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NovoThirteen®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
NovoThirteen® contains the active substance catridecacog, which is identical to human
coagulation factor XIII. NovoThirteen® is used to prevent bleeding in patients who
do not have enough factor XIII.
For more information, see Section 1. Why am I using NovoThirteen®? in the full CMI.
Do not use if you have ever had an allergic reaction to NovoThirteen® or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use NovoThirteen®? in the full CMI.
Some medicines may interfere with NovoThirteen® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Follow your doctor's instructions, including your exact dose and dosing schedule.
NovoThirteen® is for intravenous injection, and before use requires mixing the powder
in the vial with the solvent supplied in the pack.
More instructions can be found in Section 4. How do I use NovoThirteen®? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using NovoThirteen®.
With your doctor, monitor bleeding carefully, and notify them if your bleeding gets
worse.
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Things you should not do
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Do not stop using NovoThirteen® or change your dose without checking with your doctor.
Do not inject yourself without proper training from your doctor or haemophilia nurse.
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Driving or using machines
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There is no specific information on the use of NovoThirteen® and driving or using
machines.
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Drinking alcohol
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There is no specific information on any possible interactions of NovoThirteen® with
alcohol.
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Looking after your medicine
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NovoThirteen® must be stored at 2-8 °C. It should not be frozen.
Protect NovoThirteen® from light.
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For more information, see Section 5. What should I know while using NovoThirteen® ? in the full CMI.
Contact your doctor or go to hospital if you experience symptoms of a serious allergic
reaction, such as widespread skin rash, shortness of breath, wheezing, swelling of
the face, lips or tongue.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
NovoThirteen®
Active ingredient:
catridecacog (rys)
Consumer Medicine Information (CMI)
This leaflet provides important information about using NovoThirteen®. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using NovoThirteen®.
Where to find information in this leaflet:
NovoThirteen® contains the active substance catridecacog, which is identical to human
coagulation factor XIII, an enzyme necessary for blood clotting.
NovoThirteen® is used to prevent bleeding in patients who do not have enough factor
XIII. NovoThirteen® replaces the missing factor XIII and helps to stabilise the initial
blood clot by producing a mesh around the clot.
Do not use NovoThirteen® if you:
are allergic to catridecacog or to any of the ingredients in NovoThirteen® listed
at the end of this leaflet.
Check with your doctor if you:
have, or have ever had, a higher risk of blood clots forming (thrombosis), as NovoThirteen®
may increase the severity of a pre-existing blood clot
are allergic to yeast protein
are using other blood clotting factors. It is not recommended to use NovoThirteen®
and recombinant factor VIIa (another blood clotting factor) together
have or have ever had liver damage
plan to have surgery
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Unexpected bleeding
Contact your doctor immediately if you experience unexpected bleeding during treatment.
Antibodies with neutralising effect against NovoThirteen® could decrease the effectiveness
of the treatment and result in unexpected spontaneous bleeding episodes.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Do not use NovoThirteen® and blood clotting factor concentrates at the same time.
Tell your doctor before you use NovoThirteen® and medicines used to reduce the dissolving
of blood clots.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect NovoThirteen®.
How much to use
Your dose will depend on your body weight. The usual dose is 35 IU for each kilogram
of body weight.
Based on the concentration of NovoThirteen® solution, the dose volume to be injected
(in millilitres) can be calculated from this formula:
Dose volume in millilitres = 0.042 x your body weight in kg.
Dose volume in millilitres = 0.042 x your body weight in kg.
Use in small children
If you need to give NovoThirteen® to a child weighing less than 24 kg you should dilute
the reconstituted NovoThirteen® with 6.0 mL of sodium chloride 0.9% solution for injection.
This makes the dosing of small children easier. For more information see section 'Dilution
of the reconstituted product with sodium chloride 0.9% solution for injection' in
the NovoThirteen® Instructions For Use.
The dose volume for the use in small children can be calculated from this formula
Dose volume in mL = 0.117 x body weight in kilograms.
Dose volume in mL = 0.117 x body weight in kilograms.
Your doctor may adapt the dose if this is deemed necessary.
Do not adjust this dose or schedule without first consulting your doctor.
When to use NovoThirteen®
The injections are given once a month (every 28 +/- 2 days).
NovoThirteen® should be used according to your doctor's clinical assessment.
How to use NovoThirteen®
The solvent must be added (reconstitution) to the vial of NovoThirteen® powder before
the solution is injected. The solution should be clear and colourless.
Do not inject the reconstituted medicine if the solution is not clear and colourless or it has anything floating in it.
Start of treatment with NovoThirteen® should be supervised by a doctor with experience
in rare bleeding conditions.
NovoThirteen® is given as an injection into a vein (intravenously) at a rate not higher
than 2 mL per minute.
Do not inject yourself without proper training from your doctor or haemophilia nurse.
Do not use the equipment required to inject yourself if it has been dropped or it
has been damaged.
