Emtricitabine & Rilpivirine & Tenofovir

Emtricitabine/rilpivirine/tenofovir is a prescription medication used to treat HIV (Human Immunodeficiency Virus) which causes acquired immunodeficiency syndrome (AIDs) in adults. It is a single tablet that contains three prescription medicines, emtricitabine, rilpivirine, and tenofovirIn. For HIV to reproduce, it must convert its genetic material from RNA to DNA. These three antiviral medications stop the DNA from being made.

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 in tablet form and is taken once a day, with food.

Common side effects include trouble sleeping (insomnia), abnormal dreams, and headache. 

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

• Complera

Emtricitabine/rilpivirine/tenofovir may cause serious side effects. See "Drug Precautions" section.

The most common side effects of emtricitabine/rilpivirine/tenofovir include:

• trouble sleeping (insomnia)
• abnormal dreams
• headache
• dizziness
• diarrhea
• nausea
• rash
• tiredness
• depression

Additional common side effects include:

• vomiting
• stomach pain or discomfort
• skin discoloration (small spots or freckles)
• pain

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

These are not all the possible side effects of emtricitabine/rilpivirine/tenofovir. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Do not take emtricitabine/rilpivirine/tenofovir if you also take these medicines:

• other HIV medicines
• the anti-seizure medicines carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol- XR, Teril, Epitol), oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek)
• the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater, Rifamate, Rimactane, Rifadin) and rifapentine (Priftin)
• a proton pump inhibitor medicine for certain stomach or intestinal problems, including esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole sodium (Protonix), rabeprazole (Aciphex)
• more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
• St. John's wort (Hypericum perforatum)

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

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

Also tell your healthcare provider if you take:

• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take emtricitabine/rilpivirine/tenofovir.
• a histamine-2 blocker medicine, including famotidine (Pepcid), cimetidine (Tagamet), nizatidine (Axid), or ranitidine hydrochloride (Zantac). Take these medicines at least 12 hours before or at least 4 hours after you take emtricitabine/rilpivirine/tenofovir.
• the antibiotic medicines clarithromycin (Biaxin), erythromycin (E-Mycin, Eryc, ERY-TAB, PCE, Pediazole, Iloson), and troleandomycin (TAO)
• an antifungal medicine by mouth, including fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), voriconazole (Vfend)
• methadone (Dolophine)
• medicines that are eliminated by the kidney, including acyclovir (Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV, Vitrasert), valacyclovir (Valtrex), and valganciclovir (Valcyte)

This is not a complete list of drug interactions. Ask your healthcare provider for more information.

Emtricitabine/rilpivirine/tenofovir can cause serious side effects, including:

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. 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 or vomiting
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a fast or irregular heartbeat

Severe liver problems. Severe liver problems can happen in people who take emtricitabine/rilpivirine/tenofovir or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take emtricitabine/rilpivirine/tenofovir.

Call your healthcare provider right away if you have any of the following symptoms of liver problems:

• your skin or the white part of your eyes turns yellow (jaundice)
• dark "tea-colored" urine
• light-colored bowel movements (stools)
• loss of appetite for several days or longer
• nausea
• stomach pain

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.

Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection and you stop taking this medication, your HBV infection may become worse (flare-up). A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Emtricitabine/rilpivirine/tenofovir is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider.

New or worse kidney problems can happen in some people who take emtricitabine/rilpivirine/tenofovir. If you have had kidney problems in the past or take other medicines 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

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 let your emtricitabine/rilpivirine/tenofovir run out. Refill your prescription or talk to your healthcare provider before your emtricitabine/rilpivirine/tenofovir is all gone.
• Do not stop taking emtricitabine/rilpivirine/tenofovir without first talking to your healthcare provider.
• If you stop taking emtricitabine/rilpivirine/tenofovir, your healthcare provider will need to check your health often and do regular blood tests to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking emtricitabine/rilpivirine/tenofovir.

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 you take emtricitabine/rilpivirine/tenofovir, tell your healthcare provider if you:

• have liver problems, including hepatitis B or C virus infection
• have kidney problems
• have ever had a mental health problem
• have bone problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

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.

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

Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. Its purpose 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 healthcare provider 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 The Centers for Disease Control and Prevention recommends that mothers with HIV not breastfeed because they can pass the HIV through their milk to the baby.

Talk to your healthcare provider about the best way to feed your baby.

• 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 this medication 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 this medication.
• If you miss a dose of emtricitabine/rilpivirine/tenofovir within 12 hours of the time you usually take it, take your dose 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 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 this medication. The amount of virus in your blood may increase if the medicine is stopped for even a short time.

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 emtricitabine/rilpivirine/tenofovir exactly as prescribed by your doctor.  Follow the directions on your prescription label carefully.

If you take too much emtricitabine/rilpivirine/tenofovir, contact your local poison control center or go to the nearest hospital emergency room right away.

• Store emtricitabine/rilpivirine/tenofovir at room temperature 77 °F (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 emtricitabine/rilpivirine/tenofovir and all other medicines out of reach of children.

WARNINGS: 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.