- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Cl and Vd both decrease with decreasing body weight in JIA-patiënts.
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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
| Polyarticular juvenile idiopathic arthritis (JIA); juvenile psoriatic arthritis (PsA) |
|---|
|
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Renal impaiment in children > 3 months
GFR ≥30 ml/min/1.73 m2: Dose adjustment is not necessary.
GFR <30 ml/min/1.73 m2:
Children ≥40 kg: 5 mg 1dd
Children <40 kg: no data available
Clinical consequences
In renal impairment, the AUC of tofacitinib increases. This increases the risk of haematological toxicity.
Patients on dialysis
Children ≥40 kg: 5 mg 1dd
Children <40 kg: no data available
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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
Flu, pharyngitis, sinusitis, viral infection, abdominal pain, nausea, vomiting, pyrexia, headache, and cough are more common in children.
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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
If a patient develops a severe infection, tofacitinib treatment should be interrupted until the infection is controlled.
Dose interruption may be required for the treatment of dose-related laboratory abnormalities, including lymphopenia, neutropenia and anaemia. Based on the severity of the laboratory abnormalities, it is recommended to temporarily interrupt or permanently discontinue treatment (see SmPC ).
Initiation of treatment is not recommended in patients with an absolute lymphocyte count (ALC) below 750 cells/mm3, an absolute neutrophil count (ANC) below 1,200 cells/mm3 or a hemoglobin value below 6.1 mmol/L (10 g/dl).
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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 | ||
| L04AF02 | ||
| L04AF08 | ||
| 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
- Pfizer Europe MA EEIG, SmPC Xeljanz (EU/1/17/1178/010-013) 14-09-2021, www.ema.europa.eu
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Changes
Changes
