Référentiel des médicaments
Etranacogene dezaparvovec
Etranacogene dezaparvovec is a medicine in the class miscellaneous. It is used for hemophilia b.
- Classe médicamenteuse: Miscellaneous
- Indications: hemophilia b
Dernière mise à jour Sources: US FDA label
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L'essentiel
- Classe médicamenteuse
- Miscellaneous
- Noms commerciaux
- 1
- Pays et marchés
- 1
Indications
Mécanisme d'action
AAV5-based gene therapy that delivers a copy of a gene encoding the Padua variant of human coagulation Factor IX (hFIX-Padua). A single IV infusion causes cell transduction and increases circulating Factor IX activity in hemophilia B.
Posologie adulte habituelle (résumé de la notice)
Hemophilia B (congenital Factor IX deficiency): 2 × 10 13 gc/kg body weight (2 mL/kg), single IV infusion after dilution with 0.9% sodium chloride, at a constant rate of 500 mL/hour (8 mL/min); can be administered only once
Grossesse et allaitement
- Grossesse
- Unsafe Not intended for use in women. EU SmPC: should not be used during pregnancy; no human data or animal reproduction studies; fetal harm unknown. Males and female partners should use barrier contraception for 12 months. US: mouse mating study showed no adverse effects on fertility or fetal weight.
- Allaitement
- Unknown Not intended for administration in women.
Effets indésirables signalés
- Blood creatine kinase increased
- Aspartate aminotransferase increased
- Alanine aminotransferase increased
- Infusion-related reactions
- Headache
- Flu-like symptoms
Précautions particulières
- Hypersensitivity and infusion-related reactions, including anaphylaxis, can occur. Monitor during infusion and for at least 3 hours afterward; slow or stop the infusion if a reaction occurs.
- Hepatotoxicity with elevated transaminases can occur. Monitor ALT weekly for 3 months, then monthly for up to 1 year. Consider a corticosteroid course if ALT rises above the ULN or double baseline.
- All patients developed neutralizing anti-AAV5 antibodies after treatment.
Informez votre pharmacien ou votre médecin en cas de grossesse ou d'allaitement, de maladie rénale ou hépatique, d'allergies, ainsi que de tout autre médicament ou complément que vous prenez.
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- Food interactions
- IV preparation and dilution
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Questions fréquentes
What is Etranacogene dezaparvovec used for?
Etranacogene dezaparvovec is a medicine in the class miscellaneous. It is used for Hemophilia b.
What side effects have been reported with Etranacogene dezaparvovec?
Blood creatine kinase increased, Aspartate aminotransferase increased, Alanine aminotransferase increased, Infusion-related reactions, Headache, Flu-like symptoms.
Can Etranacogene dezaparvovec be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. Not intended for use in women. EU SmPC: should not be used during pregnancy; no human data or animal reproduction studies; fetal harm unknown. Males and female partners should use barrier contraception for 12 months. US: mouse mating study showed no adverse effects on fertility or fetal weight. Breastfeeding: Unknown. Not intended for administration in women.
What does Etranacogene dezaparvovec interact with?
MediHelp does not list a checked interaction for Etranacogene dezaparvovec yet. Always tell your pharmacist about every medicine you take.
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