Raltegravir (By mouth)

Isentress, Isentress HD

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.
• Film-coated tablet: Swallow the film-coated 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.

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)

• 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:
  • Severe skin reactions
  • 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.
• This medicine will not keep you from giving HIV to others. Always practice safe sex, even if your partner also has HIV. Do not 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.

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

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