raltegravir

What is the most important information I should know about raltegravir?

What is raltegravir?

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.

What should I discuss with my health care provider before taking raltegravir?

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).

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.

How should I take raltegravir?

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.

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.

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

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking raltegravir?

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 this medicine 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.

What are the possible side effects of raltegravir?

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 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.

What other drugs will affect raltegravir?

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.

Where can I get more information?

Your pharmacist can provide more information about raltegravir.