Palivizumab, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by injection to prevent lung disease caused by the respiratory syncytial virus in babies and young children.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: monoclonal antibody

Generic and brand names: palivizumab, injection; Synagis

What is this medicine used for?

This medicine is given by injection (shots) to prevent lung disease caused by the respiratory syncytial virus (RSV). It is given to babies and young children who are at high risk for RSV, including babies with bronchopulmonary dysplasia (abnormal development of lung tissue), babies with heart problems, and premature babies (those born before 35 weeks of gestation).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my child's healthcare provider know before my child receives this medicine?

Before receiving this medicine, tell the healthcare provider if your child has ever had:

• An allergic reaction to any medicine
• Bleeding or blood clotting disorders
• Low levels of platelets in the blood (thrombocytopenia)

Also, tell your healthcare provider if your child takes a blood thinner medicine, such as warfarin (Coumadin).

How do I use it?

This medicine is given by your healthcare provider. The first shot should be given before the RSV season, which is usually November through April. In some areas, the RSV season starts earlier and lasts longer. Talk to your healthcare provider about when your child should have the shots.

The child should have 1 shot each month throughout the RSV season. Keep all appointments for shots. The success of this treatment depends on getting the shots every month during the RSV season. Shots are given into the thigh muscles. If you miss an appointment for an injection, contact your healthcare provider to schedule the injection as soon as possible.

What should I watch out for?

Rarely, this medicine causes an allergic reaction. If your child develops hives, itching, tightness in the chest, or trouble breathing, contact your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.

There is a chance your child may still get RSV disease after receiving this medicine. Talk to your healthcare provider about what symptoms to watch for.

If your child needs emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist that your child has received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if your child has any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; fast, irregular heartbeat; swelling of the lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding; trouble breathing; severe dizziness or fainting; severe muscle weakness or floppiness; bluish color of skin, lips, or under fingernails; rash.

Other: Fever; redness, swelling, warmth, or pain at injection site.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your child's medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your child's medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. Be sure that you tell all healthcare providers who treat your child about all the products your child is taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.