- 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]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Juvenile idiopathic arthritis (JIA) |
|---|
|
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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
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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]
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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]
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| 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 | ||
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Reference
- Eli Lilly Nederland B.V., SmPC Olumiant (EU/1/16/1170/001-19) Rev 17, last updated: 30/10/2023, www.ema.europa.eu
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Changes
Changes
