Inaqovi 35 mg/100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Inaqovi 35mg/100mg film-coated tablets

decitabine/cedazuridine

(decitabine/cedazuridine)

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 includes information on how to report adverse reactions.

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Inaqovi is and what it is used for
2. What you need to know before taking Inaqovi
3. How to take Inaqovi
4. Possible adverse reactions
5. How to store Inaqovi
6. Contents of the pack and other information

1. What Inaqovi is and what it is used for

What Inaqovi is

Inaqovi is an anticancer medicine. It contains the active substances decitabine and cedazuridine.

What Inaqovi is used for

Inaqovi is used alone to treat acute myeloid leukaemia (AML) in adults when chemotherapy is not considered suitable. Inaqovi will be given to you when you are first diagnosed with AML.

AML is a type of cancer that affects white blood cells called myeloid cells. In AML, myeloid cells multiply and grow very rapidly in the bone marrow and blood.

How Inaqovi works

Inaqovi contains two active substances that work in different ways. Decitabine works by stopping the growth of cancer cells. It also kills cancer cells. Cedazuridine does not directly affect cancer cells, but it inhibits the breakdown of decitabine. This increases the amount of decitabine available in the body and helps enhance the effects of decitabine.

2. What you need to know before taking Inaqovi

Do not take Inaqovi

• if you are allergic to decitabine or cedazuridine, or any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding (see section 2 Breastfeeding).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Inaqovi if:

• you have lung problems;
• you have liver problems;
• you have kidney problems;
• you have heart problems.

Myelosuppression and differentiation syndrome

Inaqovi may cause severe myelosuppression (a condition in which the bone marrow cannot produce enough blood cells) or a serious immune reaction called "differentiation syndrome." Both can be fatal.

Seek urgent medical attention if you notice any signs or symptoms (for symptoms, see section 4).

Cardiovascular disease

Talk to your doctor if you have a history of heart problems so that you can be monitored for signs and symptoms of heart failure.

Blood tests

You will have blood tests during treatment. These will be performed before starting treatment with Inaqovi, at the beginning of each treatment cycle, or if you notice any signs or symptoms of myelosuppression. These tests are to check that:

• you have enough blood cells, and
• your liver and kidneys are functioning properly.

Your doctor may adjust or delay your dose of Inaqovi. Your doctor may also prescribe medications to help prevent infections.

Children and adolescents

Inaqovi must not be given to children and adolescents under 18 years of age. This medicine has not been studied in this age group.

Other medicines and Inaqovi

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines before starting treatment with Inaqovi. Inaqovi may affect how some medicines work, especially if you are also taking the following medicines to treat:

• cancer, such as cytarabine, gemcitabine, or azacitidine.

Pregnancy, contraception, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

You must not take Inaqovi during pregnancy, as it may harm the unborn baby. If you can become pregnant, a pregnancy test is recommended before starting treatment with Inaqovi.

Contraception

Women who can become pregnant must use an effective method of contraception both during treatment with Inaqovi and for 6 months after the last dose of Inaqovi.

Men with partners who can become pregnant must use an effective method of contraception both during treatment with Inaqovi and for 3 months after the last dose of Inaqovi.

Talk to your doctor about the most effective contraceptive methods.

Breastfeeding

Do not breastfeed during treatment with Inaqovi. This is because it is unknown whether Inaqovi passes into breast milk and whether it could harm your baby.

Male and female fertility

Inaqovi may affect fertility. It is unknown whether the effect on fertility is permanent. Talk to your doctor before taking this medicine if you have any concerns, or if you wish to preserve your sperm or freeze your eggs before starting treatment.

Driving and using machines

Inaqovi may affect your ability to drive or use tools or machines. If you feel tired or dizzy after taking Inaqovi, do not drive or use tools or machinery until you feel better.

Inaqovi contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to take Inaqovi

This medicine will be prescribed by a doctor experienced in the use of anticancer medicines. Always follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

The recommended dose is 1 tablet once daily for the first 5 days of a treatment cycle. This is followed by 23 days without taking this medicine. A treatment cycle is 28 days long.

• Swallow the tablets whole with water, at approximately the same time each day.
• Do not chew, crush, or split the tablets to avoid contact with the skin or release of the medicine powder into the air.
• Since taking Inaqovi with food may reduce the effectiveness of the medicine, Inaqovi should be taken without food. Take Inaqovi 2 hours before or 2 hours after a meal.

You will usually take Inaqovi for at least 4 cycles. Your doctor will perform periodic blood tests to monitor your response to treatment. Depending on your response, your doctor may delay your dose or adjust the total number of cycles.

