Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark
Alhemo is indicated for routine prophylaxis of bleeding in patients with:
Treatment should be initiated under the supervision of a physician experienced in treatment of haemophilia and/or bleeding disorders.
Treatment should be initiated in a non-bleeding state.
Treatment with rFVIIa should be discontinued at least 12 hours before starting concizumab therapy and treatment with aPCC should be discontinued at least 48 hours before.
The recommended dosing regimen is
Table 1. Individual maintenance dose based on concizumab plasma concentration:
| Concizumab plasma concentration | Once daily dose Alhemo |
|---|---|
| <200 ng/mL | 0.25 mg/kg |
| 200−4 000 ng/mL | 0.20 mg/kg |
| >4 000 ng/mL | 0.15 mg/kg |
Individual maintenance dose setting should be performed at the earliest convenience (after concizumab plasma concentration result is available) and recommended no later than 8 weeks after initiation of treatment. Additional concizumab plasma concentration measurement(s) can be taken after 8 weeks on the same maintenance dose according to the patient’s medical condition. For example, this should be considered if a patient experiences an increased bleeding frequency, a large change in body weight, has missed doses before maintenance dose setting, or acquires a comorbidity, which can lead to an increase in the overall thromboembolic risk.
Since concizumab is dosed per body weight (mg/kg), it is important to recalculate the dose (mg) when the body weight changes.
The dose (in mg) is calculated as follows: Patient body weight (kg) x dose (1, 0.15, 0.20 or 0.25 mg/kg) = total amount (mg) of concizumab to be administered.
The dose is dialled at increments of
The calculated dose is rounded off to the nearest injectable dose on the pen. The physician or nurse must assist the patient in rounding off and identifying the appropriate injectable dose on the pen. Ideally, patients should be prescribed and use a pen that can deliver the required daily maintenance dose in one injection. The nearest injectable dose can be identified by turning the scale drum on the pen or can be calculated as follows:
Divide total dose in mg by dose per increment.
Round off to nearest whole number.
Multiply by dose per increment.
Examples:
A patient’s body weight of 42 kg, using a maintenance dose of 0.15 mg/kg.
Day 1 using a loading dose of 1 mg/kg:
Day 2 and until individual maintenance dose setting using a dose of 0.20 mg/kg:
Maintenance dose:
A patient is to receive 6.3 mg of concizumab with a 60 mg/1.5 mL pre-filled pen to provide the longest pen duration (days) for this patient’s body weight.
To identify the nearest injectable dose:
A patient’s body weight of 67 kg, using a maintenance dose of 0.20 mg/kg.
Day 1, using a loading dose of 1 mg/kg:
Day 2 and until individual maintenance dose setting using a dose of 0.20 mg/kg:
Maintenance dose:
The patient is to receive 13.4 mg of concizumab with a 300 mg/3 mL pre-filled pen to provide the longest pen duration (days) for this patient’s body weight.
To identify the nearest injectable dose:
13.0 mg is a dose which can be dialled on the 300 mg/3 mL pre-filled pen and it is the injectable dose closest to 13.4 mg.
Based on technical features, the Alhemo pre-filled pens can accommodate the following body weight ranges:
For patients on a daily dose of 0.15 mg/kg body weight:
| Product strength | Body weight | Dose increment | Maximum dose per injection |
|---|---|---|---|
| 15 mg/1.5 mL | 5-53 kg | 0.1 mg | 8 mg |
| 60 mg/1.5 mL | 19-213 kg | 0.4 mg | 32 mg |
| 150 mg/1.5 mL | 47 kg and above | 1.0 mg | 80 mg |
| 300 mg/3 mL | 73 kg and above | 1.0 mg | 80 mg |
For patients on a daily dose of 0.20 mg/kg body weight:
| Product strength | Body weight | Dose increment | Maximum dose per injection |
|---|---|---|---|
| 15 mg/1.5 mL | 4-40 kg | 0.1 mg | 8 mg |
| 60 mg/1.5 mL | 14-160 kg | 0.4 mg | 32 mg |
| 150 mg/1.5 mL | 35 kg and above | 1.0 mg | 80 mg |
| 300 mg/3 mL | 55 kg and above | 1.0 mg | 80 mg |
For patients on a daily dose of 0.25 mg/kg body weight:
| Product strength | Body weight | Dose increment | Maximum dose per injection |
|---|---|---|---|
| 15 mg/1.5 mL | 3-32 kg | 0.1 mg | 8 mg |
| 60 mg/1.5 mL | 11-128 kg | 0.4 mg | 32 mg |
| 150 mg/1.5 mL | 28 kg and above | 1.0 mg | 80 mg |
| 300 mg/3 mL | 44 kg and above | 1.0 mg | 80 mg |
If more than one Alhemo pen is relevant based on body weight ranges, the pen with the highest product strength should be chosen. The higher strength pen contains more doses that can be administered, allowing the pen to be used for more days.
Alhemo is intended for long-term prophylactic treatment.
Concizumab can be administered any time during the day.
It is important that each patient adheres to their daily dosing. Adherence is particularly important during the initial 4 weeks to ensure a correct maintenance dose is properly established based on the week 4 concizumab plasma concentration (see section 4.2 on posology). Patients who miss doses before the maintenance dose has been established should resume treatment as soon as possible at the initial 0.2 mg/kg daily dose and inform their healthcare professional.
The following dosing guidelines should apply ONLY when a patient has forgotten to or neglected to take their once daily maintenance dose.
When in doubt, the patient should contact their healthcare professional.
