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Uses

What is Complera used for?

Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is commonly used to treat human immunodeficiency virus (HIV).

Complera may also be used for other conditions as determined by your healthcare provider.

How does Complera work (mechanism of action)?

People with HIV have a virus that spreads in their body and damages the immune system, making it easier for them to get very sick from other infections. Complera works to help stop the spread of HIV in your body. This helps protect and preserve the immune system and can prevent the virus from being spread to other people. 

How is Complera supplied (dosage forms)?

Complera is available as 200 mg/25 mg/300 mg oral tablets that are taken by mouth.

How should I store Complera?

Complera should be stored in the original container at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Keep tightly closed. Store in a cool, dry place.

Side Effects

What are the most common side effects of Complera?

The most common side effects of Complera are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Depression (see below)
  • Trouble sleeping
  • Headache
  • Nausea and diarrhea
  • Feeling tired 
  • Dizziness
  • Abnormal dreams
  • Rash

There may be other side effects of Complera that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Complera?

While less common, the most serious side effects of Complera are described below, along with what to do if they happen.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Complera. This can cause serious liver problems that can lead to death. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Depression. Depressed mood and suicidal thoughts have been reported in a small number of people taking one of the medicines in Complera. If you feel you are about to harm yourself or others, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.

  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior
  • New or increased thoughts of suicide or death
  • Suicide attempt

Kidney Damage. Kidney damage can happen when taking Complera. Call your healthcare provider right away if you have any of the following symptoms of kidney damage.

  • Reduced need to pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • Difficulty catching your breath or chest pain or pressure
  • Confusion
  • Nausea
  • Seizures

Weak Bones. Taking Complera for a long time may cause the bones to become weaker, leading to reduced bone density (osteopenia). It may also cause a more serious condition called osteoporosis, which can cause bones to break (fracture) more easily. If you take Complera, your healthcare provider may monitor your bone density. Call your healthcare provider if you experience symptoms of bone or joint pain. 

Lactic Acidosis. Complera may cause lactic acidosis (a buildup of lactic acid in your blood), which can be serious. Stop taking Complera and get help right away if you have any of the following symptoms of lactic acidosis.

  • General ill feeling
  • Muscle pain
  • Difficulty breathing
  • Drowsiness
  • Stomach pain

Immune System Changes. When you start Complera, your immune system might get stronger and start fighting infections that have been hiding inside your body for a long time. The type of symptoms you may have will depend on the infection. Tell your healthcare provider right away if you notice any of the following new symptoms of infection.

  • Fever, sweats, chills, or muscle aches
  • Swollen lymph nodes
  • Vision problems
  • Confusion, problems talking, or headache
  • Skin problems such as a painful rash or warts
  • Cough or coughing up blood
  • Weakness or coordination problems

Severe Allergic Reactions. Complera may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for Drug Reaction with Eosinophilia and Systemic Symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Warnings & Precautions

Who should not use Complera?

Allergies to Ingredients. People who are allergic to any of the following should not take Complera.

  • Complera
  • Emtricitabine
  • Rilpivirine
  • Tenofovir disoproxil fumarate
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Complera.

Kidney Problems. Complera should not be taken if your kidneys are not working as well as they should be. If there is a concern about the health of your kidneys, your healthcare provider may do tests to determine if they are working well enough to take this medicine.

Drug Interactions. Complera should not be taken while you are using certain other medicines. Before taking Complera, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about Complera before using it?

Do not take Complera unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Take each dose of Complera with food (not just a protein drink).

Do not share Complera with other people, even if they have the same condition as you. It may harm them.

Keep Complera out of the reach of children.

Taking antacids or supplements with Complera can make it not work as well. Talk with your healthcare provider about the best way to take antacids and supplements while taking Complera.

While Complera can help keep the HIV infection under control, it does not cure it. Also, Complera does not help protect against or prevent the spread of sexually transmitted infections (STIs), like herpes, gonorrhea, or chlamydia.

If you have HIV and hepatitis B, stopping Complera can cause a serious flare-up, or worsening, of your hepatitis B. Your healthcare provider will test you for hepatitis B before or when starting this medicine. Do not run out of Complera or stop taking it without talking to your healthcare provider first. If you have HIV and hepatitis B and stop taking Complera, keep all appointments for blood work so your healthcare provider can check the health of your liver. 

What should I tell my healthcare provider before using Complera?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Complera is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Medical Conditions. Tell your healthcare provider if you have any of the following.

  • Kidney problems
  • Liver problems, including hepatitis B
  • Bone problems
  • History of depression

Pregnancy. It is not known if or how Complera could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant while taking Complera, you can register for the Antiretroviral Pregnancy Registry (APR) at www.apregistry.com. This registry collects safety information about the use of antiretroviral medicines during pregnancy.

Breastfeeding. Do not take Complera while you are breastfeeding. Complera passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. There may be risks with breastfeeding while taking Complera and having HIV.

How can I get more information about Complera?

For more information about Complera, you can visit the manufacturer’s website at www.complera.com or call them at 800-445-3235.

Interactions

Does Complera interact with foods or drinks?

There are no known interactions between Complera and foods or drinks.

It is unknown if drinking alcohol will affect Complera.

Does Complera interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Complera.

  • A medicine used to treat seizures, such as carbamazepine, oxcarbazepine, phenobarbital, or phenytoin
  • Rifampin or rifapentine, which is a medicine commonly used to treat an infection called tuberculosis
  • A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), dexlansoprazole (Dexilant), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)
  • An H2 blocker, such as cimetidine (Tagamet), famotidine (Pepcid, Zantac), or nizatidine (Axid)
  • An antacid or supplement containing calcium, aluminum, or magnesium
  • Dexamethasone, which is a medicine for certain inflammatory conditions
  • St. John’s wort, which is a supplement that may be used to treat depression
  • A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which are contained in many prescription and OTC products for pain, swelling, and fever
  • Any aminoglycoside antibiotic, such as amikacin or gentamicin, which is given by injection to treat infections
  • A macrolide antibiotic, such as clarithromycin or erythromycin 
  • Fluconazole (Diflucan), ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Methadone, which is an opioid medicine used to treat pain or opioid use disorder
  • Any antiviral medicine, such as acyclovir, valacyclovir, or ganciclovir 
  • Any other medicine for HIV or AIDS
  • A medicine for hepatitis C
  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem

Some other medicines may alter the blood levels of Complera, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Complera. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Complera?

If you or someone else has used too much Complera, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Complera?

If you miss a dose, take it as soon as you remember if it is within 12 hours of the scheduled time. If it is more than 12 hours from your scheduled time, skip the missed dose and only take the next dose. Do not take double or extra doses.

 Missing doses of Complera can cause it to not work as well over time. So it is important not to miss or skip doses.