If you vomit

If you vomit after taking a dose, do not take another dose on the same day. Take the next dose at the usual time the following day.

Your doctor may prescribe an additional medicine for you to take before each dose of Inaqovi to help prevent nausea or vomiting during treatment.

If you take more Inaqovi than you should

An overdose may cause myelosuppression, sepsis, or pneumonia (see section 4 Possible side effects). If you take more Inaqovi than you should, seek urgent medical attention.

If you forget to take Inaqovi

If you miss a dose and less than 12 hours have passed since your usual dosing time, take the missed dose as soon as possible and then continue with your normal daily dosing schedule.

If you miss a dose and 12 hours or more have passed, do not take the missed dose. Take the next dose at the usual time the following day. Extend the dosing period by one day for each missed dose. Make sure to complete a total of 5 daily doses in each cycle.

If you stop taking Inaqovi

If you stop taking this medicine, your cancer may no longer be controlled and cancer symptoms may return. Therefore, you should only stop taking this medicine if instructed to do so by your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Immediately inform your doctor, pharmacist, or nurse if you notice any of the following serious adverse effects:

• Fever: may be a sign of infection due to low levels of white blood cells (very common: may affect more than 1 in 10 people).
• Chest pain or difficulty breathing (with or without fever or cough): may be signs of pneumonia (very common: may affect more than 1 in 10 people) or inflamed lungs (interstitial lung disease: frequency not known).
• Bleeding, including blood in stools or nosebleeds, or easy bruising: may be a sign of low blood cell counts (platelets and red blood cells) (common: may affect up to 1 in 10 people).
• Difficulty moving, speaking, understanding, or seeing; sudden severe headache, seizures, numbness or weakness in any part of the body: may be signs of bleeding inside the head (common: may affect up to 1 in 10 people).
• Dizziness or fainting, confusion or disorientation, weakness, shortness of breath, reduced urination, diarrhoea, nausea/vomiting, fever, chills or feeling very cold, moist or sweaty skin, or cough: may be signs and symptoms of a blood infection (sepsis) (very common: may affect more than 1 in 10 people).
• Fever, cough, difficulty breathing, skin rash, decreased urine output, hypotension (low blood pressure), swelling of arms or legs, and rapid weight gain: may be signs of a serious immune reaction (differentiation syndrome) (frequency not known).

Other adverse effects:

Very common (may affect more than 1 in 10 people)

• urinary tract infection;
• infection caused by bacteria, viruses, or fungi;
• elevated blood glucose levels;
• mouth or tongue ulcers due to painful inflammation of the lining of the mouth;
• diarrhoea;
• nausea and vomiting;
• abnormal liver function tests (increased ALT, AST, alkaline phosphatase, bilirubin).

Common (may affect up to 1 in 10 people)

• inflammation of the sinuses;
• headache;
• inflamed bowel (neutropenic colitis).

Uncommon (may affect up to 1 in 100 people)

• decrease in the number of red blood cells, white blood cells, and platelets;
• sudden fever with multiple painful red or red-blue raised skin lesions, usually on arms, legs, trunk, face, or neck ("Acute Febrile Neutrophilic Dermatosis" or "Sweet's Syndrome");
• heart muscle disease.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Inaqovi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP" and on the blister strip after "EXP". The expiry date refers to the last day of the stated month.

Store in the original packaging to protect from moisture.

This medicine does not require any special storage temperature conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inaqovi

• The active substances are decitabine and cedazuridine. Each film-coated tablet contains 35 mg of decitabine and 100 mg of cedazuridine.
• The other components are:

Inaqovi contains lactose and sodium, see section 2.

Tablet core

Monohydrate lactose, hypromellose (E464), sodium croscarmellose (E466), colloidal anhydrous silica, magnesium stearate (E572).

Film coating

Polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol (E1521), talc (E553b), red iron oxide (E172).

Appearance of the product and contents of the pack

Inaqovi are red, oval, biconvex, film-coated tablets, 14 mm in diameter, smooth on one side and engraved with "H35" on the other.

They are supplied in aluminium blisters containing 5 tablets.

Marketing Authorisation Holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT Amsterdam

Netherlands

Manufacturer

Skyepharma Production S.A.S.

Zone Industrielle Chesnes Ouest

55 Rue Du Montmurier

38070 Saint-Quentin-Fallavier

France

Further information on this medicinal product is available upon request to the Marketing Authorisation Holder.

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicinal products.

This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.