Reconstitution and injection:
Follow the detailed instructions on how to inject NovoThirteen® in the instructions
for use supplied with the product.
These instructions are also available via the following hyperlink:
http://medsinfo.com.au/media/noinov13
http://medsinfo.com.au/media/noinov13
NovoThirteen® is for single use in one person only.
Once NovoThirteen® has been prepared for injection, it should be used immediately.
Discard your vial after use.
If the reconstituted product is not used immediately, it should be used within 3 hours
if stored at temperatures below 25°C or within 24 hours if stored at 2 - 8°C. It
must not be frozen. If it is left longer, the medicine may no longer be sterile and
the amount of activated rFXIII will increase. Activated rFXIII may increase the risk
of getting a blood clot (thrombosis).
If it is not used in time or has been frozen, throw it away and reconstitute another
vial.
After injection:
Do not refill NovoThirteen® vials.
Follow general precautionary measures for removal and disposal of needles to eliminate
the risk of needlestick injury.
If you forget to use NovoThirteen®
You should contact your doctor as soon as possible so that they may take the appropriate
action.
Do not take a double dose to make up for a forgotten dose.
If you use too much NovoThirteen®
If you are given or if you give yourself too much NovoThirteen ®
You should immediately:
contact your doctor. Your doctor will take appropriate action.
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
Continue using NovoThirteen® for as long as your doctor tells you.
You and your doctor should monitor your bleeding. Tell your doctor or nurse if your bleeding gets worse.
Call your doctor straight away :
If you experience unexpected bleeding during your treatment with NovoThirteen®. Your
doctor may prescribe an alternative treatment to treat the bleeding.
If you experience unexpected spontaneous bleeding during treatment with Factor XIII
containing products. Antibodies against NovoThirteen® could decrease the effectiveness
of the treatment and thereby result in unexpected spontaneous bleeding episodes. Contact
your doctor immediately if bleeding occurs.
Remind any doctor, dentist or pharmacist you visit that you are using NovoThirteen®.
Things you should not do
Do not stop using NovoThirteen® without consulting your doctor
Do not change the dose or schedule without consulting your doctor
Do not give NovoThirteen® to anyone else, even if they have the same condition as
you
Do not share needles, syringes, or other injecting equipment with anyone
Do not use NovoThirteen® to treat any other complaints.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how NovoThirteen®
affects you.
There is no specific information on the use of NovoThirteen® and driving.
Drinking alcohol
Tell your doctor if you drink alcohol.
There is no specific information on any possible interactions of NovoThirteen® with
alcohol.
Looking after your medicine
Follow the instructions on the carton on how to take care of your medicine properly.
Store it at 2 - 8 °C
Do not freeze
Store it in the original package to protect it from light
Keep it where young children cannot reach it.
When to discard your medicine
Do not use NovoThirteen® after the expiry date. The expiry date refers to the last
day of that month.
Discard your medicine once the permitted storage time listed in "Reconstitution and
injection" has passed.
Discard any solution left in the vial after you have taken the dose recommended by
your doctor for your injection.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Injection site:
redness
itchiness
tenderness
pain
discomfort
Other:
headache
leg or arm pain
frequent infections, such as fever, severe chills, sore throat or mouth ulcers which
may be symptoms of a drop in the number of some types of white blood cells
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Severe allergic reaction:
sudden rash, hives or itching
swelling of the face, lips, tongue or other parts of the body
shortness of breath, wheezing or difficulty breathing
low blood pressure (cold clammy skin, rapid weak heartbeat)
feeling dizzy
sweating
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
What NovoThirteen® contains
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Active ingredient
(main ingredient)
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catridecacog (rys) 5.25 mg/mL
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Other ingredients
(inactive ingredients)
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Powder vial
sodium chloride
sucrose
polysorbate 20
histidine
sodium hydroxide and hydrochloric acid to adjust the pH.
Solvent vial
Water for injections
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Potential allergens
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N/A
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After reconstitution, 1 mL of the solution contains 833 IU catridecacog (activated).
Do not take this medicine if you are allergic to any of these ingredients.
What NovoThirteen® looks like
NovoThirteen® is supplied as a white powder, in a glass vial. The powder must be dissolved
with solvent before it is used. The pack contains solvent, supplied in a glass vial
and a sterile vial adaptor for reconstitution.
(AUST R 201776).
Who distributes NovoThirteen®?
NovoThirteen® is supplied in Australia by:
Novo Nordisk Pharmaceuticals Pty Ltd
Level 10
118 Mount Street
North Sydney NSW 2060
Australia
Further information
For further information call Novo Nordisk Medical Information on 1800 668 626 (Australia).
Always check the following websites to ensure you are reading the most recent version
of the NovoThirteen® Consumer Medicine Information:
NovoThirteen® is a registered trademark of Novo Nordisk A/S.
© 2025
Novo Nordisk A/S
This leaflet was prepared in December 2025
