Farydak
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
13-10-2023
Summary of Product characteristics
(SPC)
13-10-2023
Public Assessment Report
(PAR)
11-09-2015
Active ingredient:
panobinostat lactate anhydrous
Available from:
pharmaand GmbH
ATC code:
L01XH03
INN (International Name):
panobinostat
Therapeutic group:
Antineoplastic agents
Therapeutic area:
Multiple Myeloma
Therapeutic indications:
Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.
Product summary:
Revision: 13
Authorization status:
Authorised
Authorization date:
2015-08-28
Patient Information leaflet
38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FARYDAK 10 MG HARD CAPSULES
FARYDAK 15 MG HARD CAPSULES
FARYDAK 20 MG HARD CAPSULES
panobinostat
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 Farydak is and what it is used for
2.
What you need to know before you take Farydak
3.
How to take Farydak
4.
Possible side effects
5.
How to store Farydak
6.
Contents of the pack and other information
1.
WHAT FARYDAK IS AND WHAT IT IS USED FOR
WHAT FARYDAK IS
Farydak is an anti-cancer medicine that contains the active substance
panobinostat, which belongs to a
group of medicines called pan-deacetylase inhibitors.
WHAT FARYDAK IS USED FOR
Farydak is used to treat adult patients with a rare type of blood
cancer called multiple myeloma.
Multiple myeloma is a disorder of plasma cells (a type of blood cell)
that grow out of control in the
bone marrow.
Farydak blocks the growth of cancerous plasma cells and reduces the
number of cancer cells.
Farydak is always used together with two other medicines: bortezomib
and dexamethasone.
If you have any questions about how Farydak works or why you have been
given it, ask your doctor or
pharmacist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FARYDAK
DO NOT TAKE FARYDAK:
-
if you are allergic to panobinostat or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are breast-feeding
WARNINGS AND PRECAUTIONS
Follow all your doctor’s instructions carefully.
40
Talk to your doctor or pharmacist before taking Farydak:
Read the complete document
Summary of Product characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Farydak 10 mg hard capsules
Farydak 15 mg hard capsules
Farydak 20 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Farydak 10 mg hard capsules
Each hard capsule contains panobinostat lactate anhydrous equivalent
to 10 mg panobinostat.
Farydak 15 mg hard capsules
Each hard capsule contains panobinostat lactate anhydrous equivalent
to 15 mg panobinostat.
Farydak 20 mg hard capsules
Each hard capsule contains panobinostat lactate anhydrous equivalent
to 20 mg panobinostat.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Farydak 10 mg hard capsules
Light green opaque hard gelatin capsule (15.6–16.2 mm) containing
white to almost white powder,
with radial marking “LBH 10 mg” in black ink on cap and two radial
bands in black ink on body.
Farydak 15 mg hard capsules
Orange opaque hard gelatin capsule (19.1–19.7 mm) containing white
to almost white powder, with
radial marking “LBH 15 mg” in black ink on cap and two radial
bands in black ink on body.
Farydak 20 mg hard capsules
Red opaque hard gelatin capsule (19.1–19.7 mm) containing white to
almost white powder, with radial
marking “LBH 20 mg” in black ink on cap and two radial bands in
black ink on body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Farydak, in combination with bortezomib and dexamethasone, is
indicated for the treatment of adult
patients with relapsed and/or refractory multiple myeloma who have
received at least two prior
regimens including bortezomib and an immunomodulatory agent.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Farydak should be initiated by a physician experienced
in the use of anti-cancer
3
therapies.
Posology
The recommended starting dose of panobinostat is 20 mg, taken orally
once a day, on days 1, 3, 5, 8,
10 and 12 of a 21-day cycle. Patients should be treated initially for
eight cycles. It is recommended
that patients with clinical benefit continue the treatment
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