Rilpivirine Oral Tablets

What is this medicine?

RILPIVIRINE (RIL pi VIR een) is an antiretroviral medicine. It is used with other medicines 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.

How should I use this medicine?

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. While this drug may be prescribed for children as young as 12 years old for selected conditions, special care may be needed.

What side effects may I notice from receiving this medicine?

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

• fast, irregular heartbeat

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• suicidal thoughts or other mood changes

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

• headache

• dizziness

• nausea, vomiting

• stomach pain

• trouble sleeping

• weight gain around waist, back, or thinning of face, arms, legs

What may interact with this medicine?

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 (more than 1 dose)

• dofetilide

• dronedarone

• lumacaftor; ivacaftor

• pimozide

• rifampin

• rifapentine

• St. John's wort; Hypericum perforatum

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• certain antibiotics like clarithromycin, erythromycin, troleandomycin, rifabutin

• certain medicines for stomach problems like aluminum hydroxide, magnesium hydroxide, calcium carbonate, cimetidine, famotidine, nizatidine, ranitidine

• methadone

• other antiviral medicines for HIV or AIDS

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

What if I miss a dose?

If you miss a dose and it is within 12 hours of the time you normally take it, take your dose with food as soon as possible. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 12 hours of the time you normally take it, wait and then take the next dose at the regularly scheduled time. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep in the original bottle to protect from light. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

• heart disease

• liver disease

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to rilpivirine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

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

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