Generic Name: Palivizumab
Class: Monoclonal Antibodies
VA Class: AM800
CAS Number: 188039-54-5
Medically reviewed on June 1, 2018
Uses for Synagis
Respiratory Syncytial Virus (RSV) Infections
Recommended for infants <24 months of age who have chronic lung disease (e.g., bronchopulmonary dysplasia [BPD]), history of premature birth (gestational age ≤35 weeks), or hemodynamically significant congenital heart disease (CHD).1 6 7 8 50 51 May reduce severity of RSV infection and reduce frequency and duration of RSV-related hospitalizations in these high-risk infants.1 6 7 8 37 39 40 41 42 50 51
Need for and efficacy of palivizumab prophylaxis following institutional RSV outbreaks† (e.g., in neonatal intensive care units) not studied to date; the major means of preventing RSV illness in such situations is strict observance of infection control practices.3 8 9
Synagis Dosage and Administration
Administer first dose immediately prior to RSV season and additional doses once monthly throughout the season.1 3 8 In the northern hemisphere, RSV season typically commences in November and lasts through April, but may begin earlier or persist later in certain communities.1 3 8
AAP states that in most seasons and in most regions of the northern hemisphere, give first dose at beginning of November and the last dose at beginning of March; these 5 doses usually provide protection during the entire season.3 8 However, decisions about the specific duration of prophylaxis should be individualized according to the duration of the local RSV season.3 8
AAP recommends that clinicians consult local health departments or diagnostic virology laboratories or the CDC to determine the epidemiology of RSV in their area.8
Doses involving volumes >1 mL should be divided and injected IM at different sites.1
Respiratory Syncytial Virus (RSV) Infections
Prevention of RSV Lower Respiratory Tract InfectionsIM
Infants at high risk for RSV undergoing cardiopulmonary bypass: Give a supplemental 15-mg/kg dose as soon as possible after cardiopulmonary bypass (even if this is <1 month after the last dose).1 8 51 (See Plasma Concentrations under Pharmacokinetics.) Thereafter, give usual doses once monthly.1 8
Cautions for Synagis
Severe acute hypersensitivity reactions, including anaphylaxis, reported rarely.1
Dyspnea, cyanosis, respiratory failure, urticaria, pruritus, angioedema, hypotonia, and unresponsiveness also reported.1
If a severe hypersensitivity reaction occurs, discontinue palivizumab and initiate appropriate supportive care and therapy (e.g., epinephrine).1 Palivizumab may be continued with caution in patients who experience a milder reaction.1
Common Adverse Effects
Upper respiratory tract infection, otitis media, fever, rhinitis, hernia, elevated serum AST concentration.1
Interactions for Synagis
Formal studies have not been conducted to evaluate potential interactions between palivizumab and other drugs.1
Not specifically studied, but no apparent increase in adverse effects when used concomitantly1
Not specifically studied, but no apparent increase in adverse effects when used concomitantly1
Monthly 15-mg/kg IM doses usually adequate to maintain trough serum concentrations exceeding the ideal target throughout the dosing period (except in children undergoing cardiopulmonary bypass).4 5 Lower doses (i.e., 3 or 10 mg/kg IV, 5 or 10 mg/kg IM) result in inadequate trough concentrations.4 5
2–8°C in original container; do not freeze.1
Actions and Spectrum
Active against both major strains of RSV (subgroup A and B).1 2 In vivo neutralizing activity of the drug was confirmed in a clinical trial in RSV-infected pediatric patients as evidenced by lower recovery of RSV from lower respiratory tract secretions in palivizumab-treated patients compared with placebo recipients.1 38
Evidence from animal studies indicates palivizumab does not interfere with in vivo development of a protective immune response to RSV.2
Animal studies indicate that exposure of RSV to subinhibitory palivizumab concentrations does not enhance viral replication or pathology and does not promote emergence of resistant variants; palivizumab appeared to protect the animals against infection from subsequent RSV challenge despite systemic clearance of the drug.2 However, escape mutants (resistant viruses) have been associated with other monoclonal antibodies and the possibility that they could occur with palivizumab should be considered.8
Advice to Patients
Importance of continuing palivizumab prophylaxis in high-risk infants once monthly for the duration of the RSV season.1
Importance of contacting clinician if possible symptoms of a hypersensitivity reaction occur (e.g., dyspnea, cyanosis, respiratory failure, urticaria, pruritus, angioedema, hypotonia, unresponsiveness).1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products, and any concomitant illnesses.
