Emtricitabine/rilpivirine/tenofovir

If you also take an antacid, (Maalox, Milk of Magnesia, Mylanta, Rolaids, Tums, and others), take it at least 2 hours before or 4 hours after taking Complera.

If you also take a heartburn or GERD medicine (such as Tagamet, Pepcid, Axid, or Zantac), take it at least 12 hours before or 4 hours after taking Complera.

Taking Complera 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.

Complera can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Many drugs can interact with Complera. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• an antibiotic--clarithromycin, erythromycin, telithromycin;
• antifungal medicine--fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole; or
• antiviral medicine--acyclovir, cidofovir, ganciclovir, ledipasvir/sofosbuvir, valacyclovir, valganciclovir.

This list is not complete and many other drugs can interact with Complera. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Emtricitabine/rilpivirine/tenofovir is a prescription medication used to treat human immunodeficiency virus (HIV) infection. It is a single product that contains 3 medications: emtricitabine, rilpivirine, and tenofovir. Emtricitabine and tenofovir belong to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). Rilpivirine belongs to a group of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). NRTIs and NNRTIs work by decreasing the amount of HIV in the blood.

This medication comes as a tablet and is usually taken once a day with a meal.

Common side effects include depression, insomnia, headache, and dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Emtricitabine & Rilpivirine & Tenofovir may be found in some form under the following brand names:

• Complera

The most common side effects include the following:

• trouble sleeping (insomnia)
• abnormal dreams
• headache
• dizziness
• diarrhea
• nausea
• rash
• tiredness
• depression
• vomiting
• stomach pain or discomfort
• skin discoloration (small spots or freckles)
• pain

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. If you take an antacid during treatment with emtricitabine/rilpivirine/tenofovir, take the antacid at least 2 hours before or at least 4 hours after you take emtricitabine/rilpivirine/tenofovir.
• a medicine to block the acid in your stomach, including cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine hydrochloride (Zantac). If you take one of these medicines during treatment with emtricitabine/rilpivirine/tenofovir, take the acid blocker at least 12 hours before or at least 4 hours after you take emtricitabine/rilpivirine/tenofovir.
• any of these medicines (if taken by mouth or injection):
  • clarithromycin (Biaxin)
  • erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Iloson)
  • fluconazole (Diflucan)
  • itraconazole (Sporanox)
  • ketoconazole (Nizoral)
  • methadone (Dolophine)
  • posaconazole (Noxafil)
  • telithromycin (Ketek)
  • voriconazole (Vfend)
• medicines that are eliminated by the kidney, including acyclovir (Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert), valacyclovir (Valtrex), and valganciclovir (Valcyte)

If you take emtricitabine/rilpivirine/tenofovir, you should not take:

• other medicines that contain tenofovir (Viread, Truvada, Stribild, Atripla)
• other medicines that contain emtricitabine or lamivudine (Emtriva, Combivir, Epivir or Epivir-HBV, Epzicom, Trizivir, Atripla, Truvada, Stribild)
• rilpivirine (Edurant)
• adefovir (Hepsera)

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

• Stay under the care of your healthcare provider during treatment with emtricitabine/rilpivirine/tenofovir.
• Take emtricitabine/rilpivirine/tenofovir exactly as your healthcare provider tells you to take it.
• Always take emtricitabine/rilpivirine/tenofovir with a meal. Taking emtricitabine/rilpivirine/tenofovir with a meal is important to help get the right amount of medicine in your body. A protein drink does not replace a meal.
• Do not change your dose or stop taking emtricitabine/rilpivirine/tenofovir without first talking with your healthcare provider. See your healthcare provider regularly while taking emtricitabine/rilpivirine/tenofovir.
• If you miss a dose of emtricitabine/rilpivirine/tenofovir within 12 hours of the time you usually take it, take your dose of emtricitabine/rilpivirine/tenofovir with a meal as soon as possible. Then, take your next dose of emtricitabine/rilpivirine/tenofovir at the regularly scheduled time. If you miss a dose of emtricitabine/rilpivirine/tenofovir by more than 12 hours of the time you usually take it, wait and then take the next dose of emtricitabine/rilpivirine/tenofovir at the regularly scheduled time.
• Do not take more than your prescribed dose to make up for a missed dose.
• When your emtricitabine/rilpivirine/tenofovir supply starts to run low, get more from your healthcare provider or pharmacy. It is very important not to run out of emtricitabine/rilpivirine/tenofovir. The amount of virus in your blood may increase if the medicine is stopped for even a short time.
• If you take too much emtricitabine/rilpivirine/tenofovir, contact your local poison control center or go to the nearest hospital emergency room right away.

Avoid doing things that can spread HIV-1 infection to others.

• Do not share or re-use needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose is one tablet (containing 200 mg of emtricitabine, 25 mg of rilpivirine, and 300 mg of tenofovir) taken once daily with a meal.

If emtricitabine/rilpivirine/tenofovir is coadministered with rifabutin, an additional 25 mg tablet of rilpivirine once per day is recommended to be taken with a meal for the duration of the rifabutin coadministration.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of emtricitabine/rilpivirine/tenofovir, in combination with other antiretrovirals.

Emtricitabine/rilpivirine/tenofovir is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of emtricitabine/rilpivirine/tenofovir have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of emtricitabine/rilpivirine/tenofovir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue emtricitabine/rilpivirine/tenofovir. If appropriate, initiation of anti-hepatitis B therapy may be warranted.