Raltegravir (ral-TEG-ra-vir)

Treats HIV infection. HIV causes AIDS. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Isentress, Isentress HD

When This Medicine Should Not Be Used:

How to Use This Medicine:

Powder for Suspension, Tablet, Chewable Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Chewable tablet: You may chew or swallow the tablet whole.
  • If you have trouble chewing the 25-mg chewable tablet:
    • Place the tablet in a clean cup and add 5 milliliters (ml) of liquid (including water, juice, or breast milk).
    • Use a spoon to crush any remaining tablet and take the medicine right away.
    • You may add another 5 ml of liquid if any part of the medicine is left in the cup, mix and drink right away.
• Film-coated tablet: Swallow the tablet whole.
• Suspension:
  • Dissolve one single-use packet in 10 milliliters (mL) of water.
  • Mix the medicine by swirling the mixing cup carefully and slowly in a circle for 45 seconds. Do not shake the cup.
  • Use the dosing syringe that comes with the package to measure the right dose.
  • Take the dose within 30 minutes after you mix the liquid medicine.
  • Throw away any remaining liquid medicine.
• Do not change the dose or stop using this medicine without checking first with your doctor. If you stop the medicine even for a short time, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the chewable tablets and film-coated tablets in the original package with the bottle tightly closed. Do not open the foil packet of powder for suspension until you are ready to use it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how raltegravir works. Tell your doctor if you also use any of the following:
  • Carbamazepine, etravirine, phenobarbital, phenytoin, rifampin, tipranavir/ritonavir, zidovudine
  • Antacids containing aluminum, calcium, or magnesium
  • Medicine to lower cholesterol (including fenofibrate, gemfibrozil, statins)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have liver disease, an infection, phenylketonuria (PKU), or a history of muscle problems (including myopathy or rhabdomyolysis).
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Serious skin reactions, including Stevens-Johnson Syndrome, toxic epidermal necrosis
  • Myopathy (muscle weakness)
  • Rhabdomyolysis (muscle problem that could lead to kidney problem)
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, severe skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, joint pain
• Muscle pain, tenderness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache, dizziness
• Tiredness
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088