Akynzeo

Land: Europäische Union

Sprache: Englisch

Quelle: EMA (European Medicines Agency)

Wirkstoff:

netupitant, palonosetron hydrochloride

Verfügbar ab:

Helsinn Birex Pharmaceuticals Ltd

ATC-Code:

A04AA

INN (Internationale Bezeichnung):

netupitant, palonosetron

Therapiegruppe:

Antiemetics and antinauseants,

Therapiebereich:

Vomiting; Neoplasms; Nausea; Cancer

Anwendungsgebiete:

Akynzeo is indicated in adults for the:Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Produktbesonderheiten:

Revision: 16

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2015-05-27

Gebrauchsinformation

70
B. PACKAGE LEAFLET
71
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AKYNZEO 300 MG/0.5 MG HARD CAPSULES
netupitant/palonosetron
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 Akynzeo is and what it is used for
2.
What you need to know before you take Akynzeo
3.
How to take Akynzeo
4.
Possible side effects
5.
How to store Akynzeo
6.
Contents of the pack and other information
1. WHAT AKYNZEO IS AND WHAT IT IS USED FOR
WHAT AKYNZEO IS
Akynzeo contains two medicines (‘active substances’) called:
•
netupitant
•
palonosetron.
WHAT AKYNZEO IS USED FOR
Akynzeo is used
to help prevent adults with cancer feeling sick (nausea) or being sick
(vomiting)
while having cancer treatment called ‘chemotherapy’.
HOW AKYNZEO WORKS
Chemotherapy medicines can cause the body to release substances called
serotonin and substance P.
This stimulates the vomiting centre in the brain, making you feel or
be sick. The medicines in
Akynzeo attach to the receptors in the nervous system through which
serotonin and substance P work:
netupitant (an NK
1
receptor antagonist) blocks the receptors for substance P, and
palonosetron (a 5-
HT
3
receptor antagonist) blocks certain receptors for serotonin. By
blocking the actions of substance P
and serotonin in this way, the medicines help prevent the stimulation
of the vomiting centre and the
resulting sickness.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AKYNZEO
DO NOT TAKE AKYNZEO IF:
•
you are allergic to netupitant or palonosetron, or any of the oth

Fachinformation

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Akynzeo 300 mg/0.5 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 300 mg of netupitant and palonosetron
hydrochloride equivalent to 0.5 mg
of palonosetron.
Excipients with known effect
Each hard capsule contains 7 mg of sorbitol (E420) and 20 mg of
sucrose.
It may also contain a trace of lecithin derived from soya.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Opaque gelatin capsule of size “0” (length 21.7 mm) with white
body and caramel cap with “HE1”
printed on the body. The hard capsule is filled with three tablets and
one soft capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Akynzeo is indicated in adults for the:
-
Prevention of acute and delayed nausea and vomiting associated with
highly emetogenic
cisplatin-based cancer chemotherapy.
-
Prevention of acute and delayed nausea and vomiting associated with
moderately emetogenic
cancer chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
One 300 mg/0.5 mg capsule should be administered approximately one
hour prior to the start of each
chemotherapy cycle.
The recommended oral dexamethasone dose should be reduced by
approximately 50 % when co-
administered with netupitant/palonosetron capsules (see section 4.5
and clinical studies administration
schedule in section 5.1).
_Special populations _
_ _
_Elderly people_
No dosage adjustment is necessary for elderly patients. Caution should
be exercised when using this
medicinal product in patients over 75 years, due to the long half-life
of the active substances and the
limited experience in this population.
_Renal impairment _
3
Dosage adjustment is not considered necessary in patients with mild to
severe renal impairment. Renal
excretion for netupitant is negligible. Mild to moderate renal
impairment does not significantly affect
palonosetron pharmacokinetic parameters. Total systemic exposure to
intravenous palonosetron
i