- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information.
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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
| 5q spinal muscle atrophy (SMA) |
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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
Very common (> 10%): elevated liver enzymes (including ALT, ammonium, AST, ɣGT and liver function test).
Common (1-10%): Thrombocytopenia, vomiting, hepatotoxicity (including hepatic steatosis and hypertransaminasaemia), pyrexia, increased troponin and decreased platelet count.
Thrombotic microangiopathy, acute liver injury and acute liver failure have been reported.
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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 in children
Hypersensitivity.
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
After administration, an immune response to the capsid of the adeno-associated viral vector serotype 9 (AAV9) develops which can lead to an increase in transaminase levels and troponin-1, and a decrease in platelet counts. To inhibit this immune response, corticosteroids are recommended starting 24 hours prior to infusion.
AAV9 antibodies should be monitored prior to and during treatment, as well as transaminase levels, bilirubin, complete blood counts (including hemoglobin and platelets), creatinine and troponin-I. There is no association between high AAV9 antibody titres and the occurrence of side effects and the effect.
In acute or chronic uncontrolled active infection, treatment should be delayed due to the immunomodulatory treatment regimen.
Caution is advised in hepatic impairment (except neonatal jaundice due to bilirubin elevation) due to the lack of data on safety and efficacy.
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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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| Other drugs for disorders of the musculo-skeletal system | ||
|---|---|---|
| M09AX03 | ||
| M09AX07 | ||
| M09AX10 | ||
| M09AX09 | ||
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Reference
- Novartis Gene Therapies EU Limited, SmPC Zolgensma (EU/1/20/1443/001 -037) 17-08-2021, www.ema.europa.eu
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Changes
Changes
