MabCampath

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

alemtuzumab

זמין מ:

Genzyme Europe B.V.

קוד ATC:

L01XC04

INN (שם בינלאומי):

alemtuzumab

קבוצה תרפויטית:

Antineoplastic agents

איזור תרפויטי:

Leukemia, Lymphocytic, Chronic, B-Cell

סממני תרפויטית:

MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.

leaflet_short:

Revision: 14

מצב אישור:

Withdrawn

תאריך אישור:

2001-07-06

עלון מידע

47
B. PACKAGE LEAFLET
Medicinal product no longer authorised
48
PACKAGE LEAFLET: INFORMATION FOR THE USER
MABCAMPATH 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Alemtuzumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

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.
IN THIS LEAFLET:
1.
What MabCampath is and what it is used for
2.
Before you use MabCampath
3.
How to use MabCampath
4.
Possible side effects
5.
How to store MabCampath
6.
Further information
1.
WHAT MABCAMPATH IS AND WHAT IT IS USED FOR
MabCampath is used to treat patients with chronic lymphocytic
leukaemia (CLL), a cancer of the
lymphocytes (a type of white blood cell). It is used in patients for
whom treatment combinations
including fludarabine (another medicine used in leukaemia) are not
appropriate.
The active substance in MabCampath, alemtuzumab, is a monoclonal
antibody. A monoclonal
antibody is an antibody (a type of protein) that has been designed to
recognise and bind to a specific
structure (called an antigen) that is found in certain cells in the
body. In CLL, too many lymphocytes
are produced. Alemtuzumab has been designed to bind to a glycoprotein
(a protein that is coated with
sugar molecules) that is found on the surface of lymphocytes. As a
result of this binding, the
lymphocytes die, and this helps to control the CLL.
2.
BEFORE YOU USE MABCAMPATH
DO NOT USE MABCAMPATH IF YOU:

are allergic to alemtuzumab or to proteins of a similar origin or to
any of the other ingredients of
MabCampath (see section 6 “Further Information”). Your doctor will
inform you accordingly

have an infection

have HIV

have an active second malignancy

are pregnant (see also “Pregnancy”).
TAKE SPECIAL CARE WITH MABCAMPATH:
When you
FIRST RECEIVE
MabCampath, you may experience side effects

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
MabCampath 10 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 10 mg of alemtuzumab.
Each ampoule contains 30 mg of alemtuzumab.
Alemtuzumab is a genetically engineered humanised IgG1 kappa
monoclonal antibody specific for a
21-28 kD lymphocyte cell surface glycoprotein (CD52). The antibody is
produced in mammalian cell
(Chinese Hamster Ovary) suspension culture in a nutrient medium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Colourless to slightly yellow concentrate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MabCampath is indicated for the treatment of patients with B-cell
chronic lymphocytic leukaemia (B-
CLL) for whom fludarabine combination chemotherapy is not appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
MabCampath should be administered under the supervision of a physician
experienced in the use of
cancer therapy.
Posology
During the first week of treatment, MabCampath should be administered
in escalating doses: 3 mg on
day 1, 10 mg on day 2 and 30 mg on day 3 assuming that each dose is
well tolerated. Thereafter, the
recommended dose is 30 mg daily administered 3 times weekly on
alternate days up to a maximum of
12 weeks.
In most patients, dose escalation to 30 mg can be accomplished in 3-7
days. However, if acute
moderate to severe adverse reactions such as hypotension, rigors,
fever, shortness of breath, chills,
rashes and bronchospasm (some of which may be due to cytokine release)
occur at either the 3 mg or
10 mg dose levels, then those doses should be repeated daily until
they are well tolerated before
further dose escalation is attempted (see section 4.4).
Median duration of treatment was 11.7 weeks for first-line patients
and 9.0 weeks for previously
treated patients.
Once a patient meets all laboratory and clinical criteria for a
complete resp