Arzerra

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Ofatumumab

Διαθέσιμο από:

Novartis Europharm Ltd

Φαρμακολογική κατηγορία (ATC):

L01XC10

INN (Διεθνής Όνομα):

ofatumumab

Θεραπευτική ομάδα:

Monoclonal antibodies

Θεραπευτική περιοχή:

Leukemia, Lymphocytic, Chronic, B-Cell

Θεραπευτικές ενδείξεις:

Previously untreated chronic lymphocytic leukaemia (CLL): Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Relapsed CLL: Arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL. Refractory CLL: Arzerra is indicated for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab.,

Περίληψη προϊόντος:

Revision: 16

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2010-04-19

Φύλλο οδηγιών χρήσης

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARZERRA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION
ARZERRA 1000 MG CONCENTRATE FOR SOLUTION FOR INFUSION
ofatumumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE 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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Arzerra is and what it is used for
2.
What you need to know before you are given Arzerra
3.
How Arzerra is given
4.
Possible side effects
5.
How to store Arzerra
6.
Contents of the pack and other information
1.
WHAT ARZERRA IS AND WHAT IT IS USED FOR
Arzerra contains ofatumumab, which belongs to a group of medicines
called monoclonal antibodies.
ARZERRA IS USED TO TREAT CHRONIC LYMPHOCYTIC LEUKAEMIA
(CLL). CLL is a cancer of the blood which
affects a type of white blood cell called lymphocytes. The lymphocytes
multiply too quickly and live
too long, so there are too many of them circulating in your blood. The
disease can also affect other
organs in your body. The antibody in Arzerra recognises a substance on
the surface of lymphocytes
and causes the lymphocyte to die.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ARZERRA
YOU MUST NOT BE GIVEN ARZERRA:

if you are allergic (hypersensitive) to ofatumumab or any of the other
ingredients of this
medicine (listed in section 6).
Check with your doctor
if you think this may apply to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given Arzerra:

if you have had
HEART PROBLEMS,

if you have
LUNG DISEASE,
Check with your doctor
if you think any of these may apply to you. You may need extra
check-ups
while you are being treated with Arzerra.
Your doctor may test the amount of electrolytes, such as magnesium and
potassium, in your blood
before and during

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Arzerra 100 mg concentrate for solution for infusion
Arzerra 1000 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 20 mg of ofatumumab.
Arzerra 100 mg concentrate for solution for infusion
Each vial contains 100 mg of ofatumumab in 5 ml.
Arzerra 1000 mg concentrate for solution for infusion
Each vial contains 1000 mg of ofatumumab in 50 ml.
Ofatumumab is a human monoclonal antibody produced in a recombinant
murine cell line (NS0).
Excipient with known effect
This medicinal product contains 34.8 mg sodium per 300 mg dose, 116 mg
sodium per 1000 mg dose
and 232 mg sodium per 2000 mg dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to opalescent, colourless to pale yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Previously untreated chronic lymphocytic leukaemia (CLL)
Arzerra in combination with chlorambucil or bendamustine is indicated
for the treatment of adult
patients with CLL who have not received prior therapy and who are not
eligible for fludarabine-based
therapy.
See section 5.1 for further information.
Relapsed CLL
Arzerra is indicated in combination with fludarabine and
cyclophosphamide for the treatment of adult
patients with relapsed CLL.
See section 5.1 for further information.
3
Refractory CLL
Arzerra is indicated for the treatment of CLL in adult patients who
are refractory to fludarabine and
alemtuzumab.
See section 5.1 for further information.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Arzerra should be administered under the supervision of a physician
experienced in the use of cancer
therapy and in an environment where full resuscitation facilities are
immediately available.
Monitoring
Patients should be closely monitored during administration of
ofatumumab for the onset of infusion-
related reactions, including cytokine release syndrome, pa