Defitelio
defibrotide
defibrotide
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. 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 includes any possible side effects not listed in this leaflet. See section 4.
What Defitelio is and what it is used for
What you need to know before you are administered Defitelio
How you will be given Defitelio
Possible side effects
How to store Defitelio
Contents of the pack and other information
Defitelio is a medicine that contains the active substance defibrotide.
It is used to treat a condition called hepatic veno-occlusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots. This can be caused by medicines that are given prior to a stem cell transplantation.
Defibrotide works by protecting the cells of the blood vessels and preventing or breaking down the blood clots.
This medicine can be used in adults, and in adolescents, children and infants over one month of age.
if you are allergic to defibrotide or any of the other ingredients of this medicine (listed in section 6)
if you are using other medicines to break down blood clots such as tissue plasminogen activator.
Talk to your doctor before using Defitelio:
if you are taking medicine that increases the risk of bleeding.
if you have heavy bleeding and need a blood transfusion.
if you are undergoing surgery.
if you have problems with blood circulation because your body cannot maintain a constant blood pressure.
Defitelio is not recommended in children less than 1 month of age.
Tell your doctor if you are taking medicines to prevent blood clotting such as acetylsalicylic acid, heparins, warfarin, dabigatran, rivaroxaban or apixaban or if you are taking anti-inflammatory medicines (e.g., ibuprofen, naproxen, diclofenac and other non-steroidal anti-inflammatory medicines).
Do not use Defitelio if you are pregnant unless your disease requires treatment with Defitelio.
If you are sexually active and you or your partner could become pregnant, you both must use effective contraception during treatment with Defitelio and for 1 week after stopping the treatment.
It is not expected that Defitelio will affect your ability to drive and operate machines.
This medicine contains20.4 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.02% of the recommended maximum daily dietary intake of sodium for an adult.
The treatment with Defitelio can be initiated and continuously supervised only by an experienced doctor in a hospital or in a specialised centre for stem cells transplantation.
It will be slowly injected (over a 2-hour period) into one of your veins. This is called an ‘intravenous infusion’ or drip.
You will receive this treatment four times a day for at least 21 days or until your symptoms resolve. The recommended dose in children from one month to 18 years of age is the same as in adults.
As you will be given this medicine by a doctor or a nurse it is unlikely that a dose will be missed. However, tell your doctor or healthcare professional if you think that a dose has been forgotten. You must not be given a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Like all medicines, Defitelio can cause side effects, although not everybody gets them. For patients treated with Defitelio the following side effects were reported.
If you experience any of these side effects, you should contact your doctor immediately. Very Common (may affect more than 1 in 10 people)
low blood pressure
bleeding in general
bleeding from the nose
bleeding in the brain
bleeding in the gut
vomiting blood
bleeding in the lungs
bleeding from the infusion line
blood in the urine
bleeding from the mouth
bleeding into the skin
coagulopathy (disturbance of blood clotting)
nausea
vomiting
diarrhoea
rash
itching
fever
bleeding from the eye
blood in the stool
bleeding at the site of injection
localized blood collection out of the vessel (hematoma) in the brain
haemothorax (accumulation of blood in the area between the heart and the lung)
bruising
severe allergic reaction (you might experience swelling of the hands, face, lips, tongue or throat,
difficulty in breathing).
Side effects in children (1 month to 18 years old) are expected to be similar in type, severity and frequency and no other special precautions are needed.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Defitelio after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
Do not freeze.
Once diluted for use the infusion storage should not exceed 24 hours at 2°C -8°C unless dilution has taken place in controlled and validated aseptic conditions.
Defitelio should not be used if the solution is cloudy or contains particles.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is defibrotide. Each 2.5 mL vial contains 200 mg defibrotide and each mL
solution contains 80 mg defibrotide.
The other ingredients are sodium citrate dihydrate, hydrochloric acid and sodium hydroxide (both for pH-adjustment) and water for injections (see section 2 ‘Defitelio contains Sodium’).
Defitelio is a clear light yellow to brown concentrate for solution for infusion, free from particulate matter or turbidity.
One carton contains 10 glass vials with 2.5 mL of concentrate each.
Gentium S.r.l
Piazza XX Settembre, 2 Villa Guardia
22079 Italy
P: +39 031 5373200
F: +39 031 5373784
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Jazz Pharmaceuticals Ireland Limited Tel: +44 8450305089
This medicine has been authorised under ‘exceptional circumstances’. This means that because of the rarity of this disease and for ethical reasons it has been impossible perform a placebo-controlled clinical trials and to get complete information on this medicine.
The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
. There are also links to other websites about rare diseases and treatments.
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