Synagis (Palivizumab) Monoclonal Antibody Description for 2022
Synagis (Palivizumab) is a respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody (mAbs) indicated for the prevention of serious lower respiratory tract disease caused by the Respiratory Syncytial Virus (RSV) in pediatric patients. As a mAbs, the injection is given once a month throughout the RSV season.
Synagis gives babies born prematurely (at or before 35 weeks and who are six months of age or less at th beginning of RSV season) the infection-fighting antibodies they lack, helping protect their vulnerable lungs from RSV from a passive immunization. Infants receive “ready-made” antibodies and do not have to produce them.
Synagis is not a vaccine but can help passively protect children with certain lung or heart conditions at high risk for severe RSV disease. For example, children with BPD/CLDP or HS-CHD are more likely to be hospitalized with an RSV infection than those without these conditions. However, children can still get severe RSV disease despite receiving Synagis. And the safety and efficacy of SYNAGIS have not been established to treat RSV disease.
The American Academy of Pediatrics (AAP) strongly supported consideration for using palivizumab in eligible patients during the interseasonal spread of RSV in late 2021. This recommendation applied to regions experiencing high rates of RSV circulation in the spring and summer of 2021. Initiating palivizumab prophylaxis to eligible infants during a typical winter season is consistent with AAP policy. The 2021-22 winter RSV season is considered new rather than the continuation of the interseason spread in the spring and summer of 2021.
Synagis was approved for initial use in the U.S. by the FDA in 1998 and 2004 (BLA 103770/S-5059) and Canada, Europe, the UK, and Israel. Click Prescribing Information for SYNAGIS, including Patient Information.
SYNAGIS® is a registered trademark of Arexis AB c/o Swedish Orphan Biovitrum AB. And SYNAGIS CONNECT® is a registered trademark of Arexis AB.
Synagis (Palivizumab) Monoclonal Antibody Indication
Synagis is a mAbs given as an injection once a month throughout the RSV season. Palivizumab is an antibody, so it becomes effective within hours of injection, unlike a vaccine. Synagis 50 mg and 100 mg for injection are recommended for high-risk babies most likely to be affected by severe RSV, including:
Preemies - Babies born 35 weeks or less and six months of age or younger at the beginning of RSV season. A 2013 clinical study published in the New England Journal of Medicine showed that SYNAGIS significantly reduced RSV-related hospitalizations in late-preterm infants 33-35 wGA6.
Lung Issues - Infants who have a chronic lung condition known as BPD/CLDP (bronchopulmonary dysplasia/chronic lung disease of prematurity) require medical treatment within six months and 24 months of age or younger at the beginning of RSV season.
Heart Issues - Infants who have a heart condition known as HS-CHD (hemodynamically significant congenital heart disease) and who are 24 months of age or younger at the beginning of RSV season.
Children should not receive SYNAGIS if they have ever had a severe allergic reaction to it. Signs and symptoms of a severe allergic reaction could include an itchy rash, swelling of the face; difficulty swallowing; difficulty breathing; bluish color of the skin; muscle weakness or floppiness, and/or unresponsiveness.
Synagis (Palivizumab) Monoclonal Antibody Dosage
Single-dose liquid solution vials: 50 mg per 0.5 mL and 100 mg per 1 mL. per 15 mg per kg of body weight, administered intramuscularly before the RSV season, and the remaining doses administered monthly throughout the RSV season.
Synagis (Palivizumab) Monoclonal Antibody Safety Information
SYNAGIS is contraindicated in children who have had a previous significant hypersensitivity reaction to SYNAGIS. Cases of anaphylaxis and anaphylactic shock, including fatal cases, have been reported following initial exposure or re-exposure to SYNAGIS.
Synagis (Palivizumab) Monoclonal Antibody News 1999 - 2022
April 3, 2022 - Israel's Health Ministry authorized the expanded vaccination of premature babies against the RSV.
February 10, 2022 - Swedish Orphan Biovitrum AB announced its results for the fourth quarter and the full year of 2021.
December 17, 2021 - The American Academy of Pediatrics updated palivizumab prophylaxis guidance to prevent severe RSV infection hospitalization during the 2021-2022 RSV season.
November 13, 2018 - AstraZeneca agreed to sell Synagis (palivizumab) US rights to Swedish Orphan Biovitrum AB (Sobi).
October 1999 - Palivizumab is a new anti-RSV monoclonal antibody product indicated to prevent serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of developing RSV disease.
Synagis (Palivizumab) Monoclonal Antibody Clinical Trials
Synagis (palivizumab) has been involved in over 20 clinical trials.
An observational study, Prospective, Non-interventional Observation Study for the Use of Palivizumab in High-risk Children in Germany- SYNAGIS, was carried out to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious RSV disease.
This registry was designed as a post-marketing observational study and conducted to collect data on palivizumab administration, the risk factors for complicated RSV disease, frequency of hospitalizations, and drug adherence.