Generic Name: emtricitabine-rilpivirine-tenofovir, Oral tablet

COMPLERA

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  • COMPLERA
SECTION 1 of 4

Highlights for emtricitabine-rilpivirine-tenofovir

Oral tablet
1

This treatment is made up of three different drugs. It’s a complete treatment for human immunodeficiency virus (HIV) infection, which means you won’t likely have to take other HIV drugs.

2

It comes in one tablet that you only have to take once a day. Take it with a full meal for best absorption.

3

Complera can cause serious side effects, including depression, liver problems, and others.

4

Complera is generally effective in treating HIV infection. But, if you don’t take it as prescribed, you risk making your HIV infection worse.

5

Don’t take large doses of ibuprofen, naproxen, piroxicam, or other anti-inflammatory drugs. If you take anti-inflammatory drugs, do not take them for a long period of time. They may cause your kidneys to slow down and become less efficient, which can increase Complera’s side effects.

IMPORTANT INFORMATION
  • warning icon

    FDA Warning See Details

  • liver icon

    May cause liver disease See Details

  • serious infections icon

    May cause immune reconstitution syndrome See Details

  • warning icon

    May lead to changes in your bone density, increasing the risk of a bone break

FDA Warning

Complera has a black box warning. This is the most serious warning from the U.S. Food and Drug Administration (FDA). Though the medication can still be sold and used, a black box warning alerts doctors and patients to potentially dangerous problems.

Warning:

  • May cause lactic acidosis. In this condition, lactic acid builds up in the build. Symptoms may include nausea and weakness.
  • Not approved to treat HIV infection in people with hepatitis B virus infection. If you have hepatitis B virus infection, start this drug, and then stop, your hepatitis B virus infection can get much worse. Your doctor will need to perform liver function tests and may need to treat the hepatitis.

May cause liver disease

Signs of liver disease include fatigue, yellowing of the skin and eyes, and abdominal pain. If you experience these, call your doctor.

May cause immune reconstitution syndrome

Improving the immune system by treating HIV can sometimes cause old infections to reappear and suddenly become worse. If you have worsening symptoms of old infections, call your doctor right away.

Drug Features

Complera is a prescription drug. It is available in these forms: oral tablet.

Complera is a combination of two or more drugs in a single form. It is important to know about all the drugs in the combination because they each may have unique traits.

Why It's Used

Complera is made up of three different drugs. It comes in one tablet that you only have to take once a day. It‘s approved for use as a complete treatment for HIV, which means you won’t likely take other HIV drugs while taking Complera.

More Details

How It Works

Complera is a combination of three HIV drugs. Emtricitabine and tenofovir are nucleoside reverse transcriptase inhibitors. These prevent the HIV virus from multiplying. A third drug, rilpivirine, is a non-nucleoside reverse transcriptase inhibitor. Rilpivirine also blocks HIV from multiplying but in a different way than the other two drugs.

Why It's Used

Complera is made up of three different drugs. It comes in one tablet that you only have to take once a day. It‘s approved for use as a complete treatment for HIV, which means you won’t likely take other HIV drugs while taking Complera.

The drug is used in adults who haven’t yet been treated with antiretroviral drugs and have no more than 100,000 copies of HIV RNA/mL in their blood. This measurement is also referred to as a viral load.

Doctors may switch someone to this drug if they fall into all three of these categories:

  • have a viral load of less than 50 copies
  • have stable levels of the virus
  • have been treated with antiretroviral drugs
SECTION 2 of 4

emtricitabine-rilpivirine-tenofovir Side Effects

Oral tablet

Most Common Side Effects

Common side effects that occur with Complera include:

  • depression

  • increased cholesterol (Your doctor may find this from lab testing.)

  • diarrhea

  • difficulty sleeping

  • dizziness

  • headache

  • nausea or vomiting

  • pain

  • rash

  • skin discoloration

  • unexplained fatigue

  • unusual dreams

Tenofovir, one component of Complera, may reduce your bone mineral density. Ask your healthcare provider if bone density monitoring should be part of your treatment plan. To keep your bones strong, they may want to add calcium and vitamin D supplements to your treatment.

