Advanced Therapy

2 Drugs classified under this drug class

Advanced Therapy. Darvadstrocel 30 million cells/vial.
VIAL (suspens. for inj): 1×30 million cells. A single dose of Alofisel consists of 120 million cells supplied. in 4 vial. Each vial contains 30 million cells in 6 mL of susp. The full content of the 4 vial. must be admin. for the tmt. of up to two intern. openings and up to three exter. openings. This means that with a dose of 120 million cells it is possible to treat up to three fistula tracts that open to the perianal area. The efficacy or safety of repeat admin. of this drug has not been established.
Tmt. of complex perianal fistulas in adult pts. with non-active/mildly active luminal Crohn’s dis., when fistulas have shown an inadeq. response to at least one convention. or biologic ther. The durg should be used only after conditioning of the fistulas.
C/I: Hypersens. to the active subst. or to excipients or to bovine serum.

Advanced Therapy. anti-CD19 CAR T cells 0.4 – 2 × 10^8 cells.
0.4 – 2 × 10⁸ cells dispersion for IV. Autolog. use only. Single dose 2 × 10⁶ /kg b.w. in approx. 68 mL dispers. in an infus. bag. Recommen. to be infus. 3 to 14 days. Aft. complet.  lymphodeplet. chemother. See lit.
Tmt. adult pts. with relapse. or refract. mantle cell lymphoma after 2 or more lines of sys. ther. incl. Bruton's tyrosine kinase (BTK) inhib. unless inelig. to BTK inhib. Not indicat. for tmt. pts. with active CNS lymphoma.
C/I: hypresens. see lit.