Details for: DEFITELIO
Company: JAZZ PHARMACEUTICALS IRELAND LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02465981 | DEFITELIO | DEFIBROTIDE | 80 MG / ML | SOLUTION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
DEFITELIO 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 given prior to a stem cell transplantation.
This medicine can be used in:
- adults;
- adolescents;
- children;
- infants over one month of age.
What it does
It is believed that DEFITELIO works by protecting the cells of the blood vessels and by preventing or breaking down the blood clots.
When it should not be used
Do not use DEFITELIO if:
- if you are allergic to defibrotide sodium or other ingredients of this medicine;
- if you are using other medicines to break down blood clots such as tissue plasminogen activator (t-PA).
What the medicinal ingredient is
defibrotide sodium
What the non-medicinal ingredients are
sodium citrate dihydrate, hydrochloric acid and/or sodium hydroxide and water for injection.
What dosage form it comes in
Each 2.5 mL vial contains 200 mg of defibrotide sodium and each millilitre (1 mL) of solution contains 80 mg defibrotide sodium.
Warnings and precautions
Serious Warnings and Precautions
The treatment with DEFITELIO can only be initiated and continuously supervised by an
experienced doctor in a hospital or in a specialised centre for stem cells transplantation
You should not take anticoagulant medications such as heparin, warfarin, or alteplase at the
same time as DEFITELIO because of an increased risk of bleeding
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive DEFITELIO. Talk about any health conditions or problems you may have, including if you:
- 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.
Interactions with this medication
The following may interact with DEFITELIO:
- medicines to prevent blood clotting such as acetylsalicylic acid (aspirin), heparins, warfarin, dabigatran, rivaroxaban or apixaban;
- anti-inflammatory medicines (e.g., ibuprofen, naproxen, diclofenac and other nonsteroidal anti-inflammatory medicines).
Proper use of this medication
How to take DEFITELIO
DEFITELIO 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.
Usual Dose
The recommended dose is based on the body weight (25 mg/kg/day). The dosage is the same in children from one month to 18 years of age as in adults.
Overdose
Missed Dose
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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking DEFITELIO. If you experience
any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Hypotension (low blood pressure);
- Diarrhea;
- Vomiting;
- Nausea;
- Epistaxis (nose bleeds).
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Bleeding: from nose, in the brain, in the gut, in the lungs, from the infusion line, blood in urine, disturbance in blood clotting | ✔ | ||
| Low blood pressure (hypotension): dizziness, lightheadedness, blurred vision, weakness, fatigue, nausea, palpitations, headache, cold and/or pale skin | ✔ | ||
| Uncommon | |||
| Bleeding: from the eye, vomiting blood, blood in the stool, bleeding from the mouth, bleeding at the site of injection, localized blood collection out of the vessel (hematoma) in the brain | ✔ | ||
| Cardiac disorders: fatigue, shortness of breath, palpitations, irregular heartbeat, chest pain | ✔ | ||
| Haemothorax (accumulation of blood around the lungs): chest pain, shortness of breath, rapid heart beat | ✔ | ||
| Respiratory disorders: coughing blood, cough | ✔ | ||
| Severe allergic reaction: swelling of the hands, face, lips, tongue or throat, difficulty breathing | ✔ | ||
| Skin conditions: rash, itching, bruising, red spots on the body caused by broken blood vessels | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
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 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 2-8°C. DEFITELIO should
not be used if the solution is cloudy or contains particles.
Reporting side effects
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and
unexpected side effects to Health Canada. Your report may help to identify new side effects
and change the product safety information.
3 ways to report:
- Online at MedEffect ((www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about DEFITELIO:
- Talk to your healthcare professional;
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website https://www.jazzpharma.com, or by calling 1-800-520-5568.
Last Revised: November 22, 2019