Dosing and uses of Synagis (palivizumab)
Adult dosage forms and strengths
Not indicated
Pediatric dosage forms and strengths
powder for reconstution (injection)
- 100mg/mL
RSV Prophylaxis
Indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease
15 mg/kg IM q1Month during RSV season with first dose administered prior to the season
High risk for RSV
- Children (≤2 yr) with bronchopulmonary dysplasia
- Infants with a history of premature birth (≤35 weeks gestational age)
- Children (≤2 yr) with hemodynamically significant congenital heart disease
AAP guidelines
- Limit RSV prophylaxis to infants born before 29 weeks' gestation and to infants with chronic illness (eg, congenital heart disease, chronic lung disease)
- Give infants who qualify for prophylaxis in the first year of life no more than 5 monthly doses of palivizumab (15 mg/kg per dose) during the RSV season
- In the second year of life, palivizumab prophylaxis is recommended only for children who needed supplemental oxygen for ≥28 days after birth and who continue to need medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy)
- Clinicians may consider prophylaxis for children <24 months if they will be profoundly immunocompromised during the RSV season
- Pediatrics. 2014 Aug;134(2):415-20
Synagis (palivizumab) adverse (side) effects
>10%
Fever (27%)
Rash (26%)
1-10%
Antibody formation (1-2%)
<1%
Pain
Hernia
SGOT increased
Cough
Bronchiolitis
Pneumonia
Dyspnea
Sinusitis
Apnea
Thrombocytopenia
Failure to thrive
Diarrhea
Vomiting
Conjunctivitis
Eczema
Anemia
Angioedema
Flu syndrome
Warnings
Contraindications
Hypersensitivity
Cautions
Use caution in patients with thrombocytopenia, coagulation disorders
Inject in anterolateral thigh, not gluteal muscle
May interfere with immunological-based RSV diagnostic tests and viral culture assays
Pregnancy and lactation
Pregnancy category: C
Lactation: no studies done
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Synagis (palivizumab)
Mechanism of action
Monoclonal antibody binds to F protein on RSV; prevents virus from infecting celL
Pharmacokinetics
Half-Life: 20 days (<24 months old)
