This medicine is an antiviral combination of a nonnucleoside reverse transcriptase inhibitor (NNRTI) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) used to treat HIV infection. This medicine is not a cure for HIV or AIDS. It may also be used to treat other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. TAKE THIS MEDICINE by mouth with a meal. Do not substitute a protein drink for a meal. 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 this medicine. 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 this medicine. STORE THIS MEDICINE at 77 degrees F (25 degrees C), away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 C) is permitted. Do not store in the bathroom. DO NOT USE THIS MEDICINE if the seal over the bottle opening is broken or missing. Keep this medicine in its original container and keep the container tightly closed. KEEP THIS MEDICINE out of the reach of children and away from pets. Taking this medicine at the same time each day will help you to remember. DO NOT SUDDENLY STOP taking this medicine 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 this medicine. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE and you remember within 12 hours of the time you usually take it, take it with a meal 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.
WARNING: 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 lightheadedness; 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). THIS MEDICINE HAS NOT BEEN APPROVED TO TREAT HEPATITIS B VIRUS (HBV) INFECTION. The safety and effectiveness of this medicine 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 this medicine. Keep all doctor and lab appointments. Do not stop taking this medicine without checking with your doctor. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking adefovir, carbamazepine, dexamethasone, hydantoins (eg, phenytoin), oxcarbazepine, phenobarbital, primidone, proton pump inhibitors (PPIs) (eg, omeprazole), rifamycins (eg, rifampin), St. John's wort, or any other medicine to treat HIV infection, including etravirine or medicines that contain lamivudine, emtricitabine, rilpivirine, or tenofovir. DO NOT TAKE THIS MEDICINE if you have recently taken or currently take a medicine that may harm your kidneys (eg, an aminoglycoside antibiotic, such as gentamicin; amphotericin B; cyclosporine; a nonsteroidal anti-inflammatory drug/NSAID such as ibuprofen; tacrolimus; vancomycin). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking acyclovir, azole antifungals (eg, fluconazole), cidofovir, didanosine, ganciclovir, an H2-blocker (eg, famotidine), certain macrolide antibiotics (eg, erythromycin), methadone, certain protease inhibitors (eg, ritonavir), valacyclovir, valganciclovir, or 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. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including kidney problems or if you previously developed kidney problems while taking adefovir; lactic acidosis; abnormal liver function tests or liver problems, including hepatitis B or C infection; allergies; pregnancy; or breast-feeding. Tell your doctor if you have osteoporosis (weak bones), a family history of osteoporosis, risk factors of osteoporosis (eg, smoking, poor nutrition), a history of bone problems (eg, fracture), or a history of a certain type of irregular heartbeat (QT prolongation), mental or mood problems (eg, depression), or suicidal thoughts or actions. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have moderate to severe kidney problems, you are on dialysis, or you have previously taken other medicine to treat your HIV infection. Use of this medicine in CHILDREN under age 18 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions about taking thi
SIDE EFFECTS that may occur while taking this medicine include back pain; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; gas; headache; indigestion; joint pain; loss of appetite; mild stomach pain or discomfort; nausea; sinus drainage; skin discoloration (small spots or freckles); strange dreams; tiredness; trouble sleeping; vomiting; or weakness. If they continue or are bothersome, check with your doctor. DEPRESSION HAS BEEN REPORTED WITH THE USE OF THIS MEDICINE. 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 this medicine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bone pain; chest pain; fever; irregular heartbeat; 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; 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 lightheadedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness. 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. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately.
WHEN YOUR MEDICINE SUPPLY IS LOW, get more from your doctor or pharmacist as soon as you can. Do not stop taking this medicine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat. 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 this medicine. Be sure that each of your health care providers knows all the medicines that you are taking. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.