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Brand Names: Synagis

Generic Name: palivizumab (Pronunciation: PAL i VIZ oo mab)

• What is palivizumab (Synagis)?
• What are the possible side effects of palivizumab (Synagis)?
• What is the most important information I should know about palivizumab (Synagis)?
• What should I discuss with my healthcare provider before receiving palivizumab (Synagis)?
• How is palivizumab given (Synagis)?
• What happens if I miss a dose (Synagis)?
• What happens if I overdose (Synagis)?
• What should I avoid while receiving palivizumab (Synagis)?
• What other drugs will affect palivizumab (Synagis)?
• Where can I get more information?

What is palivizumab (Synagis)?

Palivizumab is a man-made antibody to respiratory syncytial (sin-SISH-ul) virus (RSV). RSV can cause serious illness in children. Palivizumab helps keep RSV cells from multiplying in the body.

Palivizumab is used to prevent serious lung disease caused by respiratory syncytial virus in premature infants, and infants born with certain lung disorders or heart disease.

Palivizumab will not treat a child who is already sick with RSV disease.

Palivizumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of palivizumab (Synagis)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

• high fever, ear pain or drainage, tugging at the ear;
• warmth or swelling of the ear;
• crying or fussiness, especially while lying down;
• change in sleeping patterns;
• poor feeding or loss of appetite;
• easy bruising or bleeding; or
• trouble breathing.

Less serious side effects may include:

• low fever;
• cold symptoms such as stuffy nose, sneezing, cough;
• vomiting, diarrhea; or
• pain, redness, or swelling where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about palivizumab (Synagis)?

Palivizumab should not be given to a child who has had a severe allergic reaction to it.

Before your child receives a palivizumab injection, tell your doctor if the child has a bleeding or blood-clotting disorder; or a low level of platelets in the blood.

Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Call your doctor at once if your child has a serious side effect such as high fever, ear pain or drainage, warmth or swelling of the ear; crying or fussiness, change in appetite or sleeping patterns, easy bruising or bleeding, or trouble breathing.

Call your doctor for instructions if you miss an appointment for your child's palivizumab injection.

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