palivizumab

Generic Name: palivizumab (PAL i VIZ oo mab)Brand Names: Synagis

What is palivizumab?

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 is the most important information I should know about palivizumab?

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.

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

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

If your child has any of these other conditions, he or she may need a dose adjustment or special tests to safely use this medication:

• a bleeding or blood clotting disorder; or

• a low level of platelets in the blood.

It is not known whether palivizumab is harmful to use while pregnant or breast-feeding. Although this medication is generally not used in adults, a woman of child-bearing age who is treated with palivizumab should tell her doctor if she is pregnant or breast-feeding.

How is palivizumab given?

Palivizumab is given once a month during the RSV season, which is usually November through April but may be different where you live. Your child's doctor will tell you when the medication should be given.

Palivizumab is given as an injection into a muscle. A doctor, nurse, or other healthcare provider will give this injection. You may be shown how to use the medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw the palivizumab dose into a syringe until you are ready to give an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. If you keep this medication at home, store it in the refrigerator. Do not freeze. Do not use the medication if the expiration date on the label has passed.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think your child has received too much of this medicine.

Symptoms of a palivizumab overdose are not known.

What should I avoid while receiving palivizumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Palivizumab side effects

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.

Palivizumab Dosing Information

Usual Adult Dose for Respiratory Syncytial Virus:

Hematopoietic stem cell transplant recipient: 15 mg/kg one time, infused intravenously over 30 minutes.The use of palivizumab in adults is not approved by the FDA. This dosage is based on 2 small clinical trials which included 6 patients without active RSV infection, 3 patients with RSV upper respiratory tract infection (URTI), and 12 patients with RSV interstitial pneumonia (IP). The 15 patients with active RSV infection also received aerosolized ribavirin. The 3 patients with URTI recovered, 10 of the patients with IP survived for the 28-day study period, and 2 of the IP patients died. The virologic outcome of the 6 patients without active RSV was not stated.

Usual Pediatric Dose for Respiratory Syncytial Virus:

15 mg/kg IM once monthly during RSV season.

What other drugs will affect palivizumab?

There may be other drugs that can interact with palivizumab. Tell your doctor about all the prescription and over-the-counter medications your child has received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about palivizumab.

• 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 06/29/2009 11:09:24 AM.