LamiVUDine-raltegravir

Raltegravir and lamivudine are antiviral medicines that prevent human immunodeficiency virus (HIV) cells from multiplying in your body.

Lamivudine and raltegravir is a combination medicine used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Lamivudine and raltegravir is usually given with other HIV medications in a treatment regimen.

This medicine is not a cure for HIV or AIDS.

Lamivudine and raltegravir may also be used for purposes not listed in this medication guide.

Lamivudine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine. Your doctor may want to check your liver function for several months after you stop using lamivudine and raltegravir.

You should not use this medicine if you are allergic to lamivudine or raltegravir.

To make sure this medicine is safe for you, tell your doctor if you have:

• a history of pancreatitis;
• liver disease (especially hepatitis B or C);
• kidney disease; or
• a muscle disorder.

Some people taking lamivudine develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

Tell your doctor if you are pregnant or plan to become pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of lamivudine and raltegravir on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Lamivudine and raltegravir should not be given to a child younger than 6 years old, or weighing less than 66 pounds.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of serious muscle disorder--unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, and dark colored urine); or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

This medicine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment. Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
• cold sores, sores on your genital or anal area;
• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

• headache;
• nausea, diarrhea;
• fever, tired feeling;
• sleep problems (insomnia);
• runny or stuffy nose, cough; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid taking an antacid (such as Di-Gel, Gaviscon, Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, and others) within 2 hours before or 2 hours after you take lamivudine and raltegravir. Certain antacids can make it harder for your body to absorb raltegravir.

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Other drugs may interact with lamivudine and raltegravir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Lamivudine and raltegravir doses are based on weight in children, and any changes may affect your child's dose.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Keep the bottle tightly closed when not in use.

If you have hepatitis B you may develop liver symptoms after you stop taking lamivudine and raltegravir, even months after stopping. Your doctor may want to check your liver function for several months after you stop using this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.