Alhemo

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Administer Alhemo by subcutaneous injection to the abdomen or thigh with daily rotation of injection sites. ( 2.2 ) Recommended dosing regimen:
• Day 1: Loading dose of 1 mg/kg
• Day 2:
• Once daily dose of 0.2 mg/kg until individualization of maintenance dose ( 2.1 ) o 4 weeks after initiation of treatment:
• For dose optimization, measure concizumab‑mtci plasma concentration by Concizumab Enzyme-Linked Immunosorbent Assay (ELISA) prior to administration of next scheduled dose using an FDA-authorized test for the measurement of concizumab-mtci concentration in plasma. See full Prescribing Information for important preparation and administration instructions and dosage adjustment. ( 2.1 , 2.3 , 2.4 ) 2.1 Recommended Dosage For subcutaneous use only. Alhemo should be administered once daily.
• Avoid missed doses. Recommended dosing regimen:
• Day 1: Loading dose of 1 mg/kg
• Day 2:
• Once daily dose of 0.2 mg/kg until individualization of maintenance dose (see below)
• 4 weeks after initiation of treatment:
• For dose optimization measure concizumab-mtci plasma concentration by Concizumab Enzyme-Linked Immunosorbent Assay (ELISA) prior to administration of next scheduled dose using an FDA-authorized test. Information on the FDA-authorized test for the measurement of concizumab-mtci plasma concentration is available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm. Once the concizumab-mtci concentration result is available, individualize the maintenance dose of Alhemo no later than 8 weeks after initiation of treatment, based on the following concizumab-mtci plasma concentrations:
• o Less than 200 ng/mL:
• adjust to a once daily dose of 0.25 mg/kg o 200 to 4,000 ng/mL:
• continue once daily dose of 0.2 mg/kg o Greater than 4,000 ng/mL:
• adjust to a once daily dose of 0.15 mg/kg The calculated dose is rounded off to the nearest injectable dose as follows:
• 60 mg/1.5 mL (40 mg/mL) in increments of 0.4 mg (brown label)
• 150 mg/1.5 mL (100 mg/mL) in increments of 1 mg (gold label)
• 300 mg/3 mL (100 mg/mL) in increments of 1 mg (white label) Additional measurements of concizumab-mtci plasma concentration should be taken at routine clinical follow-ups provided the patient has been on the same maintenance dose for 8 weeks of treatment to ensure steady state plasma concentration. Maintenance of concizumab plasma concentration above 200 ng/mL is important to decrease the risk of bleeding episodes. If concizumab-mtci plasma concentration remains below 200 ng/mL at two consecutive measurements, evaluate the benefits of continued Alhemo treatment versus the potential risk of bleeding events, and consider alternative therapies if available. As Alhemo is dosed by body weight (mg/kg), it is important to recalculate the dose when patients experience body weight changes. Missed Dose Adherence to daily dosing of Alhemo is important to maintain protection against bleeding. This is especially important during the initial 4 weeks of treatment to ensure a correct maintenance dose is established. Patients who miss a dose during the initial 4-week period should inform their healthcare professional and resume once daily dosing at the initial 0.2 mg/kg dose level. Missed Doses Once the Maintenance Dose Has Been Established The following dosing guidelines should apply ONLY when a patient has forgotten to or neglected to take their once daily maintenance dose:
• 1 missed dose: Resume once daily treatment at the maintenance dose level
• 2 to 6 missed doses:
• Resume treatment with a double dose followed by once daily treatment at the maintenance dose level
• 7 or more missed doses:
• Physician should be contacted, and a new loading dose should be considered [see Dosage and Administration ( 2.1 )] Management of Breakthrough Bleeds No dose adjustment of Alhemo is required in the case of breakthrough bleeds. Management in the Perioperative Setting No dose adjustment of Alhemo is required in the case of minor surgeries. As there is limited experience in the perioperative setting, it is generally recommended to pause Alhemo at least 4 days prior to major surgery. Alhemo 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. If necessary, consult a physician experienced in surgery of patients with bleeding disorders. Immune Tolerance Induction The safety and efficacy of concomitant use of Alhemo in patients receiving ongoing Immune Tolerance Induction (ITI), a desensitization strategy for the eradication of inhibitors, have not been established, and no data are available. Careful assessment of the potential benefits and risks should be performed if continuation or initiation of Alhemo during ITI is considered. 2.2 Changing to Alhemo from Other Hemostatic Products
• Discontinue treatment with rFVIIa at least 12 hours before starting Alhemo.
• Discontinue treatment with activated prothrombin complex concentrate (aPCC) at least 48 hours before starting Alhemo .
• Discontinue prophylactic use of standard half-life factor VIII (FVIII) or factor IX (FIX) at least 24 hours before starting Alhemo.
• When changing from other products to Alhemo, the half-life of the previous product should be considered. Healthcare providers should discuss with patients receiving Alhemo and/or their caregivers the dose and schedule of bypassing agents or FVIII or FIX, if required, while receiving Alhemo prophylaxis. 2.3 Instructions and Dosage Modification for Breakthrough Bleeding Treatment with FVIII or FIX or all 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 FVIII or FIX or bypassing agents (e.g., rFVIIa or aPCC), the lowest-approved dose and the dose interval in the approved product labeling is recommended. For aPCC, a maximum dose of 100 units/kg body weight within 24 hours is recommended. For severe bleeds, follow the dosing instructions provided in the approved labeling for the specific product based on clinical judgement. 2.4 Administration and Use Instructions Treatment is intended for use under the guidance of a healthcare provider. Treatment should be initiated in a nonbleeding state. Alhemo may be self-administered or administered by a caregiver after appropriate training and reading the Instructions for Use, if a healthcare provider determines that is appropriate. Administer Alhemo 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, scars, or stretch marks. Children and lean patients should be instructed to use injection techniques that minimize risk of intramuscular injection, e.g. injecting into a pinched fold of skin. Always use a new needle for each injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Alhemo is a clear to slightly opalescent and colorless to slightly yellow solution that may contain translucent to white particles.
• Do not use if the solution is discolored. Each Alhemo prefilled pen is for use by a single patient. An Alhemo pen must not be shared between patients, even if the needle is changed. Alhemo is recommended to be used with NovoFine ® or NovoFine ® Plus needles with a gauge of 32 and a length of 4 mm. If needles longer than 4 mm are used, injection techniques that minimize the risk of intramuscular injection should be used. Instructions for delivering the dosage are provided in the Instructions for Use leaflet enclosed with each Alhemo single-patient-use prefilled pen.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Use in children

