Raltegravir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Raltegravir is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Raltegravir is not a cure for HIV or AIDS.

Raltegravir is for use in adults and children who weigh at least 4.4 pounds (2 kilograms).

Raltegravir may also be used for purposes not listed in this medication guide.

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction: fever, joint or muscle pain, trouble breathing, stomach pain, vomiting, dark urine, yellowing of the skin or eyes, burning eyes, mouth sores, rash, blistering or peeling skin, or swelling in your face or throat.

Raltegravir comes as a tablet, a chewable tablet, and as granules for oral suspension to take by mouth. Raltegravir (Isentress^®) tablets, chewable tablets, and oral suspension are usually taken with or without food twice a day. Raltegravir (Isentress^® HD) tablets are usually taken with or without food once a day. Take raltegravir at the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take raltegravir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them. If you are taking the chewable tablets, you may chew or swallow them whole.

For children who have trouble chewing, the chewable tablets may be crushed and mixed with 1 teaspoon (5 mL) of liquid such as water, juice, or breast milk in a clean cup. The tablets will absorb the liquid and fall apart within 2 minutes. Using a spoon, crush any remaining pieces of the tablets. Drink the mixture right away. If any of the medication is left in the cup, add another teaspoonful (5 mL) of liquid, swirl and take it right away.

Before you take raltegravir oral suspension for the first time, read the written instructions that come with it that describe how to prepare the medication. Empty the contents of one granule packet into the mixing cup and add 2 teaspoons (10 mL) of water. Gently swirl the contents in the mixing cup for 45 seconds; do not shake. Use the dosing syringe provided to measure the amount of medication that your doctor has prescribed. Use the mixture within 30 minutes of preparation and discard any remaining suspension.

Continue to take raltegravir even if you feel well. Do not stop taking raltegravir or your other anti-HIV medications without talking to your doctor. If you stop taking raltegravir or skip doses, your condition may become worse and the virus may become resistant to treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take raltegravir with or without food.

Do not crush, chew, or break a regular tablet. Swallow it whole.

The raltegravir chewable tablet may be chewed or swallowed whole.

Raltegravir oral suspension is a powder that must be mixed with water before you take it.

The smaller, 25-milligram chewable tablet may be crushed and mixed in a cup with a teaspoon of liquid such as water, juice, or breast milk.

Use mixed medicine right away. Do not save it for later use.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

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

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Keep the chewable tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

You should not take Isentress HD film-coated tablets if you weigh less than 88 pounds (40 kilograms).

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Tell your doctor if you have ever had:

• a muscle disorder or muscle damage;

• high blood levels of an enzyme called creatine kinase (a sign of muscle damage);

• kidney disease (or if you are on dialysis);

• liver disease; or

• mental illness or depression.

Raltegravir chewable tablets contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

It is not known whether raltegravir will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using raltegravir.

HIV can be passed to your baby if the virus is not controlled during pregnancy. If you are pregnant, your name may be listed on a registry to track any effects of antiviral medicine on the baby. Use your medications properly to control HIV.

Do not breastfeed while using this medicine. 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.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet included with the tablets to absorb moisture) from your bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb raltegravir.

Using raltegravir may not prevent your disease from spreading. 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.

Stop taking raltegravir and get emergency medical help if you have signs of an allergic reaction: fever, general ill feeling, tiredness, joint or muscle pain, trouble breathing; upper stomach pain, vomiting, loss of appetite, dark urine, yellowing of the skin or eyes; burning eyes, blisters or mouth sores; rash, hives, blistering or peeling skin; swelling of your face, lips, tongue, or throat.

In rare cases, raltegravir can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Raltegravir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of raltegravir may include:

• nausea;

• headache, dizziness;

• tired feeling; or

• sleep problems (insomnia).

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect raltegravir, especially:

• fenofibrate or gemfibrozil;

• rifampin;

• HIV or AIDS medicine--etravirine, ritonavir, tipranavir, zidovudine;

• seizure medicine--carbamazepine, phenobarbital, phenytoin; or

• a "statin" cholesterol-lowering medicine--Crestor, Lipitor, Pravachol, Vytorin, Zocor, and others.

This list is not complete and many other drugs may affect raltegravir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory while taking raltegravir. Your doctor will order certain lab tests to check your body's response to raltegravir.

Do not let anyone else take your medication.

Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.