Levact 100mg Powder for Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bendamustine hydrochloride

Available from:

Astellas Pharma GmbH

ATC code:

L01AA; L01AA09

INN (International Name):

Bendamustine hydrochloride

Dosage:

100 milligram(s)

Pharmaceutical form:

Pdr/Conc/Soln for Infus

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Nitrogen mustard analogues; bendamustine

Authorization status:

Not marketed

Authorization date:

2010-10-08

Patient Information leaflet

600X148MM (LSN-CON-23) (P) V2
P2030-A
_LEVACT_ is a medicine which is used for the treatment
of certain types of cancer (cytotoxic medicine).
_LEVACT_ is used alone (monotherapy) or in combination
with other medicines for the treatment of the
following forms of cancer:
-
chronic lymphocytic leukaemia in cases where
fludarabine combination chemotherapy is not
appropriate for you,
-
non-Hodgkin lymphomas, which had not, or only
shortly, responded to prior rituximab treatment,
-
multiple myeloma in cases where thalidomide or
bortezomib containing therapy is not appropriate
for you.
1. WHAT _LEVACT_ IS AND WHAT IT IS USED FOR
PACKAGE LEAFLET: INFORMATION FOR THE USER
_LEVACT _
® 25 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
_LEVACT _
® 100 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Bendamustine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE, IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1. What _LEVACT_ is and what it is used for
2. What you need to know before you use _LEVACT_
3. How to use _LEVACT_
4. Possible side effects
5. How to store _LEVACT_
6. Contents of the pack and other information
DO NOT USE _LEVACT_
-
if you are allergic to bendamustine hydrochloride
or any of the other ingredients of this medicine
(listed in section 6);
-
while breast-feeding, if treatment with _LEVACT_ is
necessary during lactation you must discontinue
breast-feeding (see section warnings and
precautions on breastfeeding);
-
if you have severe liver dysfunction (damage to the
functional cells of the liver);
-
if you have yellowing of the skin or whites

Summary of Product characteristics

Health Products Regulatory Authority
24 March 2021
CRN00C52M
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levact 100mg Powder for Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 100 mg bendamustine hydrochloride.
1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride
when reconstituted according to section 6.6.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
White, microcrystalline powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
First-line treatment of chronic lymphocytic leukaemia (Binet stage B
or C) in patients for whom fludarabine combination
chemotherapy is not appropriate.
Indolent non-Hodgkin’s lymphomas as monotherapy in patients who have
progressed during or within 6 months following
treatment with rituximab or a rituximab containing regimen.
Front line treatment of multiple myeloma (Durie-Salmon stage II with
progress or stage III) in combination with prednisone for
patients older than 65 years who are not eligible for autologous stem
cell transplantation and who have clinical neuropathy at
time of diagnosis precluding the use of thalidomide or bortezomib
containing treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Monotherapy for chronic lymphocytic leukaemia _
100 mg/m² body surface area bendamustine hydrochloride on days 1 and
2; every 4 weeks up to 6 times.
_Monotherapy for indolent non-Hodgkin’s lymphomas refractory to
rituximab_
120 mg/m² body surface area bendamustine hydrochloride on days 1 and
2; every 3 weeks for at least 6 times.
_Multiple myeloma_
120 - 150 mg/m² body surface area bendamustine hydrochloride on days
1 and 2, 60 mg/m² body surface area prednisone i.v.
or per os on days 1 to 4; every 4 weeks for at least 3 times.
_Hepatic impairment_
On the basis of pharmacokinetic data, no dose adjustment is necessary
in patients with mild hepatic impairment (serum
bilirubin < 1.2mg/dl). A 30% d