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Palivizumab: Drug information

Palivizumab: Drug information
(For additional information see "Palivizumab: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Synagis
Brand Names: Canada
  • Synagis
Pharmacologic Category
  • Monoclonal Antibody
Dosing: Pediatric

(For additional information see "Palivizumab: Pediatric drug information")

Note: See Use for description of patients for whom palivizumab prophylaxis may be considered.

Respiratory syncytial virus, prevention

Respiratory syncytial virus (RSV), prevention: Infants and Children <24 months: IM: 15 mg/kg once monthly throughout RSV season; first dose administered prior to commencement of RSV season; if hospitalized at the start of RSV season, palivizumab should be given 48 to 72 hours before discharge or promptly after discharge (AAP 2014). Note: For the 2022–2023 RSV season, the AAP supports continued palivizumab use (more than the typical 5 doses) in regions where RSV activity remains high (AAP 2022); if hospitalization occurs for breakthrough RSV infection, monthly prophylaxis should be discontinued for the remainder of that season (AAP 2014).

Cardiopulmonary bypass patients: IM: Administer a 15 mg/kg dose as soon as possible after cardiopulmonary bypass procedure or at the conclusion of extracorporeal membrane oxygenation, even if <1 month from previous dose. A 58% decrease in palivizumab serum concentrations has been noted after cardiopulmonary bypass (AAP 2014).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Infants and Children <24 months: There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

Infants and Children <24 months: There are no dosage adjustments provided in the manufacturer's labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intramuscular [preservative free]:

Synagis: 50 mg/0.5 mL (0.5 mL); 100 mg/mL (1 mL)

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intramuscular:

Synagis: 50 mg/0.5 mL (0.5 mL); 100 mg/mL (1 mL)

Administration: Pediatric

Parenteral: IM: Administer undiluted solution IM, preferably in the anterolateral aspect of the thigh; gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. Injection volume over 1 mL should be given as a divided dose. Do not dilute product; do not shake or vigorously agitate the vial.

Use: Labeled Indications

Respiratory syncytial virus prophylaxis: Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with a history of premature birth (≤35 weeks gestational age) and who are ≤6 months at the beginning of RSV season; pediatric patients with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are ≤24 months at the beginning of RSV season; or pediatric patients with hemodynamically significant congenital heart disease (CHD) and who are ≤24 months at the beginning of RSV season.

The American Academy of Pediatrics (AAP 2014) recommends RSV prophylaxis with palivizumab during RSV season for:

Infants born at ≤28 weeks 6 days gestational age and <12 months at the start of RSV season

Infants <12 months of age with chronic lung disease (CLD) of prematurity

Infants ≤12 months of age with hemodynamically significant CHD

Infants and children <24 months of age with CLD of prematurity necessitating medical therapy (eg, supplemental oxygen, bronchodilator, diuretic, or chronic steroid therapy) within 6 months prior to the beginning of RSV season

AAP also suggests that palivizumab prophylaxis may be considered in the following circumstances:

Infants <12 months of age with congenital airway abnormality or neuromuscular disorder that decreases the ability to manage airway secretions

Infants <12 months of age with cystic fibrosis with clinical evidence of CLD and/or nutritional compromise

Children <24 months with cystic fibrosis with severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persist when stable) or weight for length less than the 10th percentile

Infants and children <24 months who are profoundly immunocompromised

Infants and children <24 months undergoing cardiac transplantation during RSV season

Limitations of use: Safety and efficacy have not been established for treatment of RSV disease.

Medication Safety Issues
Sound-alike/look-alike issues:

Synagis may be confused with Synalgos-DC, Synflorix, Synvisc

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Dermatologic: Skin rash (12%)

Miscellaneous: Fever (27%)

1% to 10%: Immunologic: Antibody development (1% to 2%)

<1%, postmarketing, and/or case reports: Anaphylaxis (very rare; includes angioedema, dyspnea, hypotonia, pruritus, respiratory failure, unresponsiveness, urticaria), hypersensitivity reaction, injection site reaction, thrombocytopenia

Contraindications

Significant prior hypersensitivity reaction to palivizumab or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Known hypersensitivity to other humanized monoclonal antibodies.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Anaphylaxis and anaphylactic shock, some fatal cases, have been reported following initial exposure or re-exposure to palivizumab; other acute hypersensitivity reactions (may be severe), have also been reported. If a significant hypersensitivity reaction occurs, permanently discontinue therapy. If anaphylaxis or other significant hypersensitivity reaction occurs, administer appropriate medications (eg, epinephrine) and provide supportive care as required. If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration.

