BEMUNAT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MGVIAL USP

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Bendamustine Hydrochloride

Tilgængelig fra:

NATCO PHARMA ASIA PTE. LTD.

ATC-kode:

L01AA09

Lægemiddelform:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Sammensætning:

Bendamustine Hydrochloride 100.00 mg

Indgivelsesvej:

INTRAVENOUS

Recept type:

Prescription Only

Fremstillet af:

Natco Pharma Ltd. - Pharma Division

Autorisation status:

ACTIVE

Autorisation dato:

2017-06-05

Produktets egenskaber

1 INDICATIONS AND USAGE
1.1 CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
Bendamustine hydrochloride for infusion is indicated for the treatment
of patients with chronic lymphocytic leukemia.
Efficacy relative to first line therapies other than chlorambucil has
not been established.
1.2 NON-HODGKIN’S LYMPHOMA (NHL)
Bendamustine hydrochloride for infusion is indicated for the treatment
of patients with indolent B-cell non-Hodgkin’s
lymphoma that has progressed during or within six months of treatment
with rituximab or a rituximab-containing
regimen.
2 DOSAGE AND ADMINISTRATION
2.1 DOSING INSTRUCTIONS FOR CLL
Recommended Dosages
The recommended dose is 100 mg/m
2
administered intravenously over 30 minutes on Days 1 and 2 of a 28-day
cycle, up to 6 cycles.
Dose Delays. Dose Modifications and Reinitiation of Therapy for CLL:
Bendamustine hydrochloride for infusion administration should be
delayed in the event of Grade 4 hematologic
toxicity or clinically significant ≥ Grade 2 non-hematologic
toxicity. Once non -hematologic toxicity has recovered to ≤
Grade 1 and/or the blood counts have improved (Absolute Neutrophil
Count (ANC) ≥ 1 x 10
9
/L, platelets ≥ 75 x 10
9
/L),
Bendamustine hydrochloride for infusion can be reinitiated at the
discretion of the treating physician. In addition, dose
reduction may be warranted. _[See Warnings and Precautions (5.1)] _
Dose modifications for hematologic toxicity: for Grade 3 or greater
toxicity, reduce the dose to 50 mg/m
2
on Days 1
and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the
dose to 25 mg/m
2
on Days 1 and 2 of each cycle.
Dose modifications for non- hematologic toxicity: for clinically
significant Grade 3 or greater toxicity, reduce the dose
to 50 mg/m
2
on Days 1 and 2 of each cycle.
Dose re-escalation in subsequent cycles may be considered at the
discretion of the treating physician.
2.2 DOSING INSTRUCTIONS FOR NHL
Recommended Dosages
The recommended dose is 120 mg/m
2
administered intravenously over 60 minutes on Days 1 and 2 of a 21-day
cycle, up