Synagis

What Is Synagis?

Synagis (palivizumab) is a man-made antibody to respiratory syncytial virus (RSV) used to prevent serious lung disease caused by RSV 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.

What Are Side Effects of Synagis?

Common side effects of Synagis include:

• diarrhea,
• vomiting,
• fever,
• cough,
• earache,
• runny or stuffy nose,
• sneezing,
• other cold symptoms,
• rash, or
• injection site reactions (pain, redness, or swelling).

Tell your doctor if your child has a serious side effect of Synagis including:

• high fever, ear pain or drainage, tugging at the ear;
• warmth or swelling of the ear;
• crying or fussiness, especially while lying down;
• changes in sleeping patterns;
• poor feeding or loss of appetite;
• easy bruising or bleeding; or
• trouble breathing.

Dosage for Synagis

The recommended dose of Synagis is 15 mg per kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season.

What Drugs, Substances, or Supplements Interact with Synagis?

There may be other drugs that can interact with Synagis. 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. Synagis is not indicated for adult usage.

Synagis During Pregnancy or Breastfeeding

It is not known whether Synagis can cause fetal harm or could affect reproductive capacity when administered to a pregnant woman. Because this drug is not for adult use, it is not recommended while breastfeeding.

Additional Information

Our Synagis (palivizumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Synagis Consumer Information

Get emergency medical help if your child has signs of an allergic reaction: hives, severe rash, itching; rapid or difficult breathing; blue-colored lips, skin, or fingernails; muscle weakness, being hard to wake up; swelling of the face, lips, tongue, or throat.

Common side effects may include:

• fever; or
• rash.

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.

Read the entire detailed patient monograph for Synagis (Palivizumab)

 

Synagis Professional Information

SIDE EFFECTS

The most serious adverse reactions occurring with Synagis are anaphylaxis and other acute hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Synagis (n=1639) compared with placebo (n=1143) in children 3 days to 24.1 months of age at high risk of RSV-related hospitalization in two clinical trials. Trial 1 was conducted during a single RSV season and studied a total of 1502 children less than or equal to 24 months of age with BPD or infants with premature birth (less than or equal to 35 weeks gestation) who were less than or equal to 6 months of age at study entry. Trial 2 was conducted over four consecutive seasons among a total of 1287 children less than or equal to 24 months of age with hemodynamically significant congenital heart disease.

In Trials 1 and 2 combined, fever and rash were each reported more frequently among Synagis than placebo recipients, 27% versus 25%, and 12% versus 10%, respectively. Adverse reactions observed in the 153-patient crossover study comparing the liquid and lyophilized formulations were comparable for the two formulations, and were similar to those observed with Synagis in Trials 1 and 2.

Immunogenicity

In Trial 1, the incidence of anti-palivizumab antibody following the fourth injection was 1.1% in the placebo group and 0.7% in the Synagis group. In children receiving Synagis for a second season, one of the fifty-six children had transient, low titer reactivity. This reactivity was not associated with adverse events or alteration in serum concentrations. Immunogenicity was not assessed in Trial 2.

A trial of high-risk preterm children less than or equal to 24 months of age was conducted to evaluate the immunogenicity of the lyophilized formulation of Synagis (used in Trials 1 and 2 above) and the liquid formulation of Synagis. Three hundred seventy-nine children contributed to the 4 to 6 months post-final dose analysis. The rate of anti-palivizumab antibodies at this time point was low in both formulation groups (anti-palivizumab antibodies were not detected in any subject in the liquid formulation group and were detected in one subject in the lyophilized group (0.5%), with an overall rate of 0.3% for both treatment groups combined).

These data reflect the percentage of children whose test results were considered positive for antibodies to palivizumab in an enzyme-linked immunosorbent assay (ELISA) and are highly dependent on the sensitivity and specificity of the assay.

The ELISA has substantial limitations in detecting anti-palivizumab antibodies in the presence of palivizumab. Immunogenicity samples tested with the ELISA assay likely contained palivizumab at levels that may interfere with the detection of anti-palivizumab antibodies.

An electrochemical luminescence (ECL) based immunogenicity assay, with a higher tolerance for palivizumab presence compared to the ELISA, was used to evaluate the presence of anti-palivizumab antibodies in subject samples from two additional clinical trials. The rates of anti-palivizumab antibody positive results in these trials were 1.1% and 1.5%.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Synagis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: severe thrombocytopenia (platelet count less than 50,000 per microliter)

General Disorders and Administration Site Conditions: injection site reactions Limited information from post-marketing reports suggests that, within a single RSV season, adverse events after a sixth or greater dose of Synagis are similar in character and frequency to those after the initial five doses.

Read the entire FDA prescribing information for Synagis (Palivizumab)