PIQRAY alpelisib 300 mg daily dose blister (150 mg tablet)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alpelisib, Quantity: 150 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide

Administration route:

Oral

Units in package:

Twenty eight (28) 150 mg tablets (300 mg daily dose /14 day pack), Fifty six (56) 150 mg tablets (300 mg daily dose /28 day pack )

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PIQRAY in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, HER2-negative, advanced or metastatic breast cancer with a PIK3CA mutation as detected by a validated test following progression on or after an endocrine-based regimen

Product summary:

Visual Identification: Pale red, unscored, ovaloid and curved with beveled edges film-coated tablet, imprinted with UL7 on one side and NVR on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/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:

Registered

Authorization date:

2020-03-20

Patient Information leaflet

PIQRAY
®
P
I
Q
R
A
Y
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING PIQRAY?
PIQRAY contains the active ingredient Alpelisib. PIQRAY is used with a
medicine called fulvestrant to treat certain types of
advanced breast cancer in adult women and men.
For more information, see Section 1. Why am I using PIQRAY? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PIQRAY?
Do not use if you have ever had an allergic reaction to PIQRAY or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
PIQRAY? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PIQRAY and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE PIQRAY?
•
The usual dose of PIQRAY is 300 mg (two 150 mg film-coated tablets)
taken orally, once daily. You should take PIQRAY
immediately after food, at approximately the same time each day.
More instructions can be found in Section 4. How do I use PIQRAY? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PIQRAY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
PIQRAY.
•
Have regular blood tests to monitor your condition.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly (unless your doctor tells you
to).
DRIVING
OR USING
MACHINES
•
PIQRAY has minor influence on the ability to drive and use machines.
Be cautious when driving or using
machines in case you feel tired with taking PIQRAY.
DRINKING
ALCOHOL
•
There are no known interactions between

Summary of Product characteristics

This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION - PIQRAY
 (ALPELISIB) TABLETS
1.
NAME OF THE MEDICINE
Alpelisib
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
All PIQRAY tablets contain alpelisib.
PIQRAY 50 mg tablet
Each tablet contains 50 mg of alpelisib.
PIQRAY 150 mg tablet
Each tablet contains 150 mg of alpelisib.
PIQRAY 200 mg tablet
Each tablet contains 200 mg of alpelisib.
EXCIPIENTS
For the list of excipients, see section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
FILM COATED TABLETS
PIQRAY 50 mg tablet
Light pink, unscored, round and curved with bevelled edges, imprinted
with “L7” on one side and
“NVR” on the other side.
PIQRAY 150 mg tablet
Pale red, unscored, ovaloid and curved with bevelled edges, imprinted
with “UL7” on one side and
“NVR” on the other side.
PIQRAY 200 mg tablet
Light red, unscored, ovaloid and curved with bevelled edges, imprinted
with “YL7” on one side
and “NVR” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PIQRAY in combination with fulvestrant, is indicated for the treatment
of postmenopausal women,
and men, with hormone receptor positive, HER2-negative, advanced or
metastatic breast cancer
with a PIK3CA mutation as detected by a validated test following
progression on or after an
endocrine-based regimen.
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment with PIQRAY should be initiated by a physician experienced
in the use of anticancer
therapies.
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
Page 2 of 26
Patients with HR positive, HER2 negative advanced breast cancer should
be selected for treatment
with PIQRAY, based on the presence of a PIK3CA mutation in tumour or
plasma specimens, using
a validated test. If a mutation is not detected in a plasma specimen,
test tumour tissue if available.
The safety and efficacy of alp