Takeda Israel Ltd

Monoclonal Antibody. Brentuximab Vedotin 50 mg.
VIAL (Pwdr. for conc. for solution for IV infus.): 1 x 50 mg. Previous. Untreat. HL: The recom. dose in comb. with chemother. (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]) is 1.2 mg/kg admin. as an IV infus. over 30 min. on days 1 and 15 of each 28-day cycle for 6 cycles.
Primary prophylaxis with growth factor support (G-CSF), begin. with the 1^ST dose, is recom. for all pts. with prev. untreat. HL receiv. comb. ther.
HL at incr. risk of relapse or progression: 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks.
Tmt. should start follow. recovery from ASCT based on clinical judgment. These pts. should receive up to 16 cycles.
Relapsed or refract. HL: 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks. dose for the retreatment of pts. who have previously responded to tmt. -1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks.. Alternatively, tmt. may be started at the last tolerated dose.
Previous. untreated sALCL or other CD30-express. peripheral T-cell lymphomas: in comb. with chemother. (cyclophosphamide [C], doxorubicin [H]& prednisone [P] [CHP]) is 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks for 6 to 8 cycles.
Primary prophylaxis with G-CSF, beginning with the first dose, is recom. for all pts. with prev. untreated sALCL or other CD30-expressing peripheral T-cell lymphomas, receiving comb. ther.
Refer to the SmPCs of chemotherapy agents given in comb. with ADCETRIS for pts. with prev. untreated sALCL or other CD30-expressing peripheral T-cell lymphomas.
Relapsed or refractory sALCL: 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks.
Init. dose for the retreatment of pts. who have prev. responded to tmt. with Brentuximab vedotin is 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks. See lit.
Tmt. of adult pts. with previos. untreated Stage III or IV classical Hodgkin lymphoma (cHL), in comb. with doxorubicin, vinblastine, and dacarbazine.
Tmt. of adult pts. with CD30+ HL at incr. risk of relapse or progress. follow. autologous stem cell transplant (ASCT).
Tmt. of adult pts. with relapsed or refractory CD30+ Hodgkin lymphoma (HL): ASCT, or at least two prior therapies when ASCT or multi-agent chemother. is not a tmt. option.
Syst. anaplastic large cell lymphoma & Peripheral T-cell lymphomas (PTCL).
Tmt. of adult pts. with previously untreated system. anaplastic large cell lymphoma (sALCL) or other CD30-expres. peripheral T-cell lymphomas (PTCL), includ. angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in comb. with cyclophosphamide, doxorubicin, and prednisone.
Tmt. of adult pts. with relapsed or refract. sALCL.
Tmt. of adult pts. with CD30+ cutan. T-cell lymphoma (CTCL) after at least 1 prior system. ther.
C/I: Hypersens., comb. use with Bleomycin.

Human Coagulation Factor VIII (rDNA). Octocog Alfa 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU.
VIAL: 1 x 250, 500, and 1000 IU (+ 5 ml
solv. dev. for reconst.). Dosage must be
ajust. individ.
Tmt. and prophylax. of bleed. in pts. with
Haemophilia A.
C/I: Hypersens. to the active subst., to
any of the excip. or to mouse or hamster
prot.

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.

Protein Kinase Inhibitor. Brigatinib 30 mg, 90 mg.
F.C. TABS.: 30. The recom. dose regimen for is: 90 mg×1/d for the first 7 days;
If 90 mg is tolerat. during the first 7 d, incr. the dose to 180 mg ×1/d.
Admin. will cont. until dis. progres. or unaccept. toxicity.
If Brigatinib is interrupt. for 14 d. or longer for reasons other than ADR's, resume tmt. at 90 mg ×1/d for 7 d. before incr. to the prev. tolerated dose.
Tmt. of pts. with anaplastic lymphoma kinase (ALK)-positive metastat. non-small cell lung cancer (NSCLC) who have progres. on or are intolerant to crizotinib.
C/I: Hypersens.

Antihemophilic Factor VIII 220 - 1700 IU.
INFUS: (Dry pwdr): 10 ml. See lit.
Hemophil. A (classical hemophil.) for
prevent and control of hemorrhag.
episodes. Not indicat. in von Willebrand’s
disease.

Antivirals. Podophyllotoxin 5 mg/ml.
SOL.: 3.5 ml (with cotton applic. tips).
Apply twice dly. for 3 consec. days.
Then a tmt. free interval of 4 d. Ther.
can be repeated up to max. duration of
4 wks. Lesions in female & lesions
greater than 4cm2 in male should be
treat. under direct med. supervis.
Otherwise tmt. at home.
Ext. genital warts.
C/I: Hypersens., Pregn, lact., child. under
12 yrs. old. Inflamed or bleed. pointed
condylomata, or open wounds follow.
surgical procedures. Simultan. admin. of
other preparat. contain. Podophylline.