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

Palivizumab is usually administered once a month during the RSV season. Your healthcare provider will give you detailed instructions on when the shot will be administered.

What is palivizumab?

Palivizumab is a man-made antibody to respiratory syncytial virus (RSV), a virus that can cause serious illness in children. Palivizumab inhibits the actions of RSV and helps to prevent the disease.

Palivizumab is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

Palivizumab may also be used for purposes other than those listed here.

What should I discuss with my healthcare provider before taking palivizumab?

Do not take palivizumab without first talking to your doctor if you have

• a bleeding or blood clotting disorder; or

• a low level of platelets in the blood.

You may not be able to use palivizumab, or you may require a dosage adjustment or special monitoring during treatment.

RSV IG is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use palivizumab without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether palivizumab passes into breast milk. Do not use palivizumab without first talking to your doctor if you are breast-feeding a baby.

How should I take palivizumab?

Palivizumab will be administered by intramuscular (into the muscle) injection by a healthcare provider. If palivizumab is being administered at home, your healthcare provider will give you instructions for administration.

Palivizumab is usually administered once a month during the RSV season. Your healthcare provider will give you detailed instructions on when the shot will be administered.

Your healthcare provider will store palivizumab as directed by the manufacturer. If palivizumab is being stored at home, your healthcare provider will give you storage instructions.

What happens if I miss a dose?

Contact your healthcare provider if a dose of palivizumab is missed.

What happens if I overdose?

Seek emergency medical attention if an overdose of palivizumab is suspected. No information is available regarding an overdose of palivizumab.

What should I avoid while taking palivizumab?

There are no restrictions on food, beverages, or activity during treatment with palivizumab.

What are the possible side effects of palivizumab?

Seek emergency medical attention or notify the doctor immediately if a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to palivizumab is experienced.

Other less serious side effects may also occur. Talk to your doctor if any of the following occur:

• rash;

• pain, redness, or swelling at the injection site;

• fever; or

• vomiting or diarrhea.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect palivizumab?

It is not known whether other medications will interact with palivizumab. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products during treatment with palivizumab.

Where can I get more information?

Your pharmacist has additional information about palivizumab written for health professionals that you may read.

What does my medication look like?

Palivizumab is available with a prescription under the brand name Synagis as an injectable formulation. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.