NOTE: Depending on the supplier/strength selected, the products shipped may have different packaging.

Why is Complera prescribed?

Complera (Emtricitabine/Rilpivirine/Tenofovir disoproxil) is a medication that combines emtricitabine, rilpivirine, and tenofovir, all of which are antiviral drugs that work to prevent the human immunodeficiency virus (HIV) from multiplying in the body. HIV leads to acquired immunodeficiency syndrome (AIDS).

Complera is prescribed to treat HIV in individuals who have not previously used HIV medications. It is intended for adults and children aged 12 and older.

What does it do?

HIV is a virus that spreads throughout the body and weakens the immune system, making individuals more vulnerable to severe infections. Complera helps stop the spread of HIV within the body, which helps protect and maintain the immune system. Additionally, it can reduce the risk of transmitting the virus to others.

Why is Complera prescribed?

Take Complera exactly as prescribed by your healthcare provider with a usual dose of one tablet per day with food, as this is important to ensure you receive the correct amount of medicine.

If your healthcare provider decides to stop Complera and switches you to new HIV-1 medications that include Rilpivirine tablets, these tablets should also be taken with a meal.

How should I take it?

Take Complera exactly as prescribed by your healthcare provider with a usual dose of one tablet per day with food, as this is important to ensure you receive the correct amount of medicine.

If your healthcare provider decides to stop Complera and switches you to new HIV-1 medications that include Rilpivirine tablets, these tablets should also be taken with a meal.

What if I missed a dose?

If you miss a dose of Complera within 12 hours of your usual time, take it with food as soon as possible. Then, take your next dose at the regular scheduled time. If more than 12 hours have passed since your missed dose, skip the missed dose and take your next dose at the usual time.

What are the special precautions before taking Complera?

You should not take Complera if you are allergic to Rilpivirine, Emtricitabine, or Tenofovir. Do not take Complera with other medications that contain Tenofovir, Adefovir, Emtricitabine, Rilpivirine, or Lamivudine.

There are several other medications that can reduce the effectiveness of Rilpivirine and should not be taken with Complera, including:

• Dexamethasone
• St. John's wort
• Tuberculosis medications, such as Rifabutin, Rifampin, or Rifapentine
• Seizure medications, including Oxcarbazepine, Phenobarbital, Carbamazepine, or Phenytoin
• Stomach acid reducers, such as Dexlansoprazole, Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole, or Rabeprazole

To ensure Complera is safe for you, inform your doctor if you have a history of:

• Kidney disease
• Liver disease (including hepatitis B or C)
• Depression or mental health conditions
• Long QT syndrome (either personally or in your family)

Some people taking tenofovir may develop a serious condition called lactic acidosis. This is more common in women, those who are overweight, have liver disease, or have been on HIV/AIDS treatment for a long time. Discuss your risks with your doctor. Complera is not approved for use in individuals under 12 years old or weighing less than 77 pounds (35 kilograms).

Does it have any side effects?

Some people may develop lactic acidosis while taking HIV medication, which can worsen over time and be fatal. Get emergency help if you experience even mild symptoms such as stomach pain, nausea with vomiting, fast or irregular heart rate, muscle pain or weakness, numbness or cold feeling in your arms and legs, trouble breathing, dizziness, or severe weakness or fatigue. Contact your doctor immediately if you experience:

• Severe depression, confusion, unusual thoughts or behaviors, or suicidal thoughts or actions
• Increased thirst and urination, weakness, loss of appetite, or constipation
• Kidney problems, including little or no urination, painful or difficult urination, feeling tired, swelling in your feet or ankles, or short of breath
• Liver problems, such as swelling around your midsection, upper stomach pain, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes)
• Signs of inflammation in your body, like swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, upper stomach pain, jaundice (yellowing of the skin or eyes), chest pain, new or worsening cough with fever, or trouble breathing.

Common side effects may include:
• Changes in body fat distribution, particularly in the arms, legs, face, neck, breasts, or waist
• Depressed mood, sleep problems (insomnia), or strange dreams
• Headache, dizziness, or tiredness
• Nausea or diarrhea
• Rash

This is not a complete list of side effects. Contact your doctor for advice about any side effects that you may experience.

Is it safe to take it with another drug?

It is important to note that all drugs have corresponding side effects and adverse reactions. Additional information may be obtained when you ask your doctor or pharmacist.

In particular, make sure to discuss the use of any of the following before starting Complera:

• Antacids or supplements containing aluminum, calcium, or magnesium
• Antiviral medicines such as Valacyclovir, Acyclovir, or Ganciclovir
• Dexamethasone, used for certain inflammatory conditions
• Medications for seizures, such as Carbamazepine, Phenobarbital, Oxcarbazepine, or Phenytoin
• Proton pump inhibitors (PPIs) like Esomeprazole (Nexium), Lansoprazole (Prevacid), Dexlansoprazole (Dexilant), Omeprazole (Prilosec), Pantoprazole (Protonix), or Rabeprazole (Aciphex)
• Hepatitis C treatments
• H2 blockers such as Cimetidine (Tagamet), Famotidine (Pepcid, Zantac), or Nizatidine (Axid)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) like Ibuprofen, Naproxen, and others found in many pain, swelling, and fever medications
• Macrolide antibiotics like clarithromycin or erythromycin
• Methadone, an opioid used to treat pain or opioid use disorder
• Aminoglycoside antibiotics, such as Amikacin or Gentamicin, given by injection to treat infections
• Antifungal medications like Itraconazole (Sporanox, Tolsura), Posaconazole (Noxafil), Fluconazole (Diflucan), Ketoconazole, or Voriconazole (Vfend)
• Any medication that can cause QT prolongation, a potentially serious heart rhythm issue
• Rifampin or Rifapentine, used to treat tuberculosis
• St. John’s wort, a supplement sometimes used for depression
Other medications may affect the blood levels of Complera, or Complera may affect the levels of other medicines. Be sure to inform your healthcare provider about all medications you are currently taking or have recently used.
How should I store it?
Store Complera at room temperature, between 68°F and 77°F (20°C to 25°C). Keep it in its original container and ensure the container is tightly closed. Do not use Complera if the seal on the bottle is broken or missing. Keep Complera and all other medications out of the reach of children.
What action should I take in case of overdose?
If you take an overdose of Complera, immediately contact your local poison control center or go to the nearest emergency room.
Is it safe for pregnant or breastfeeding women?

Pregnancy: It is not known how Complera may affect pregnancy or if it could harm an unborn baby. Inform your healthcare provider if you are pregnant or planning to become pregnant.

Breastfeeding: Do not use Complera while breastfeeding, as it passes into breast milk. Let your healthcare provider know if you are breastfeeding or plan to breastfeed. There may be risks associated with breastfeeding while taking Complera and having HIV.

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