Raltegravir, Oral

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KEY POINTS

• This medicine is taken by mouth to treat HIV-1 infection. It is not a cure for HIV infection. Take it exactly as directed. Do not stop taking this medicine or change your dosage unless directed to do so by your healthcare provider.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: integrase strand transfer inhibitor (anti-HIV)

Generic and brand names: raltegravir, oral; Isentress Tablets; Isentress Chewable Tablets; Isentress Granules for Oral Suspension

What is this medicine used for?

This medicine is taken by mouth to treat HIV-1 infection. It is usually taken with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver disease
• Muscle disorders such as rhabdomyolysis or myopathy
• Phenylketonuria (PKU). The chewable tablet contains phenylalanine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine or change your dosage unless directed to do so by your healthcare provider. Do not let your medicine run out. The amount of virus in your blood may increase if you stop the medicine, even for a short time.

Check with your healthcare provider before using this medicine in children under 4 weeks old.

This medicine comes in regular tablets, chewable tablets, and granules for suspension. Do not switch between the different forms of this medicine without your talking to your healthcare provider.

If you have the regular tablets, do not break, crush, or chew them. Swallow them whole.

If you have the granules for suspension, carefully follow the directions in the medicine package for mixing. Use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct. Use the medicine within 30 minutes after mixing it. Discard any leftover medicine from the mixing cup. Take this medicine with other medicines your healthcare provider prescribes.

You may take the medicine with or without food. However, if you take it with a meal, do not eat foods high in fat because they may affect the way this medicine works.

What if I miss a dose?

Do not miss any doses. If you do miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine is not a cure for HIV infection. You may continue to get illnesses associated with advanced HIV infection, including other infections. This medicine does not reduce the risk of spreading HIV through sexual contact or blood contamination. Continue to practice safe sex and do not share needles. Do not give this medicine to other people, even if they have the same symptoms you have.

Your immune system may get stronger and start to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting this medicine.

This medicine can cause liver problems. Contact your healthcare provider right away if you have severe tiredness, vomiting, loss of appetite, dark urine, fever, headache, muscle or joint pain, or yellowing of your eyes and skin. You need to have lab tests regularly to see how this medicine affects you. Keep all appointments for tests.

If you develop hives, an itchy rash, blisters, or peeling skin, stop taking the medicine and contact your provider right away.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider about any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe rash or rash with a fever; blistering; mouth sores; red eyes; swelling; unusual muscle weakness or pain; unexplained joint pain; breathing problems; decreased urination; dark urine; yellowing of your eyes or skin; light-colored bowel movements; unexplained loss of appetite; fever; unusual tiredness or weakness; severe stomach pain, nausea, or vomiting; depression or thoughts of suicide.

Other: Diarrhea, nausea, trouble sleeping, headache, dizziness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antacids that contain aluminum or magnesium, such as Gaviscon, Maalox, and Mylanta
• Antiseizure medicines such as fosphenytoin (Cerebyx), phenobarbital, and phenytoin (Dilantin, Phenytek)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), gemfibrozil (Lopid), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Medicines to block or prevent stomach acid such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), and pantoprazole (Protonix)
• Other HIV medicines such as abacavir (Ziagen), atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), tenofovir (Viread), tipranavir (Aptivus), and zidovudine (Retrovir)
• Red yeast rice
• Rifabutin (Mycobutin)
• Rifampin (Rifadin)
• Rifapentine (Priftin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

Keep the granules for oral suspension in the original container. Do not open the foil packet until ready for use.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.