infants at highest risk of RSV

Dosing and Administration

SYNAGIS® dosing calculator

The recommended dose of SYNAGIS is 15 mg/kg of body weight 
given monthly by IM injection. The first dose of SYNAGIS should be 
administered prior to commencement of the respiratory syncytial 
virus (RSV) season and the remaining doses should be administered 
monthly throughout the RSV season.1*

*An infant may receive 5 or more monthly doses of SYNAGIS during the RSV season. RSV seasonal onset and duration 
can vary by year and geographic region. Year-round activity has been reported in Florida and Puerto Rico.1-5

Infants at higest risk RSV

Enter patient weight and select “Calculate dose” to get the dosage in mL

Note: Tool will not calculate if weight exceeds 15.8 kg (35 lbs). Injection volume over 1 mL should be given as a divided dose.

Dose of SYNAGIS

 

The recommended dose of SYNAGIS is 15 mg/kg of body weight given monthly by IM injection: patient weight(kg) x 15mg/kg ÷ 100 mg/mL.

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Tool will not calculate if weight exceeds 15.8kg (35 lbs)

Try again

Enter patient weight and select “Calculate dose” to get the dosage in mL

Note: Tool will not calculate if weight exceeds 15.8 kg (35 lbs). Injection volume over 1 mL should be given as a divided dose.

Dose of SYNAGIS

 

The recommended dose of SYNAGIS is 15 mg/kg of body weight given monthly by IM injection: patient weight(kg) x 15mg/kg ÷ 100 mg/mL.

Try again

Tool will not calculate if weight exceeds 15.8kg (35 lbs)

Try again

Please see Dosing Guide below and refer to full Prescribing Information. 

Information presented on this site is intended to be a guide only, and not a substitute for the independent judgment of healthcare professionals. 

Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season. The efficacy of SYNAGIS at doses less than 15 mg/kg, or of dosing less frequently than monthly throughout the RSV season, has not been established.1

Father Holding highest-risk infant image

Weight-based dosing allows you to protect your highest-risk infants optimally throughout the entire RSV season

With SYNAGIS, you administer a weigh-tailored dose every 28 to 30 days. As infants grow and gain weight, each dose is determined by the weight of each infant at the time of administration. And when the season is longer than usual or interseasonal RSV activity occurs, monthly dosing provides continuous protection.1

  • Dosing Guide

    Reviews information on SYNAGIS storage, preparation, and administration

  • Dosing Calendar

    Tool to help schedule dosing appointments

Preparation

  • Using aseptic techniques, attach a sterile needle to a sterile syringe
  • Remove the flip top from the vial and clean the rubber stopper with 70% isopropyl alcohol or equivalent
  • DO NOT dilute the product
  • DO NOT shake vial
  • Using the needle, withdraw the appropriate volume of SYNAGIS for your patient
  • SYNAGIS does not contain a preservative and should be administered immediately after withdrawal from vial
  • SYNAGIS is supplied in single-use vials. DO NOT re-enter the vial. Discard any unused portion
SYNAGIS palivizumab 50 MG and 100 MG vials

Administration

SYNAGIS® (palivizumab) should be administered in a dose of 15 mg/kg via IM injection using aseptic technique, preferably in the anterolateral aspect of the thigh.

The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.

injection site image
SYNAGIS palivizumab 50 MG and 100 MG packaging

After SYNAGIS has been administered, notify the Specialty Pharmacy to initiate the refill process for the next dose, if needed.

IM=intramuscular; RSV=respiratory syncytial virus. 

REFERENCES: 1. SYNAGIS (palivizumab) [prescribing information]. Waltham, MA: Sobi, Inc. 2021. 2. Respiratory syncytial virus infection (RSV): RSV surveillance & research. Centers for Disease Control and Prevention. Reviewed July 17, 2023. Accessed October 28, 2023. https://www.cdc.gov/rsv/research/index.html 3. Centers for Disease Control and Prevention. Brief report: respiratory syncytial virus activity—United States, July 2012–June 2014. MMWR Morb Mortal Wkly Rep. 2014;63(48):1133-1136. 4. Mullins JA, Lamonte AC, Bresee JS, Anderson LJ. Substantial variability in community respiratory syncytial virus season timing. Pediatr Infect Dis J. 2003;22(10):857-862. 5. Molinari Such M, García I, García L, et al. Respiratory syncytial virus-related bronchiolitis in Puerto Rico. P R Health Sci J. 2005;24(2):137-140. 

All imagery is for illustrative purposes only.
 

ALL INFANTS ARE NOT THE SAME

INDICATION

SYNAGIS, 50 mg and 100 mg for injection, is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:

  • with a history of premature birth (≤35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season
  • with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season
  • with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season

Limitations of Use

The safety and efficacy of SYNAGIS have not been established for treatment of RSV disease.

INDICATION & IMPORTANT SAFETY INFORMATION

INDICATION

SYNAGIS, 50 mg and 100 mg for injection, is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:

  • with a history of premature birth (≤35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season
  • with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season
  • with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season

Limitations of Use

The safety and efficacy of SYNAGIS have not been established for treatment of RSV disease.

Contraindications

Previous significant hypersensitivity reaction to SYNAGIS.

Warnings and Precautions

Hypersensitivity Reactions: Anaphylaxis and anaphylactic shock (including fatal cases) and other severe acute hypersensitivity reactions have been reported. Permanently discontinue SYNAGIS and administer appropriate medication if such reactions occur.

Coagulation Disorders: SYNAGIS should be given with caution to children with thrombocytopenia or any coagulation disorder.

RSV Diagnostic Test Interference: Palivizumab may interfere with immunological-based RSV diagnostic tests, such as some antigen detection-based assays.

Adverse Reactions

Serious Adverse Reactions: The most common serious adverse reactions occurring with SYNAGIS are anaphylaxis and other acute hypersensitivity reactions.

Most Common Adverse Reactions: The most common adverse reactions are fever and rash.

Postmarketing Experience: Severe thrombocytopenia and injection site 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.

These are not all the possible risks associated with SYNAGIS. Please see full Prescribing Information for SYNAGIS, including Patient Information. To report suspected adverse reactions, contact Sobi North America at 1-866-773-5274 or the FDA at 1-800-FDA-1088.

For Statutory Pricing Disclosure, visit synagishcp.com/wac-pricing.