Synagis is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus rsv in children at high risk for rsv disease. Highlights of prescribing information for intravenous. The american academy of pediatrics aap committee on infectious diseases has updated its guidance on the use of palivizumab synagis prophylaxis in infants and children at. Clinical criteria recommendations from magellan medicaid administration, inc august, 2014. Read the patient information leaflet if available from your health care professional before your child starts receiving palivizumab and before each injection. The plan will begin approving requests for synagis.
Synagis palivizumab health care professional website. Data on file, 3110106, astrazeneca pharmaceuticals lp. Synagis must not be used in people who are hypersensitive allergic to palivizumab, any of the other ingredients or other humanised monoclonal. Aap issues updated guidance on palivizumab prophylaxis for. Zolgensma pronounced zoljensmuh replaces the function of the missing. The synagis copay program helps lessen the burden of outofpocket costs to parents or guardians of patients receiving synagis by assisting qualified individuals with their outofpocket costs. May cause extrapyramidal andor withdrawal symptomsin neonates with third trimester. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for synagis palivizumab. Synagis is used to prevent serious lung disease caused by respiratory syncytial virus in premature infants, and infants born with certain lung disorders or. Synagis palivizumab for intramuscular administration description.
Please see full prescribing information for synagis, including patient information. Authorization may be granted for a maximum of five monthly doses at 15 mgkg intramuscularly based upon the. Prior authorization is required to ensure the safe, clinically appropriate. Synagis is the first monoclonal antibody approvedto provide passive immunity for an. Palivizumab helps keep rsv cells from multiplying in the body. Synagis against the benefits they expect it will have for. Neupogen is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresissee clinical studies 14.
Insert the needle into the vial and withdraw an appropriate volume of solution into the syringe. Review of palivizumab in the prophylaxis of respiratory. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in highrisk infants. Palivizumab solution for injection does not contain a preservative, is.
Revised recommendations concerning palivizumab prophylaxis. If you are in the us and would like additional information regarding astrazeneca drugs, please contact. Concentrations 40 mcgml attained within 2 days after a single 15mgkg im dose. In children receiving synagis for a second season, one of the fiftysix children had transient, low titer.
If you are in the us and would like additional information regarding astrazeneca drugs, please contact the information center at astrazeneca at 18778931510 18778931510. Lift the package away from the adapter and discard the package. Population pharmacokinetics of palivizumab, a humanized anti. The respiratory syncytial virus rsv was isolated for the first time in 1955 in a monkey. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids.
Synagis palivizumab injection, for intramuscular use. Synagis palivizumabi,ii,iii length of authorization. May 12, 2017 insert the needle into the vial and withdraw into the syringe an appropriate volume of solution. Raptiva efalizumab for injection, subcutaneous warning. Updated guidance for palivizumab prophylaxis among infants. May cause extrapyramidal andor withdrawal symptomsin neonates with third trimester exposure. Synagis criteria, 20192020 page 3 of 3 version 1 last updated 08292019 references footnotes. Learn more about rsv and synagis with a parents guide to rsv, faqs, some helpful. October 4, 2019 copyright 20112019 health information designs, llc 25 publication history.
Synagis is a respiratory syncytial virus rsv f protein inhibitor monoclonal antibody. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for synagis palivizumab skip to. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while. Dec 15, 2014 the american academy of pediatrics aap committee on infectious diseases has updated its guidance on the use of palivizumab synagis prophylaxis in infants and children at increased risk of. Synagis palivizumab for intramuscular administration. For the full list of all side effects reported with synagis, see the package leaflet. No formal drugdrug interaction studies were conducted. Zolgensma is given as a onetime infusion into the vein. Committee on infectious diseases, policy statementmodified recommendations for use of palivizumab for prevention of respiratory. Respiratory syncytial virus, or rsv, is a very common virus that most children will catch by 2 years of. Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. Immunogenicity in trial 1, the incidence of antipalivizumab antibody following the fourth injection. The quickvue rsv test is a dipstick immunoassay that detects respiratory syncytial virus rsv antigen viral fusion protein directly from nasopharyngeal swab, nasopharyngeal aspirate, or nasalnasopharyngeal wash specimens for symptomatic pediatric patients eighteen years of age and younger. Synagis is a respiratory syncytial virus rsv f protein inhibitor monoclonal.
