Raltegravir Oral Suspension

What is this medication?

RALTEGRAVIR (ral TEG ra veer) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Isentress

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• liver disease
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• an unusual or allergic reaction to raltegravir, other medicines, lactose, foods, dyes, or preservative
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Follow the directions on the prescription label. Mix well before using. Use a specially marked syringe to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take it with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborns for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• carbamazepine
• certain antacids
• etravirine
• phenobarbital
• phenytoin
• rifampin
• tipranavir

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• feeling anxious, depressed, or paranoid
• fever or chills, sore throat
• muscle pain or weakness
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• suicidal thoughts or other mood changes
• trouble passing urine or change in the amount of urine
• unusual bleeding or bruising
• unusually weak or tired
• weight gain around waist, back, or thinning of face, arms, legs

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• dizziness
• headache
• nausea, vomiting
• stomach pain
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.