Referência de medicamentos
Valoctocogene roxaparvovec
Valoctocogene roxaparvovec is a medicine in the class miscellaneous. It is used for hemophilia a.
- Classe do medicamento: Miscellaneous
- Indicado para: hemophilia a
Última atualização Fontes: EMA SmPC
Para profissionais de saúde — apenas referência. Esta página é um resumo breve, não é aconselhamento médico nem substitui a bula oficial ou o julgamento clínico. Verifique sempre antes de prescrever ou dispensar.
O conteúdo clínico desta página está disponível apenas em inglês.
Pontos-chave
- Classe do medicamento
- Miscellaneous
- Código ATC
- B02BD15
- Interações conhecidas
- 40 (Grave: 6 · Moderada: 33 · Leve: 1)
- Nomes comerciais
- 1
- Países e mercados
- 1
Para que é usado
Como funciona
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 habitual em adultos (resumo da bula)
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.
Gravidez e amamentação
- Gravidez
- 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.
- Amamentação
- 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.
Efeitos adversos relatados
- ALT increased
- AST increased
- LDH increased
- CPK increased
- Nausea
- Headache
Contraindicações
- Hypersensitivity to the active substance or any excipient.
- Active infections (acute or uncontrolled chronic), or known significant hepatic fibrosis or cirrhosis.
Quem deve ter cuidado
- 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.
Informe ao farmacêutico ou ao médico sobre gravidez ou amamentação, doença renal ou hepática, alergias e todos os outros medicamentos ou suplementos que você usa.
Principais interações (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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Perguntas frequentes
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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