Importance of advising caregivers of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Injection, for IM use only
50 mg/0.5 mL
MedImmune, (also marketed by Ross)
100 mg/1 mL
MedImmune, (also marketed by Ross)
AHFS DI Essentials. © Copyright 2018, Selected Revisions June 1, 2006. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
1. MedImmune, Inc. Synagis (palivizumab) for intramuscular administration prescribing information. Gaithersburg, MD; 2004 Jul 23.
2. Johnson S, Oliver C, Prince GA et al. Development of a humanized monoclonal antibody (MEDI-493) with potent in vitro and in vivo activity against respiratory syncytial virus. J Infect Dis. 1997; 176:1215-24. http://www.ncbi.nlm.nih.gov/pubmed/9359721?dopt=AbstractPlus
3. Committee on Infectious Diseases, American Academy of Pediatrics. Red book: 2003 report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2003:523-8.
4. Subramanian KNS, Weisman LE, Rhodes T et al. Safety, tolerance and pharmacokinetics of a humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. Pediatr Infect Dis J. 1998; 17:110-15. http://www.ncbi.nlm.nih.gov/pubmed/9493805?dopt=AbstractPlus
5. Sáez-Llorens X, Casta˜no E, Null D et al. Safety and efficacy of intramuscular humanized monoclonal antibody to respiratory syncytial virus in premature infants with bronchopulmonary dysplasia. Pediatr Infect Dis J. 1998; 17:787-91. http://www.ncbi.nlm.nih.gov/pubmed/9779762?dopt=AbstractPlus
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. 1998;102:531-7.
7. Storch GA. Humanized monoclonal antibody for prevention of respiratory syncytial virus infection. Pediatrics. 1998; 102:648-51. http://www.ncbi.nlm.nih.gov/pubmed/9738192?dopt=AbstractPlus
8. American Academy of Pediatrics Committee on Infectious Diseases and Committee on Fetus and Newborn. Revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous for the prevention of respiratory syncytial virus infections. Pediatrics. 2003; 112:1442-6. http://www.ncbi.nlm.nih.gov/pubmed/14654627?dopt=AbstractPlus
9. American Academy of Pediatrics Committee on Infectious Diseases, Committee on Fetus and Newborn. Respiratory syncytial virus immune globulin intravenous: indications for use. Pediatrics. 1997; 99:645-50. http://www.ncbi.nlm.nih.gov/pubmed/9093323?dopt=AbstractPlus
10. Massachusetts Public Health Biologic Laboratories. RespiGam [respiratory syncytial virus immune globulin intravenous (human), (RSV-IGIV)] liquid formulation, solvent detergent treated prescribing information. Boston, MA; 2000 May.
11. Massachusetts Public Health Biologic Laboratories. RespiGam [respiratory syncytial virus immune globulin intravenous (human), (RSV-IGIV)] product monograph. Boston, MA; 1996 May.
