This medicine is a combination of antiviral medicines used to treat HIV infection. It is used alone (you do not need to take other medicine with it to treat HIV). It is not a cure for HIV or AIDS.
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 food. DO NOT take an antacid that contains aluminum, magnesium, or calcium within 2 hours before or after you take this medicine. 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. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original container, away from heat, moisture, and light. Do not store in the bathroom. Do not use if the seal on the bottle is broken or missing. KEEP THIS MEDICINE out of the reach of children and away from pets. CONTINUE TO TAKE this medicine even if you feel well. Do not miss any doses. Taking this medicine at the same time each day will help you remember. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, 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 this type of medicine. The risk may be greater in women, 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) or 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. Safety and effectiveness of this medicine in patients with both HBV and HIV have not been confirmed. Some patients with both HBV and HIV who took this medicine had severe worsening of HBV after they stopped taking it. Patients who have both HBV and HIV need close medical follow-up for at least several months after they stop this medicine. Keep all doctor and lab appointments. Do not stop 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 also take adefovir, alfuzosin, avanafil, boceprevir, cabazitaxel, cisapride, crizotinib, an ergot medicine (eg, dihydroergotamine), lovastatin, lurasidone, oral midazolam, pimozide, a rifamycin (eg, rifampin), ritonavir, salmeterol, silodosin, simvastatin, St. John's wort, tamsulosin, telaprevir, ticagrelor, triazolam, vincristine liposome, medicine that contains lamivudine, another medicine that contains emtricitabine or tenofovir, or other medicine to treat HIV. DO NOT TAKE IT if you take sildenafil to treat pulmonary arterial hypertension (PAH). DO NOT TAKE IT if you take or have recently taken a medicine that may harm your kidneys (eg, amphotericin B; cyclosporine; a nonsteroidal anti-inflammatory drug / NSAID, such as ibuprofen; tacrolimus; vancomycin). Ask your doctor if you are unsure if any of your medicines might harm your kidneys. ADDITIONAL MONITORING may be needed if you are taking other prescription or nonprescription medicines (eg, used for abortion, aches and pains, allergies, angina, asthma or other lung or breathing problems, birth control, blood thinning, cancer, cystic fibrosis, depression or other mental or mood problems, diabetes or high blood sugar, erectile dysfunction, gout, hepatitis, high blood pressure, high cholesterol, immune system suppression, infections, inflammation, intermittent claudication, irregular heartbeat or other heart problems, migraines, myelofibrosis, nausea and vomiting, prostate problems, PAH, seizures, sleeping problems, stomach or bowel problems, Tourette syndrome), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort). Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with this medicine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including kidney problems; a history of lactic acidosis, abnormal liver function tests, or liver problems (eg, HBV); allergies; pregnancy; or breast-feeding. TELL YOUR DOCTOR if you are very overweight or you have osteoporosis (weak bones), a history of bone problems (eg, fracture), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition). USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe liver problems or moderate to severe kidney problems. Contact your doctor or pharmacist if you have any questions or concerns about takin
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, headache, indigestion, joint pain, mild stomach pain, nausea, nose or throat irritation, runny or stuffy nose, sinus pain or drainage, strange dreams, tiredness, trouble sleeping, or vomiting. If they continue or are bothersome, check with your doctor. 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. THE RISK OF CERTAIN SEVERE SIDE EFFECTS (eg, lactic acidosis, severe liver problems) may be greater in women, patients who are very overweight (obese), and 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 this medicine. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bone pain; fever; mental or mood changes (eg, depression); muscle pain, weakness, or cramping; numbness, burning, pain, or tingling in the hands or feet; severe or persistent dizziness; severe stomach or back pain (with or without nausea or vomiting); 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 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). 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; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare 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.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.