Dolutegravir; Rilpivirine oral tablets

What is this medication?

DOLUTEGRAVIR; RILPIVIRINE (doe loo teg ra veer; RIL pi VIR een) is 2 antiretroviral medicines in 1 tablet. It is used to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): JULUCA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• liver disease
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• an unusual or allergic reaction to dolutegravir, rilpivirine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water and food. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• certain medicines for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• certain medicines for stomach problems like esomeprazole, pantoprazole, omeprazole, lansoprazole, rabeprazole
• cisapride
• dexamethasone
• dofetilide
• dronedarone
• lumacaftor; ivacaftor
• pimozide
• rifampin
• rifapentine
• St. John's wort; Hypericum perforatum
• thioridazine
• ziprasidone

This medicine may also interact with the following medications:

• buffered medicines, like buffered aspirin
• calcium supplements
• certain antibiotics like clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin
• certain medicines for stomach problems like aluminum hydroxide, magnesium hydroxide, calcium carbonate, cimetidine, famotidine, nizatidine, ranitidine
• iron supplements
• metformin
• methadone
• other antiviral medicines for HIV or AIDS
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• sucralfate

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care provider for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care provider or pharmacist for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• muscle or joint pain
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• suicidal thoughts or other mood changes

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.