Synagis (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.
Synagis 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.
Synagis will not treat a child who is already sick with RSV disease.
Synagis may also be used for other purposes not listed in this medication guide.
Important information
Synagis should not be given to a child who has had a severe allergic reaction to it.
Before your child receives a Synagis 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 Synagis 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 after receiving Synagis, 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 Synagis injection.
Before receiving Synagis
Synagis 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 Synagis:
It is not known whether Synagis 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 Synagis should tell her doctor if she is pregnant or breast-feeding.
How is Synagis given?
Synagis 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.
Synagis 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 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 Synagis bottle or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.
Synagis can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using this medicine.
If you keep this medication at home, store it in the refrigerator. Do not freeze.
Do not use Synagis if the expiration date on the label has passed.
What happens if I miss a dose?
Since Synagis is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
Call your doctor for instructions if you miss an appointment for your child"s Synagis 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 Synagis overdose are not known.
What should I avoid?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Synagis side effects
Get emergency medical help if your child has any of these signs of an allergic reaction to Synagis: 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:
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high fever, ear pain or drainage, tugging at the ear;
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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 Synagis side effects may include:
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low fever;
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cold symptoms such as stuffy nose, sneezing, cough;
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vomiting, diarrhea; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Synagis?
There may be other drugs that can interact with Synagis. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
