FARYDAK panobinostat (as lactate) 20 mg hard capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

panobinostat lactate

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

panobinostat lactate

Authorization status:

Registered

Patient Information leaflet

FARYDAK
®
1
FARYDAK
®
_Panobinostat (as lactate) _
CONSUMER MEDICINE INFORMATION (CMI)
WARNING
The following information is needed to use FARYDAK safely and
effectively. Diarrhoea, cardiac toxicities, bleeding
and infections can be severe and could be fatal. If you have any
concerns or questions about this medicine, please
talk to your doctor. Familiarize yourself with the serious side
effects described below and under the
SIDE EFFECTS heading near the end of this document. Remember to report
side effects to your doctor. Your
doctor will need to monitor your progress closely.
FARYDAK CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
•
DIARRHOEA
is common with FARYDAK and can be severe. Tell your doctor right away
if you have abdominal
(stomach) cramps, loose stool, diarrhoea, or if you feel like you are
becoming dehydrated. Your doctor may prescribe
medicines to help prevent or treat these side effects. Taking or using
stool softeners or laxative medicines may worsen
diarrhoea, talk to your doctor before taking or using these medicines.
Taking or using stool softeners or laxative medicines
may worsen diarrhoea, talk to your doctor before taking or using these
medicines.
Your doctor will do regular tests to check the levels of fluid and
electrolytes in your blood during treatment with
FARYDAK.
•
HEART PROBLEMS
. FARYDAK can cause severe heart problems which can lead to death.
Your risk of heart problems
may be increased if you have a condition called “long QT syndrome”
or other heart problems. Your doctor will do blood
tests to check your electrolytes and do an electrocardiogram (ECG)
tests before and during treatment with FARYDAK.
Contact your doctor and get emergency medical help right away if you
have any of the following symptoms of heart
problems:
-
chest pain
-
faster or slower heart beat
-
palpitations (feel like your heart is racing)
-
feel lightheaded or faint
-
dizziness
-
blue coloured lips
-
shortness of breath
-
swelling in your legs
•
BLEEDING.
FARYDAK can cause severe bleeding which can lead to

Summary of Product characteristics

Page 1
FARYDAK
®
Panobinostat (as lactate)
WARNING
DIARRHOEA OCCURRED IN 68% OF FARYDAK-TREATED PATIENTS, WAS SEVERE IN
25%, RESULTING IN
DEHYDRATION AND ELECTROLYTE DISTURBANCES. MONITOR PATIENTS CAREFULLY
PARTICULARLY IN THOSE
WITH PRE-EXISTING RENAL FAILURE. TWO FATALITIES RESULTING FROM ACUTE
RENAL FAILURE WERE
REPORTED IN FARYDAK TREATED PATIENTS.
SEVERE AND FATAL CARDIAC ISCHAEMIC EVENTS, SEVERE ARRHYTHMIAS, AND ECG
CHANGES HAVE
OCCURRED IN PATIENTS RECEIVING FARYDAK. ARRHYTHMIAS MAY BE EXACERBATED
BY ELECTROLYTE
ABNORMALITIES.
SEVERE NEUTROPENIA OCCURRED IN 34% OF FARYDAK TREATED PATIENTS AND MAY
CONTRIBUTE TO
AN INCREASED RISK OF SERIOUS AND FATAL INFECTIONS.
SEVERE THROMBOCYTOPENIA OCCURRED IN 67% OF FARYDAK TREATED PATIENTS
AND MAY BE
ASSOCIATED WITH AN INCREASED RISK OF SERIOUS AND FATAL HAEMORRHAGE.
CLOSE MONITORING OF PATIENTS IS REQUIRED (SEE PRECAUTIONS; DOSAGE AND
ADMINISTRATION
SECTION FOR MONITORING RECOMMENDATIONS AND DOSE MODIFICATIONS).
Panobinostat (free base): C
21
H
23
N
3
O
2
;
CAS: 404950-80-7
N
H
N
H
O
NHOH
CH
3
CH
3
OH
O
O
H
.
Page 2
Panobinostat lactate (salt form on anhydrous basis): C
21
H
23
N
3
O
2
.C
3
H
6
O
3
; CAS: 960055-56-5
Relative molecular mass: 349.4 (free base) + 90.1 (lactic acid) =
439.5
DESCRIPTION
Panobinostat (as lactate) is a white to slightly yellowish or brownish
powder that is slightly
soluble in water, ethanol (25°C) and practically insoluble in
n-octanol. The pH of a 0.1% (m/V)
aqueous solution of panobinostat lactate, anhydrous at room
temperature (21-22°C), measured
potentiometrically is approximately 6.0.
The capsule active contents are:
FARYDAK 10 mg hard capsule contains 10 mg panobinostat (12.576 mg
panobinostat lactate),
FARYDAK 15 mg hard capsule contains 15 mg panobinostat (18.864 mg
panobinostat lactate)
and FARYDAK 20 mg hard capsule contains 20 mg panobinostat (25.152 mg
panobinostat
lactate).
The capsule inactive contents are: Magnesium stearate, mannitol,
microcrystalline cellulose,
pregelatinised maize starch.
The hard capsule is made from g