Eculizumab

Generic name
Eculizumab
Brand name
ATC Code
L04AJ01
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Eculizumab

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

  child 10 kg child 30 kg child 70 kg
Cl ml/hour 2,2 5,3 10,4
Vd (l) 1,21 2,76 5,23
T1/2 el 349 - 378 hours (14,5-16 days) 349 - 378 hours (14,5-16 days) 349 - 378 hours (14,5-16 days)

Source: SmPC; values based on a PK model incorporating multiple-dose PK data from 22 pediatric aHUS patients.

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

Atypical haemolytic-uraemic syndrome (aHUS), paroxysmal nocturnal haemoglobinuria (PNH), C3 glomerulopathy (C3G), Refractory generalized myasthenia gravis (gMG)
  • Intravenous
    • 5 up to 10 kg

      • Weeks 1 and 2: 300 mg/dose once a week
        Then: 300 mg/dose once every 3 weeks

      • Treatment by a paediatric specialist (nephrologist) who has experience with using eculizumab for this indication.

    • 10 up to 20 kg

      • Week 1: 600 mg/dose once a week
        Week 2: 300 mg/dose once a week
        Then: 300 mg/dose once every 2 weeks

      • Treatment by a paediatric specialist (nephrologist) who has experience with using eculizumab for this indication.

    • 20 up to 30 kg

      • Week 1 and 2 and 3: 600 mg/dose once a week
        Then: 600 mg/dose once every 2 weeks

      • Treatment by a paediatric specialist (nephrologist) who has experience with using eculizumab for this indication.

    • 30 up to 40 kg

      • Weeks 1 and 2: 600 mg/dose once a week
        Week 3: 900 mg/dose once a week
        Then: 900 mg/dose once every 2 weeks

      • Treatment by a paediatric specialist (nephrologist) who has experience with using eculizumab for this indication.

    • ≥ 40 kg

      • aHUS, C3G:
        weeks 1, 2, 3, 4: 900 mg/dose once a week
        week 5: 1200 mg/dose once a week
        then: 1200 mg/dose once every 2 weeks

        No research has been done into the use of eculizumab for C3G

        PNH:
        weeks 1, 2, 3, 4: 600 mg/dose once a week
        week 5: 900 mg/dose once a week
        then 900 mg/dose once every two weeks

      • Treatment by a paediatric specialist (nephrologist) who has experience with using eculizumab for this indication.

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

The side effects in children are comparable to those in adults. Headaches occur most often in children with PNH.

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

Contra-indications

No information available on specific contra indications in children.

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

Before starting the therapy, administer immunization according to the applicable immunization guidelines; vaccinate or revaccinate against meningococcal infection (Neisseria meningitidis) at least two weeks before starting the therapy and pay careful attention during the therapy to early signs of a meningococcal infection (various serogroups are possible). 

If the therapy is started less than two weeks after any vaccinations, consider using antibiotic prophylaxis.

If an undesired episode occurs during the administration of Soliris, the infusion can be decelerated or discontinued, depending on the doctor’s judgement. If the infusion is decelerated, the total infusion time must not be longer than two hours for adults and adolescents and four hours for children aged less than 12 years.

Interactions

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

IMMUNOSUPPRESSANTS

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

Selective immunosuppressants
L04AA24
L04AA32
L04AA13
L04AA02
L04AA06
L04AA31
L04AA04
L04AA44
Other immunosuppressants
L04AX01
L04AX03
Tumor necrosis factor alpha (TNF-alpha) inhibitors
L04AB04
L04AB01
L04AB06
L04AB02
Interleukin inhibitors
L04AC03
L04AC02
L04AC08
L04AC13
L04AC19
L04AC10
L04AC22
L04AC07
L04AC05
Calcineurin inhibitors
L04AD01
L04AD02
Sphingosine-1-phosphate (S1P) receptor modulators
L04AE01
Janus-associated kinase (JAK) inhibitors
L04AF02
L04AF02
L04AF08
L04AF01
Monoclonal antibodies
L04AG04
Mammalian target of rapamycin (mTOR) kinase inhibitors
L04AH02
L04AH01
Complement inhibitors
L04AJ02
Dihydroorotate dehydrogenase (DHODH) inhibitors
L04AK02

References

  1. Alexion Europe SAS, SPC Soliris (EU/1/07/393/001) Rev 36; 21-08-2023, www.ema.europa.eu
  2. Bomback AS et al., Eculizumab in the treatment of membranoproliferative glomerulonephritis., Nephron Clin Pract., 2014, 128(3-4), 270-6
  3. Häffner K et al., Successful therapy of C3Nef-positive C3 glomerulopathy with plasma therapy and immunosuppression., Pediatr Nephrol., 2015, May 19
  4. Payette A et al., A case of C3 glomerulonephritis successfully treated with eculizumab., Pediatr Nephrol., 2015, Jun;30(6), 1033-7
  5. Sánchez-Moreno A et al., Eculizumab in dense-deposit disease after renal transplantation., Pediatr Nephrol., 2014, Oct;29(10):, 2055-9
  6. Vivarelli M et al., Treatment of C3 glomerulopathy with complement blockers., Semin Thromb Hemost., 2014, Jun;40(4), 472-7

Changes

Therapeutic Drug Monitoring


Overdose