80 mg / mL concentrate for infusion solution 
defibrotide

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.
  • If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What Defitelio is and what it is used for

Defitelio is a medicine that contains the active substance defibrotide.

It is used to treat a disease called hepatic venous-occlusive disease, which causes the blood vessels in the liver to be damaged and clogged by blood clots. This can be caused by drugs that are given before a stem cell transplant.

Defibrotide works by protecting the cells of the blood vessels, preventing the formation of blood clots, or breaking down clots that have formed.

It can be used in adults and adolescents, children and infants from 1 month of age.

What you need to know before you take Defitelio

Do not use Defitelio

  • if you are allergic to defibrotide or any of the other ingredients of this medicine (listed in section 6)
  • if you are taking other medicines that break down blood clots, e.g. tissue plasminogen activator.

Warnings and cautions

Talk to your doctor before using Defitelio

  • if you are taking medicines that increase the risk of bleeding
  • if you have major bleeding and need a blood transfusion
  • if you are going to have surgery
  • if you have problems with blood circulation due to your body not being able to maintain constant blood pressure.

Children and young people

Defitelio is not recommended for children under 1 month.

Other medicines and Defitelio

Tell your doctor if you are taking medicines to prevent blood clots, e.g. acetylsalicylic acid heparins, warfarin, dabigatran, rivaroxaban, or apixaban and if you are taking anti-inflammatory drugs (eg ibuprofen, naproxen, diclofenac, and other non-steroidal anti-inflammatory drugs).

Pregnancy and breastfeeding

Do not use Defitelio if you are pregnant unless your illness requires treatment with Defitelio.

If you are sexually active and you or your partner may become pregnant, you must both use an effective contraceptive during treatment with Defitelio and for 1 week after stopping treatment.

Driving and using machines

Defitelio is not expected to affect your ability to drive or use machines.

Defitelio contains sodium

This medicine contains 20.4 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 1.02% of the highest recommended daily intake of sodium for adults.

3. How to get Defitelio

Treatment with Defitelio should only be started and continuously monitored by an experienced doctor in a hospital or at a specialist center for stem cell transplants.

The drug is injected slowly (over 2 hours) into a vein. This is called an “intravenous infusion” or “drip”.

You will receive treatment four times a day for at least 21 days or until your symptoms have disappeared.

The recommended dose for children between 1 month and 18 years is the same as for adults.

If you forget to give you a dose of Defitelio

Because you are receiving this medicine from a doctor or nurse, it is unlikely that a dose will be missed. However, tell your doctor or healthcare professional if you think a dose has been missed. You should not receive a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported in patients treated with Defitelio.

If you get any of these side effects, talk to your doctor immediately.

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

  • low blood pressure

Common (may affect up to 1 in 10 people)

  • bleeding, general
  • bleeding from the nose
  • bleeding in the brain
  • bleeding in the intestine
  • bloody vomiting
  • bleeding in the lungs
  • bleeding from the infusion line
  • blood in the urine
  • bleeding from the mouth
  • bleeding in the skin
  • coagulopathy (disturbed blood coagulation)
  • nausea
  • vomiting
  • diarrhea
  • rash
  • itching
  • fever.

Uncommon (may affect up to 1 in 100 people)

  • bleeding from the eyes
  • blood in the stool
  • bleeding at the injection site
  • local blood collection outside the vessel (hematoma) in the brain
  • hemothorax (accumulation of blood between the heart and lungs)
  • bruises
  • severe allergic reaction (may manifest as swelling of the hands, face, lips, tongue, or throat, as well as difficulty breathing).

Children and young people

Adverse reactions in children (1 month to 18 years) are expected to be the same in terms of type, severity, and frequency, and no special precautions are needed.

5. How to store Defitelio

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 vial label after EXP. The expiration date is the last day of the specified month.

Do not freeze.

After dilution, the infusion solution may be stored for a maximum of 24 hours at 2 ° C-8 ° C unless dilution has taken place under controlled and approved aseptic conditions.

Defitelio should not be used if the solution is cloudy or contains particles.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is defibrotide. A vial of 2.5 ml contains 200 mg of defibrotide and each mL of solution contains 80 mg of defibrotide.
  • The other ingredients are sodium citrate (dihydrate), hydrochloric acid, and sodium hydroxide (both used to adjust the pH value), and water for injections (see section 2 “Defitelio contains sodium”).

What the medicine looks like and the contents of the pack

Defitelio is a clear light yellow to brown concentrate for infusion solution, without solid particles or turbidity.

One carton contains 10 glass vials with 2.5 ml of concentrate each.

Marketing Authorization Holder and Manufacturer

Gentium Srl

Piazza XX Settembre, 2

Villa Guardia

22079 Italy

Phone +39 031 5373200

Fax +39 031 5373784

info@gentium.it

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

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Muhammad Nadeem

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