Volibris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ambrisentan 5mg

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Ambrisentan 5 mg

Dosage:

5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Ambrisentan 5mg Excipient: Croscarmellose sodium Opadry II Pink 85G94065 Lactose Magnesium stearate Microcrystalline cellulose

Units in package:

Blister pack, PVC/PvdC/Al foil, 30 tablets, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Johnson Matthey Pharmaceutical Materials Inc.

Therapeutic indications:

Volibris is indicated for the treatment of: · idiopathic pulmonary arterial hypertension (PAH) · pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD) in patients with WHO functional class II, III or IV symptoms.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PvdC/Al foil - 30 tablets - 60 months from date of manufacture stored at or below 30°C

Authorization date:

2009-01-21

Patient Information leaflet

VOLIBRIS
1
VOLIBRIS
_5 MG AND 10 MG FILM COATED TABLETS _
_Ambrisentan _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING
VOLIBRIS.
This leaflet answers some common
questions about VOLIBRIS. 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 VOLIBRIS
against the benefits they expect it
will have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VOLIBRIS IS
USED FOR
VOLIBRIS contains the active
ingredient ambrisentan which is a
type of medicine called an endothelin
receptor antagonist (ERA). It is used
to treat adults with pulmonary
arterial hypertension (PAH), which is
high blood pressure in the blood
vessels (the pulmonary arteries) that
carry blood from the heart to the
lungs. In people with PAH, these
arteries get narrower, so the heart has
to work harder to pump blood
through them. This causes people to
become tired, dizzy and short of
breath. VOLIBRIS widens the
pulmonary arteries, making it easier
for your heart to pump blood through
them. This lowers the blood pressure
and relieves your symptoms.
VOLIBRIS is not recommended for
use in children as there have been no
studies of its effects in children.
VOLIBRIS must not be used for the
treatment of idiopathic pulmonary
fibrosis (IPF) and must not be used in
patients who have IPF with or
without secondary pulmonary
hypertension.
VOLIBRIS is available as 5 mg and
10 mg tablets.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
VOLIBRIS
DO NOT TAKE VOLIBRIS IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
ambrisentan
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicine.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheez

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
VOLIBRIS
(AMBRISENTAN) TABLETS
TERATOGENICITY
VOLIBRIS MAY CAUSE BIRTH DEFECTS AND IS CONTRAINDICATED IN PREGNANCY
(SEE
SECTION 4.3 CONTRAINDICATIONS).
1
NAME OF THE MEDICINE
VOLIBRIS (ambrisentan) 5 mg and 10 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VOLIBRIS 5 mg tablets
Each film-coated tablet contains 5 mg ambrisentan. The tablet contains
lactose.
VOLIBRIS 10 mg tablets
Each film-coated tablet contains 10 mg ambrisentan.
Excipient(s) with known effect:
The tablets contain lactose and Allura Red AC Aluminium Lake (E129).
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
VOLIBRIS 5 mg tablets are pale pink, square convex tablet engraved
‘GS’ on one
face and ‘K2C’ on the other.
VOLIBRIS 10 mg tablets are deep pink, oval convex tablet engraved 'GS'
on one
face and 'KE3' on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VOLIBRIS is indicated in adults aged
≥
18 years for the treatment of:
•
idiopathic pulmonary arterial hypertension (iPAH),
•
pulmonary arterial hypertension associated with connective tissue
disease (PAH-
CTD),
in patients with WHO functional class II, III or IV symptoms.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should only be initiated by a physician experienced in the
treatment of
PAH.
DOSE
VOLIBRIS should be taken orally at a dose of 5 mg once daily.
Additional benefit
may be obtained by increasing the dose to 10 mg (see sections 4.8
UNDESIRABLE
EFFECTS and 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Efficacy and
Safety).
Limited data suggest that the abrupt discontinuation of Volibris is
not associated with
rebound worsening of PAH.
Use with cyclosporin A
When co-administered with cyclosporin A, the dose of ambrisentan
should be limited
to 5 mg once daily (see sections 4.5 INTERACTIONS WITH OTHER MEDICINES
AND OTHER FORMS OF INTERACTION and 5.2 PHARMACOKINETIC
PROPERTIES).
Special populations
_Paediatric population _
Safety and efficacy of VOLIBRIS have not been establish