INQOVI 35/100 decitabine 35 mg and cedazuridine 100 mg tablet bottle

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

decitabine, Quantity: 35 mg; cedazuridine, Quantity: 100 mg

Διαθέσιμο από:

Otsuka Australia Pharmaceutical Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: lactose monohydrate; colloidal anhydrous silica; magnesium stearate; croscarmellose sodium; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

5 film-coated tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

INQOVI 35/100 is indicated for the treatment of adult patients with myelodysplastic syndromes (MDS) intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups, and patients with chronic myelomonocytic leukaemia (CMML).

Περίληψη προϊόντος:

Visual Identification: Oval-shaped film-coated red tablet, plain-faced on one side and debossed with H35 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-11-02

Φύλλο οδηγιών χρήσης

INQOVI
® 35/100
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®
3
5
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1
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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 INQOVI 35/100?
INQOVI 35/100 contains the active ingredients decitabine and
cedazuridine. INQOVI 35/100 is used to treat myelodysplastic
syndrome (MDS) or chronic myelomonocytic leukaemia (CMML). For more
information, see Section 1. Why am I using INQOVI
35/100? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE INQOVI 35/100?
Do not use if you have ever had an allergic reaction to INQOVI 35/100
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
INQOVI 35/100? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with INQOVI 35/100 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 INQOVI 35/100?
•
Always take this medicine exactly as your doctor or pharmacist has
told you
•
Take one tablet daily on the first five days of each 28 day treatment
cycle or as directed by your doctor.
•
Swallow the tablets whole on an empty stomach with a full glass of
water, and avoid eating at least 2 hours before and 2 hours
afterwards. Do not chew or break the tablets.
More instructions can be found in Section 4. How do I use INQOVI
35/100? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING INQOVI 35/100?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
INQOVI 35/100.
•
Call your doctor straight away if you feel very unwell, have a fever
and chills, bleed or bruise easily
•
Keep all your

Αρχείο Π.Χ.Π.

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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
https://www.tga.gov.au/reporting-problems
AUSTRALIAN PRODUCT INFORMATION – INQOVI
® 35/100
(DECITABINE AND CEDAZURIDINE) TABLETS
1
NAME OF THE MEDICINE
Decitabine and cedazuridine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each INQOVI 35/100 tablet contains 35 mg of decitabine and 100 mg of
cedazuridine.
Excipients with known effect: contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet
INQOVI 35/100 is a biconvex, oval-shaped, red film-coated tablet,
plain-faced on one side
and debossed with “H35” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INQOVI 35/100 is indicated for treatment of adult patients with
myelodysplastic syndromes
(MDS) intermediate-1, intermediate-2, and high-risk International
Prognostic Scoring System
groups, and patients with chronic myelomonocytic leukaemia (CMML).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dose of INQOVI 35/100 is 1 tablet containing 35 mg of
decitabine and
100 mg of cedazuridine taken orally once daily on Days 1 through 5 of
each 28-day cycle for
a minimum of 4 cycles. Best response may take longer than 4 cycles.
Continue treatment as
long as the patient continues to benefit. Repeat cycles every 28 days
in the absence of
haematologic toxicities not attributed to active disease and blood
counts show absolute
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neutrophil count at least 1,000/µL and platelets at least 50,000/µL,
or at least return to
pretreatment levels.
Delay or reduce the dose per cycle for haematologic toxicity (see
Dosage
adjustment, Haematological toxicity).
Prior to initiation of INQOVI 35/100, conduct baseline laboratory
testing including complete
blood cell counts with platelets, serum hepatic panel, and serum
creatinine.
Obtai