When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use if you had an allergic reaction to raltegravir.

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.
• Film-coated tablet: Swallow the film-coated tablet whole.
• Suspension:
  
  • Dissolve one single-use packet in 5 milliliters (mL) of water.
  • Mix the medicine by swirling the mixing cup carefully and slowly in a circle. Do not turn the cup upside down.
  • 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 talking to your doctor first. Contact your doctor or pharmacist for a refill when your supply of this medicine is running low.
• 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 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:
  
  • Rifampin
  • Zidovudine
  • Medicine to lower cholesterol
• Do not take this medicine together with an antacid that contains aluminum or magnesium. Wait at least 2 hours before or after you take raltegravir to take an antacid.

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 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 or allergic reactions (may be life-threatening)
  • Myopathy
  • Rhabdomyolysis (which can cause kidney problems)
• Your immune system may get stronger when you start taking HIV medicine. Sometimes the immune system will start to fight an infection or other health problem, such as pneumonia or tuberculosis. 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.

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, or severe skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, or joint pain
• Muscle pain, tenderness, or weakness

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