Other warnings/precautions:

• Appropriate use: Palivizumab is not recommended for the prevention of health care-associated RSV disease (AAP 2014). Efficacy has not been established for treatment of RSV disease and use is not recommended (AAP 2014, AAP 2019 [reaffirmed]). A large placebo-controlled trial evaluated 413 infants ≤3 months of age (median age: 49 days) admitted to the hospital through an emergency department with RSV+ bronchiolitis; the treatment group (n=208) received a single dose of palivizumab (15 mg/kg IV); there was no difference between groups in readmission in the 3 weeks following hospital discharge, time to readiness for discharge, or transfer to intensive care during admission (Alansari 2019).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Pregnancy Considerations

Not for adult use.

Breastfeeding Considerations

Not for adult use.

Monitoring Parameters

Observe for anaphylactic or severe allergic reactions; respiratory syncytial virus infection.

Mechanism of Action

Exhibits neutralizing and fusion-inhibitory activity against RSV; these activities inhibit RSV replication in laboratory and clinical studies

Pharmacokinetics

Bioavailability: Infants and Children <24 months without congenital heart disease (CHD): IM: 70%.

Half-life elimination: Infants and Children <24 months without CHD: 20 to 24.5 days.

Time to peak, serum: IM: Infants and Children <24 months: 3 to 5 days (Resch 2017); palivizumab concentrations sufficient to inhibit respiratory syncytial virus 2 days after administration (Sáez-Llorens 1998).

Excretion: Clearance is similar regardless of gestational age, though interpatient variability is high (48.7% coefficient of variation). Clearance may be slightly increased (~20%) in patients with chronic lung disease of prematurity or in the presence of antipalivizumab antibodies (Robbie 2012).

Pharmacokinetics: Additional Considerations

Pediatric: Trough palivizumab concentrations are similar in pediatric patients with and without congenital heart disease. However, serum concentrations are reduced by an average of 58% following cardiopulmonary bypass (AAP 2014).

Pricing: US

Solution (Synagis Intramuscular)

50 mg/0.5 mL (per 0.5 mL): $2,090.71

100 mg/mL (per mL): $3,947.86

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Abbosynagis (IL);
  • Synagis (AE, AR, AT, AU, BE, BG, BH, BO, BR, CH, CL, CO, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IQ, IR, IT, JO, JP, KR, KW, LB, LT, LU, LV, LY, MT, MX, MY, NL, NO, NZ, OM, PE, PL, PR, PT, QA, RO, RU, SA, SE, SG, SI, SK, SY, TR, TW, UY, VE, YE, ZA)


