呼吸道合胞病毒单克隆抗体使用说明书

Injectable Medication Guideline:
Synagis (Palivizumab)
Background:
Respiratory syncytial virus (RSV) is a common disease of childhood and causes acute upper respiratory tract infections in patients of all ages. Most RSV-infected infants experience upper respiratory tract symptoms, and 20% to 30% develop lower respiratory tract infections with their first RSV infection. Certain conditions increase the risk of severe or fatal RSV infection. These include preterm birth; cyanotic or complicated congenital heart disease, especially when the condition causes pulmonary hypertension; chronic lung disease of prematurity, and immunodeficiency disease or therapy causing immunosuppression at any age. In the U.S., more than 125,000 hospitalizations due to RSV infection occur annually. Outbreaks of RSV usually begin in November or December, peak in January or February, and end in March or April.
Synagis (palivizumab), a humanized mouse RSV monoclonal antibody, has been shown to reduce the risk of serious RSV disease and to reduce RSV-related hospitalizations in high-risk infants and children. Synagis is administered at a dose of 15mg/kg once every 30 days. Five monthly doses will provide more than 20 weeks of protective serum antibody concentration for most infants. Synagis is administered intramuscularly (IM). Synagis is not effective in the treatment of RSV and it is not approved or recommended for this indication. Synagis is FDA-approved for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestation), and children with hemodynamically significant congenital heart disease (CHD). Synagis is associated with high cost. Patients receiving Synagis must meet strict approval criteria. Criteria (based on documented RSV risk factors):
∙Infants born at 28 weeks gestation or earlier and who are less than 12 months of age as of November 1st. A maximum of five monthly doses is recommended for patients in this category.
∙Infants born between 29 to 32 weeks gestation and who are less than 6 months of age as of November 1st. A maximum of five monthly doses is recommended for patients in this category.
∙Infants born between 32 to 35 weeks gestation and who are less than 3 months of age as of November 1st and who have one of the following two risk factors for hospitalization due to RSV: ∙Infant attends child care, defined as a home or facility where care is provided for any number of infants or young toddlers in the child care facility; or
∙Infant has school age siblings or school age relatives living in the house
∙Infants in this category may receive prophylaxis with Synagis until they reach 3 months of age and should receive a maximum of 3 monthly doses.
∙Infants with chronic lung disease (CLD) who are less than 2 years of age as of November 1st who are receiving or have received medical therapy for CLD within the past 6 months (includes supplemental oxygen, nebulizer treatments, bronchodilators, diuretics, or chronic corticosteroid therapy). A maximum of five monthly doses is recommended for patients in this category.
∙Infants born before 35 weeks gestation who have congenital abnormalities of the airway or neuromuscular disease. A maximum of five monthly doses is recommended for patients in this category.
∙Infants and children who are less than 2 years of age as of November 1st with hemodynamically significant cyanotic or acyanotic congenital heart disease. Those most likely to benefit are infants and children receiving medication for congestive heart failure (digoxin, diuretic), those with moderate to severe pulmonary hypertension, and those with cyanotic heart disease. A maximum of five monthly doses is recommended for patients in this category.
∙Infants and children with immune deficiency who may benefit from RSV prophylaxis (severe combined immunodeficiency, acquired immunodeficiency syndrome (HIV/AIDS), transplant recipients, or children immunocompromised due to chemotherapy). A maximum of five monthly doses is recommended for patients in this category.
Injectable Medication Guideline:
Synagis (Palivizumab)
CCS Guidelines for the Authorization of Synagis:
Infants and children must meet above criteria in addition to meeting the following CCS criteria: ∙Infant or child must have a CCS-eligible condition
∙The request for Synagis shall be made by the CCS authorized pediatric subspecialist or the CCS approved Special Care Center; or the request shall be made by a CCS-paneled pediatrician authorized in conjunction with a CCS paneled pediatric subspecialist or CCS approved Special Care Center
∙Premature infants who are currently eligible only for diagnostic services through the high-risk infant follow-up program are not eligible for CCS authorization of palivizumab
Synagis Dosing:
15mg/kg to be administered intramuscularly once a month
Note: Providers may bill for one vial of Synagis even if only part of the vial was given to the recipient and the remainder of the drug was discarded. However, the provider may not bill for the 100 mg vial when the dose required for the recipient is ≤ than 50 mg.
Cost (AWP as of December 2011):
∙Synagis (palivizumab) 50mg vial (each) = $1,915
∙Synagis (palivizumab) 100mg vial (each) = $2,675
REFERENCES
1. American Academy of Pediatrics. Summaries of Infectious Diseases, Repiratory Syncytial Virus. Red
Book 2009.
2. Meissner HC and Bocchini JA. Reducing RSV hospitalizations. AAP modifies recommendations for
use of palivizumab in high-risk infants, young children. American Academy of Pediatrics News. July 2009. Volume 30 (7):1-2.
3. American Academy of Pediatrics, Subcommittee on Diagnosis and Management of Bronchiolitis.
Diagnosis and management of bronchiolitis. Pediatrics. 2006;116 (4): 1774-1793.
4. American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and
Newborn. Prevention of respiratory syncytial virus infections: indications for the use of palivizumab and update on the use of RSV-IGIV. Pediatrics. 1998;102(5):1211-16.
5. Meissner HC, et al. Prevention of respiratory syncytial virus infection in high risk infants: consensus
opinion on the role of immunoprophylaxis with respiratory syncytial virus hyperimmune globulin.
Pediatr Infect Dis J. 1996;15(12):1059-68.
6. The Impact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal
antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants.
Pediatrics. 1996;97:137-140.
7. California Department of Health Care Services. Palivizumab (Synagis). N.L. 04-0509, August 2009.
8. Sondheimer HM, Cabalka AK, Feltes TF, Piazza FM, Conner EM, and the Cardiac Synagis Study
Group. Palivizumab (PV) prevents hospitalization due to respiratory syncytial virus (RSV) in young children with serious congenital heart disease (CHD). Protocol CP048. Presented at the Cardiology Section of American Academy of Pediatrics Conference, Oct.18, 2002. Data on file, MedImmune, Inc.
9. Romero JR. Palivizumab prophylaxis of respiratory syncytial virus disease from 1998 to 2002: results
from four years of palivizumab usage. Pediatr Infect Dis J. 2003;22(2):S46-S54.
10. Holman RC, et al. Risk factors for bronchiolitis-associated deaths among infants in the United States.
Pediatr Infect Dis J. 2003;22(6):483-489.
11. Synagis Product Information. MedImmune. March 2009. Gaithersburg, MD.。