Palivizumab

J06B - Immunoglobulins ATC J06BD01 Antibody approved 1998 Parenteral

JFDA label: Synagis 50mg/0.5ml Solution For Injection

Mechanism of Action

Inhibitor of Fusion glycoprotein F0 — Fusion glycoprotein F0 inhibitor

Target	Action	Gene / class
Fusion glycoprotein F0 efficacy	INHIBITOR	F · Surface antigen

Indications

Approved

Respiratory syncytial virus prophylaxis

Class profile

targetVirus	RSV
viralClass	Pneumoviridae (-ssRNA)
targetStep	F protein neutralization (monoclonal antibody, prevents cell-cell fusion)
resistanceBarrier	Moderate (K272N/E mutation in site II of F protein; prophylaxis not treatment)
crossResistance	No cross-resistance with small molecule F protein inhibitors
source	DHHS/AASLD/manufacturer-PIL

Contraindications

Source: Lexicomp

Additional contraindications (not in U.S. labeling): Known hypersensitivity to other humanized monoclonal antibodies Absolute
Significant prior hypersensitivity reaction to palivizumab or any component of the formulation Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Skin and subcutaneous tissue disorders (1)

Very Common Skin rash

General disorders and administration site conditions (1)

Very Common Fever

Other (1)

Common Immunologic: Antibody development

Dosing

Source: Lexicomp

(For additional information see "Palivizumab: Pediatric drug information") Respiratory syncytial virus prophylaxis: IM: Infants and children Note: American Academy of Pediatrics (AAP) recommends a maximum of 5 doses per season; 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 an additional 15 mg/kg dose as soon as possible after cardiopulmonary bypass procedure or at the conclusion of extracorporeal membrane oxygenation, even if

There are no dosage adjustments provided in the manufacturer’s labeling.

Warnings & Precautions

Source: Lexicomp

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. Drug-drug interactions:

Drug-drug interactions

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions:

Appropriate use

Palivizumab is not recommended for the prevention of health care-associated RSV disease (AAP 2014). Safety and efficacy have not been established for treatment of RSV disease.

Pregnancy & Lactation

Pregnancy

Not for adult use.

Lactation

Not for adult use.

Monitoring

Efficacy	Viral load (undetectable = success); CD4 count (HIV); hepatic enzymes and HBV/HCV DNA (hepatitis); clinical resolution of acute viral illness
Toxicity	Renal function (most antivirals are renally cleared); LFTs; resistance testing if virological failure; CBC
Clinical pearl	For HIV, undetectable viral load at 6 months predicts long-term treatment success. Resistance testing is mandatory at virological failure.
Counseling	Do not miss doses — even brief interruptions can cause viral rebound and resistance selection. Report any side effects early rather than stopping independently.

Biology & Pharmacokinetics

Pharmacokinetics

Half-life	Infants and Children Clearance: Infants and Children

Registered Products (1)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Synagis 50mg/0.5ml Solution For Injection	Injection 50 mg/0.5 ml	1 vial	Shawi & Rushedat Drug Store	—