UPTRAVI selexipag 600 microgram film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

selexipag, Quantity: 600 microgram

Available from:

Janssen-Cilag Pty Ltd

INN (International Name):

selexipag

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: iron oxide red; hyprolose; Carnauba Wax; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; mannitol; maize starch; iron oxide black

Administration route:

Oral

Units in package:

60 film coated tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

UPTRAVI is indicated for the treatment of:,- idiopathic pulmonary arterial hypertension;,- heritable pulmonary arterial hypertension;,- pulmonary arterial hypertension associated with connective tissue disease;,-pulmonary arterial hypertension associated with congenital heart disease with repaired shunts;,-pulmonary arterial hypertension associated with drugs and toxins;,in patients with WHO functional class II, III or IV symptoms

Product summary:

Visual Identification: UPTRAVI 600 microgram, light violet, debossed with '6' on one side, round, film-coated tablet.; 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:

2016-03-24

Patient Information leaflet

UPTRAVI (220919) ACMI
1
This leaflet was prepared in September 2022. Please check with your
pharmacist if an updated version of this leaflet has been
made available.
UPTRAVI
®
(UP-TRA-VEE)
_Selexipag (se-le-xi-pag) 200, 400, 600, 800, 1000, 1200, 1400, 1600
micrograms film coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about UPTRAVI.
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 using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, SPEAK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT UPTRAVI IS
USED FOR
UPTRAVI contains the active
substance selexipag. It is a medicine
that acts on a receptor that is the
target of a natural substance called
"prostacyclin".
UPTRAVI is used for the long-term
treatment of pulmonary arterial
hypertension (PAH) in adults.
It can be used on its own or with
other medicines for PAH. PAH is
high blood pressure in the blood
vessels that carry blood from the
heart to the lungs (the pulmonary
arteries). In people with PAH, these
arteries narrow, so the heart has to
work harder to pump blood through
them. This may cause people to feel
tired, dizzy, short of breath, or
experience other symptoms.
UPTRAVI widens the pulmonary
arteries and reduces their hardening.
This makes it easier for the heart to
pump blood through the pulmonary
arteries. It relieves the symptoms of
PAH and improves the course of the
disease.
Your doctor however, may prescribe
UPTRAVI for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
BEFORE YOU TAKE
UPTRAVI
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE UPTRAVI IF:
1.
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO SELEXIPAG OR ANY OF
THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
PLEAS

Summary of Product characteristics

11.210802
1
UPTRAVI (220826) API
AUSTRALIAN PRODUCT INFORMATION
UPTRAVI
®
(SELEXIPAG)
FILM-COATED
TABLET
1
NAME OF THE MEDICINE
UPTRAVI selexipag
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Selexipag is a pale yellow crystalline powder that is practically
insoluble in water. In the solid state
selexipag is very stable, is not hygroscopic, and is not light
sensitive.
Each round film-coated tablet contains 200 micrograms or multiples
thereof (respectively 400, 600,
800, 1000, 1200, 1400, or 1600 micrograms) selexipag. The film-coated
tablets are not light sensitive.
Refer to Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
UPTRAVI 200 micrograms, light yellow, debossed with '2', round,
film-coated tablet.
UPTRAVI 400 micrograms, red, debossed with '4', round, film-coated
tablet.
UPTRAVI 600 micrograms, light violet, debossed with '6', round,
film-coated tablet.
UPTRAVI 800 micrograms, green, debossed with '8', round, film-coated
tablet.
UPTRAVI 1000 micrograms, orange, debossed with '10', round,
film-coated tablet.
UPTRAVI 1200 micrograms, dark violet, debossed with '12', round,
film-coated tablet.
UPTRAVI 1400 micrograms, dark yellow, debossed with '14', round,
film-coated tablet
UPTRAVI 1600 micrograms, brown, debossed with '16', round, film-coated
tablet
Refer to Section 6.5 NATURE AND CONTENTS OF CONTAINER.
11.210802
2
UPTRAVI (220826) API
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
UPTRAVI is indicated for the treatment of:
•
idiopathic pulmonary arterial hypertension
•
heritable pulmonary arterial hypertension
•
pulmonary arterial hypertension associated with connective tissue
disease
•
pulmonary arterial hypertension associated with congenital heart
disease with repaired
shunts
•
pulmonary arterial hypertension associated with drugs and toxins
in patients with WHO functional class II, III or IV symptoms.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment should only be initiated and monitored by a physician
experienced in the treatment of
pulmonary arterial hypertension (PAH).
Selexipag