Baricitinib

Generic name
Baricitinib
Brand name
ATC Code
L04AF02
Compare …

Baricitinib

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Paediatric patients with juvenile idiopathic arthritis:
Body Weight
 10 - <20 kg <30 kg 20 - <30 kg ≥30 kg
Mean age [years] (range)
 5,1 (2,0 – 8,0) 8,1 (2,0 – 16,0 ) 10,3 (6,0 – 16,0 ) 14,1 (9,0 – 17,0)
Cmax [ng/mL] 77,6 62,1 51,2 60,7
T1/2 [h] (mean) 8 - 9

 

Paediatric patients with atopic dermatitis:
Body Weight 10 - <20 kg <30 kg 20 - <30 kg ≥30 kg
Mean age [years] (range) 4,8 (2,0 – 6,9) 6,4 (2,0 -11,1) 7,5 (4,8 – 11,1) 13,5 (6,2 – 17,9)
Cmax [ng/mL] 73,4 60,4 52,0 57,0
T1/2 [h] (mean) 13 - 18


[SmPC Olumiant]

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

Juvenile idiopathic arthritis (JIA)
  • Oral
    • ≥ 2 years and 10 up to 30 kg
      • 2 mg/day in 1 dose

      • Consider discontinuation of treatment if no beneficial effect is observed after 12 weeks.

    • ≥ 2 years and ≥ 30 kg
      • 4 mg/day in 1 dose

      • Consider discontinuation of treatment if no beneficial effect is observed after 12 weeks.

    • ≥ 2 years and 10 up to 30 kg
      [1]
      • 2 mg/day in 1 dose

      • Consider discontinuation of treatment if no beneficial effect is observed after 12 weeks.

    • ≥ 2 years and ≥ 30 kg
      [1]
      • 4 mg/day in 1 dose

      • Consider discontinuation of treatment if no beneficial effect is observed after 12 weeks.

Renal impaiment in children > 3 months

GFR 30 - 60 ml/min/1.73 m2: 50 % of the recommended daily dose
GFR <30 ml/min/1.73 m2: Use not recommended

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

Pediatric patients (2 - 18 years) with juvenile idiopathic arthritis:

Very common (>10%): headache

Common (1 - 10%): neutropenia < 1 000 cells/mm3, pulmonary embolism

Pediatric patients (2 - 18 years) with atopic dermatitis:

The safety profile in these patients was comparable to that observed in the adult population.

Common (1 - 10%): neutropenia (< 1 x 109 cells/L)

[SmPC Oluminat]

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

Lipids
Dose dependent increases in blood lipid parameters were reported in paediatric and adult patients treated with baricitinib. Elevations in low density lipoprotein (LDL) cholesterol decreased to pre-treatment levels in response to statin therapy in adults. In both paediatric and adult patients, lipid parameters should be assessed approximately 12 weeks following initiation of therapy and thereafter patients should be managed according to international clinical guidelines for
hyperlipidaemia.

[SmPC Oluminat]

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
L04AF08
L04AF01
Monoclonal antibodies
L04AG04
Mammalian target of rapamycin (mTOR) kinase inhibitors
L04AH02
L04AH01
Complement inhibitors
L04AJ01
L04AJ02
Dihydroorotate dehydrogenase (DHODH) inhibitors
L04AK02

Reference

  1. Eli Lilly Nederland B.V., SmPC Olumiant (EU/1/16/1170/001-19) Rev 17, last updated: 30/10/2023, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose