Prescribing Information for the Patient

Inaqovi 35 mg/100 mg Film-Coated Tablets

decitabina/cedazuridina

(decitabine/cedazuridine)

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prescribing information carefully before starting to take this medicine, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prescribing information. See section 4.

What is Inaqovi

Inaqovi is a cancer medication. It contains the active ingredients decitabine and cedazuridine.

What is Inaqovi used for

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

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

How Inaqovi works

Inaqovi contains two active ingredients 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 to increase the effects of decitabine.

Do not take Inaqovi

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take 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 severe immune reaction called "differentiation syndrome". Both can be fatal.

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

Cardiovascular disease

Consult your doctor if you have a history of heart problems so that they can monitor you for signs and symptoms of heart failure.

Blood tests

You will have blood tests during treatment. These will be done before starting treatment with Inaqovi, at the start 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 correctly.

Your doctor may change or delay your dose of Inaqovi. Your doctor may also give you medicines to help prevent infections.

Children and adolescents

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

Other medicines and Inaqovi

Inform your doctor, pharmacist or nurse if you are taking, have taken recently, or may need to take any other medicine 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 citarabine, gemcitabine or azacitidine.

Pregnancy, contraception, breastfeeding and fertility

Pregnancy

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

You should not take Inaqovi during pregnancy, as it may harm the fetus. If you can become pregnant, it is recommended that you have a pregnancy test before starting treatment with Inaqovi.

Contraception

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

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

Discuss the most effective contraceptive methods with your doctor.

Breastfeeding

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

Male and female fertility

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

Driving and operating machinery

Inaqovi may affect your ability to drive or use tools or machinery. 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 told you that you have an intolerance to certain sugars, consult them before taking this medicine.

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

This medication will be prescribed by a doctor with experience in using cancer medications. Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

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

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

You will normally take Inaqovi for at least 4 cycles. Your doctor will perform periodic blood tests to check your response to treatment. Your doctor may delay the dose and change the total number of cycles, depending on how you respond to treatment.

If you vomit

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

Your doctor may prescribe an additional medication that you should take before each dose of Inaqovi to prevent nausea or vomiting during treatment.

If you take more Inaqovi than you should

A 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 the usual time you take it, take the missed dose as soon as possible and continue with your regular daily dosing schedule.

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

If you stop taking Inaqovi

If you stop taking this medication, it is possible that your cancer will no longer be controlled and cancer symptoms may reappear. Therefore, you should only stop taking this medication if your doctor tells you to.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor, pharmacist, or nurse immediately if you notice any of the following serious side effects:

• Fever: it may be a sign of an infection caused by 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 of inflamed lungs (interstitial lung disease: unknown frequency).
• Bleeding, including blood in the stool or nasal bleeding or the appearance of bruises with greater ease: may be a sign of low levels of blood cells (platelets and red blood cells) (common: may affect up to 1 in 10 people).
• Difficulty moving, speaking, understanding, or seeing; severe and sudden headache, convulsions, numbness, or weakness in any part of the body: may be signs of bleeding in the head (common: may affect up to 1 in 10 people).
• Sensation of dizziness or fainting, confusion, disorientation, weakness, shortness of breath, decreased urination, diarrhea, nausea/vomiting, fever, chills, or feeling very cold, sweaty skin, or cough: may be signs and symptoms of blood infection (sepsis) (very common: may affect more than 1 in 10 people).
• Fever, cough, difficulty breathing, skin rash, decreased urination, low blood pressure, swelling of arms or legs, and rapid weight gain: may be signs of a severe immune reaction (differentiation syndrome) (unknown frequency).

Other side effects:

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

• Urinary tract infection;
• Infection caused by bacteria, viruses, or fungi;
• High levels of glucose in the blood;
• Mouth or tongue ulcers due to painful inflammation of the mouth lining;
• Dysentery;
• Nausea and vomiting;
• Altered liver function tests (increased ALAT, ASAT, alkaline phosphatase, bilirubin).

Common(may affect up to 1 in 10 people)

• Paranasal sinus inflammation;
• Headache;
• Colitis (neutropenic colitis).

Rare(may affect up to 1 in 100 people)

• Decreased number of red blood cells, white blood cells, and platelets;
• Sudden fever with multiple painful red or reddish-purple spots or patches on the skin, usually on the arms, legs, trunk, face, or neck («Acute febrile neutrophilic dermatosis» or Sweet syndrome»);
• Cardiac muscle disease.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after «CAD» and the blister pack after «EXP». The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Inaqovi

• The active principles 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

Core of the tablet

Lactose monohydrate, hypromellose (E464), croscarmellose sodium (E466), anhydrous colloidal 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 film-coated, oval, biconvex tablets, 14 mm in diameter, smooth on one side and with the inscription "H35" engraved 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

Responsible for manufacturing

BSP Pharmaceuticals S.p.A.

Via Appia Km. 65,561

04013 Latina Scalo (LT)

Italy

R-PHARM Germany GmbH

Heinrich-Mack-Straße 35

89257 Illertissen

Germany

Further information about this medicinal product can be obtained by contacting the marketing authorisation holder.

Last update of the summary of product characteristics:

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 summary of product characteristics can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.