Isentress

If you miss a dose, give it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Give the next dose at the regular time. Do not double the dose to catch up.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used to lessen the risk of HIV infection after contact with the virus (for example, due to a needle stick). Ask your doctor for more details.

Headache, nausea, or trouble sleeping may occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your child's immune system gets stronger, it can begin to fight off infections they already had, possibly causing disease symptoms to come back. Your child could also have symptoms if their immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if your child has any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes).

Tell the doctor right away if your child has any serious side effects, including: nausea/vomiting that doesn't stop, signs of kidney problems (such as change in the amount of urine), loss of appetite, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

Changes in body fat may occur while your child is taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with the doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking raltegravir, tell the doctor or pharmacist if your child is allergic to it; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: liver disease (such as hepatitis B, hepatitis C), muscle disorders (such as rhabdomyolysis, myopathy), high blood levels of creatine kinase (high CK test results).

Before having surgery, tell the doctor or dentist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

This formulation of raltegravir is not usually used by adults. It is unlikely to be used during pregnancy or breastfeeding. Consult the doctor if you have any questions about this medication.

See also How to Use section.

Drug interactions may change how medications work or increase the risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

A product that may interact with this drug is: orlistat.

If you are breastfeeding your child, ask the doctor if any medications that you are using may pass into the breast milk and interact with this medication.

Store in the original container at room temperature away from light and moisture. Do not open foil packet until you are ready to use the medication. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Read the Patient Information Leaflet if available from your pharmacist before you start giving raltegravir to your child and each time you get a refill. If you have any questions, ask the doctor or pharmacist.

Give this medication to your child by mouth with or without food as directed by the doctor, usually once or twice daily. The dosage is based on your child's medical condition, response to treatment, age, weight, and other medications your child may be taking. Be sure to tell the doctor and pharmacist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

Empty the contents of one packet in the mixing cup. Measure the amount of water as directed using the syringe and add it to the mixing cup. Mix well by gently swirling the cup. Do not shake. Measure the dose using the syringe. Do not use a household spoon because you may not get the correct dose. Give the dose within 30 minutes after mixing. Discard any portion you do not use.

Avoid using antacids that contain aluminum or magnesium while taking this medication. These antacids can make raltegravir work less well.

It is very important to continue giving this medication (and other HIV medications) exactly as prescribed by the doctor. Do not skip any doses.

Do not increase the dose or give this drug more often or for longer than prescribed. Your child's condition will not improve any faster, and the risk of side effects will increase.

Do not give more or less of this drug than prescribed or stop giving it (or other HIV medicines) even for a short time unless directed to do so by the doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time(s) every day.

Do not switch between the film-coated tablet, the chewable tablet, or the powder packet for oral suspension forms of raltegravir without asking your doctor or pharmacist first.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.