Targretin

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

bexarotene

Διαθέσιμο από:

Eisai GmbH

Φαρμακολογική κατηγορία (ATC):

L01XF03

INN (Διεθνής Όνομα):

bexarotene

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Lymphoma, T-Cell, Cutaneous

Θεραπευτικές ενδείξεις:

Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.

Περίληψη προϊόντος:

Revision: 23

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2001-03-29

Φύλλο οδηγιών χρήσης

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
TARGRETIN 75 MG SOFT CAPSULES
BEXAROTENE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Targretin is and what it is used for
2.
What you need to know before you take Targretin
3.
How to take Targretin
4.
Possible side effects
5.
How to store Targretin
6.
Contents of the pack and other information
1.
WHAT TARGRETIN IS AND WHAT IT IS USED FOR
The active substance in Targretin, bexarotene, belongs to a group of
medicines known as retinoids,
which are related to vitamin A.
Targretin capsules are used by patients with advanced stage cutaneous
T-cell lymphoma (CTCL)
whose disease has not responded to other therapies. CTCL is a
condition in which certain cells of the
body’s lymph system called T-lymphocytes become cancerous and affect
the skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TARGRETIN
DO NOT TAKE TARGRETIN:
-
if you are allergic to bexarotene or any of the other ingredients of
this medicine (listed in section
6).
-
if you are pregnant or breast feeding or if you can become pregnant
and are not using effective
birth control measures.
-
if you have a history of pancreatitis, have uncontrolled lipid (blood
fats) elevations (high blood
cholesterol or high blood triglycerides), have a condition known as
hypervitaminosis A, have
uncontrolled thyroid disease, have insufficient liver function or have
an ongoing systemic
infection.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Targretin
-
if you have a known hypersensiti

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Targretin 75 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 75 mg of bexarotene.
Excipient(s) with known effect: sorbitol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule.
Off-white capsule, containing a liquid suspension and imprinted with
“Targretin”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Targretin is indicated for the treatment of skin manifestations of
advanced stage cutaneous T-cell
lymphoma (CTCL) in adult patients refractory to at least one systemic
treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Bexarotene therapy should only be initiated and maintained by
physicians experienced in the treatment
of patients with CTCL.
Posology
The recommended initial dose is 300 mg/m
2
/day. Initial dose calculations according to body surface
area are as follows:
TABLE 1
RECOMMENDED INITIAL DOSE
Initial dose level (300 mg/m
2
/day)
Number of 75 mg Targretin
capsules
Body Surface Area (m
2
)
Total daily dose (mg/day)
0.88 – 1.12
300
4
1.13 - 1.37
375
5
1.38 - 1.62
450
6
1.63 - 1.87
525
7
1.88 - 2.12
600
8
2.13 - 2.37
675
9
2.38 - 2.62
750
10
_Dose modification guidelines_
The 300 mg/m
2
/day dose level may be adjusted to 200 mg/m
2
/day then to 100 mg/m
2
/day, or
temporarily suspended, if necessitated by toxicity. When toxicity is
controlled, doses may be carefully
readjusted upward. With appropriate clinical monitoring, individual
patients may benefit from doses
above 300 mg/m
2
/day. Doses greater than 650 mg/m
2
/day have not been evaluated in patients with
CTCL. In clinical trials, bexarotene was administered for up to 118
weeks to patients with CTCL.
Treatment should be continued as long as the patient is deriving
benefit.
3
_Paediatric population_
The safety and efficacy of bexarotene in children (aged below 18
years) have not been established. No
data are available.
_Elderly patients_
Of the total number of patients with CTCL in clinical st