Synagis 100 mg/mL intramuscular solution

Generic name:
Palivizumab - injection

Pronunciation
(PAL-i-VIZ-ue-mab)

Brand name(s)
Synagis

Palivizumab is used in certain infants and young children to prevent serious lung infections (such as pneumonia) that are caused by a certain virus (respiratory syncytial virus-RSV). Palivizumab works by preventing the growth of the virus. This medication is not used to treat RSV infection, but should be continued even if your child gets the RSV infection to prevent a more serious infection.

Read the Patient Information Leaflet if available from your health care professional before your child starts receiving palivizumab and before each injection. If you have any questions, ask your doctor or pharmacist.

This medication is given into a muscle (usually the thigh) by a health care professional as directed by your child's doctor, usually once a month during RSV season. RSV season in the northern hemisphere usually starts in October and runs through April. The dosage is based on your child's weight.

Your child should receive this medication regularly to get the most benefit from it. To help you remember, mark the days on a calendar when your child should receive the medication.

Fever or pain/redness/swelling at the injection site may occur. If any of these effects last or get worse, tell your 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.

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 your 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 www.fda.gov/medwatch.

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 using palivizumab, 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:

• bleeding/blood clotting problems (such as low platelets, coagulation disorder)

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

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

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

This medication may interfere with certain lab tests (such as RSV diagnostic tests, virus culture tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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.

Keep all regular medical and lab appointments.

It is important to get each dose of this medication as scheduled. If your child misses a dose, ask the doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

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.