AKYNZEO netupitant/palonosetron (as hydrochloride) 300 mg/500 mcg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

netupitant, Quantity: 300 mg; palonosetron hydrochloride, Quantity: 0.56 mg (Equivalent: palonosetron, Qty 0.5 mg)

Available from:

Juniper Biologics Pty Ltd

INN (International Name):

netupitant,Palonosetron hydrochloride

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: microcrystalline cellulose; sucrose laurate; povidone; croscarmellose sodium; purified water; silicon dioxide; sodium stearylfumarate; magnesium stearate; glyceryl caprylate/caprate; glycerol; polyglyceryl-3 dioleate; butylated hydroxyanisole; nitrogen; Gelatin; titanium dioxide; iron oxide yellow; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; ethanol absolute; iron oxide black; sorbitol; 1,4-sorbitan; mannitol

Administration route:

Oral

Units in package:

1 capsule

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AKYNZEO is indicated in adult patients for: Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Product summary:

Visual Identification: AKYNZEO is supplied as a hard, opaque, gelatin capsule with white body and caramel cap with HE1 printed on the body; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-05-06

Patient Information leaflet

AKYNZEO
®
1
AKYNZEO
®
_Netupitant (ne-TU-pi-tant) 300mg and Palonosetron (pa-lo-NOS-etron)
500 microgram capsules _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Akynzeo. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT AKYNZEO IS USED
FOR
This medicine is used to prevent
nausea (feeling sick) and vomiting
caused by cancer chemotherapy in
adult patients.
It is a combination medicine which
contains two active ingredients. The
active ingredients are called
netupitant and palonosetron.
Netupitant belongs to a group of
medicines called 'neurokinin-1
(NK1) receptor antagonists'.
Palonosetron belongs to a group of
medicines called 'serotonin (5-HT3)
receptor antagonists'.
Akynzeo works by blocking the
actions of substances in your body
and brain that are thought to cause
nausea and vomiting.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend its use in children under
the age of 18 years.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF:
•
You are pregnant
•
You are allergic to any medicine
containing palonosetron or
netupitant
•
You are allergic to any of the
ingredients listed at the end of
this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
or a tight feeling in your chest
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching

Summary of Product characteristics

AKYNZEO
®
CAPSULE
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION – AKYNZEO
® (NETUPITANT
AND PALONOSETRON (AS HYDROCHLORIDE)) CAPSULE
1
NAME OF THE MEDICINE
Netupitant
Palonosetron (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each AKYNZEO hard gelatin capsule contains three 100 mg netupitant
(300 mg total) immediate
release tablets and one 500 microgram palonosetron (as hydrochloride)
soft capsule.
For the full list of excipients, see Section 6.1 List of excipients.
300 mg / 500 micrograms: AUST R 222237.
3
PHARMACEUTICAL FORM
AKYNZEO is supplied as a hard, opaque, gelatin capsule with white body
and caramel cap with
“HE1” printed on the body.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
AKYNZEO is indicated in adult patients for:
Prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses
of highly emetogenic cancer chemotherapy.
Prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses
of moderately emetogenic cancer chemotherapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
One AKYNZEO 300 mg/500 microgram capsule should be administered
approximately one hour
prior to the start of each chemotherapy cycle.
To be taken orally.
The hard capsule should be swallowed whole.
AKYNZEO can be taken with or without food.
The concomitant use of dexamethasone is recommended.
AKYNZEO
®
CAPSULE
Page 2 of 24
The recommended oral dexamethasone dose should be reduced by
approximately 50 % when
co-administered with AKYNZEO (see Table 1 and Table 3 in Section 5.1
Pharmacodynamic
properties; Clinical Trials).
ELDERLY POPULATION
No dosage adjustment is necessary for elderly patients.
PAEDIATRIC POPULATION
The safety and efficacy of AKYNZEO in children have not been
established. No data are available._ _
PATIENTS WITH RENAL IMPAIRMENT
Dosage adjustment for AKYNZEO is not considered necessary in patients
with mild to moderate
renal impairment. Use of AYKNZEO in patients with severe renal
impairment or end stage ren