Patient leaflet - Alhemo 300 mg/3 ml solution for injection in Pre-filled pen

1. What Alhemo® is and what it is used for

What Alhemo® is

Alhemo® contains the active substance concizumab, which belongs to a group of medicines called ‘monoclonal antibodies’. Concizumab is a protein that recognises and binds to a target in the blood involved in the coagulation process.

What Alhemo® is used for

Alhemo is used to prevent or reduce the frequency of bleeds in adults and adolescents from 12 years with:

haemophilia A with inhibitors.
haemophilia B with inhibitors.

Haemophilia A is inborn blood clotting factor VIII deficiency and haemophilia B is inborn blood clotting factor IX deficiency.

How Alhemo® works

Concizumab blocks a natural factor in your blood that prevents blood from clotting. This factor is called tissue factor pathway inhibitor. This blocking makes the clotting of your blood more effective and therefore helps prevent or reduces bleeds when you are lacking a clotting factor. Alhemo® acts independently of factor VIII and factor IX and independently of inhibitors to these.

2. What you need to know before you use Alhemo®

Do not use Alhemo®

If you are allergic to concizumab or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions

Allergic reactions

There is a risk that you may experience an allergic reaction. Stop the treatment and contact your doctor if you have symptoms of allergic reactions such as rash, redness, hives and itching. You could also experience symptoms of severe allergic reactions such as:

Itching on large areas of skin
Redness and/or swelling of lips, tongue, face or hands
Difficulty in swallowing
Shortness of breath
Wheezing
Tightness of the chest
Pale and cold skin
Fast heartbeat
Dizziness due to low blood pressure.

Stop using Alhemo® and immediately seek emergency help if you have symptoms of severe allergic reactions.

Blood clots

Blood clots can form anywhere in the body.

Stop using Alhemo® and contact your doctor immediately, if you have symptoms of blood clots such as:

Swelling, warmth, pain, or redness of the skin – these could be symptoms of a blood clot in your
legs or arms.
Feeling short of breath, severe chest pain – these could be symptoms of blood clots in your heart or
lungs.
Headache, feeling confused, trouble with speech or movement, numbness in face, eye pain or
swelling, or problems with your vision – these could be symptoms of a blood clot in your brain or eyes.
Sudden pain in stomach or lumbar area – these could be symptoms of blood clots in your gut or
kidneys.

Children and adolescents

Alhemo® is not recommended for children under 12 years with haemophilia A with inhibitors or haemophilia B with inhibitors.

Other medicines and Alhemo®

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

Use a highly effective method of contraception during treatment with Alhemo® and for 7 weeks after your last injection. Talk to your doctor about the type of contraceptive to use. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

Alhemo® is unlikely to affect your ability to drive or use machines.

Alhemo® contains sodium and polysorbates

This medicine contains less than 1 mmol sodium (23 mg) per dose that is to say essentially ‘sodium-free’. This medicine contains 0.25 mg of polysorbate 80 in each mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use Alhemo®

See the detailed Instructions for use on the other side of this leaflet before using your Alhemo® pre-filled pen.

Ask your doctor if you need to use alternative injection techniques, e.g. lean patients and adolescents may need to inject into a loosely held fold of skin to avoid injecting too deep (into the muscle). Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist, or nurse if you are not sure.

Management of breakthrough bleeds

Before you start using Alhemo® talk with your doctor about how to handle a potential bleed.

The recommended dose for adults and adolescents is

Starting dose on day 1: 1 mg per kg body weight
From day 2 until the maintenance dose is set: 0.20 mg per kg body weight once daily
Individual maintenance dose as decided by the doctor: 0.15, 0.20 or 0.25 mg per kg body weight
once daily.

Alhemo® is injected under the skin of your abdomen or thigh and can be used any time of the day.

If you use more Alhemo® than you should

Contact your doctor immediately.

If you forget to use Alhemo®

Alhemo® can be used any time of the day.

One or more missed doses of Alhemo® affects how well the medicine works. It is important to take Alhemo® every day.

