Consumer Information for: TRETTEN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Tretten® is recombinant blood coagulation Factor XIII A-subunit. Tretten® is used to prevent bleeding in patients who do not have enough Factor XIII A-subunit.

What it does

Tretten® replaces the missing Factor XIII A-subunit and helps to stabilize the initial blood clot.

When it should not be used

Do not use Tretten® if you are allergic (hypersensitive) to catridecacog or to any ingredient in the formulation or component of the container.

Do not use Tretten® without talking to your doctor, if you are pregnant, planning to become pregnant, or are breast feeding.

What the medicinal ingredient is

The medicinal ingredient is recombinant Factor XIII A-subunit (catridecacog).

What the non-medicinal ingredients are

Tretten® contains the following non-medicinal ingredients: L-histidine, polysorbate 20, sodium chloride, and sucrose.

What dosage form it comes in

Tretten® comes as a freeze-dried powder containing 2500 IU/vial (corresponding to 15 mg/vial). The powder in the vial is reconstituted (dissolved) with the solvent (sterile water) that is supplied with your Tretten®. After reconstitution, 1 mL of solution contains 833 IU of catridecacog (corresponding to 5 mg/mL).

Warnings and precautions

Once you have prepared Tretten® for injection it should be used immediately. For proper storage instructions see “Proper use of this medication” and “How to store it”.

BEFORE you use Tretten® talk to your doctor if you have, or have ever had any of the following:

  • A higher risk of blood clots forming (thrombosis), as Tretten® may increase the severity of a pre-existing clot.
  • Liver damage.
  • Experienced unexpected spontaneous bleeding during treatment with Factor XIII containing products. Antibodies against Tretten® could decrease the effectiveness of the treatment and thereby result in unexpected spontaneous bleeding episodes. Contact your doctor immediately if bleeding occurs.
Interactions with this medication

Please tell your doctor if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Do not use Tretten® and rFVIIa (another blood clotting factor) together.

Proper use of this medication

Always use Tretten® exactly as your doctor has told you. You should check with your doctor if you are not sure.

Tretten® is given as an injection into a vein. For instructions on how to prepare and administer Tretten® please refer to the sections ‘Preparing Your Injection’ and ‘Giving Your Injection’ located at the end of this insert.

Once you have prepared Tretten® for injection it should be used immediately. This is because if not stored correctly, the medicine may no longer be sterile. Also, the amount of activated Factor XIII in the medicine may increase. Activated Factor XIII may increase the severity of a pre-existing blood clot. It is therefore important that you store Tretten® according to the storage instructions below.

Usual dose

  • Your dose will depend on how much you weigh.
  • The usual dose is 35 IU for each kilogram of body weight.
  • The injections are given once a month.

Overdose

There is limited information on overdosing with Tretten®.. None of the reported cases have had a medical consequence. If you have injected more Tretten®. than you should, talk to your doctor immediately.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you forget an injection of Tretten® talk to your doctor immediately. Do not take a double dose to make up for a forgotten dose.

Stopping your treatment

If you stop using Tretten®. you are not protected against bleeding. Do not stop using Tretten®. without talking to your doctor. Your doctor will explain what might happen if you stop treatment and will discuss other options with you.

Side effects and what to do about them

Unwanted effects are possible with all medicines. Tell your doctor as soon as possible if you do not feel well while you are receiving treatment with Tretten®.

If you have an allergic reaction, see a doctor immediately. The signs may include:

  • Hives
  • Itching
  • Swelling
  • Difficulty breathing
  • Low blood pressure (paleness and coldness of skin, rapid heartbeat)
  • Feeling dizzy and sweating

The following is not a complete list of side effects. For any unexpected effects while taking Tretten®, contact your doctor.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor Only if severe Talk with your doctor In all cases Stop taking drug and call your doctor immediately
Common
Headache ✔    
Pain where injection is given ✔    
Pain in legs and arms ✔    
Increase in infections ✔    
Uncommon
Hives     ✔
Itching     ✔
Swelling     ✔
Difficulty breathing     ✔
Paleness, coldness of skin, rapid heartbeat     ✔
Dizziness and sweating     ✔

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.

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 (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Patient Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9
    Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

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.

How to store
  • Keep out of the reach and sight of children
  • Do not use Tretten® after the expiry date which is stated on the label and the outer carton
  • Store in the original package in order to protect from light
  • Store in a refrigerator
  • Do not freeze

It is recommended to use the reconstituted product immediately.

