Emtricitabine (em-trye-SYE-ta-been), Rilpivirine (ril-pi-VIR-een), Tenofovir Alafenamide (ten-OF-oh-vir al-a-FEN-a-mide)

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

Brand Name(s):

Odefsey

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. Take this medicine with a meal.
• 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. Keep the medicine in the original bottle.

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 using dexamethasone, rifampin, rifapentine, St John's wort, a seizure medicine (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin), or proton pump inhibitor stomach medicine (including dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole).
• There are many other drugs that can interact with this medicine. Make sure your doctor knows about all other medicines you are using.
• If you take antacids that contain aluminum, magnesium, or calcium, take the antacid at least 2 hours before or 4 hours after you take this medicine.
• If you take a stomach medicine for heartburn or ulcers (including cimetidine, famotidine, nizatidine, ranitidine), take the stomach medicine at least 12 hours before or 4 hours after you take this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or if you have kidney problems, liver disease (including hepatitis B or C), or heart rhythm problems.
• This medicine may cause the following problems:
  • Lactic acidosis (too much acid in your blood)
  • Liver problems
  • Serious skin reactions
  • Drug reaction with eosinophilia and systemic symptoms (DRESS), which can damage organs such as the liver, kidney, or heart
  • Kidney problems
• This medicine can cause depression and thoughts of suicide. Tell your doctor if you have a history of depression or mental health problems.
• Your immune system may get stronger when you take HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• 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.
• 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.
• 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
• Change in how much or how often you urinate
• Dark urine or pale stools, nausea, loss of appetite, stomach pain, yellow skin or eyes
• Depression, unusual changes in behaviors or moods, thoughts of hurting yourself
• Fast breathing, trouble breathing, nausea and vomiting, lightheadedness, severe weakness, tiredness, or confusion
• Fever, skin rash, swollen glands in your armpits, neck, or groin

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

• Headache, tiredness, sleepiness
• Weight gain around your neck, upper back, breast, or waist

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