Usual Pediatric Dose for Respiratory Syncytial Virus

Recommended dosage:

• Neonate and infants born during or entering their first respiratory syncytial virus (RSV) season: 50 mg intramuscularly once (for children less than 5 kg) or 100 mg intramuscularly once (for children 5 kg or greater)

• Children up to 24 months of age who remain at increased risk for severe RSV in their second RSV season: A single 200 mg dose intramuscularly, administered as two 100 mg injections (2 x 100 mg).

• Children undergoing cardiac surgery with cardiopulmonary bypass: An additional dose is recommended via intramuscular route as soon as the child is stable after surgery to ensure adequate vaccine serum levels.
• In the first RSV season: If surgery is within 90 days after receiving the vaccine, the additional dose should be based on current body weight. See above for body weight dosing. If more than 90 days have elapsed since receiving the vaccine, the additional dose should be 50 mg regardless of body weight.
• In the second RSV season: If surgery is within 90 days after receiving the vaccine, the additional dose should be 200 mg, regardless of body weight. If more than 90 days have elapsed since receiving the vaccine, the additional dose should be 100 mg regardless of body weight.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

CONTRAINDICATIONS: History of serious hypersensitivity reactions, including anaphylaxis to this vaccine or to any of its excipients.

Safety and efficacy have not been established in patients older than 24 months of age.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For intramuscular administration only.
• Do not use if the pre-filled syringe has been dropped or damaged, the security seal on the carton has been broken, or the expiration date has passed.
• This vaccine can be administered in separate syringes and at different injection sites with other childhood vaccines. Do not mix with any vaccine or medication.
• There is no information regarding co-administration with other immunoglobulin products.
• Palivizumab should not be administered to infants who have received this vaccine in the same season.
• Children who received palivizumab in their first respiratory syncytial virus (RSV) season and remain vulnerable to severe RSV disease can receive this vaccine prior to or during their second season.

• Store in the refrigerator between 2C to 8C (36F to 46F). It must be used within 8 hours once removed from the refrigerator.
• It may be kept at room temperature 20C to 25C (68F to 77F) for a maximum of 8 hours.
• Store in the original carton and protect from light until time of use.
• Do not freeze. Do not shake. Do not expose to heat.

• The manufacturer's product information should be consulted

• Read Vaccine Information Statement (VIS) provided or available at (www.cdc.gov/vaccines).
• Discuss and report possible adverse reactions with the healthcare provider.