Référentiel des médicaments
Beremagene geperpavec
Beremagene geperpavec is a medicine in the class miscellaneous.
- Classe médicamenteuse: Miscellaneous
Dernière mise à jour Sources: EMA SmPC
Réservé aux professionnels de santé — à titre de référence uniquement. Cette page est un bref résumé, pas un avis médical, et ne remplace ni la notice officielle ni le jugement clinique. Vérifiez toujours avant de prescrire ou de délivrer.
Le contenu clinique de cette page n'est disponible qu'en anglais.
L'essentiel
- Classe médicamenteuse
- Miscellaneous
- Code ATC
- D03AX16
- Noms commerciaux
- 1
- Pays et marchés
- 1
Mécanisme d'action
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.
Posologie adulte habituelle (résumé de la notice)
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.
Grossesse et allaitement
- Grossesse
- 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.
- Allaitement
- 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.
Effets indésirables signalés
- Chills
- Pruritus
- Cough
- Rhinorrhea
- Erythema
- Rash
Contre-indications
- Hypersensitivity to the active substance or to any of the excipients.
Précautions particulières
- 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.
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
- Paediatric dosing
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- IV preparation and dilution
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Questions fréquentes
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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