Riferimento farmaci
Prademagene zamikeracel
Prademagene zamikeracel is a medicine in the class miscellaneous.
- Classe del farmaco: Miscellaneous
Ultimo aggiornamento Fonti: US FDA label
Per operatori sanitari — solo a scopo di riferimento. Questa pagina è una sintesi breve, non è un parere medico e non sostituisce il RCP ufficiale né il giudizio clinico. Verificare sempre prima di prescrivere o dispensare.
Il contenuto clinico di questa pagina è disponibile solo in inglese.
In breve
- Classe del farmaco
- Miscellaneous
- Nomi commerciali
- 1
- Paesi e mercati
- 1
Come agisce
Autologous cells gene-modified through RVV transduction to express COL7A1 and produce C7 protein, formed into cellular sheets for topical application onto wounds. This addresses the absent or low C7 protein and anchoring fibrils in RDEB.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
RDEB wounds: dose based on wound surface area, topical application to wounds only (autologous); one sheet covers 41.25 cm2; up to twelve sheets supplied; apply all selected sheets in a single surgical session
Gravidanza e allattamento
- Gravidanza
- Unknown Gene-corrected skin sheets applied to wounds in dystrophic epidermolysis bullosa. No human data and no animal reproduction studies. Women who could become pregnant should use effective contraception at the time of treatment.
- Allattamento
- Unknown No information on passage into milk or infant effects; no animal studies. LactMed: not necessarily a reason to stop breastfeeding, but weigh the theoretical risk of retroviral-vector insertional oncogenesis against the benefits.
Effetti indesiderati segnalati
- Procedural pain
- Pruritus
Chi deve prestare attenzione
- Severe hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur; monitor and treat per standard practice.
- Retroviral vector-mediated insertional oncogenesis may potentially occur; monitor patients lifelong for malignancies.
- Transmission of infectious agents may occur because human and bovine-derived reagents are used in manufacture.
Informare il farmacista o il medico di gravidanza o allattamento, malattie renali o epatiche, allergie e di ogni altro farmaco o integratore assunto.
Per gli utenti Pro+
Sblocca la pagina completa
Crei un account e avvii una prova di Pro+ per aprire la monografia completa di Prademagene zamikeracel: dosi, gravidanza e allattamento, effetti indesiderati, avvertenze e tutte le interazioni.
- Dosing by age, kidney and liver function, and further dose lines
- Paediatric dosing
- How to give it
- Patient counselling points
Provi Pro+ gratis per 14 giorni sul web. Nessuna carta.
Altri farmaci della stessa classe
Domande frequenti
What is Prademagene zamikeracel used for?
Prademagene zamikeracel is a medicine in the class miscellaneous.
What side effects have been reported with Prademagene zamikeracel?
Procedural pain, Pruritus.
Can Prademagene zamikeracel be taken in pregnancy or while breastfeeding?
Pregnancy: Unknown. Gene-corrected skin sheets applied to wounds in dystrophic epidermolysis bullosa. No human data and no animal reproduction studies. Women who could become pregnant should use effective contraception at the time of treatment. Breastfeeding: Unknown. No information on passage into milk or infant effects; no animal studies. LactMed: not necessarily a reason to stop breastfeeding, but weigh the theoretical risk of retroviral-vector insertional oncogenesis against the benefits.
What does Prademagene zamikeracel interact with?
MediHelp does not list a checked interaction for Prademagene zamikeracel yet. Always tell your pharmacist about every medicine you take.
Monografie complete, posologie e verifica delle interazioni nell'app MediHelp
Apra il riferimento completo, verifichi le interazioni tra più farmaci e usi gli strumenti di posologia nell'app MediHelp.
