This medicine is an antiviral reverse transcriptase inhibitor used for treating HIV infection in combination with other medicines. It is also used to treat chronic hepatitis B virus (HBV) infection. It may also be used for 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 food as directed. ONLY USE THE DOSING SCOOP that comes with this medicine to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose. WASH AND DRY YOUR HANDS immediately before preparing your dose. MIX THE PRESCRIBED DOSE OF THIS MEDICINE with 1/4 to 1/2 cup (2 to 4 oz) of a soft food that can be swallowed without chewing (eg, applesauce, baby food, yogurt). Do NOT mix this medicine with liquid. It may float to the top even after stirring. Stir the mixture with a spoon until it is well mixed. Take your dose right away after mixing to avoid a bad taste. WASH AND DRY THE DOSING SCOOP after each use. Do NOT store it in the bottle. 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. If you have hepatitis B, your condition could become worse if you suddenly stop taking this medicine. DO NOT take more than the recommended dose, change your dose, or stop taking this medicine or any of your medicines without checking with your doctor. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. 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 Do not keep medicine that is out of date or that you no longer need.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. TAKING THIS MEDICINE at the same time each day will help you remember to take it. Continue to take this medicine even if you feel well. Do NOT miss any doses. 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 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). SOME PATIENTS WITH HEPATITIS B VIRUS (HBV) infection who took this medicine had severe worsening of HBV infection after they stopped it. Patients who have HBV 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, other medicines that contain tenofovir, or a medicine that may harm the kidney (eg, aminoglycoside antibiotics, such as gentamicin; amphotericin B; cyclosporine; nonsteroidal anti-inflammatory drugs / NSAIDs, 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, ganciclovir, valacyclovir, valganciclovir, didanosine, or HIV protease inhibitors (eg, atazanavir, lopinavir/ritonavir). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of abnormal liver function tests, liver problems, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of kidney problems (including kidney problems from taking another medicine called adefovir), if you are on dialysis, or if you are overweight. Tell your doctor if you have osteoporosis (weak bones), a family history of osteoporosis, other risk factors of osteoporosis (eg, smoking, poor nutrition), or a history of bone problems (eg, fracture). Tell your doctor if you have both HIV and HBV infections. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe liver problems (eg, an enlarged liver) or lactic acidosis. 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 back pain; diarrhea; dizziness; gas; headache; indigestion; loss of appetite; nausea; runny or stuffy nose; sweating; 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 anxiety; bone pain; change in the amount of urine produced; chest pain; depression; fever, chills, or persistent sore throat; muscle pain, weakness, or cramping; numbness, burning, pain, or tingling in the hands or feet; severe or persistent nausea or vomiting; shortness of breath; symptoms of lactic acidosis (eg, unusual weakness or tiredness; 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; stomach pain). 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, 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.
If you have HIV infection, you should be tested for HBV infection before you start to take this medicine. If you have HBV infection, you should be tested for HIV infection before you start to take this medicine. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.