Label: Information for the User

Dacogen 50 mg Powder for Concentrate for Solution for Infusion

decitabina

Read this label carefully before starting to use this medicine, because

it contains important information for you.

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

What is Dacogen

Dacogen is a cancer medication. It contains the active ingredient “decitabine”.

What is Dacogen used for

Dacogen is used to treat a type of cancer called “acute myeloid leukemia” or “AML”. It is a type of cancer that affects the blood cells. Dacogen will be administered when AML is first diagnosed. This medication is only used in adults.

How Dacogen works

Dacogen works by preventing the growth of cancer cells. It also destroys cancer cells.

If you have any questions about how Dacogen works or why you have been prescribed this medication, consult your doctor or nurse.

No use Dacogen:

• If you are allergic to decitabine or any of the other components of this medication (listed in section 6).
• If you are breastfeeding.

If you are unsure whether the above conditions apply to you, consult your doctor, pharmacist, or nurse before using Dacogen.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Dacogen if you have

• A low platelet count, red blood cells, or white blood cells,
• An infection,
• Liver disease,
• Severe kidney disease,
• Heart disease.

If you are unsure whether the above conditions apply to you, consult your doctor, pharmacist, or nurse before using Dacogen.

Tests or controls

You will have blood tests before starting treatment with Dacogen and at the beginning of each treatment cycle. These tests are to check that:

• You have enough blood cells, and
• Your liver and kidneys are functioning correctly.

Consult your doctor about the meaning of your blood test results.

Children and adolescents

Dacogen should not be used in children or adolescents under 18 years old.

Use of Dacogen with other medications

Inform your doctor, nurse, or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription and herbal remedies. Dacogen may affect how other medications work. Additionally, some other medications may affect how Dacogen works.

Pregnancy and lactation

• If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.
• You should not use Dacogen if you are pregnant because it may harm your child. Inform your doctor immediately if you become pregnant during treatment with Dacogen.
• You cannot breastfeed your child if you are using Dacogen, as it is unknown whether the medication passes into breast milk.

Male and female fertility and contraception

• Males should not father a child while using Dacogen.
• Males should use effective contraceptive methods during treatment and for 3 months after stopping treatment.
• Consult your doctor if you wish to preserve your semen before starting treatment.
• Females should use effective contraceptive methods during treatment. It is
• unknown when it is safe for females to become pregnant after stopping treatment.
• Consult your doctor if you wish to freeze your eggs before starting treatment.

Driving and operating machinery

You may feel tired or weak after using Dacogen. If so, do not drive or use tools or machines.

Dacogen contains potassium and sodium

• This medication contains 0.5 mmol of potassium in each vial. After preparing the medication, it contains less than 1 mmol (39 mg) of potassium, which is essentially "potassium-free".
• This medication contains 0.29 mmol (6.67 mg) of sodium (main component of table salt/for cooking) in each vial. After preparing the medication, it contains between 13.8- 138 mg of sodium per dose, equivalent to 0.7-7% of the recommended daily maximum sodium intake for an adult. Consult your doctor if you follow a low-sodium diet.

Dacogen will be administered by a doctor or nurse trained to administer this type of medication.

Recommended Dose

• Your doctor will calculate your dose of Dacogen, which will depend on your height and weight (body surface area).
• The dose is 20 mg/m2 of body surface area.
• You will receive Dacogen daily for 5 days, followed by 3 weeks without medication. This is called a "treatment cycle" and will be repeated every 4 weeks. You will normally receive a minimum of 4 treatment cycles.
• Your doctor may delay the dose and modify the total number of cycles, depending on how you respond to treatment.

How Dacogen is Administered

The solution is administered intravenously (as an infusion) over a period of one hour.

If You Receive More Dacogen Than You Should

This medication will be administered by your doctor or nurse. It is very unlikely that you will receive an overdose (overdose), but if you do, your doctor will evaluate you and manage any adverse effects appropriately.

If You Have Missed a Dacogen Appointment

If you forget an appointment, request another as soon as possible. This is because it is essential to follow the administration schedule for this medication to be as effective as possible.

If you have any further questions about using this medication, consult with your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. With this medicine, the following side effects may occur.

