This medicine is an antiviral combination of 2 reverse transcriptase inhibitors used to treat HIV infection in combination with other medicines. This medicine is also used in combination with safer sex practices to reduce the risk of getting HIV in patients who are at high risk of getting infected with HIV through sex. It may also be used for other conditions as determined by your doctor.
Follow the directions for taking this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE BY MOUTH with or without food. ASK YOUR DOCTOR if you should take a calcium and vitamin D supplement while you are taking this medicine. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees 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. DO NOT KEEP MEDICINE THAT IS OUT OF DATE or that you no longer need. If you throw any medicines away, make sure that children or pets cannot find them. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. DO NOT SUDDENLY STOP taking this medicine without checking with your doctor. Some conditions (eg, hepatitis B) could become worse if you suddenly stop taking this medicine. Taking this medicine at the same time each day will help you remember to take it. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. DO NOT take more than 1 dose in the same day.
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 or cramps; 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 this medicine experienced severe worsening of HBV infection after they stopped it. 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. IF YOU ARE TAKING THIS MEDICINE TO REDUCE THE RISK OF GETTING HIV, you must have a negative HIV test before you start this medicine and at least every 3 months during use. Tell your doctor if you think you have been exposed to HIV. Contact your doctor right away if you develop fever, headache, tiredness, joint or muscle aches, vomiting, diarrhea, sore throat, rash, night sweats, or swollen glands or lymph nodes, or if you have had any of these symptoms within one month before starting this medicine. 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 taking adefovir, medicines that contain lamivudine, or another medicine that contains emtricitabine or tenofovir. DO NOT TAKE THIS MEDICINE if you 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). Ask your doctor if you are not sure if any of your medicines might harm your kidneys. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking acyclovir, cidofovir, didanosine, ganciclovir, certain protease inhibitors (eg, atazanavir, lopinavir/ritonavir, tipranavir), valacyclovir, or valganciclovir. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of kidney problems, lactic acidosis, abnormal liver function tests or liver problems (eg, HBV infection), allergies, pregnancy, or breast-feeding. Tell your doctor if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors for osteoporosis (eg, smoking, poor nutrition), or if you have a history of bone problems (eg, fracture). USE OF THIS MEDICINE IS NOT RECOMMENDED if you are taking this medicine to treat HIV and you also have severe kidney problems or you are on dialysis. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are taking this medicine to reduce the risk of getting HIV and you have kidney problems or have not had an HIV test. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include abnormal skin sensations; back pain; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; headache; indigestion; joint pain; mild stomach pain; nausea; sinus pain or drainage; strange dreams; tiredness; trouble sleeping; vomiting; weakness; or weight loss. 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. 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 or persistent nausea or vomiting; shortness of breath; stomach pain; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain or cramps; 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); or 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.
KEEP A LIST OF ALL 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. 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.