YONSA MPRED abiraterone acetate 125 mg tablet bottle and methylprednisolone 4 mg tablet bottle composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methylprednisolone, Quantity: 4 mg

Available from:

Sun Pharma ANZ Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: Gelatin; maize starch; magnesium stearate; purified talc; lactose monohydrate

Administration route:

Oral

Units in package:

120 abiraterone acetate 125 mg tablets, 30 Methylprednisolone 4 mg tablets, 60 Methylprednisolone 4 mg tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

YONSA MPRED is indicated for the treatment of patients with: newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), or; patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) or; patients with mCRPC who have received prior chemotherapy containing a taxane.

Product summary:

Visual Identification: White to almost white, round, flat, bevelled edge, scored tablets.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-03-29

Patient Information leaflet

YONSA MPRED™
1
YONSA MPRED™
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.
1.
WHY AM I USING YONSA MPRED?
YONSA MPRED is a combination pack which contains two different
medicines, YONSA tablets and Methylprednisolone tablets.
YONSA tablets contain the active ingredient abiraterone acetate and
Methylprednisolone tablets contain the active ingredient
methylprednisolone. YONSA MPRED is used to treat prostate cancer that
has spread to other parts of the body
For more information, see Section 1. Why am I using YONSA MPRED? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE YONSA MPRED?
Do not use if you have ever had an allergic reaction to abiraterone
acetate, methylprednisolone 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
YONSA MPRED? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with YONSA MPRED 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 YONSA MPRED?
YONSA MPRED should be used regularly each day. The dosage recommended
by the doctor will depend on your condition
More instructions can be found in Section 4. How do I use YONSA MPRED?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING YONSA MPRED?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
YONSA MPRED.
•
Keep all of your doctor's appointments so that your condition can be
monitored.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
DRIVING OR USING
MACHINES
•
YONSA MPRED may cause dizziness in some people. Be careful before you
drive or use any machines
or tools until you know how YONSA MPRED affects y

Summary of Product characteristics

Page 1 of 35
AUSTRALIAN PRODUCT INFORMATION – YONSA MPRED™ ABIRATERONE ACETATE
4 MG TABLET AND METHYLPREDNISOLONE 4 MG TABLET COMPOSITE PACK
1 NAME OF THE MEDICINE
Abiraterone acetate and methylprednisolone.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
YONSA MPRED contains 125 mg abiraterone acetate tablets (YONSA) and 4
mg methylprednisolone tablets.
EXCIPIENTS WITH KNOWN EFFECTS
YONSA MPRED contains sugars as lactose.
Each abiraterone acetate tablet (YONSA) contains lactose monohydrate.
Each methylprednisolone tablet contains lactose monohydrate.
Methylprednisolone tablets contain
sulfites.
For the full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Abiraterone acetate 125 mg tablet (YONSA): White to off‐white
modified oval shaped tablet debossed with
‘125 FP’.
Methylprednisolone 4 mg tablet: White to almost white, round, flat,
bevelled edge, scored tablets.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
YONSA MPRED is indicated for the treatment of patients with:

newly diagnosed high‐risk metastatic hormone sensitive prostate
cancer (mHSPC) in combination with
androgen deprivation therapy (ADT), or

patients with metastatic advanced prostate cancer (castration
resistant prostate cancer, mCRPC) who
are asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy (ADT) or

patients with mCRPC who have received prior chemotherapy containing a
taxane.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose of YONSA abiraterone acetate tablets is 500 mg
(four 125 mg tablets) administered
orally once daily in combination with methylprednisolone.
The recommended dose of methylprednisolone for metastatic hormone
sensitive prostate cancer is 4 mg
administered once daily. The recommended dose of methylprednisolone
for metastatic castration resistant
prostate cancer is 4 mg administered twice daily. (See section 4.4
Special Warnings and Precautions for
Use ‐ Corticosteroid
withdrawal and coverage of stress situations).
IMPORTANT ADMINISTRATIO