50 mg powder for concentrate for infusion solution 
decitabine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Dacogen is and what it is used for 
2. What you need to know before you use Dacogen 
3. How to use Dacogen 
4. Possible side effects 
5. How to store Dacogen 
6. Contents of the packaging and other information 

1. What Dacogen is and what it is used for

What Dacogen is

Dacogen is a cancer medicine. It contains the active substance “decitabine”.

What Dacogen is 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 your blood cells. You will not receive Dacogen until you have been diagnosed with AML. It is only used in adults.

How Dacogen works

Dacogen works by preventing cancer cells from growing. It also kills cancer cells.

Talk to your doctor or nurse if you have any questions about how Dacogen works or why this medicine has been prescribed for you.

2. What you need to know before you use Dacogen

Do not use Dacogen:

  • if you are allergic to decitabine or any of the other ingredients of this medicine (listed in section 6).
  • if you are breast-feeding.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist, or nurse before using Dacogen.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Dacogen if you have any

  • low platelet count, red blood cells, or white blood cells.
  • an infection.
  • a liver disease.
  • a serious kidney disease.
  • a heart disease.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist, or nurse before using Dacogen.

Samples or checks

You will take blood samples before your Dacogen treatment begins and at the beginning of each treatment cycle. These samples are to verify that:

  • you have enough blood s
  • your liver and kidneys are working properly.

Talk to your doctor about what your blood test results mean.

Children and young people

Dacogen should not be used by children or adolescents under 18 years of age.

Other medicines and Dacogen

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter and herbal remedies. This is because Dacogen may affect the way some other medicines work. Also, some other medicines may affect the way Dacogen works.

Pregnancy and breastfeeding

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
  • You should not use Dacogen if you are pregnant as it may harm your baby. Tell your doctor immediately if you become pregnant during treatment with Dacogen.
  • Do not breast-feed while using Dacogen as it is not known if this medicine passes into breast milk.

Male and female fertility and birth control

  • Men should not make a woman pregnant while using Dacogen.
  • Men should use effective contraception during treatment and up to 3 months after stopping treatment.
  • Talk to your doctor if you want to store your semen before starting treatment.
  • Women should use effective contraception during treatment. It is not known when it is safe for women to become pregnant after treatment.
  • Talk to your doctor if you wish to freeze your eggs before starting treatment.

Driving and using machines

You may feel tired or dull when using Dacogen. If this happens, do not drive or use machines.

Dacogen contains potassium and sodium

  • This medicine contains 0.5 mmol of potassium in each vial. After preparation of the medicament contains less than 1 mmol (39 mg) of potassium per dose, ie essentially “potassium-free”.
  • This medicine contains 0.29 mmol (6.67 mg) sodium (the main ingredient in common salt/table salt) in each vial. After preparation of the drug, it contains 13.8 mg-138 mg sodium per dose. This corresponds to 0.7‑7% of the highest recommended daily intake of sodium for adults. Talk to your doctor if you have been prescribed a low-salt diet.

3. How to use Dacogen

Dacogen will be given to you by a doctor or nurse who is trained to give this type of medicine.

How much to give

  • Your doctor will determine your dose of Dacogen. This is determined by your height and weight (body surface area).
  • Dose one is 20 mg / m2 body surface area.
  • You will receive Dacogen every day for 5 days. Then 3 weeks without the drug. This is called a “treatment cycle”, and it is repeated every 4 weeks. You will usually receive at least 4 treatment cycles.
  • Your doctor may delay your treatment and change the number of cycles depending on how you respond to the treatment.

How Dacogen is given

The solution is given in a vein (as an infusion ). This will take an hour.

If you take more Dacogen than you should

This medicine will be given to you by your doctor or nurse. If you are suspected of taking too much (an overdose), your doctor will check for any side effects and treat them appropriately.

If you have missed a time when you should have received Dacogen

If you miss an appointment, you should book a new one as soon as possible. It is important to follow the dosing schedule for the medicine to be as effective as possible.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.

Immediately tell your doctor or nurse if you notice any of the following serious side effect s

  • Fever: this may be a sign of infection caused by a low white blood cell count (very common).
  • Chest pain or shortness of breath (with or without fever or cough): this may be a sign of an infection of the lungs called pneumonia (very common) or inflammation of the lungs (interstitial lung disease [no known frequency]) or cardiomyopathy(heart muscle disease [ uncommon]) which can cause swollen ankles, hands, legs, and feet.
  • Bleeding: including blood in the stool. This may be a sign of bleeding in the stomach or intestines (common).
  • Problems moving, talking or understanding or seeing, sudden severe headache, seizures, numbness, or weakness in any part of the body. This may be a sign that you have bleeding inside your head (usually).
  • Difficulty breathing, swollen lips, itching, or rash. This may be an allergic (hypersensitivity) reaction (common).

Tell your doctor or nurse immediately if you notice any of the serious side effects mentioned above.

Other side effects with Dacogen include

Very common (affects more than 1 user in 10)

  • urinary tract infection
  • other infection in any part of the body caused by bacteria, viruses, or fungi
  • bleeding or easy bruising – this may be a sign of a decreased platelet count ( thrombocytopenia )
  • fatigue or paleness – this may be a sign of a decrease in red blood cell count ( anemia )
  • high blood sugar levels
  • headache
  • nosebleeds
  • diarrhea
  • vomiting
  • nausea
  • fever
  • abnormal liver function

Common (affects up to 1 in 10 people)

  • an infection in the blood caused by bacteria – this may be a sign of a low white blood cell count
  • sore or runny nose, sore sinuses
  • cold sores or sores on the tongue
  • increased level of “bilirubin” in the blood

Uncommon (affects up to 1 in 100 people)

  • decreased number of red blood cells, white blood cells, and platelets (pancytopenia)
  • heart muscle disease
  • red, raised painful spots on the skin, fever, increased white blood cell count – these may be signs of “acute febrile neutrophil dermatosis” or “Sweet’s syndrome”

No known frequency (cannot be calculated from the available data)

  • inflammation of the intestine (enterocolitis, colitis, and caecum in inflammation) with symptoms such as abdominal pain, bloating, or diarrhea. Enterocolitis can lead to blood poisoning and can be associated with death.

5. How to store Dacogen

  • Your doctor, nurse, or pharmacist is responsible for storing Dacogen.
  • 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 and bottle label after EXP. The expiration date is the last day of the specified month.
  • Do not store above 25 ° C.
  • After reconstitution, the concentrate must be further diluted within 15 minutes with a cold infusion solution. This reconstituted solution can be stored in a refrigerator at 2 ° C – 8 ° C for up to 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 not disposing of used Dacogen properly.

6. Contents of the packaging and other information

Content declaration

  • The active substance is decitabine. Each powder vial contains 50 mg of decitabine. After reconstitution with 10 ml of water for injections, each ml of concentrate contains 5 mg of decitabine.
  • The other ingredients are potassium dihydrogen phosphate (E340), sodium hydroxide (E524), and hydrochloric acid (for pH adjustment). See section 2.

What the medicine looks like and the contents of the pack

Dacogen is a white to off-white powder for concentrate for solution for infusion. It is supplied in a 20 ml glass vial containing 50 mg decitabine. Each pack contains 1 vial.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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