If the reconstituted product is not used immediately, it should be used within 3 hours of reconstitution, and can be stored at room temperature during this period. Any unused product stored at room temperature for 3 or more hours should be discarded.

Alternatively, if the reconstituted product is not administered immediately, it should be stored in the refrigerator at 2°C - 8°C for no longer than 24 hours. After this period the product should be discarded.

If the product is diluted with 0.9% sodium chloride (for those patients weighing less than 24 kg), the storage and stability recommendations specified above are still applicable.

Do not freeze reconstituted Tretten® or store it in syringes.

More information

If you still have questions or would like more information, please contact your doctor.

This document plus the full product monograph, prepared for health professionals can be found at:
http://www.novonordisk.ca or by contacting Novo Nordisk Canada Inc., at: 1-800-465-4334.

This leaflet was prepared by Novo Nordisk Canada Inc.

Tretten® is a registered trademark of Novo Nordisk Health Care AG and is used under license by Novo Nordisk Canada Inc.

© 2017
Novo Nordisk Canada Inc.

Last revised: June 2017

Preparing your injection

To reconstitute and administer this product you will need the following tools: 10 mL syringe or size of syringe as most convenient according to injection volume, alcohol swabs, the vial adapter included, and an infusion set (tubing, butterfly needle).

Reconstitute only with the solvent provided with Tretten® (sterile water for injection).

Always use sterile technique.

Before starting, wash your hands with soap and water and dry with a clean towel.

Bring the powder and solvent vials to room temperature, but not above 25C. You can do this by holding the vials in your hands until they feel as warm as your hands.

Remove the plastic caps from the two vials. If the caps are loose or missing, do not use the vials. Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry prior to use.
The product is reconstituted using the vial adapter included.

Remove the protective paper from the vial adapter, without taking the vial adapter out of the protective cap. Attach the vial adapter to the solvent vial (sterile water for injection). Take care not to touch the spike on the vial adapter.
Once attached, remove the protective cap from the vial adapter by lightly squeezing the protective cap with your thumb and index finger.
Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent vial (3.2 mL sterile water).
Screw the syringe tightly onto the vial adapter on the solvent vial. Inject air into the vial by pushing the plunger until you feel a clear resistance.
Hold the syringe with the solvent vial upside down. Pull the plunger to draw the solvent into the syringe.
Remove the empty solvent vial by tipping the syringe with the attached vial adapter.
Click the vial adapter, still attached to the syringe onto the powder vial. Hold the syringe slightly tilted with the vial facing downwards. Push the plunger slowly to inject the solvent into the powder vial. Make sure not to aim the stream of solvent directly at the powder as this will cause foaming.
Gently swirl the vial until all the powder is dissolved. Do not shake the vial as this will cause foaming. Check the solution for bits and discolouration. If you notice either, do not use it. The reconstituted product is a clear, colourless solution.

If you need a larger dose, repeat the procedure in a separate syringe until you have reached your required dose.
Special Additional Instructions for Patients Weighing Less than 24 kg
If the body weight is less than 24 kg, the reconstituted Tretten® should be diluted with 6.0 mL of 0.9% sodium chloride. Your doctor will let you know if this is the case, and instruct you on how to dilute Tretten®.

Important Information
Once you have prepared Tretten® it should be used immediately. This is because if left, the medicine may no longer be sterile. Also, the amount of activated Tretten® in the medicine will increase. Activated Tretten® may increase your risk of getting a blood clot (thrombosis).

If the reconstituted product is not used immediately, it should be used within 3 hours of reconstitution, and can be stored at room temperature during this period. Any unused product stored at room temperature for 3 hours should be discarded.

Alternatively, if the reconstituted product is not administered immediately, it should be stored in the refrigerator at 2°C - 8°C for no longer than 24 hours. After this period the product should be discarded.

Giving your injection

Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the syringe). Hold the syringe with the vial upside down and pull the plunger to draw up the amount calculated for the injection.
Unscrew the vial adapter with the vial. The product is now ready for injection.

Follow the injection procedure as instructed by your healthcare professional.
Safely dispose of the syringe, vial adapter, infusion set and vials. Any unused product or waste material should be disposed of in accordance with local requirements.
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