Riferimento farmaci
Valoctocogene roxaparvovec
Valoctocogene roxaparvovec is a medicine in the class miscellaneous. It is used for hemophilia a.
- Classe del farmaco: Miscellaneous
- Indicato per: hemophilia a
Ultimo aggiornamento Fonti: EMA SmPC
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In breve
- Classe del farmaco
- Miscellaneous
- Codice ATC
- B02BD15
- Interazioni note
- 40 (Maggiore: 6 · Moderata: 33 · Minore: 1)
- Nomi commerciali
- 1
- Paesi e mercati
- 1
Per cosa si usa
Come agisce
AAV5-based gene therapy vector that expresses B-domain deleted SQ recombinant human factor VIII (hFVIII-SQ) under a liver-specific promoter, replacing the missing factor VIII. Vector DNA forms episomal transgenes that support long-term hFVIII-SQ production.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
Severe haemophilia A: 6 × 1013 vg/kg body weight, intravenous, as a single infusion. Dose volume in mL = body weight in kg multiplied by 3.
Gravidanza e allattamento
- Gravidanza
- Unsafe Gene therapy for men with severe haemophilia A. No pregnancy data or animal studies; theoretical risk of vector DNA reaching fetal cells. EU label: should not be used in pregnancy; not recommended in women who could become pregnant. Partners of treated men: double-barrier contraception for 6 months.
- Allattamento
- Unknown Not known if the vector or factor VIII it produces passes into milk; no LactMed record. EU label: a risk to the infant cannot be excluded; should not be used while breastfeeding. It is licensed for men, so use while breastfeeding is not expected.
Effetti indesiderati segnalati
- ALT increased
- AST increased
- LDH increased
- CPK increased
- Nausea
- Headache
Controindicazioni
- Hypersensitivity to the active substance or any excipient.
- Active infections (acute or uncontrolled chronic), or known significant hepatic fibrosis or cirrhosis.
Chi deve prestare attenzione
- Only for patients demonstrated to lack anti-AAV5 antibodies by a validated assay; not indicated with a history of factor VIII inhibitors.
- Hepatic reactions (ALT increase) occur in most patients; monitor ALT and factor VIII activity and give corticosteroids as needed.
- Infusion-related reactions can occur; monitor during and after infusion.
Informare il farmacista o il medico di gravidanza o allattamento, malattie renali o epatiche, allergie e di ogni altro farmaco o integratore assunto.
Interazioni principali (40)
- Dantrolene + Valoctocogene roxaparvovec Major
- Efavirenz + Valoctocogene roxaparvovec Major
- Flutamide + Valoctocogene roxaparvovec Major
- Nevirapine + Valoctocogene roxaparvovec Major
- Propylthiouracil + Valoctocogene roxaparvovec Major
- Valoctocogene roxaparvovec + Valproic acid Major
- Allopurinol + Valoctocogene roxaparvovec Moderate
- Amiodarone + Valoctocogene roxaparvovec Moderate
- Amoxicillin-clavulanic acid + Valoctocogene roxaparvovec Moderate
- Azathioprine + Valoctocogene roxaparvovec Moderate
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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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Domande frequenti
What is Valoctocogene roxaparvovec used for?
Valoctocogene roxaparvovec is a medicine in the class miscellaneous. It is used for Hemophilia a.
What side effects have been reported with Valoctocogene roxaparvovec?
ALT increased, AST increased, LDH increased, CPK increased, Nausea, Headache.
Can Valoctocogene roxaparvovec be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. Gene therapy for men with severe haemophilia A. No pregnancy data or animal studies; theoretical risk of vector DNA reaching fetal cells. EU label: should not be used in pregnancy; not recommended in women who could become pregnant. Partners of treated men: double-barrier contraception for 6 months. Breastfeeding: Unknown. Not known if the vector or factor VIII it produces passes into milk; no LactMed record. EU label: a risk to the infant cannot be excluded; should not be used while breastfeeding. It is licensed for men, so use while breastfeeding is not expected.
What does Valoctocogene roxaparvovec interact with?
MediHelp lists 40 known interactions for Valoctocogene roxaparvovec. Major: 6 · Moderate: 33 · Minor: 1. The most serious include Dantrolene, Efavirenz, Flutamide.
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