For country code abbreviations (show table)
  1. Alansari K, Toaimah FH, Almatar DH, El Tatawy LA, Davidson BL, Qusad MIM. Monoclonal antibody treatment of RSV bronchiolitis in young infants: a randomized trial. Pediatrics. 2019;143(3):e20182308. [PubMed 30760509]
  2. American Academy of Pediatrics (AAP). AAP Publications Reaffirmed. Pediatrics. 2019;144(2). pii: e20191767. doi: 10.1542/peds.2019-1767. [PubMed 31358666]
  3. American Academy of Pediatrics (AAP). Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134(2):415-420. doi: 10.1542/peds.2014-1665. [PubMed 25070315]
  4. American Academy of Pediatrics (AAP). Interim guidance for use of palivizumab prophylaxis to prevent hospitalization from severe respiratory syncytial virus infection during the current atypical interseasonal RSV spread. Available at https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/interim-guidance-for-use-of-palivizumab-prophylaxis-to-prevent-hospitalization/. Updated August 10, 2021. Accessed August 24, 2021.
  5. American Academy of Pediatrics (AAP). Updated guidance: use of palivizumab prophylaxis to prevent hospitalization from severe respiratory syncytial virus infection during the 2022-2023 RSV season. Available at https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/interim-guidance-for-use-of-palivizumab-prophylaxis-to-prevent-hospitalization/. Updated November 17, 2022. Accessed November 28, 2022.
  6. Boeckh M, Berrey MM, Bowden RA, et al, “Phase 1 Evaluation of the Respiratory Syncytial Virus-Specific Monoclonal Antibody Palivizumab in Recipients of Hematopoietic Stem Cell Transplants,” J Infect Dis, 2001, 184(3):350-4. [PubMed 11443562]
  7. Chávez-Bueno S, Mejías A, Merryman RA, et al, "Intravenous Palivizumab and Ribavirin Combination for Respiratory Syncytial Virus Disease in High-Risk Pediatric Patients," Pediatr Infect Dis J, 2007, 26(12):1089-93. [PubMed 18043443]
  8. de Fontbrune FS, Robin M, Porcher R, et al. Palivizumab treatment of respiratory syncytial virus infection after allogeneic hematopoietic stem cell transplantation. Clin Infect Dis. 2007;45(8):1019-1024. [PubMed 17879919]
  9. Feltes TF, Cabalka AK, Meissner HC, et al, “Palivizumab Prophylaxis Reduces Hospitalization Due to Respiratory Syncytial Virus in Young Children With Hemodynamically Significant Congenital Heart Disease,” J Pediatr, 2003, 143(4):532-40. [PubMed 14571236]
  10. Giebels K, Marcotte JE, Podoba J, et al, "Prophylaxis Against Respiratory Syncytial Virus in Young Children With Cystic Fibrosis," Pediatr Pulmonol, 2008, 43(2):169-74. [PubMed 18085710]
  11. Helmink BJ, Ragsdale CE, Peterson EJ, Merkel KG. Comparison of intravenous palivizumab and standard of care for treatment of respiratory syncytial virus infection in mechanically ventilated pediatric patients. J Pediatr Pharmacol Ther. 2016;21(2):146-154. [PubMed 27199622]
  12. 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(5):1215-24. [PubMed 9359721]
  13. Malley R, DeVincenzo J, Ramilo O, et al, "Reduction of Respiratory Syncytial Virus (RSV) in Tracheal Aspirates in Intubated Infants by Use of Humanized Monoclonal Antibody to RSV F Protein," J Infect Dis, 1998, 178(6):1555-61. [PubMed 9815203]
  14. “Palivizumab, a Humanized Respiratory Syncytial Virus Monoclonal Antibody, Reduces Hospitalization From Respiratory Syncytial Virus Infection in High-Risk Infants. The IMpact-RSV Study Group,” Pediatrics, 1998, 102(3 Pt 1):531-7.
  15. Resch B. Product review on the monoclonal antibody palivizumab for prevention of respiratory syncytial virus infection. Hum Vaccin Immunother. 2017;13(9):2138-2149. [PubMed 28605249]
  16. Robbie GJ, Zhao L, Mondick J, Losonsky G, Roskos LK. Population pharmacokinetics of palivizumab, a humanized anti-respiratory syncytial virus monoclonal antibody, in adults and children [published correction appears in Antimicrob Agents Chemother. 2012;56(10):5431]. Antimicrob Agents Chemother. 2012;56(9):4927-4936. [PubMed 22802243]
  17. Sáez-Llorens X, Castaño E, Null D, et al. Safety and pharmacokinetics of an intramuscular humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. The MEDI-493 Study Group. Pediatr Infect Dis J. 1998;17(9):787-791. [PubMed 9779762]
  18. Sáez-Llorens X, Moreno MT, Ramilo O, et al, "Safety and Pharmacokinetics of Palivizumab Therapy in Children Hospitalized With Respiratory Syncytial Virus Infection," Pediatr Infect Dis J, 2004, 23(8):707-12. [PubMed 15295219]
  19. Subramanian KN, Weisman, LE, Rhodes T, et al, “Safety, Tolerance and Pharmacokinetics of a Humanized Monoclonal Antibody to Respiratory Syncytial Virus in Premature Infants With Bronchopulmonary Dysplasia. MEDI-493 Study Group,” Pediatr Infect Dis J, 1998, 17(2):110-5. [PubMed 9493805]
  20. Synagis (palivizumab) [prescribing information]. Waltham, MA: Sobi Inc; November 2021.
  21. Synagis (palivizumab) [product monograph]. Mississauga, Ontario, Canada: AstraZeneca Canada Inc; July 2021.
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