Thalidomide BMS (previously Thalidomide Celgene)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Thalidomide

Saatavilla:

Bristol-Myers Squibb Pharma EEIG

ATC-koodi:

L04AX02

INN (Kansainvälinen yleisnimi):

thalidomide

Terapeuttinen ryhmä:

Immunosuppressants

Terapeuttinen alue:

Multiple Myeloma

Käyttöaiheet:

Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy.Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).

Tuoteyhteenveto:

Revision: 31

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2008-04-16

Pakkausseloste

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
THALIDOMIDE BMS 50 MG HARD CAPSULES
thalidomide
WARNING
THALIDOMIDE CAUSES BIRTH DEFECTS AND FOETAL DEATH. DO NOT TAKE
THALIDOMIDE IF YOU ARE PREGNANT
OR COULD BECOME PREGNANT. YOU MUST FOLLOW THE CONTRACEPTION ADVICE
GIVEN TO YOU BY YOUR
DOCTOR.
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Thalidomide BMS is and what it is used for
2.
What you need to know before you take Thalidomide BMS
3.
How to take Thalidomide BMS
4.
Possible side effects
5.
How to store Thalidomide BMS
6.
Contents of the pack and other information
1.
WHAT THALIDOMIDE BMS IS AND WHAT IT IS USED FOR
WHAT THALIDOMIDE BMS IS
Thalidomide BMS contains an active substance called thalidomide. This
belongs to a group of
medicines which affect how your immune system works.
WHAT THALIDOMIDE BMS IS USED FOR
Thalidomide BMS is used with two other medicines called
‘melphalan’ and ‘prednisone’ to treat
adults with a type of cancer called multiple myeloma. It is used in
people who have recently been
diagnosed and who have not been prescribed another medicine for their
multiple myeloma before who
are aged 65 years and over, or aged less than 65 years who cannot be
treated with high dose
chemotherapy, which can be very difficult for the body to handle.
WHAT IS MULTIPLE MYELOMA
Multiple myeloma is a type of cancer which affects a certain type of
white blood cell, called the
plasma cell. These cells collect in the bone marrow and divide out of
contro

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Thalidomide BMS 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg of thalidomide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
White opaque capsules marked “Thalidomide BMS 50 mg”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thalidomide BMS in combination with melphalan and prednisone is
indicated as first line treatment of
patients with untreated multiple myeloma, aged ≥ 65 years or
ineligible for high dose chemotherapy.
Thalidomide BMS is prescribed and dispensed according to the
Thalidomide BMS Pregnancy
Prevention Programme (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and monitored under the supervision of
physicians with expertise in
managing immunomodulatory or chemotherapeutic agents and a full
understanding of the risks of
thalidomide therapy and monitoring requirements (see section 4.4).
Posology
The recommended dose of thalidomide is 200 mg orally per day.
A maximum number of 12 cycles of 6 weeks (42 days) should be used.
TABLE 1: STARTING DOSES FOR THALIDOMIDE IN COMBINATION WITH MELPHALAN
AND PREDNISONE
AGE
(YEARS)
ANC
*
(/ΜL)
PLATELET COUNT
(/ΜL)
THALIDOMIDE
A,B
MELPHALAN
C,D,E
PREDNISONE
F
≤ 75
≥ 1,500
AND
≥ 100,000
200 mg daily
0.25 mg/kg daily
2 mg/kg daily
≤ 75
< 1,500 but
≥ 1,000
OR
< 100,000 but
≥ 50,000
200 mg daily
0.125 mg/kg daily
2 mg/kg daily
> 75
≥ 1,500
AND
≥ 100,000
100 mg daily
0.20 mg/kg daily
2 mg/kg daily
> 75
< 1,500 but
≥ 1,000
OR
< 100,000 but
≥ 50,000
100 mg daily
0.10 mg/kg daily
2 mg/kg daily
*
ANC: Absolute Neutrophil Count
a
Thalidomide dosed once daily at bedtime on Days 1 to 42 of each 42-day
cycle.
b
Due to the sedative effect associated with thalidomide, administration
at bedtime is known to generally improve tolerability.
c
Melphalan dosed once daily on Days 1 to 4 of each 42-day cycle.
d
Melphalan dosing: reduce by 50 % for mode