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 should I discuss with my healthcare provider before taking 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:
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 should I take palivizumab?
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 of palivizumab?
Call your doctor for instructions if you miss an appointment for your child's palivizumab
injection.
Where can I get more information about palivizumab?
Your pharmacist has information about palivizumab written for health professionals that you may read.
What are the possible side effects of palivizumab?
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;
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crying or fussiness, especially while lying down;
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change in sleeping patterns;
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poor feeding or loss of appetite;
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easy bruising or bleeding; or
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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?
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 avoid while taking palivizumab?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
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.
What happens if I have an overdose of palivizumab?