Raltegravir

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Raltegravir comes as a tablet, HD tablet, chewable tablet, and as granules for oral suspension to take by mouth. Take the tablet, chewable tablet, or granules for oral suspension with or without food twice a day. Take the HD tablet with or without food once a day. Take raltegravir at the same time(s) every day.

Take raltegravir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets and HD tablets whole; do not split, chew, or crush them. If you are taking the chewable tablets, you may chew or swallow them whole.

For children who have trouble chewing, the chewable tablets may be crushed and mixed with 1 teaspoon (5 mL) of liquid such as water, juice, or breast milk in a clean cup. The tablets will absorb the liquid and fall apart within 2 minutes. Crush any remaining pieces of the tablets with a spoon. Drink the mixture right away. If any of the medication is left in the cup, add another teaspoonful (5 mL) of liquid, swirl, and take it right away.

Before you take raltegravir granules for oral suspension for the first time, read the written instructions that come with it that describe how to prepare the medication. Empty the contents of one granule packet into the mixing cup and add 2 teaspoons (10 mL) of water. Gently swirl the contents in the mixing cup for 45 seconds; do not shake. Use the dosing syringe provided to measure the amount of medication that your doctor has prescribed. Use the mixture within 30 minutes of preparation. Discard any remaining suspension.

Continue to take raltegravir even if you feel well. Do not stop taking raltegravir or your other anti-HIV medications without talking to your doctor. If you stop taking raltegravir or skip doses, your condition may become worse and the virus may become resistant to treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What special precautions should I follow?

Before taking raltegravir,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking raltegravir. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription products may interact with raltegravir: antacids containing aluminum and/or magnesium. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking raltegravir. Do not start any of these medications while taking raltegravir without discussing with your healthcare provider.

• tell your doctor if you are being treated with dialysis (medical treatment to clean the blood when the kidneys are not working properly), or if you have or have ever had hepatitis, muscular disease or swelling of the muscles, or rhabdomyolysis (a skeletal muscle condition).

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking raltegravir, call your doctor.

• tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking raltegravir.

• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability), you should know that the chewable tablets contain aspartame that forms phenylalanine.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. Call your doctor if you have new or worsening symptoms during your treatment with raltegravir.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take two tablets of raltegravir at the same time to make up for a missed dose.

What side effects can this medicine cause?

Raltegravir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• insomnia (difficulty falling asleep or staying asleep)
• dizziness
• tiredness
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• muscle pain or tenderness, muscle weakness, dark or cola-colored urine
• itching; rash; hives; fever; skin blisters or peeling; mouth lesions; red, itchy, or swollen eyes; swelling of the eyes, face, lips, tongue, throat, hands, feet, ankles, or arms; difficulty breathing or swallowing;
• extreme tiredness; nausea; vomiting; loss of appetite; pain in the upper right part of the stomach; yellowing of the skin or eyes; pale stools
• fever, sore throat, cough, chills, and other signs of infection

Raltegravir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet included with the tablets to absorb moisture) from your bottle.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What other information should I know?

Keep all appointments with your doctor and the laboratory while taking raltegravir. Your doctor will order certain lab tests to check your body's response to raltegravir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

Brand name(s)

• Isentress^®
• Isentress^® HD