Palivizumab (Injection)

When This Medicine Should Not Be Used

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
• Bluish color of the lips, fingernails, or skin.
• Difficulty with breathing or troubled breathing.
• Earache or swelling in the ear.
• Fast, pounding, or uneven heartbeat.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting, or stomach pain.
• Redness, swelling, pain, or a lump where the shot was given.
• Skin rash.

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

Introduction

Palivizumab (pal-i-VIZ-yoo-mab)

Prevents serious lung infections caused by respiratory syncytial virus (RSV) in babies born prematurely or those who have lung problems.

Brand Name(s)

Synagis

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• A nurse or other trained health professional will give you this medicine.
• This medicine is usually given once a month during the RSV season, which is the time of year that RSV is most common in your community. Your child should receive the first shot of this medicine before the season starts to help prevent serious infections from the RSV virus.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• Your child needs to receive these shots on a fixed schedule. If you must cancel an appointment, reschedule it as soon as possible.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• Make sure your doctor knows if your child has any bleeding problems or low platelets in the blood (thrombocytopenia).
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if your child has a rash; itching; hoarseness; lightheadedness, dizziness, or fainting; trouble breathing; trouble swallowing; or any swelling of the hands, face, or mouth after receiving the medicine.
• If your child has certain types of heart disease and needs to have a corrective surgery, your doctor may need to give your child an additional shot of this medicine soon after surgery.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.