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Synagis

Generic name: palivizumab [PAL-i-VIZ-oo-mab]
Drug class: immune globulins

What are Synagis?

Synagis is a human-made antigen against respiratory syncytial viruses (RSV). RSV can be a serious problem for children. Palivizumab prevents RSV cells from growing in the body. Synagis prevents serious lung disease in premature babies and those born with heart or lung diseases.

Synagis is most effective in children aged 24 months or less at the start of the RSV season (or 6 months or less for premature babies). The medication will not work on a child who is already sick from RSV.

Warnings

A child with a severe reaction to palivizumab should not receive Synagis. Tell your doctor before your child gets the injection if your child has a bleeding disorder, a blood clotting disorder, or a low platelet count in the blood.

If your child experiences a serious adverse reaction after taking this medication, call your doctor immediately. These include high fever, ear drainage or pain, ear swelling or warmth, crying or fussiness, changes in sleeping or eating patterns, easy bruising and bleeding, or difficulty breathing.

Before you take this drug

A child with a severe reaction to palivizumab should not receive Synagis.

Tell your doctor about any of the following to ensure that Synagis will be safe for your child:

  • A bleeding or blood clotting disorder;
  • Low levels of platelets are a sign that the blood is low in platelets.

Similar/related drugs

Arexvy, Abrysvo, ribavirin, Beyfortus, Nirsevimab, and palivizumab

How to take Synagis?

The Synagis injection is given into a muscle. Your child will receive this injection from a healthcare provider. The Synagis injection is administered once a week during the RSV (Respiratory Syncytial Virus) season. This is normally November to April, but it may vary depending on where you live. Your child should receive their first RSV injection before the RSV season starts.

During RSV, your child will need to receive Synagis every 28–30 days. Each injection will protect your child for approximately 1 month from RSV. Keep all scheduled appointments for your child. If your child becomes ill with RSV, they should still receive their scheduled Synagis shots. This medicine may cause unexpected results in certain medical tests. Inform any doctor that you see about your use of this medication.

What happens if I miss the dose?

If you are unable to attend the appointment with your child for an injection, call your doctor.

What happens if I overdose?

Overdoses are unlikely because this medication is administered by a health professional in a medical environment.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverages or activities for you to follow, it is imperative that you comply.

Side effects of Synagis

If your child shows any of these symptoms of an allergic response to Synagis, you should seek immediate medical attention: hives or severe rash; rapid or difficulty breathing; blue lips, fingernails, or skin; muscle weakness; being difficult to wake up Swelling of the face, lips, or throat.

Synagis may cause side effects such as:

  • Fever

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Details on dosage

The usual pediatric dose for respiratory syncytial virus:

Children 24 months of age or younger:
15 mg/kg IM monthly during RSV Season (the first dose is to be given prior to the start of the RSV Season, and the rest doses are to be given every month throughout the RSV Season).
Comments:
Children who contract RSV should continue to be treated with monthly doses during the RSV season.
In the northern hemisphere, the RSV season usually begins in November and continues through April. However, it can start earlier or last longer in some communities.
After cardiopulmonary bypass, serum levels of this medication are reduced. The additional dose should be given to children who have undergone cardiopulmonary bypass as soon as possible (even before a month after the previous dose). The doses are then administered as per schedule, every month.
Use: To prevent serious lower respiratory tract diseases caused by respiratory syncytial disease (RSV) among children at high risk of RSV. When prescribing the drug, it is important to consider:
Safety and efficacy have been established in children with BPD, infants who had a history of premature birth (less than or equal to 35 weeks gestational age), and children with hemodynamically important congenital heart disease (CHD).
The treatment of RSV has not been proven to be safe and effective.

Interaction with other drug

Palivizumab may interact with other drugs, such as prescription and over-the-counter medicines, herbal products, and vitamins. Inform your doctor of all the medicines you are currently taking and those that you will begin or stop taking.