Palivizumab
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of palivizumab
Drugs List
Therapeutic Indications
Uses
Prevention of serious lower respiratory tract disease caused by RSV
The manufacturer recommends palivizumab for 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 who are less than 6 months of age at the onset of the RSV season
Children less than 2 years of age who have received treatment for bronchopulmonary dysplasia within the last 6 months
Children less than 2 years of age with haemodynamically significant congenital heart disease
The Joint Committee on Vaccination and Immunisation have adopted the following recommendations for the use of palivizumab in passive immunisation against RSV. Palivizumab is recommended for use in all infants in the following groups:
Children under 9 months who have chronic lung disease (CLD) and who were born prematurely. The definition of CLD is oxygen dependency for at least 28 days from birth
Children under 6 months who have haemodynamically significant, acyanotic congenital heart disease (CHD) who were born preterm
Palivizumab should also be considered during the RSV season for the following groups of infants:
All children under the age of 24 months who have severe combined immunodeficiency syndrome (SCID), until immune reconstituted
All children who are on long term ventilation (LTV) aged under 12 months at the start of the RSV season
All children who are on LTV aged under 24 months at the start of the RSV season with additional co-pathology (heart disease/pulmonary hypertension, intrinsic lung disease (as reflected by oxygen dependency)
Dosage
Children
Palivizumab is intended for children less than 2 years of age at high risk of respiratory syncytial viral disease (RSV).
15 mg/kg bodyweight given once a month during anticipated periods of RSV risk in the community.
The first dose should be administered prior to the beginning of the RSV season. Subsequent monthly doses should be administered throughout the RSV season. The benefit in terms of protection beyond 5 doses has not been established.
Children who are hospitalised due to RSV should continue to receive monthly palivizumab doses for the rest of the RSV season to reduce the risk of re-hospitalisation.
Children undergoing cardiac bypass should receive 15 mg/kg bodyweight as soon as they are stable following surgery to ensure adequate palivizumab serum levels. Subsequent monthly doses should be administered throughout the RSV season in children that continue to be at high risk of RSV disease.
Administration
For intramuscular administration, preferably into the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site due to the risk of sciatic nerve damage.
The injection should be given using standard aseptic techniques.
Injection volumes greater than 1 ml should be administered as divided doses.
Contraindications
None known
Precautions and Warnings
Acute infection
Febrile disorder
Coagulopathy
Thrombocytopenia
Resuscitation facilities must be immediately available
May affect results of some laboratory tests
Pregnancy and Lactation
Pregnancy
Not applicable - intended for children of 2 years or less.
Lactation
Not applicable - intended for children of 2 years or less.
Side Effects
Anaphylactic shock
Anaphylaxis
Apnoea
Asthenia
Constipation
Convulsions
Cough
Diarrhoea
Drowsiness
Haemorrhage
Hyperkinesia
Hypersensitivity reactions
Injection site reactions
Leucopenia
Nervousness
Pain - generalised
Pyrexia
Rash
Rhinitis
Thrombocytopenia
Urticaria
Vomiting
Wheezing
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2015
Reference Sources
Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 14 September 2015.
Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 14 September 2015.
Summary of Product Characteristics: Synagis 50 mg or 100 mg powder and solvent for solution for injection. AbbVie Ltd. Revised July 2015.
Summary of Product Characteristics: Synagis 100 mg solution for injection. AbbVie Ltd. Revised July 2015.
Immunisation against infectious disease - 'The Green Book'.
Respiratory syncytial virus - Amended September 2015
Department of Health.
Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/458469/Green_Book_Chapter_27a_v2_0W.PDF and
Available at: https://webarchive.nationalarchives.gov.uk/20130107105354/https://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_120395.pdf
Last accessed: September 14, 2015
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.