Generic Name: emtricitabine/rilpivirine/tenofovir (EM-trye-SYE-ta-been/RIL-pi-VIR-een/ten-OF-oh-vir)
Brand Name: Complera
Severe and sometimes fatal lactic acidosis (a buildup of lactic acid in the blood) and liver problems have occurred with tenofovir. The risk may be greater in women. It may also be greater in patients who are very overweight or patients who have been taking nucleoside medicines (eg, emtricitabine, tenofovir) for a long time.
Tell your doctor right away if you develop symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat). Tell your doctor right away if you develop symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, nausea, stomach pain).
Complera has not been approved to treat hepatitis B virus (HBV) infection. The safety and effectiveness of Complera in patients who have both HBV and HIV infection have not been confirmed. Some patients with both HBV and HIV infection who took emtricitabine or tenofovir experienced severe worsening of HBV infection after they stopped taking them. Patients who have both HBV and HIV infection need close medical follow-up to check for worsening liver problems for at least several months after they stop Complera. Keep all doctor and lab appointments. Do not stop taking Complera without checking with your doctor.
Complera is used for:
Treating HIV infection. Complera is not a cure for HIV or AIDS. It may also be used for other conditions as determined by your doctor.
Complera is an antiviral combination of a nonnucleoside reverse transcriptase inhibitor (NNRTI) and 2 nucleoside reverse transcriptase inhibitors (NRTIs). It works by reducing the amount of HIV in the body by blocking its ability to multiply.
Do NOT use Complera if:
- you are allergic to any ingredient in Complera
- you have moderate to severe kidney problems or if you are on dialysis
- you have previously taken other medicine to treat your HIV infection
- you are taking any other medicine to treat HIV infection, including etravirine, medicines that contain lamivudine, or another medicine that contains emtricitabine, rilpivirine, or tenofovir
- you are taking adefovir, carbamazepine, dexamethasone, hydantoins (eg, phenytoin), oxcarbazepine, phenobarbital, primidone, proton pump inhibitors (PPIs) (eg, omeprazole), rifamycins (eg, rifampin), or St. John's wort
- you have recently taken or are currently taking a medicine that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], tacrolimus, vancomycin). Ask your doctor if you are not sure if any of your medicines might harm your kidneys
Contact your doctor or health care provider right away if any of these apply to you.
Before using Complera:
Some medical conditions may interact with Complera. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have kidney problems; lactic acidosis; abnormal liver function tests or liver problems, including hepatitis B or C infection
- if you have previously developed kidney problems while taking adefovir
- if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition), or if you have a history of bone problems (eg, fracture)
- if you have a history of a certain type of irregular heartbeat (QT prolongation), mental or mood problems (eg, depression), or suicidal thoughts or actions
- if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (QT prolongation). Check with your doctor or pharmacist if you are uncertain if any of your medicines may increase this risk
Some MEDICINES MAY INTERACT with Complera. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Acyclovir, adefovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, or medicines that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, an NSAID [eg, ibuprofen], tacrolimus, vancomycin) because they may increase the risk of Complera's side effects. Ask your doctor or pharmacist if you are not sure if any of your medicines may affect your kidneys
- Azole antifungals (eg, fluconazole, ketoconazole); other medicines that contain emtricitabine, rilpivirine, or tenofovir; lamivudine; certain macrolide antibiotics (eg, clarithromycin, erythromycin, troleandomycin); certain protease inhibitors (eg, atazanavir, lopinavir/ritonavir, tipranavir), or telithromycin because they may increase the risk of Complera's side effects
- Carbamazepine, dexamethasone, an H2 blocker (eg, famotidine, ranitidine), hydantoins (eg, phenytoin), oxcarbazepine, phenobarbital, PPIs (eg, omeprazole), primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease Complera's effectiveness
- Didanosine because the risk of its side effects may be increased by Complera
- Methadone because its effectiveness may be decreased by Complera
This may not be a complete list of all interactions that may occur. Ask your health care provider if Complera may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Complera:
Use Complera as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Complera. Talk to your pharmacist if you have questions about this information.
- Take Complera by mouth with food. Do not substitute a protein drink for food.
- If you are also taking an antacid (eg, that contains magnesium, aluminum, calcium), take it at least 2 hours before or 4 hours after you take Complera.
- If you are also taking an H2 blocker (eg, ranitidine, famotidine, cimetidine, nizatidine), take it at least 12 hours before or 4 hours after you take Complera.
- Continue to take Complera even if you feel well. Do not miss any doses.
- Do not suddenly stop taking Complera without checking with your doctor. This may cause the virus to become less sensitive to this or other medicines. Some conditions (eg, hepatitis B) could become worse if you suddenly stop taking Complera.
- Taking Complera at the same time each day will help you remember to take it.
- If you miss a dose of Complera and you remember within 12 hours of the time you usually take it, take it with food as soon as possible and then go back to your regular dosing schedule. If you miss your dose by more than 12 hours of the time you usually take it, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Complera.
Important safety information:
- Complera may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Complera with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose, change your dose, or stop taking Complera without checking with your doctor.
- You should be tested for HBV infection before you start to take Complera.
- Keep a list of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using Complera. Be sure that each of your health care providers knows all the medicines that you are taking.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Complera, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
- Complera is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
- Complera does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
- Complera is not for the treatment of HBV. If you have HBV and HIV, you will need close medical follow-up for several months after stopping treatment with Complera. Follow-up includes medical exams and blood tests to check for HBV infection that could be getting worse.
- The risk of severe side effects (eg, lactic acidosis, severe liver problems) may be greater in women. It may also be greater in patients who are very overweight (obese) or patients who have taken nucleoside medicines (eg, emtricitabine, tenofovir) for a long time. Talk with your doctor if you have questions about your risk for severe side effects from Complera.
- Depression has been reported with the use of Complera. Contact your doctor right away if you experience mental or mood changes (eg, depressed mood, unusual negative thoughts, anxiety, restlessness). Contact your doctor right away if you develop suicidal thoughts or actions.
- Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Complera. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
- Complera may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Complera.
- Complera will not prevent you from getting sexually transmitted diseases (STDs). Always use a condom during sexual intercourse.
- Ask your doctor if you should take a calcium and vitamin D supplement while you are taking Complera.
- Lab tests, including liver function, kidney function, and bone mineral density, may be performed while you use Complera. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Complera should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Complera while you are pregnant. It is not known if this medicine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Complera to the baby. Do not breast-feed while taking Complera.
Possible side effects of Complera:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; headache; indigestion; joint pain; loss of appetite; mild stomach pain or discomfort; nausea; nose or throat irritation; skin discoloration (small spots or freckles); strange dreams; tiredness; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; fever, chills, or persistent cough or sore throat; irregular heartbeat; mental or mood changes (eg, depression, unusual negative thoughts, anxiety, restlessness); muscle pain or weakness; numbness, burning, pain, or tingling; severe or persistent dizziness; severe or persistent nausea, vomiting, or stomach or back pain; shortness of breath; suicidal thoughts or behaviors; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Complera:
Store Complera at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use Complera if the seal over the bottle opening is broken or missing. Keep Complera in its original container and keep the container tightly closed. Keep Complera out of the reach of children and away from pets.
- If you have any questions about Complera, please talk with your doctor, pharmacist, or other health care provider.
- Complera is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Complera or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Complera. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Complera. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Complera.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.