12. Groothuis JR, Simoes EAF, Levin MJ et al et al. Prophylactic administration of respiratory syncytial virus immune globulin to high-risk infants and young children. N Engl J Med. 1993; 329:1524-30. http://www.ncbi.nlm.nih.gov/pubmed/8413475?dopt=AbstractPlus
13. McIntosh K. Respiratory syncytial virus—successful immunoprophylaxis at last. N Engl J Med. 1993; 329:1572- 3. http://www.ncbi.nlm.nih.gov/pubmed/8413482?dopt=AbstractPlus
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16. La Via WV, Marks MI, Stutman HR. Respiratory syncytial virus puzzle: clinical features, pathophysiology, treatment, and prevention. J Pediatr. 1992; 121:503-10. http://www.ncbi.nlm.nih.gov/pubmed/1403380?dopt=AbstractPlus
17. Groothuis JR, Simoes EAF, Hemming VG et al et al. Respiratory syncytial virus (RSV) infection in preterm infants and the protective effects of RSV immune globulin (RSVIG). Pediatrics. 1995; 95:463-7. http://www.ncbi.nlm.nih.gov/pubmed/7700741?dopt=AbstractPlus
18. Groothuis JR. Role of antibody and the use of respiratory syncytial virus immunoglobulin in the prevention of respiratory syncytial virus disease in preterm infants with and without bronchopulmonary dysplasia. Pediatr Infect Dis J. 1994; 13:454-8. http://www.ncbi.nlm.nih.gov/pubmed/8072836?dopt=AbstractPlus
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20. Groothuis JR. Role of antibody and use of respiratory syncytial virus (RSV) immune globulin to prevent severe RSV disease in high-risk children. J Pediatr. 1994; 124(Suppl):S28-32. http://www.ncbi.nlm.nih.gov/pubmed/8169755?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=4181569&blobtype=pdf
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22. Meissner HC. Economic impact of viral respiratory disease in children. J Pediatr. 1994; 124(Suppl):S17-21. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=4181569&blobtype=pdf
23. Hemming VG. Viral respiratory diseases in children: classification, etiology, epidemiology, and risk factors. J Pediatr. 1994; 124(Suppl):S13-6. http://www.ncbi.nlm.nih.gov/pubmed/8169752?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=4181569&blobtype=pdf
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25. Hall CB, McCarthy CA. Respiratory syncytial virus. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s principles and practice of infectious diseases. 4th ed. New York: Churchill Livingstone; 1995:1501-19.
26. Hemming VG, Prince GA, Groothuis JR et al. Hyperimmune globulins in prevention and treatment of respiratory syncytial virus infections. Clin Microbiol Rev. 1995; 8:22-33. http://www.ncbi.nlm.nih.gov/pubmed/7704893?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=172847&blobtype=pdf
27. Meissner HC, Welliver RC, Chartrand SA 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; 15:1059-68. http://www.ncbi.nlm.nih.gov/pubmed/8970212?dopt=AbstractPlus
28. Gilchrist S, Török TJ, Gary HE Jr et al. National surveillance for respiratory syncytial virus, United States, 1985–1990. J Infect Dis. 1994; 170:986-90. http://www.ncbi.nlm.nih.gov/pubmed/7930745?dopt=AbstractPlus
29. Hay JW, Ernst RL, Meissner HC. Respiratory syncytial virus immune globulin: a cost-effectiveness analysis. Am J Managed Care. 1996; 2:851-61.
30. Murguia de Sierra T, Kumar ML, Wasser TE et al. Respiratory syncytial virus-specific immunoglobulins in preterm infants. J Pediatr. 1993; 122:787-91. http://www.ncbi.nlm.nih.gov/pubmed/8496762?dopt=AbstractPlus
31. Whimbey E, Champlin RE, Couch RB et al. Community respiratory virus infections among hospitalized adult bone marrow transplant recipients. Clin Infect Dis. 1996; 22:778-82. http://www.ncbi.nlm.nih.gov/pubmed/8722930?dopt=AbstractPlus
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37. Medimmune, Inc, Gaithersburg, MD: Personal communication.
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51. Feltes TF, Cabalka, AK, Meissner C et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr. 2003; 143:532-40. http://www.ncbi.nlm.nih.gov/pubmed/14571236?dopt=AbstractPlus
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