Alhemo – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Alhemo, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 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. • severe haemophilia A (when the factor VIII blood level is less than 1%) without inhibitors.
- haemophilia B with inhibitors.
- moderate/severe haemophilia B (when the factor IX blood level is less than or equal to 2%) without 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. The safety and benefits of this medicine are not yet known in this population.
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.
87 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. H ow 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 You may need to use factor VIII, factor IX, or bypassing agents to treat episodes of breakthrough bleeding while using Alhemo. Carefully follow your healthcare provider’s instructions regarding when and how to use these factor VIII or factor IX products or bypassing agents.
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.
88 • 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 national reporting system listed in Appendix V . 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.
89 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
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: htt p://www.ema.europa.eu 90 Instructions for u se Alhemo 300 mg/3 mL solution for injection in pre -filled pen concizumab Alhemo Outer needle cap Inner needle cap Needle Paper tab Pen overview and needle example Pen label Dose counter Dose pointer Dose selector Dose button Pen cap Pen scale Pen window 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.
Check your pen 1 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.
Attach a new needle 2 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.
92 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.
Outer needle cap (Keep it) Inner needle cap (Dispose of it) 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.
1 mg selected 93 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.
Example 24 mg 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>.
94 Remove the needle 6 Remove the needle from your pen after eac h 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.
Do you need a larger dose than you can dial?
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.
After your dose 7 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.
How much Alhemo is left in your pen?
The pen scale shows approximately how much Alhemo is left in your pen.
Example:
200 mg left 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 m illigrams left in the pen. The number shown on the dose counter is the number of m illigrams left in your pen.
If the dose counter shows 80, there are 80 mg or more left in the pen. The example below shows 34 mg of Alhemo left in the pen.
Example:
34 mg left 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 “H ow to store Alhemo ” 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 . [Text for the front page of the folded leaflet] Package leaflet and Instructions for use
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Alhemo (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1881).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.