Palivizumab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: February 20, 2026🚩 Report this page

Palivizumab

Antiviral Monoclonal Antibodies

Sold as Synagis

GB MHRAEU EMA

Drug class: Antiviral Monoclonal Antibodies
Availability: See label
Markets covered: 2
Products on record: 3

Overview

Palivizumab is an active pharmaceutical ingredient in the Antiviral Monoclonal Antibodies group (J06BD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	February 20, 2026
EU European Union	EMA	1	December 12, 2025

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised February 20, 2026[1]

Synagis is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: • Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.
• Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months. • Children less than 2 years of age and with haemodynamically significant congenital heart disease.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised December 12, 2025[2]

Synagis is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease:  Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.
 Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.  Children less than 2 years of age and with haemodynamically significant congenital heart disease.

How to take

Sources & citations

[1]MHRA (UK) · PLGB179010362 · revised February 20, 2026
[2]European Medicines Agency · EMEA/H/C/000257 · revised December 12, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised February 20, 2026[1]

Summary of the safety profile The most serious adverse reactions occurring with palivizumab are anaphylaxis and other acute hypersensitivity reactions. Common adverse reactions occurring with palivizumab are fever, rash, and injection site reaction.
Tabulated list of adverse reactions Adverse reactions both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1,000 to < 1/100; rare ≥ 1/10,000 to <1/1,000 ) in studies conducted in premature and bronchopulmonary dysplasia paediatric patients, and paediatric congenital heart disease patients.
The adverse reactions identified via post-marketing surveillance are reported voluntarily from a population of uncertain size; it is not always possible to reliably estimate their frequency or establish a causal relationship to palivizumab exposure.
The frequency for these "ADRs" as presented in the table below was estimated using the safety data of the two registration clinical studies. The incidences of these reactions in these studies showed no difference between the palivizumab and placebo groups and the reactions were not drug related.
1 Clinical studies # ADRs identified from post-marketing surveillance Description of selected adverse reactions Post-marketing experience Post-marketing serious spontaneous adverse reactions reported during palivizumab treatment between 1998 and 2002 covering four RSV seasons were evaluated.
A total of 1,291 serious reports were received where palivizumab had been administered as indicated and the duration of therapy was within one season. The onset of the adverse reactions occurred after the sixth or greater dose in only 22 of these reports (15 after the sixth dose, 6 after the seventh doses and 1 after the eight dose).
These adverse reactions are similar in character to those after the initial five doses. Palivizumab treatment schedule and adverse reactions were monitored in a group of nearly 20,000 infants tracked through a patient compliance registry between 1998 and 2000.
Of this group 1,250 enrolled infants had 6 injections, 183 infants had 7 injections, and 27 infants had either 8 or 9 injections. Adverse reactions observed in patients after a sixth or greater dose were similar in character and frequency to those after the initial 5 doses.
In a small open label prospective trial of 14 subjects, who received 6 doses, the adverse events reported were consistent with the known safety profile of palivizumab. In an observational, post-marketing, database study, a small increase in the frequency of asthma was observed among preterm palivizumab recipients; however, the causal relationship is uncertain.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised February 20, 2026[1]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Allergic reactions including very rare cases of anaphylaxis and anaphylactic shock have been reported following palivizumab administration.
8). Medicinal products for the treatment of severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, should be available for immediate use following administration of palivizumab. A moderate to severe acute infection or febrile illness may warrant delaying the use of palivizumab, unless, in the opinion of the physician, withholding palivizumab entails a greater risk.
A mild febrile illness, such as mild upper respiratory infection, is not usually reason to defer administration of palivizumab. Palivizumab should be given with caution to patients with thrombocytopaenia or any coagulation disorder.
The efficacy of palivizumab when administered to patients as a second course of treatment during an ensuing RSV season has not been formally investigated in a study performed with this objective. The possible risk of enhanced RSV infection in the season following the season in which the patients were treated with palivizumab has not been conclusively ruled out by studies performed aiming at this particular point.

This is not medical advice. Consult a qualified healthcare professional.