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life-threatening, or if you think you’re experiencing a medical emergency, call 9-1-1.

  • severe depression or mood changes. This may include suicidal thoughts or thoughts of hurting yourself. If this happens, stop taking the drug and call your doctor right away.

  • symptoms of lactic acidosis (excess acid in your blood), including unusual muscle pain, difficulty breathing, feeling cold in your arms and legs, dizziness, or irregular heartbeat

  • symptoms that indicate a liver problem, including yellowing of the skin or whites of the eyes, darkened urine, appetite loss, nausea, stomach pain, and pale-colored stools

  • symptoms of slower kidney function, including puffiness, fatigue, or aching. You may have no symptoms. Your doctor can check your kidney function while you’re taking this drug.

Pharmacist's Advice
Healthline Pharmacist Editorial Team

Complera does not cause drowsiness.

Take during the middle of, or immediately after, a meal.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 4

emtricitabine-rilpivirine-tenofovir May Interact with Other Medications

Oral tablet

Complera can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Do not take the following medications with this drug:

  • carbamazepine
  • dexamethasone
  • didanosine
  • phenobarbital
  • phenytoin
  • oxcarbazepine
  • St. John’s wort
  • vincristine (liposomal)

Medications That Might Interact with This Drug

Antacids

Antacids could affect how well your body absorbs Complera. If you take antacids (calcium, magnesium, or aluminum containing products) tell your doctor and pharmacist. You may still be able to take antacids and calcium if they’re separated from doses of Complera by at least two hours.

Other HIV Drugs

Complera is a complete treatment for HIV infection. It includes all the components needed to treat infection. Don’t combine it with other HIV medications.

Drugs for Other Conditions

Medications used for several conditions interact with Complera. If you’re taking any of the following medications, ask your doctor or pharmacist if you should take them while on Complera. These drugs may require dose adjustments or shouldn’t be taken at the same time:

  • adefovir dipivoxil 
  • acyclovir
  • aminoglycosides (vancomycin and other antibiotics)
  • cidofovir
  • cisapride
  • fluconazole and other antifungal medications, including itraconazole, ketoconazole, posaconazole, and voriconazole
  • ganciclovir
  • cimetidine and other drugs used to reduce stomach acid, including famotidine, nizatidine, and ranitidine
  • clarithromycin and other related antibiotics, including erythromycin and telithromycin
  • ibuprofen and other anti-inflammatory drugs. Taking large doses or taking these long-term may cause your kidneys to slow down and become less efficient, which can increase Complera’s side effects.
  • methadone
  • rifabutin
  • valacyclovir
  • valganciclovir

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

People with kidney disease

If you have kidney disease and your kidney function (creatinine clearance) is slower than 50 mL per minute, this drug isn’t recommended. Complera can make your kidneys run less efficiently and slow them down. This means that your kidneys will not remove waste products as efficiently. Reduced kidney function increases your risk of Complera side effects.

People with liver disease

If you have severe liver disease, your liver may not filter out toxins and Complera well enough. This could lead to a buildup of the drug in your body. Your doctor may decide not to give you the drug. If you have mild liver disease, your liver is likely still filtering out toxins well, and you can still take Complera.

Pregnant women

Complera is a pregnancy category B drug. That means two things:

  1. Studies of the drug in pregnant women haven’t shown risk to the fetus.
  2. There aren’t enough studies done in humans to show the drug poses a risk to the fetus.

Complera should only be used in pregnancy if the benefit outweighs the risk to the baby. There are other HIV drugs that are more commonly used in pregnancy. If you’re pregnant or plan to become pregnant, talk to your doctor before taking this drug.

Women who are nursing

Complera can be passed through breast milk and can pass to a breastfeeding child. Exposing breastfeeding infants to Complera may make them resistant to the drug later in life. It’s not recommended to breastfeed while taking the drug.

For Seniors

If you are 65 years or older, your body may process this drug more slowly. Your doctor may start you on a lowered dose so that too much of this drug does not build up in your body. Too much of the drug in your body can be toxic.

