Raltegravir Chewable Tablets

What is this medication?

RALTEGRAVIR (ral TEG ra veer) helps manage the symptoms of HIV infection. It works by limiting the spread of HIV in the body. This medication is not a cure for HIV or AIDS and it may still be possible to spread HIV to others while taking it. It does not prevent other sexually transmitted infections (STIs).

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
• Phenylketonuria
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to raltegravir, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. You can take it with or without food. If it upsets your stomach, take it with food.

When taking whole tablets: Tablets may be chewed or swallowed whole.

When using 25-mg tablets to make a suspension: Place the tablets in a small, clean cup. Add 5 mL of liquid, such as water, juice, or breast milk, for each tablet. After 2 minutes, crush any remaining pieces of the tablets with a spoon. Take the dose right away after mixing. If any part of dose is left in cup, add another 5 mL of liquid, swirl, and take right away.

For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the HIV virus resistant to this and other medications. Keep taking this therapy unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 4 weeks 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 care team for regular checks on your progress. Discuss any new symptoms with your care team. You will need to have important blood work done while taking this medication.

HIV is spread to others through sexual or blood contact. Talk to your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

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

• Dizziness
• Fatigue
• Headache
• Nausea
• Trouble sleeping
• Worsening mood, feelings of depression

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 and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer wanted or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.