No dose adjustment of Alhemo should be done in case of breakthrough bleeds.
Physicians should discuss with the patient and/or caregiver about the dose and schedule of bypassing agents, if required while receiving concizumab prophylaxis.
Treatment with bypassing agents (e.g., rFVIIa or aPCC) can be used for breakthrough bleeds, and the dose and duration will depend on the location and severity of the bleed.
For mild and moderate bleeds that require additional treatment with bypassing agents (e.g., rFVIIa or aPCC), the lowest approved dose and the dose interval as in the approved label is recommended. Furthermore, for aPCC a maximum dose of 100 U/kg body weight within 24 hours is recommended.
For severe bleeds it is recommended to follow the dosing scheme provided in the approved label for the specific product based on clinical judgement.
No dose adjustment of Alhemo is needed in case of minor surgeries.
Before major surgery, a healthcare professional experienced in treatment of haemophilia and/or bleeding disorders should be consulted. As there is limited clinical experience in using concizumab during major surgeries, it is generally recommended to pause concizumab at least 4 days prior to elective major surgery. Concizumab therapy can be resumed 10-14 days after surgery on the same maintenance dose without a new loading dose, considering the overall clinical picture of the patient. The criteria for major surgery are any invasive operative procedure that requires ≥3 doses of bypassing therapy and/or where any one or more of the following occur:
The safety and efficacy of concomitant use with concizumab in patients receiving ongoing ITI, a desensitisation strategy for eradication of inhibitors, have not been established. No data is available. Careful assessment of potential benefits and risks should be performed if continuation or initiation of concizumab during ITI is considered.
No dose adjustments (besides individual maintenance dose setting) are recommended in patients ≥65 years of age. No data are available in patients aged 65 years and older. For more information, see section 5.2.
No dose adjustments (besides individual maintenance dose setting) are recommended in patients with renal impairment. Limited or no data are available in patients with mild, moderate, and severe renal impairment, see section 5.2.
No dose adjustments (besides individual maintenance dose setting) are recommended in patients with hepatic impairment. Limited or no data are available in patients with hepatic impairment, see section 5.2.
The safety and efficacy of Alhemo in children aged < 12 years has not yet been established. No data are available.
Alhemo is for subcutaneous use only.
Concizumab comes in a ready-to-administer pre-filled pen. Needles are not included, see section 6.5.
Concizumab should be administered daily, at any time point of the day, not necessarily the same time point every day.
Concizumab may be self-administered, or administered by a caregiver, after receiving appropriate training by a health care professional and reading the Instructions for Use.
Concizumab should be administered by subcutaneous injection to the abdomen or thigh with rotation of injection site every day. Subcutaneous injections should not be given in areas where the skin is tender, bruised, red or hard, or areas where there are moles or scars.
A new needle should always be used for each injection.
Each Alhemo pre-filled pen is for use by a single patient. An Alhemo pre-filled pen must not be shared between patients, even if the needle is changed.
For comprehensive instructions on the administration of the medicinal product, see section 6.6 and the package leaflet.
There is limited experience with overdose of concizumab. Cases of up to 5 times the intended dose have been reported with no clinical consequences. Accidental overdose may result in hypercoagulability and patients should contact their physician for monitoring.
3 years.
Store for up to 4 weeks at a temperature up to 30°C or in a refrigerator.
Chemical and physical in-use stability has been demonstrated for 28 days at 30°C or in a refrigerator. From a microbiological point of view, once opened, the product may be stored for a maximum time of 28 days at 30°C or in a refrigerator. Other in-use storage times and conditions are the responsibility of the user.
Store in a refrigerator (2°C-8°C).
Do not freeze. Keep away from the cooling element in the refrigerator.
Store the pre-filled pen with the cap on to protect the solution from light.
Store the pre-filled pen without a needle attached. This ensures accurate dosing, and prevents contamination, infection, and leakage.
Do not freeze. Keep away from the cooling element in the refrigerator.
Alhemo should be protected from heat and light and should not be stored in direct sunlight.
For storage conditions after first opening of the medicinal product, see section 6.3.
Alhemo is provided in a portable multi-dose disposable pre-filled pen, which consists of a 1.5 mL or 3 mL glass cartridge sealed in a pen-injector, made of plastic components and metal springs. The cartridge is closed at the bottom with a rubber disc, and at the top with a laminate rubber disc sealed with an aluminium cap. The rubber discs are not made with natural rubber latex.
The pre-filled pen is packed in a carton. Alhemo is available in the following pack sizes, and the dose button and the cartridge holder on the pen-injector is colour–coded according to strength:
Not all pack sizes may be marketed.
Injection needles are not included. Alhemo is designed to be used with NovoFine Plus or NovoFine needles with a gauge of 32 and a length of 4 mm. If needles longer than 4 mm are used, injection techniques that minimise the risk of intramuscular injection should be used, e.g. injecting into a loosely held skinfold.
For a more comfortable injection, allow the medicinal product to warm up to room temperature if it was stored in the refrigerator. Do not use artificial heating sources.
Inspect the solution visually prior to use. Alhemo in the pen window is a clear to slightly opalescent and colourless to slightly yellow liquid and practically free from visible particles. Translucent to white particles of protein are acceptable.
Do not use if the medicinal product is discoloured.
Comprehensive instructions for the preparation and administration of the medicinal product are provided in the ‘Instructions for Use’.
Adolescents and lean patients should be instructed to use injection techniques that minimise the risk of intramuscular injection, e.g. injecting into a loosely held skinfold.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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