Emtricitabine & Rilpivirine & Tenofovir

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 is a prescription HIV (Human Immunodeficiency Virus) medicine that:

• is used to treat HIV-1 in adults who have never taken HIV medicines before, and
• who have an amount of HIV in their blood (this is called 'viral load') that is no more than 100,000 copies/mL. Your healthcare provider will measure your viral load.

HIV is the virus that causes AIDS (Acquired Immunodeficiency Syndrome).This medication is not a cure for HIV infection. You should stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses. Sustained decreases of HIV in the blood are linked to reduced risk of progression to AIDS and death.

It is not known if emtricitabine/rilpivirine/tenofovir is safe and effective in children under the age of 18 years.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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.

Serious side effects have been reported with this medication, including the following:

• A build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take emtricitabine/rilpivirine/tenofovir or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death.
  • You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking emtricitabine/rilpivirine/tenofovir or a similar medicine containing nucleoside analogs for a long time.
  • Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:
    • feeling very weak or tired
    • have unusual (not normal) muscle pain
    • have trouble breathing
    • have stomach pain with nausea (feel sick to your stomach)
    • vomiting
    • feel cold, especially in your arms and legs
    • feel dizzy or lightheaded
    • have a fast or irregular heartbeat
• New or worse kidney problems, including kidney failure, can happen in some people who take emtricitabine/rilpivirine/tenofovir. Your healthcare provider should do blood tests to check your kidneys before starting treatment with emtricitabine/rilpivirine/tenofovir. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with emtricitabine/rilpivirine/tenofovir.
• Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:
  • feeling sad or hopeless
  • feeling anxious or restless
  • have thoughts of hurting yourself (suicide) or have tried to hurt yourself
• Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with emtricitabine/rilpivirine/tenofovir. Liver problems can also happen during treatment with emtricitabine/rilpivirine/tenofovir in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with emtricitabine/rilpivirine/tenofovir.
• Bone problems can happen in some people who take emtricitabine/rilpivirine/tenofovir. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones.
• Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effect of these conditions are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine.

Do not take this medication if you are:

• allergic to emtricitabine/rilpivirine/tenofovir or to any of its ingredients
• taking the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• taking the antimycobacterials rifampin or rifapentine
• taking proton pump inhibitors, such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole
• taking the glucocorticoid systemic dexamethasone (more than a single dose)
• taking St. John's wort (Hypericum perforatum)

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)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of emtricitabine/rilpivirine/tenofovir, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking emtricitabine/rilpivirine/tenofovir, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are no well-done studies that have been done in humans with emtricitabine/rilpivirine/tenofovir. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is advisable to avoid breastfeeding because at least two of the drugs contained in this medication can be passed to the baby in breast milk. It is not known whether this could harm the baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in breast milk.

• 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.

• Store emtricitabine/rilpivirine/tenofovir at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
• Keep emtricitabine/rilpivirine/tenofovir in its original container and keep the container tightly closed.
• Do not use emtricitabine/rilpivirine/tenofovir if the seal over the bottle opening is broken or missing.
• Keep this and all other medications out of the reach of children.

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.