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

• Fever: it may be a sign of an infection caused by low white blood cell levels (very common).
• Chest pain or difficulty breathing (with or without fever or cough): they may be signs of a lung infection called "pneumonia" (very common) or interstitial lung disease (unknown frequency) or myocarditis (rare heart muscle disease) that may be accompanied by swelling of ankles, hands, legs, and feet.
• Bleeding: including blood in the stool. It may be a sign of bleeding in the stomach or intestine (common).
• Difficulty moving, speaking, or understanding, or difficulty seeing; severe and sudden headache, convulsions, numbness, or weakness in any part of the body. These may be symptoms of bleeding inside the head (common).
• Difficulty breathing, swelling of the lips, itching, or skin rash. They may be due to an allergic reaction (hypersensitivity) (common).

Consult your doctor or nurse immediately if you experience any of the serious side effects mentioned.

Other side effects of Dacogen are

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

• Urinary tract infection
• Other infections in any part of the body, caused by bacteria, viruses, or fungi
• Bleeding or formation of hematomas with greater ease - may be signs of a decrease in the number of platelets in the blood (thrombocytopenia)
• Feeling tired or pale - may be signs of a decrease in the number of red blood cells (anemia)
• High blood sugar levels
• Headache
• Nasal bleeding
• Diarrhea
• Vomiting
• Nausea
• Fever
• Altered liver function

Common(may affect up to 1 in 10 patients)

• Blood infection caused by bacteria - may be a sign of low white blood cell levels
• Nasal congestion or discharge, nasal sinus pain
• Sores in the mouth or tongue
• Increased levels of "bilirubin" in the blood

Rare(may affect up to 1 in 100 patients)

• Decrease in the number of red blood cells, white blood cells, and platelets (pancytopenia)
• Heart muscle disease
• Red, elevated, and painful skin plaques, fever, increased white blood cells - may be signs of "Acute Febrile Neutrophilic Dermatosis" or "Sweet Syndrome"

Unknown(frequency cannot be estimated from available data)

• Inflamed intestine (enterocolitis, colitis, and typhlitis), with symptoms of abdominal pain, gas, or diarrhea. Enterocolitis may lead to septicemia complications and may be associated with fatal outcome.

Reporting of 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 on the safety of this medicine.

• Your doctor, nurse, or pharmacist is responsible for the conservation of Dacogen.
• 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 and on the vial label after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 25°C.
• After reconstitution, the concentrate must be diluted within 15 minutes using refrigerated infusion liquids. The prepared diluted solution can be stored refrigerated at 2°C - 8°C for a maximum of 3 hours, followed by up to 1 hour at room temperature (20°C – 25°C) before administration.
• Your doctor, nurse, or pharmacist is responsible for the correct disposal of unused Dacogen.

Decitabine Composition

• The active ingredient is decitabine. Each vial of powder contains 50 mg of decitabine. After reconstitution with 10 ml of injectable water, each ml of the concentrate contains 5 mg of decitabine.
• The other components are potassium dihydrogen phosphate (E340), sodium hydroxide (E524), and hydrochloric acid (to adjust the pH). See section 2.

Product Appearance and Packaging Contents

Decitabine is a white or almost white powder for concentrate solution for infusion. It is presented in a 20 ml glass vial containing 50 mg of decitabine. Each package contains 1 vial.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

To obtain more information about this medication, please contact the local representative of the marketing authorization holder:

Last Review Date of this Leaflet: MM/YYYY

The detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu/ .

-----------------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

1. RECONSTITUTION

Precautions should be taken to avoid skin contact with the solution and to use protective gloves. Standard procedures for handling cytotoxic drugs should be followed.

The powder should be reconstituted in aseptic conditions with 10 ml of injectable water. After reconstitution, each milliliter contains approximately 5 mg of decitabine at a pH of 6.7 to 7.3. Within 15 minutes of reconstitution, the solution should be further diluted with refrigerated infusion liquids (2°C – 8°C) (sodium chloride 9 mg/ml (0.9%) or 5% glucose solution) to achieve a final concentration of 0.15 to 1.0 mg/ml.

For the shelf life and storage precautions after reconstitution, see section 5 of the leaflet.

2. ADMINISTRATION

Infuse the reconstituted solution intravenously over a period of 1 hour.

3. ELIMINATION

The vials are for single use and any remaining solution should be discarded.

The disposal of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.