VERZENIO abemaciclib 150 mg tablet blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

abemaciclib, Quantity: 150 mg

थमां उपलब्ध:

Eli Lilly Australia Pty Ltd

फार्मास्यूटिकल फॉर्म:

Tablet, film coated

रचना:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; purified talc; iron oxide yellow; silicon dioxide; polyvinyl alcohol; macrogol 3350; sodium stearylfumarate; titanium dioxide

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

14, 56, 42, 70

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

Early Breast Cancer VERZENIO in combination with endocrine therapy is indicated for the adjuvant treatment of patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node-positive early breast cancer at high risk of recurrence.,In pre- or peri-menopausal women, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.,Advanced or Metastatic Breast Cancer VERZENIO is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or following prior endocrine therapy.,In pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

उत्पाद समीक्षा:

Visual Identification: Modified oval tablets with "Lilly" debossed on one side and 150 mg on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2019-04-08

सूचना पत्रक

VERZENIO™
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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 VERZENIO?
VERZENIO contains the active ingredient abemaciclib. VERZENIO is used
to treat patients with certain types of breast cancer which
have not spread to other parts of the body or spread beyond the
original tumour and/or to other organs.
For more information, see Section 1. Why am I using VERZENIO? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VERZENIO?
Do not use if you have ever had an allergic reaction to VERZENIO 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
VERZENIO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VERZENIO 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 VERZENIO?
•
Swallow tablet whole with a full glass of water
•
Do not chew, crush or split the tablets before swallowing. VERZENIO
may be taken with or without food.
More instructions can be found in Section 4. How do I use VERZENIO? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VERZENIO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or anaesthetist you visit that
you are using VERZENIO.
•
If you become pregnant while taking this medicine, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or lower the dosage without checking
with the doctor.
•
Do not take grapefruit products while on this therapy as it may
in

उत्पाद विशेषताएं

VA6.0Apr2022
Supersedes VA5.0 MON2April2021
Page 1 of 31
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 PI – VERZENIO™ (ABEMACICLIB) TABLET
1
NAME OF THE MEDICINE
Abemaciclib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abemaciclib (VERZENIO) 50 mg film-coated tablets
Each film-coated tablet contains 50 mg abemaciclib.
_Excipients with known effect _
Each film-coated tablet contains 14 mg of lactose (monohydrate).
Abemaciclib (VERZENIO) 100 mg film-coated tablets
Each film-coated tablet contains 100 mg abemaciclib.
_Excipients with known effect _
Each film-coated tablet contains 28 mg of lactose (monohydrate).
Abemaciclib (VERZENIO) 150 mg film-coated tablets
Each film-coated tablet contains 150 mg abemaciclib.
_Excipients with known effect _
Each film-coated tablet contains 42 mg of lactose (monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
VERZENIO 50 mg film-coated tablets
Beige, modified oval tablet debossed with “Lilly” on one side and
“50” on the other.
VERZENIO 100 mg film-coated tablets
White, modified oval tablet debossed with “Lilly” on one side and
“100” on the other.
VERZENIO 150 mg film-coated tablets
Yellow, modified oval tablet debossed with “Lilly” on one side and
“150” on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Early Breast Cancer
VERZENIO in combination with endocrine therapy is indicated for the
adjuvant treatment of
patients with hormone receptor (HR) positive, human epidermal growth
factor receptor 2
(HER2) negative, node-positive early breast cancer at high risk of
recurrence.
▼

VA6.0Apr2022
Supersedes VA5.0 MON2April2021
Page 2 of 31
In pre- or peri-menopausal women, endocrine therapy should be combined
with a luteinising
hormone-releasing hormone (LHRH) agonist.
Advanced o