Bendamustine Hydrochloride

3 Drugs classified under this active ingredient

Nitrogen mustard analogues. Bendamustine Hydrochloride 25,100 mg.
VIAL(Pwdr. for concentrate for sol. for IV infus.):1×25,100 mg.
Monother. for CLL 100 mg/m² bdy. surface area bendamustine HCl on days 1 and 2; every 4 wks. up to 6 times.
Monother. for indolent non-Hodgkin’s lymphomas refract. to rituximab
120 mg/m² bdy. surface area bendamustine HCl on days 1 and 2;
every 3 wks. for at least 6 times.
Follicular non-Hodgkin’s lymphoma: Comb. with rituximab
The dose is 90 mg/m² body surface area bendamustine HCl on days 1 and 2
plus 375 mg/m² rituximab on day 1; repetition every 4 wks. See lit.
1^st -line of CLL (Binet stage B or C) in pts. for whom fludarabine comb. chemother. is not appropiate. Indolent non-Hodgkin’s lymphomas as monother.in pts., who have progress. during or within 6 mnths. follow. tmt. with rituximab or a rituximab contain. regimen. Follicular non-Hodgkin’s lymphoma as 1^st  line tmt. in comb. with rituximab.
C/I: Hypersens.
Lact.
Sev. hep. impair. (serum bilirub. > 3.0 mg/dl).
Jaundice.
Severe bone marrow suppres. and severe blood count alterations (leukocyte and/or platelet values dropped to < 3,000/μl or < 75,000/μl, respectively).

Alkylating Agent. Bendamustine Hydrochloride 25 mg, 100 mg.
VIAL (pwdr. for concentrate. for sol. for infus.): 5x25, 100 mg. Monother. for chron. lymphoc. leuk.: 100 mg/m² bdy. surf. area bendamustine HCl on 1^st and 2^nd day; every 4 wks. up to 6 times.
Monother. for indolent non-Hodgkin's lymphoma. refract. to rituximab: 120 mg/m² bdy. surf. area bendamustine HCl on on 1^st and 2^nd day; every 3 wks. for at least 6 times.
Follic. non-Hodgkin’s lymphom.: Comb. with rituximab: The dose is 90 mg/m² bdy. surf. area Demustin I.V. on 1^st and 2^nd day plus 375 mg/m² rituximab on 1^st day; repetit. every 4 wks.
1^st-line tmt. of chron. lymphoc. leuk. (Binet stage B/C) in pts. for whom fludarabine comb. chemother. is not appropr..
Indolent non-Hodgkin's lymphoma. as monother. in pts., who have progres. during or within 6 mnths. follow. tmt. with rituximab or a rituximab contain. regimen.
Follicular non-Hodgkin’s lymphom. as 1^st line tmt. in comb. with rituximab.
C/I: Hypersens. Lact. Sev. hep. impair. (serum bilirub. > 3.0 mg/dl). Jaundice. Sev. bone marrow suppres. and severe blood count alterat. (leukocyte and/or platelet values dropped to < 3,000/μl or < 75,000/μl, respectively). Major surg. less than 30 days before start of tmt. Infec., espec. involv. leukocytopenia. Yellow fever vaccin.

Alkylating Agent. Bendamustine Hydrochloride 25 mg, 100 mg.
VIAL (PWDR. CONC. FOR SOL. FOR IFUS.):
1,5×100 mg, 5x25 mg.
For IV infus. over 30-60 min: Monother.
for CLL 100 mg/m² body surface area
1st day and 2nd ; every 4 weeks.
Monother. for indolent non-Hodgkin’s
lymph. refractory to rituximab 120 mg/
m² body surface area on 1st and 2nd;
every 3 weeks. Tmt. should be termin.
or delayed if leukocyte and/or platelet
values drop. to < 3,000/μl or < 75,000/
μl, respectively. Tmt. can be cont. after
leukocyte values have incr.to > 4,000/
μl and platelet values to > 100,000/μl.
See lit.
1st -line tmt. of CLL (Binet stage B or C) in
pt. for whom fludarabine comb.
chemother. is not appropriate. Indolent
non-Hodgkin’s lymph. as monother. in pts.,
who have progressed during or within 6
months follow. tmt. with rituximab or a
rituximab contain.regimen.
C/I: Hypersens., lact.; Severe hep. impair.
(serum bilirubin > 3.0 mg/dl); Jaundice;
Sev. bone marrow suppres. and sev.
blood count alter. (LEU and/or PLT
values dropped to < 3,000/μl or <
75,000/μl, respectively); Major surgery <
30 days before start of tmt.; Infect.,
especially invol. leukocytopenia; Yellow
fever vaccin.