Poteligeo

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Mogamulizumab

Διαθέσιμο από:

Kyowa Kirin Holdings B.V.

Φαρμακολογική κατηγορία (ATC):

L01XC25

INN (Διεθνής Όνομα):

mogamulizumab

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Sezary Syndrome; Mycosis Fungoides

Θεραπευτικές ενδείξεις:

Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

Περίληψη προϊόντος:

Revision: 6

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-11-22

Φύλλο οδηγιών χρήσης

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
POTELIGEO 4 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
mogamulizumab
.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 POTELIGEO is and what it is used for
2.
What you need to know before you use POTELIGEO
3.
How POTELIGEO is given
4.
Possible side effects
5.
How to store POTELIGEO
6.
Contents of the pack and other information
1.
WHAT POTELIGEO IS AND WHAT IT IS USED FOR
POTELIGEO contains the active substance mogamulizumab, which belongs
to a group of medicines
called monoclonal antibodies. Mogamulizumab targets cancer cells which
are then destroyed by the
immune system (the body’s defence).
This medicine is used to treat adults with mycosis fungoides and
Sézary syndrome, which are types of
cancers called cutaneous T-cell lymphomas. The medicine is for use in
patients who have received at
least one medicine given by mouth or by injection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE POTELIGEO
_ _
DO NOT USE POTELIGEO:
-
if you are allergic to mogamulizumab or any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE USING POTELIGEO IF YOU:
-
ever had a severe skin reaction with this medicine.
-
ever had an infusion reaction with this medicine (possible symptoms of
an infusion reaction are
listed in section 4).
-
have human immunodeficiency virus (HIV), herpes, cytomegalovirus
(CMV), or hepatitis B or
C infection, or other on-going infections.
-
have had or plan to have a stem cell transplant, either using your own
cells or a donor’s.
-
have had tumour lysis syndrome (a complication involving the
destruction of ca

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
POTELIGEO 4 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20 mg of mogamulizumab in 5 mL, corresponding to 4
mg/mL.
Mogamulizumab is produced in Chinese hamster ovary cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to slightly opalescent, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
POTELIGEO is indicated for the treatment of adult patients with
mycosis fungoides (MF) or Sézary
syndrome (SS) who have received at least one prior systemic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and supervised by physicians experienced
in the treatment of cancer, and
should only be administered by healthcare professionals in an
environment where resuscitation
equipment is available.
Posology
The recommended dose is 1 mg/kg mogamulizumab administered as an
intravenous infusion over at
least 60 minutes. Administration is weekly on days 1, 8, 15 and 22 of
the first 28-day cycle, followed
by infusions every two weeks on Days 1 and 15 of each subsequent
28-day cycle until disease
progression or unacceptable toxicity.
POTELIGEO should be administered within 2 days of the scheduled day.
If a dose is missed by more
than 2 days, the next dose should be administered as soon as possible,
after which the dosing schedule
should be resumed with doses given based on the new scheduled days.
Pre-medication with anti-pyretic and anti-histamine is recommended for
the first POTELIGEO
infusion. If an infusion reaction occurs, administer pre-medication
for subsequent POTELIGEO
infusions.
Dose modification
_Dermatologic reactions_
Patients receiving mogamulizumab have experienced drug rash (drug
eruption), some of which were
severe and/or serious.
_ _
•
In the event of a rash (drug related) with severity of Grade 2 or 3
(moderate or severe),
t