Monoclonal Antibody

44 Drugs classified under this drug class

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.

Monoclonal Antibody, VEGF Inhibitor. Bevacizumab 25 mg/ml.
VIALS: 1 x 100 mg/4 ml; 1 x 400
mg/16ml.
Dosage adjust. individ. for each pt.
accord to the med. cond. accord. to
prescr. info.
Tmt. metastat. Carcinoma of the colon or
rectum, to be used in combinat. With
fluoropyrimidine-based chemother.
Firstline tmt. metastat. Breast cancer, in
comb. with Paclitaxel. tmt.
unresect.,advanced, metastat./recurrent
NSCLC other than predom. squamous cell
histology, in add. to platinum-based
chemother. tmt. advanc./metastat. Renal
cell cancer, in comb. with interferon alfa-
2a. Firstline tmt. advanc./metastat. Renal
cell cancer, in comb. with interferon alfa-
2a. As single agent tmt. glioblastom. In
pts. with progress. dis. foll. prior ther.
Front-line tmt. in comb. with paclitaxel.
and carboplatin advanc. (FIGO III B, III
C,IV) epithelial ovar., fallop. tube, or
primary peritoneal canc. in pts at high risk
for recurrence (resid. dis. aft.debulk.). in
comb. with carboplatin and gemcitabine
tmt of adult pts. with first recur.of
platinum-sensit. epithelial ovar., fallopian
tube or prim. peritoneal cancer who have
not received prior therapy with
Bevacizumab or other VEGF inhibit. or
VEGF receptor–targeted agents.
C/I: Hypersens. active substance/
excips./ chinese hamster ovary/ other recombinant human or humanized
antibodies., pregn.

Monoclonal Antibody. Belimumab 120 mg, 400 mg.
VIAL (pwdr. for concentrate for sol. for infus.): 1×120mg.
VIAL (pwdr. for concentrate for sol. for infus.): 1×400mg.
Benlysta 120,400 mg: Premed. includ. an antihistamine, with/without an antipyretic, may be admin. before the  infus. The recomm. dose is 10 mg/kg on Days 0, 14 and 28, and at 4-wk. interv. thereafter. The patient’s condition should be evaluated continuous. Discont. of tmt. should be consid. if there is no improve. in dis. control after 6 mnths. of tmt. See lit.
Indic. as add-on ther. in adult pts. with active, autoantibody-posit. system. lupus erythematosus (SLE) with a high degree of dis. activity (e.g., positive anti-dsDNA and low complement) despite standard ther.
C/I: Hypersens.

Monoclonal Antibody. Belimumab 200 mg.
PRE-FILL. PEN (sol. for S.C. inj.): 1, 4×200mg/ml.
PRE-FILL.SYR. (sol. for S.C. inj.): 1, 4×200mg/ml.
Benlysta 200mg/ml: 200 mg once wkly., admin. S.C. dosing is not based on weight.
The pt’s. condition should be evaluat. continuous. Discont. of tmt. should be consid. if there is no improv. in dis.  control after 6 mnths. of tmt.
If a dose is missed, it should be admin. as soon as possible. Thereafter, pts. can resume dosing on their usual day of admin., or start a new wkly.
Transit. from IV to S.C. admin.: If a pt. is being transitioned from IV admin. to S.C. admin., the 1^st S.C. inj. should be admin. 1-4 wks. after the last IV dose. See lit.
Indic. as add-on ther. in adult pts. with active, autoantibody-posit. system. lupus erythematosus (SLE) with a high degree of dis. activity (e.g., positive anti-dsDNA and low complement) despite standard ther.
C/I: Hypersens.

Monoclonal Antibody. Inotuzumab Ozogamicin 1 mg/vial.
VIAL(pwdr. for concentrat. for sol. for infus.): 1. The drug should be admin. in 3- to 4-wk. cycles.
For pts. proceed. to haematopoietic stem cell transplant (HSCT), the recommend. duration of tmt. is 2 cycles. A 3^rd cycle may be consid. for those pts. who do not achieve a complete remis. (CR) or complete remiss. with incomp. haematolog. recovery (CRi) and min. residual dis. (MRD) negative. after 2 cycles. For pts. not proceed. to HSCT, addit. cycles of tmt, up to a max. of 6 cycles, may be admin. Pts. who do not achieve a CR/CRi within 3 cycles should discont. tmt.
For the 1^st t cycle, the recomm. total dose: Inotuzumab ozogamicin for all pts. is 1.8 mg/m² per cycle, given as 3 divid. doses on Days 1 (0.8 mg/m²), 8 (0.5 mg/m²), and 15 (0.5 mg/m²). Cycle 1 is 3 wks. in durat., but may be extend. to 4 wks. if the pt. achieves a CR or CRi, and/or to allow recovery from toxicity.
For subseq. cycles, the recomm. total dose: Inotuzumab ozogamicin is 1.5 mg/m² per cycle given as 3 divided doses on Days 1 (0.5 mg/m²), 8 (0.5 mg/m²), and 15 (0.5 mg/m²) for pts. who achieve a CR/CRi or 1.8 mg/m² per cycle given as 3 divided doses on Days 1 (0.8 mg/m²), 8 (0.5 mg/m²), and 15 (0.5 mg/m²) for pts. who do not achieve a CR/CRi. Subseq. cycles are 4 wks. in durat.
Dose modific. may be required based on individ. safety and tolerab. Manag. of some ADR's. See lit.
Indic. as monother. for the tmt. of adult. with relapsed or refract. CD22-posit. B cell precurs. acute lymphoblast. leuk. (ALL). Adult pts. with Philadelphia chromosome posit. (Ph+) relapsed or refract. B cell precursor ALL should have failed tmt. with at least 1 tyrosine kinase inhib.(TKI).
C/I: Hypersens. Pts. who have experienc. prior confirm. severe or ongoing venoocclusive hep. dis. /sinusoidal obstruct. syndr. (VOD/SOS). Pts. with serious ongoing hep. dis.e.g., cirrhosis, nodular regenerative hyperplasia, active hepatitis).