Palivizumab

Generic name
Palivizumab
Brand name
ATC Code
J06BD01
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Palivizumab

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

In prophylactic studies in premature infants and paediatric populations with bronchopulmonary dysplasia the average half-life of palivizumab was 20 days and monthly intramuscular doses of 15 mg/kg led to an average of 30 days serum off-peak concentrations of the active component of about 40 mcg/ml after the first injection, about 60 mcg/ml after the second injection and about 70 mcg/ml after the third and fourth injection.
In the study on congenital heart diseases, a monthly intramuscular dosage of 15 mg/kg led to average 30-day serum trough concentrations of the active component of about 55 mcg/ml after the first injection and about 90 mcg/ml after the fourth injection.
In 139 children with a cardiopulmonary bypass of the congenital heart diseases study who received palivizumab and for whom pairs of serum samples were available, the average serum concentration of palivizumab was about 100 μg/ml for the cardiac bypass, which reduced to about 40 micrograms/ml after the bypass.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Prophylaxis for RSV infection
  • Intramuscular
    • 0 years up to 2 years
      • 15 mg/kg/dose once every 4 weeks.

      • Indicated for the following patient groups:

        •  children born after a pregnancy of 32 weeks or less and who were younger than 6 months at the start of the RSV season.

        Note: the SPC reports a pregnancy of 35 weeks or less. However, palivuzumab is only compensated for children who are born after a pregnancy of 32 weeks or less (CFH recommendation of 29 June 2009).

        • children younger than two years who needed treatment for bronchopulmonary dysplasia in the preceding 6 months
        • children younger than 2 years who have a congenital heart complaint that is haemodynamically significant


        If possible, start before the RSV season (October-March) and then during the RSV season

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Very common (>10 %): Skin rash, pyrexia.

Common (1-10 %): Apnoea, injection site reactions.

Uncommonl (0,1-1 %): Convulsion, thrombocytopenia, urticaria

Frequency unknown: Anaphylaxis, anaphylactic shock (in some cases with fatal outcome)

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Hypersensitivity to other humanised monoclonal antibodies

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In moderate to severe acute infection or febrile illness, weigh the benefits and risks of delaying injection. Caution in patients with thrombocytopenia or any coagulation disorder. Caution in patients with thrombocytopenia or any coagulation disorder. Be mindful of the occurrence of a possible anaphylactic reaction or shock. Palivizumab may interfere with immune-based diagnostic RSV testing and inhibits virus replication in cell cultures. It does not interfere with reverse transcriptase polymerase chain reaction-based tests. [SmPC Synagis]

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

IMMUNOGLOBULINS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Immunoglobulins, normal human
J06BA02
J06BA01
Specific immunoglobulins
J06BB01
J06BB04
J06BB02
J06BB03
Antibacterial monoclonal antibodies
J06BC03
IMMUNOGLOBULINS, NORMAL HUMAN
J06BA02
J06BA01
Antiviral monoclonal antibodies
J06BD07
J06BD08

References

  1. Abbot Laboratories Ltd, SPC Synagis EU/1/99/117/001, www.ema.europa.eu, Geraadpleegd 26 maart 2013, http://www.ema.europa.eu/humandocs/PDFs/EPAR/Synagis/emea-combined-h257nl.pdf
  2. Feltes TF et al, Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart diseaese., J. Pediatr, 2003, 143(4), 532-40

Changes

Therapeutic Drug Monitoring


Overdose