Consumer medicine information

Inqovi 35 mg/100 mg Tablets

Decitabine + Cedazuridine

BRAND INFORMATION

Brand name

Inqovi 35/100

Active ingredient

Decitabine + Cedazuridine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Inqovi 35 mg/100 mg Tablets.

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 doctor's appointments so that your progress can be checked
  • Use contraception while undergoing treatment.
Things you should not do
  • Do not stop using this medicine without talking to your doctor
  • Do not give your medicine to anyone else, even if they have the same condition as you.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how INQOVI 35/100 affects you.
Looking after your medicine
  • Store below 25°C.

For more information, see Section 5. What should I know while using INQOVI 35/100? in the full CMI.

6. Are there any side effects?


The most common side effects are tiredness, nausea, diarrhoea, constipation, or sudden shortness of breath. Serious side-effects include fever, chills, sudden shortness of breath, dry cough and tiredness which may be signs of infection; bleeding, or bruising more than normal.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Inqovi 35/100

Active ingredient

Decitabine + Cedazuridine

Schedule

S4

 

1 Name of 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

4.9 Overdose

There is no known antidote for overdosage with Inqovi 35/100. Overdosage could cause increased myelosuppression, and neutropenia-related infections such as pneumonia and sepsis. For patients who experience overdose, closely monitor, and provide appropriate supportive treatment.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Cedazuridine and decitabine are genotoxic.
Decitabine increased mutation frequency in L5178Y mouse lymphoma cells, and mutations were produced in an Escherichia coli lac-I transgene in colonic DNA of decitabine-treated mice. Decitabine also caused chromosomal rearrangements in larvae of fruit flies.
Cedazuridine was genotoxic in a reverse bacterial mutation assay (Ames test) and in an in vitro chromosomal aberration assay in human lymphocytes. Negative results were obtained for cedazuridine in an in vivo mouse bone marrow micronucleus test.
Carcinogenicity. Carcinogenicity studies with decitabine, cedazuridine or the two medicines in combination have not been conducted.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Decitabine. Decitabine is a nucleoside metabolic inhibitor. Decitabine is white to off-white solid with the molecular formula of C8H12N4O4 and a molecular weight of 228.21 daltons. Its IUPAC chemical name is 4-amino-1-[(2R,4S,5R)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,3,5-triazin-2(1H)-one and it has the following structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDECITA.gif Cedazuridine. Cedazuridine is a cytidine deaminase inhibitor. Cedazuridine is white to off-white solid with molecular formula of C9H14F2N2O5 and a molecular weight of 268.21 daltons. Its international union of pure and applied chemistry (IUPAC) chemical name is (4R)-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-hydroxy-1,3-diazinan-2-one and has the following structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCEDAZU.gif CAS number. Decitabine. 2353-33-5.
Cedazuridine. 1141397-80-9.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/INQOVIST.gif