- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information is present at this moment.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Relapsing Remitting Multiple Sclerose (RRMS) |
|---|
|
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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.
Patients on dialysis
Do not use in dialysis
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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
The side effects in children are generally similar to those in adults.
In children, the following side effects are more common than in adults: alopecia, infections (nasopharyngitis and upper respiratory tract infections), CPK increase, paraesthesia and abdominal pain.
Also reported: pancreatitis (see warnings and precautions)
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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
In children, pancreatitis has been reported with symptoms such as abdominal pain, nausea, and/or vomiting and elevated serum amylase and lipase levels. If pancreatitis is suspected, determine pancreatic enzymes and related laboratory parameters. If pancreatitis is confirmed, discontinue treatment and initiate an accelerated elimination procedure with colestyramine or activated charcoal (see Dosage).
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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 | ||
| L04AF01 | ||
| Monoclonal antibodies | ||
|---|---|---|
| L04AG04 | ||
| Mammalian target of rapamycin (mTOR) kinase inhibitors | ||
|---|---|---|
| L04AH02 | ||
| L04AH01 | ||
| Complement inhibitors | ||
|---|---|---|
| L04AJ01 | ||
| L04AJ02 | ||
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Reference
- Sanofi-Aventis Groupe, SmPC Aubagio (EU/1/13/838/001) Rev 26; 22-08-2023, www.ema.europa.eu
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Changes
Changes
