Ravulizumab

Generic name
Ravulizumab
Brand name
ATC Code
L04AJ02

Ravulizumab

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

  PNH aHUS
Vd steady state - mean (SD) 5,30 (0,9) l 5,22 (1,85) l
T½ mean (SD) 49,6 (9,1) days 51,8 (16,2) das
Cl mean (SD) 0,08 (0,022) l/day 0,08 (0,04) l/day

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)
  • Intravenous
    • 10 up to 20 kg
      • Initial dose: 600 mg/dose, once only.
      • Maintenance dose: 2 weeks after initial dose: 600 mg/dose once every 4 weeks.
    • 20 up to 30 kg
      • Initial dose: 900 mg/dose, once only.
      • Maintenance dose: 2 weeks after initial dose: 2.100 mg/dose once every 8 weeks.
    • 30 up to 40 kg
      • Initial dose: 1.200 mg/dose, once only.
      • Maintenance dose: 2 weeks after initial dose: 2.700 mg/dose once every 8 weeks.
    • 40 up to 60 kg
      • Initial dose: 2.400 mg/dose, once only.
      • Maintenance dose: 2 weeks after initial dose: 3.000 mg/dose once every 8 weeks.
    • 60 up to 100 kg
      • Initial dose: 2.700 mg/dose, once only.
      • Maintenance dose: 2 weeks after initial dose: 3.300 mg/dose once every 8 weeks.

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 effect profile in children is similar to that in adults. 

The most common side effects in children are abdominal pain, nasopharyngitis and pyrexia. 

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

No information available on specific warnings and precautions in children.

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
L04AJ01
Dihydroorotate dehydrogenase (DHODH) inhibitors
L04AK02

Reference

  1. Alexion Europe SAS, SmPC Ultomiris (EU 1/19/137/001) Rev.13, 26-09-2023, www.emea.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose