medicine:

• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• Tell your doctor if you are pregnant, or if you have liver disease (including hepatitis B or C), kidney disease, depression, or a history of mental problems.
• This medicine may cause the following problems:
  • Drug reaction with eosinophilia and systemic symptoms (DRESS), which can damage organs, including the liver, kidney, or heart
  • Liver problems
  • Depression, unusual thoughts or behavior
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Feeling sad or depressed, anxious, or restless, unusual thoughts or behavior, thoughts of hurting yourself or others
• Fever, skin rash, or swollen glands in your armpits, neck, or groin

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

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