Tecfidera

Tecfidera (Dimethyl fumarate)

Το 2013 εγκρίθηκε από τον Αμερικανικό Οργανισμό Φαρμάκων και Τροφίμων (FDA) ένα νέο φάρμακο για τη θεραπεία της Πολλαπλής Σκλήρυνσης. Το Tecfidera (Φουμαρικός Διμεθυλεστέρας) αποτελεί την  πλέον πρόσφατη επιλογή για θεραπεία της νόσου από του στόματος (κάψουλα).

teccapluseΑνήκει στην κατηγορία των ανοσοτροποποιητικών φαρμάκων. Ο μηχανισμός δράσης του στη θεραπεία της Πολλαπλής Σκλήρυνσης -όπως και των περισσοτέρων από τα άλλα φάρμακα- δεν είναι απολύτως γνωστός. Παράλληλα έχει επίσης και κυτταροπροστατευτική, αντιοξειδωτική δράση ενεργοποιώντας ένα μηχανισμό καταστροφής των επιθετικών Τ-λεμφοκυττάρων, διακόπτοντας με αυτό τον τρόπο τη διαδικασία “απόπτωσης” (θανάτου) των νευρικών κυττάρων.

Ενα από τα χαρακτηριστικά που κάνει το Tecfidera ιδιαίτερο είναι ο πολύ γρήγορος μεταβολισμός του μέσα στο σώμα: Φτάνει στη μεγαλύτερη συγκέντρωση πολύ σύντομα (Tmax= 8 ώρες) και απομακρύνεται από τον οργανισμό επίσης πολύ σύντομα. Τα χαρακτηριστικά αυτά κάνουν πιό εύκολη την διαχείρηση τυχόν παρενεργειών ή τυχόν ανεπιθύμητων κυήσεων κλπ. Επίσης αυτός είναι ο λόγος που συνιστάται η χορήγηση του φαρμάκου να γίνεται σε δύο δόσεις.

Σε μελέτες που έγιναν φάνηκε ότι η θεραπεία με Tecfidera μείωσε κατά 50% περίπου τον αριθμό των ώσεων σε σχέση με ασθενείς χωρίς θεραπεία. Μιά άλλη μελέτη επίσης (DEFINE) έδειξε μείωση του ρυθμού που αυξάνεται η αναπηρία αλλά και των βλαβών που εμφανίζονται στη Μαγνητική Τομογραφία.

 

Τί πρέπει να προσέχουν όσοι κάνουν θεραπεία με Tecfidera

Εξετάσεις αίματος
Δεν έχει ελεγχθεί η δράση του Tecfidera σε άτομα που έχουν χαμηλό αριθμό λευκοκυττάρων. Για το λόγο αυτό πρέπει να γίνεται μία εξέταση αίματος πρίν την έναρξη της θεραπείας.

Επίσης συνιστάται η εξέταση αίματος κάθε 6-12 μήνες κατά τη διάρκεια της θεραπείας.

Οι πιο συνηθισμένες ανεπιθύμητες ενέργειες
Είναι οι “εξάψεις” και οι γαστρεντερικές διαταραχές (ναυτία, έμετος, διάρροιες), οι οποίες αντιμετωπίζονται και πολύ σπάνια αποτελούν αιτία για διακοπή της θεραπείας
Εγκυμοσύνη-θηλασμός-γονιμότητα
Δεν ενδείκνυται η χρήση του Tecfidera σε εγκύους, διότι μελέτες που έγιναν σε ζώα έδειξαν πιθανή τοξική επίδραση στο έμβρυο.

Δεν είναι γνωστό εάν το Tecfidera περνά στο γάλα του θηλασμού και για αυτό είναι προτιμότερο να αποφεύγεται ο θηλασμός κατά τη διάρκεια της θεραπείας ή το αντίστροφο, να αποφεύγεται η θεραπεία κατά τη διάρκεια του θηλασμού.

Από τα λίγα στοιχεία που υπάρχουν φαίνεται ότι το Tecfidera δεν επηρεάζει τη γονιμότητα.

Όλες οι λεπτομέρειες της θεραπείας, η δόση, πότε το διακόπτουμε, πότε το αρχίζουμε είναι αποφάσεις που πρέπει να τις παίρνετε ΜΑΖΙ με το γιατρό σας.Χαράλαμπος Καραγιαννίδης, Νευρολόγος Ψυχίατρος

 

 

Άλλα φάρμακα για την πολλαπλή σκλήρυνση

 

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Χαράλαμπος Καραγιαννίδης

Νευρολόγος - Ψυχιατρος