raltegravir

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

Before using raltegravir, tell your doctor if you are allergic to any drugs, or if you have a muscle disorder, kidney disease, or liver disease.

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.

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.

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing 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.

Call your doctor at once if you have serious side effects such as easy bruising or bleeding, signs of a new infection, jaundice (yellowing of the skin or eyes), muscle weakness with fever and dark colored urine, or if you urinate less than usual or not at all.

What is raltegravir?

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

Raltegravir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Raltegravir is not a cure for HIV or AIDS.

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?

You should not use this medication if you are allergic to raltegravir.

To make sure you can safely take raltegravir, tell your doctor if you have any of these other conditions:

• a muscle disorder;
• kidney disease;
• liver disease;
• a history of mental illness or depression.

FDA pregnancy category C. 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 this medication. 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 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.

How should I take raltegravir?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take raltegravir with or without food.

Use raltegravir 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.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking raltegravir?

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing 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?

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

Call your doctor at once if you have a serious side effect such as:

• pale skin, easy bruising or bleeding;
• signs of a new infection, such as fever or chills, cough, or flu symptoms;
• sore throat and headache with a severe blistering, peeling, and red skin rash;
• drowsiness, confusion, increased thirst, lower back pain, urinating less than usual or not at all;
• depressed mood, unusual thoughts about hurting yourself;
• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Less serious side effects may include:

• vomiting, diarrhea;
• tired feeling;
• dizziness; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

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?

Tell your doctor about all other medicines you use, especially:

• rifampin (Rifadin, Rifamate, Rimactane);
• phenobarbital (Solfoton); or
• cholesterol medications such as atorvastatin (Lipitor), fluvastatin (Lescol), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor), and others.

This list is not complete and other drugs may interact with raltegravir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about raltegravir.

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