Thalidomide Accord 50mg Hard Capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

THALIDOMIDE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

L04AX02

INN (International Name):

THALIDOMIDE 50 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

THALIDOMIDE 50 mg

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2019-11-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
THALIDOMIDE ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Thalidomide Accord
3.
How to take Thalidomide Accord
4.
Possible side effects
5.
How to store Thalidomide Accord
6.
Contents of the pack and other information
1.
WHAT THALIDOMIDE ACCORD IS AND WHAT IT IS USED FOR
WHAT THALIDOMIDE ACCORD IS
Thalidomide Accord contains an active substance called thalidomide.
This belongs to a group of
medicines which affect how your immune system works.
WHAT THALIDOMIDE ACCORD IS USED FOR
Thalidomide Accord 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 divid

Summary of Product characteristics

Page 2 of 22
1.
NAME OF THE MEDICINAL PRODUCT
Thalidomide Accord 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg of thalidomide.
Excipient with known effect
Each capsule contains approximately 1.81 mg of sodium and 28.8 mg of
isomalt.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
White opaque hard capsules size number 4.
The capsule filling is a white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thalidomide Accord 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 Accord is prescribed and dispensed according to the
Thalidomide Accord
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.
Page 3 of 22
TABLE 1: STARTING DOSES FOR THALIDOMIDE IN COMBINATION WITH MELPHALAN
AND
PREDNISONE
AGE
(YEAR
S)
ANC*
(/ΜL)
PLATELET
COUNT
(/ΜL)
THALIDOMIDE
A,B
MELPHALAN
C,D,E
PREDNISONE
F
≤ 75
≥ 1,500
AN
D
≥ 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
AN
D
≥ 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 improv