SECTION 4 of 4

How to Take emtricitabine-rilpivirine-tenofovir (Dosage)

Oral tablet

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What Are You Taking This Medication For?

Human immunodeficiency virus (HIV) infection

Brand: Complera

Form: Oral Tablet
Strength: Emtricitabine 200 mg/rilpivirine 25 mg/tenofovir 300 mg
Adult Dosage (ages 18 years and older)

Take one tablet once a day. Take it with a full meal for best absorption.

Child Dosage (ages 0-17 years)

Dosage for people younger than 18 years has not been established.

Special considerations
  • Rifabutin: If you’re also taking rifabutin, your doctor may add an extra 25 mg dose of rilpivirine to your dose of Complera. Rifabutin makes your liver work faster. It may cause you to process the rilpivirine in Complera faster, so the Complera might not work as well for you. Adding the extra dose of rilpivirine makes certain that Complera can give you the best possible result.
  • Kidney Disease: Complera isn’t recommended in people who have moderate to severe kidney disease. It could worsen your kidney disease and can make your kidneys run less efficiently, raising your risk of Complera side effects.
  • Liver Disease: If you have severe liver disease, your doctor may decide not to give you Complera. Severe liver disease may cause your body to not process the drug well. The drug may not work, or it may accumulate in your body. This could lead to unpredictable results or increased side effects. If you have mild liver disease, you can still take this drug because your liver is still filtering out toxins and drugs well.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Keeping HIV under control requires long-term treatment and long-term effort. There can be very serious health consequences if you don’t take this drug exactly how your doctor tells you.

If You Stop Taking It, Miss a Dose, or Don’t Take It on Schedule

If you stop taking this medication, miss doses, or don’t take it on schedule, your HIV can become worse. You may have many more serious infections and HIV-related problems.

If You Don’t Take It on Schedule

Taking your drug at the same time every day increases your ability to keep the virus under control. If you don’t, you risk worsened infection.

If You Miss a Dose

If you forget to take your dose, take it as soon as you remember. If it’s only a few hours until your next dose, wait and take the single dose at your regular time. Never take two tablets at once.

How Can I Tell if the Drug is Working?

Your doctor will need to run lab tests to see if this drug is working well for you. Tests may include:

  • checking CD4 blood counts. CD4 cells are special immune system cells in your blood.
  • a special X-ray to scan bone density
  • blood tests to check kidney and liver function

Complera is a long-term drug.

Take every day as a long-term treatment. Stop taking it only if your doctor tests you and decides to change your treatment.

It’s okay to crush and cut the Complera tablet

However, you should talk to your doctor about modifying the dose amount.

Store at room temperature: 68–77°F (20–25°C)

Keep the medication tightly closed and in its original container. Protect from moisture. Changes in temperature, heat, and light can all spoil the drug.

Note: Be careful of moist environments, including bathrooms. To keep drugs away from moisture, store them somewhere other than your bathroom and any other damp location.

Clinical Monitoring

Your doctor will need to run lab tests to see if this drug is working well for you. Tests may include:

  • checking CD4 blood counts. CD4 cells are special immune system cells in your blood.
  • a special X-ray to scan bone density
  • blood tests to check kidney and liver function

Not every pharmacy stocks this drug, so call ahead

If you only need a few tablets, you should call and ask if your pharmacy dispenses only a small number of tablets. Some pharmacies can't dispense only part of a bottle.

This drug is often available from specialty pharmacies through your insurance plan. These pharmacies operate like mail order pharmacies and ship the drug to you.

In larger cities, there will often be HIV pharmacies where you can have your prescriptions filled. Ask your doctor if there's a HIV pharmacy in your area.

Hidden Costs

Complera can be very expensive if it’s not covered by insurance.

Insurance

Many insurance companies will require a prior authorization before approving and paying for this drug. Check with your insurance plan.

What does the pill look like?

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Are There Any Alternatives?

There are many drugs and combinations that can treat HIV infection. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.


Show Sources

Content developed in collaboration with Susan J. Bliss, RPh, MBA

Medically reviewed by Stacey Boudreaux, PharmD and Alan Carter, PharmD on January 22, 2015

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Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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