Referência de medicamentos
Beremagene geperpavec
Beremagene geperpavec is a medicine in the class miscellaneous.
- Classe do medicamento: Miscellaneous
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
- D03AX16
- Nomes comerciais
- 1
- Países e mercados
- 1
Como funciona
Gene therapy using a replication-defective HSV-1 vector carrying COL7A1. After cutaneous application it transduces keratinocytes and fibroblasts, and the vector genome stays in the nucleus without integrating into host DNA. The cells then produce COL7, which forms anchoring fibrils that hold epidermis and dermis together.
Dose habitual em adultos (resumo da bula)
Wounds in dystrophic epidermolysis bullosa: applied cutaneously to wounds once a week in small droplets in a grid pattern about 1 cm by 1 cm apart; maximum total weekly dose for adults 2 mL (4×109 PFU). Apply until wounds close; prioritise re-opened wounds; do not give if no wounds are present.
Gravidez e amamentação
- Gravidez
- Unknown Topical gene therapy gel; no human data. EU label: not recommended in pregnancy. US: advise effective contraception during treatment. Pregnant people should not prepare or apply the gel and should avoid treated wounds and dressings.
- Amamentação
- Unknown No data on milk presence or infant effects. EU label: a risk cannot be excluded; decide whether to stop breastfeeding or therapy. US: weigh benefit. Avoid infant contact with treated wounds.
Efeitos adversos relatados
- Chills
- Pruritus
- Cough
- Rhinorrhea
- Erythema
- Rash
Contraindicações
- Hypersensitivity to the active substance or to any of the excipients.
Quem deve ter cuidado
- Do not apply to wounds with confirmed or suspected squamous cell carcinoma; other wounds may still be treated.
- Risk of transmission of infectious agents exists; monitor patients for signs and symptoms of infection after treatment.
- Contains genetically modified organisms; protective equipment (gloves, mask, eye protection) should be worn when handling. Pregnant women should not prepare, administer or handle dressing waste.
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Paediatric dosing
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- IV preparation and dilution
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Perguntas frequentes
What is Beremagene geperpavec used for?
Beremagene geperpavec is a medicine in the class miscellaneous.
What side effects have been reported with Beremagene geperpavec?
Chills, Pruritus, Cough, Rhinorrhea, Erythema, Rash.
Can Beremagene geperpavec be taken in pregnancy or while breastfeeding?
Pregnancy: Unknown. Topical gene therapy gel; no human data. EU label: not recommended in pregnancy. US: advise effective contraception during treatment. Pregnant people should not prepare or apply the gel and should avoid treated wounds and dressings. Breastfeeding: Unknown. No data on milk presence or infant effects. EU label: a risk cannot be excluded; decide whether to stop breastfeeding or therapy. US: weigh benefit. Avoid infant contact with treated wounds.
What does Beremagene geperpavec interact with?
MediHelp does not list a checked interaction for Beremagene geperpavec yet. Always tell your pharmacist about every medicine you take.
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