If you miss your daily dose of Alhemo®:

If you miss a dose during the first 4 weeks of treatment, contact your doctor to discuss how to resume. If you miss a dose after dose maintenance setting:

If you missed 1 daily dose, resume your daily dose
If you missed 2 to 6 daily doses, take your daily dose twice (as two separate injections each
corresponding to a daily dose), and then continue taking your daily dose the next day.
If you missed 7 or more daily doses, contact your doctor right away as you will need to receive a
new loading dose before continuing your daily dose the next day

If you are in doubt, contact your doctor

If you stop using Alhemo®

You may no longer be protected against bleeding. Do not stop using Alhemo® without talking to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Alhemo® and immediately contact your doctor if you have any symptoms of severe allergic reactions or symptoms of blood clots. See "Warnings and precautions" in section 2.

Other side effects

Very common: may affect more than 1 in 10 people

Injection site reactions such as redness, bleeding, itching, hives, swelling, pain, numbness.

Common: may affect up to 1 in 10 people

Allergic reaction.

Uncommon: may affect up to 1 in 100 people

Blood clots

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Alhemo®

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 pen label and carton after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice that the solution is discoloured.

Before use

Store unused Alhemo® pens at 2 °C - 8 °C in a refrigerator.
Store your new, unused pen with the pen cap on.
When stored in the refrigerator, do not store the pen directly next to the cooling element.
Do not use Alhemo® if it has been frozen or stored at temperatures above 30 °C.

After first use

Store the Alhemo® pen you are currently using without a needle attached for up to 28 days
(4 weeks), either:
- In the refrigerator at 2 °C - 8 °C.
  Do not store the pen directly next to the cooling element. Do not use Alhemo® if it has been frozen.
  or
- At room temperatures below 30 °C.
  Discard the pen if it has been stored above 30 °C. Do not store the pen in direct sunlight.
Store your in-use Alhemo® pen with the pen cap on.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Alhemo® contains

The active substance is concizumab.
One millilitre Alhemo® 300 mg/3 mL contains 100 mg concizumab.
The other ingredients are L-Arginine hydrochloride, L-Histidine, sodium chloride, sucrose, polysorbate 80, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment) and water for injections. See also section 2 "Alhemo contains sodium and polysorbates”.

What Alhemo® looks like and contents of the pack

Alhemo® is a clear to slightly unclear and colourless to slightly yellow solution for injection in pre-filled disposable pen. Transparent to white particles of protein are acceptable.

Alhemo 300 mg/3 mL is available as a unit pack containing 1 pre-filled pen. Needles for injection are not included.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S

Novo Alle 1

DK-2880 Bagsvaerd

Denmark

This leaflet was last revised in 09/2025.

Do Not Use

300 mg/3 mL

Alhemo® and NovoFine® are trademarks owned by Novo Nordisk A/S, Denmark.

Novo Nordisk A/S

Package leaflet and

Instructions for use Alhemo®

solution for injection in pre-filled pen

concizumab

Check your pen

Check pen label

Look at the name and colour to make sure you have the correct medicine.

Inspect medicine

Pull off the pen cap and check that Alhemo® in the pen window is a clear to slightly unclear and colourless to slightly yellow solution. Transparent to white particles of protein are acceptable. If Alhemo® looks discoloured do not use the pen.

Check expiry date

Check the expiry date on the pen label to make sure it has not passed. If the expiry date has passed, do not use the pen.

If your pen is cold

You can inject Alhemo® right from the refrigerator or let it reach room temperature before you inject. You can warm the pen in the palms of your hands. Do not use any other heating sources.

1 After your dose

Put the pen cap back on your pen to protect Alhemo® from light.

Now your pen is ready for storage until you need it next time.

After first use do not use your pen for more than 28 days.

7 What is in this package?

1 Alhemo® pre-filled pen
Package leaflet

Needles are not included.

Read the instructions and make sure you have received training from your doctor or nurse before you use the pen.

Follow the instructions from your doctor or nurse on how to use Alhemo® and how often you should inject Alhemo®.

The pen is pre-filled with 300 mg of Alhemo® for subcutaneous use only (injection in the skin). The pen contains several doses of Alhemo®.

The pen can deliver a maximum of 80 mg in one injection. The interval on the dose counter is 1 mg. If you need more than 80 mg, you need to inject multiple times.

Information for safety

The pen is for single patient use only and must not be shared. Sharing your pen or needles may lead to infection and transmission of disease.

Always use a new needle for each injection. Do not re-use needles as this may lead to needle blockage, infection and incorrect dosing.

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any solution.

Where on my body should I inject my dose?

You can inject in the skin of:

Your stomach (abdomen) OR
Your thigh.

Inject at a 90° angle. The grey areas on the picture to the right show the injection sites. For every injection, select a new injection site at least

5 centimetres away from where you last injected.

