Lenalidomide Stragen 15 mg, harde capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

LENALIDOMIDE 15 mg/stuk

Beschikbaar vanaf:

Ohre Pharma 1 rue des Ursulines 37000 TOURS (FRANKRIJK)

ATC-code:

L04AX04

INN (Algemene Internationale Benaming):

LENALIDOMIDE 15 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Lenalidomide

Autorisatie datum:

2019-07-15

Bijsluiter

11027
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE STRAGEN
® 15 MG, HARDE CAPSULES
lenalidomide
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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] contains the active substance ‘lenalidomide’. This
medicine belongs to a group of
medicines which affect how your immune system works.
[Product name] is used in adults for
•
Multiple Myeloma
•
Myelodysplastic syndromes
•
Mantle cell lymphoma
•
Follicular lymphoma
MULTIPLE MYELOMA
Multiple myeloma is a type of cancer which affects a certain kind of
white blood cell, called the
plasma cell.
These cells collect in the bone marrow and divide, becoming out of
control. This can damage the
bones and kidneys.
Multiple myeloma generally cannot be cured. However, the signs and
symptoms can be greatly
reduced or disappear for a period of time. This is called a
‘response’.
Newly diagnosed multiple myeloma - in patients who have had a bone
marrow transplant
[Product name] is used on its own as a maintenance therapy after
patients have recovered enough
following a bone marrow transplant.
Newly diagnosed multiple myeloma – in patients who cannot have a
bone marrow transplant
[Product name] is taken with other medicines. These may include:
•
a chemo

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Stragen 15 mg, harde capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 15 mg of lenalidomide.
Excipient(s) with known effect:
Each capsule contains 199.3 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Harde capsule.
Opaque white body and opaque blue to light blue cap, with a length of
approximately 21.7 mm, marked “L9NL”
and “15”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Multiple myeloma
Lenalidomide Stragen as monotherapy is indicated for the maintenance
treatment of adult patients with newly
diagnosed multiple myeloma who have undergone autologous stem cell
transplantation.
Lenalidomide Stragen as combination therapy with dexamethasone, or
bortezomib and dexamethasone, or
melphalan and prednisone (see section 4.2) is indicated for the
treatment of adult patients with previously
untreated multiple myeloma who are not eligible for transplant.
Lenalidomide Stragen in combination with dexamethasone is indicated
for the treatment of multiple
myeloma in adult patients who have received at least one prior
therapy.
Follicular lymphoma
Lenalidomide Stragen in combination with rituximab (anti-CD20
antibody) is indicated for the treatment of
adult patients with previously treated follicular lymphoma (Grade 1
– 3a).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lenalidomide Stragen treatment should be supervised by a physician
experienced in the use of anti-cancer
therapies.
For all indications described below:
•
Dose is modified based upon clinical and laboratory findings (see
section 4.4).
•
Dose adjustments, during treatment and restart of treatment, are
recommended to manage Grade 3 or 4
thrombocytopenia, neutropenia, or other Grade 3 or 4 toxicity judged
to be related to lenalidomide.
•
In case of neutropenia, the use of growth factors in patient
management should be considered.
11027
•
If less than 12 hours has elapsed since missing a dose, the p