Insert the needle into the vial and withdraw into the syringe an appropriate volume of solution. Zolgensma was not evaluated in patients with advanced sma. May 04, 2020 insert the needle into the vial and withdraw into the syringe an appropriate volume of solution. Synagis palivizumab rationale for inclusion in pa program. These trough concentrations listed in the palivizumab package insert exhibit substantial interindividual variability. Resources for specialty pharmacy providers synagis. Synagis palivizumab dose, indications, adverse effects. Palivizumab is a composite of human 95% and murine 5%. Synagis contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, rsv. Synagis is a prescription medication that is used to help prevent a serious lung disease caused by respiratory syncytial virus rsv in children. Jan 06, 2020 synagis palivizumab is a manmade antibody to respiratory syncytial virus rsv. Protecting your highrisk baby from severe rsv disease pdf. Synagis palivizumab injection was fda approved in june 1998 for the prevention of infection in highrisk pediatric patients due to respiratory syncytial virus rsv, the most common cause of pneumonia and bronchiolitis in infancy and early childhood. Insert the needle into the vial and withdraw an appropriate volume of solution into the.
The plan will begin approving requests for synagis beginning october 1. Synagis reference guide for safe and effective use from the american society of. Synagis pharmacokinetics absorption bioavailability. Synagis palivizumab dose must be administered after october 15 and the last dose before march 31. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of synagis while maintaining optimal therapeutic outcomes. Synagis should be administered in a dose of 15 mg per kg intramuscularly using aseptic technique, preferably in the anterolateral aspect of the thigh. Zolgensma onasemnogene abeparvovecxioi is a prescription gene therapy used to treat children less than 2 years old with spinal muscular atrophy sma. Thereafter the genes were inserted into a plasmid expressed from.
Synagis vial and wipe the rubber stopper with a disinfectant e. The quickvue rsv test is a dipstick immunoassay that detects respiratory syncytial virus rsv antigen viral fusion protein directly from nasopharyngeal swab, nasopharyngeal aspirate, or. Review of palivizumab in the prophylaxis of respiratory syncytial virus rsv in highrisk infants. The ndc number for the four administration dose pack carton is 5024205804. Synagis 50 mg powder and solvent for solution for injection. American academy of pediatrics, committee on infectious diseases and bronchiolitis guidelines committee. Committee on infectious diseases, policy statementmodified recommendations for use of. In man, the virus was described in 1957 in two neonates presenting with an airway. Administer immediately after drawing the dose into the syringe.
Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the rsv season. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory. Slight variations to the rsv season may be announced by the massachusetts department of. Palivizumab, a highly potent rsvneutralizing monoclonal antibody mab. Information for the user synagis 100 mgml solution. While significant advances in the knowledge of rsv biology, immunology, and epidemiology have been made in the last 40 years, there continues to be significant controversy over the optimum management of infants with acute rsv infection. Committee on infectious diseases, policy statementmodified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections. Synagis palivizumab is supplied as a sterile lyophilized product for reconstitution with sterile water for injection. Highlights of prescribing information initial dose of. The most common side effects with synagis seen in between 1 and 10 patients in 100 are fever and rash. Synagis palivizumab is a manmade antibody to respiratory syncytial virus rsv. Synagis palivizumab is a humanized monoclonal antibody igg1. Synagis palivizumab prescribing information az medical. Synagis does not treat rsv infections nor prevent nonsevere rsv infections and is therefore not indicated for the purpose 1.
Interactions sections of the package insert for those products. Page 2 of 21 full prescribing information 1 indications and usage 1. Highlights of prescribing information when administering with. Maximum monthly synagis doses per rsv season 5 at 15 mgkg per dose. Synagis is indicated for the prevention of serious lower respiratory tract disease caused by rsv in children at high risk of rsv disease.