Remove the needle

Remove the needle from your pen after each injection by inserting the needle tip into the outer needle cap without touching the needle or the cap.

When the needle is covered, carefully push the outer needle cap completely on. Unscrew the needle. Do not touch the back end of the needle.

Dispose of the needle as instructed by your doctor, nurse, pharmacist or local authorities.

Pen overview and

needle example

Needle

Paper tab

Pen scale

Outer needle cap

Inner needle cap

Dose selector

Dose button

Dose counter

Dose pointer

Pen window

Pen label

Pen cap

Inject your dose 5

Read through steps a. to e. before you start injecting. This is to make sure you get your full dose.

a. Select the injection site. See Where on my body should I inject my

dose?

b. Insert the needle straight into your stomach (abdomen) or thigh at

a 90° angle.

c. Press and hold the dose button down until the dose counter returns to

<0>.

d. While the needle is still in your skin, count slowly to 6, after the

dose counter has returned to <0>.

e. Retract the needle from your skin.

The pen clicks during dosing and you might also

hear or feel a click when the dose counter

returns to <0>.

Test the flow 3

A drop of Alhemo® may appear at the needle tip, but you should still test the Alhemo® flow before each injection to avoid underdosing:

a. Turn the dose selector one marking to select 1 mg. See A in the figure below. Hold the pen with the needle pointing upwards.

b. Press the dose button. See B.

c. Watch for a stream of Alhemo® leaving the needle tip. See B.

If no stream appears, go to Troubleshooting if no stream appears when testing the flow.

2 Attach a new needle

Take a new needle and tear off the paper tab.

Push the needle straight onto your pen. Turn
until it is on tight. See A.
Pull off the outer needle cap and keep it. See B.
Pull off the inner needle cap and dispose of it.
See B.

Never use a bent or damaged needle.

Use only needles recommended by your doctor or nurse. This pen is designed to be used with NovoFine® Plus 32G x 4 mm or NovoFine® 32G x 4 mm injection needles. If you use needles longer than 4 mm, talk to your doctor or nurse about how to perform your injection.

Example:

34 mg left

The example below shows 34 mg of Alhemo® left in the pen.

Troubleshooting if no stream appears when testing the flow (step 3)

If no stream appears, repeat step 3 up to six times until
you see a stream.
If still no stream appears, prepare a new needle (step 2)
and test again (step 3).
If still no stream appears after using a new needle, do not
use the pen. Use a new pen.
Storage
See section 5 "How to store Alhemo®" on the reverse side of this leaflet.
Take good care of your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might not get the intended effect of this medicine.
Do not expose your pen to dust, dirt or liquid.
Do not wash, soak or lubricate your pen. If necessary, clean it with mild detergent on a moistened cloth.
Keep your pen out of sight and reach of others, especially children.
Disposing of Alhemo® pens, needles and packaging material
When your pen is empty you must dispose of it according to your local regulations.
You cannot refill your pen.
To reduce the risk of a needle stick, dispose of used needles immediately as instructed by your doctor, nurse, pharmacist or local authorities.
The packaging material (the carton and leaflet) is recyclable. The pen scale shows approximately how much Alhemo® is left in your pen.

If you want to see more accurately how much Alhemo® is left in your pen, turn the dose selector until it stops. The dose pointer will line up with the number of milligrams left in the pen. The number shown on the dose counter is the number of milligrams left in your pen. If the dose counter shows 80, there are 80 mg or more left in the pen.

Example: 200 mg left

How much Alhemo® is left in your pen?

Select your dose 4

Turn the dose selector to select your prescribed dose.

Confirm that you have selected the correct dose.

You can adjust your dose by turning the dose selector in either direction.

If you need a larger dose than you can dial, you must inject yourself multiple times to get your full dose. For more information, see step 6.

The pen contains 300 mg of Alhemo®.

The pen can deliver a maximum of 80 mg in one injection.

Instructions for use

8-9103-01-010-X

Do you need a larger dose than you can dial?

6

If you need a larger dose than you can dial, you must inject yourself more than once to get your full dose. Repeat steps 1 to 6 until you have received your full dose. When you have received your full dose go to step 7.

Use a new needle for each injection.
Test the Alhemo® flow before each injection.
Accurately calculate how much to inject in each injection to receive your full dose.

1 mg selected

Example 24 mg

Outer

needle

cap

(Keep it)

Inner