• The safety and effectiveness of Alhemo for hemophilia A and B with and without inhibitors have been established in pediatric patients aged 12 years and older.
• Use of Alhemo for this indication is supported by evidence from adequate and well-controlled studies in adult and pediatric patients aged 12 years and older [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] .
• The safety and effectiveness of Alhemo for hemophilia A and B with and without inhibitors have not been established in pediatric patients younger than 12 years of age.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of Alhemo did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
• Thromboembolic Events [see Warnings and Precautions ( 5.1 )]
• Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )]
• Increased Laboratory Values of Fibrin D-dimer and Prothrombin Fragment 1.2 [see Warnings and Precautions ( 5.3 )] The most frequently reported adverse reactions (incidence ≥5%) were injection site reactions, headache and urticaria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. The data in the WARNINGS AND PRECAUTIONS reflect exposure to Alhemo based on pooled data from clinical trials explorer3 (phase 1b), explorer4 (phase 2), explorer5 (phase 2), explorer7 (phase 3) and explorer8 (phase 3), in which a total of 320 male patients with hemophilia A with and without inhibitors and hemophilia B with and without inhibitors received at least one dose of Alhemo as routine prophylaxis. The patients were exposed for a total of 475 exposure years. Patients with HAwI (hemophilia A with inhibitors) and HBwI (hemophilia B with inhibitors) The data described below reflect exposure of 52 patients with HAwI and HBwI who were previously treated on-demand therapy and who were randomized in explorer7 to arm 1 to receive on- demand treatment with bypassing agents (n = 19) or arm 2 to receive Alhemo prophylaxis (n = 33) at the recommended dosing regimen [see Clinical Studies ( 14.1 )] . The median duration of treatment was 31.1 weeks (range 3.9, 72.9 weeks) in arm 1 (on-demand arm) and 40.1 weeks (range 3.1, 56.3 weeks) in arm 2 (Alhemo prophylaxis). Serious adverse reactions were reported in 6.1% of patients who received Alhemo. These serious adverse reactions were renal infarct and hypersensitivity reaction. Permanent discontinuation of Alhemo due to an adverse reaction occurred in 1 patient due to a renal infarct. Dosage interruptions of Alhemo due to an adverse reaction occurred in 1 patient (3%) and was a hypersensitivity reaction. The most common adverse reactions (≥5%) were injection site reactions and urticaria (see Table 1 ). Table 1. Adverse Reactions Reported in ≥5% HAwI and HBwI Patients Randomized to Alhemo in Explorer7 Adverse Reaction Alhemo Prophylaxis N=33 (%) On-demand Treatment N=19 (%) Injection site reactions 18% 0% Urticaria 6% 0% Injection site reactions included:
• Injection site bruising, Injection site erythema, Injection site hematoma, Injection site hemorrhage, Injection site reaction and Injection site urticaria. Urticaria included:
• Urticaria and Injection site urticaria. Patients with HA (hemophilia A without inhibitors) and HB (hemophilia B without inhibitors) The data described below reflect exposure of 63 patients with HA and HB who were previously treated on-demand therapy and who were randomized in explorer8 to arm 1 to receive on- demand treatment with factor product (n = 21) or arm 2 to receive Alhemo prophylaxis (n = 42) at the recommended dosing regimen [see Clinical Studies ( 14.2 )] . The median duration of treatment was 24.1 weeks (range 23.6, 56.1 weeks) in arm 1 (on- demand arm) and 32.1 weeks (range 3.9, 33.6 weeks) in arm 2 (Alhemo prophylaxis). The most common adverse reactions (≥5%) were injection site reactions and headache (see Table 2 ). Table 2. Adverse Reactions Reported in ≥5% HA and HB Patients Randomized to Alhemo in Explorer8 Adverse Reaction Alhemo Prophylaxis N=42 (%) On-demand Treatment N=21 (%) Injection site reactions 7% 0% Headache 7% 0% Injection site reactions included:
• injection site reaction, injection site rash, and injection site nodule

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
• Thromboembolic events:
• Inform patients of the signs and symptoms of thromboembolic events, including swelling, warmth, pain, or redness of the skin (and that these could be symptoms of a blood clot in the legs or arms); shortness of breath or severe chest pain (and that these could be symptoms of blood clots in the chest [heart and lungs]).; headache, confusion, difficulty with speech or movement, numbness of the face, eye pain or swelling, or vision problems (and that these could be symptoms of a blood clot in the brain or eyes); or sudden pain in the stomach or lumbar area (and that these could be symptoms of blood clots in the gut or kidneys). Advise patients to contact their healthcare provider for mild reactions and to seek urgent medical attention for moderate to severe reactions [see Warnings and Precautions ( 5.1 )] . o In conditions in which tissue factor is overexpressed (e.g., advanced atherosclerotic disease, crush injury, cancer, or septicemia), there may be a risk of thromboembolic events or disseminated intravascular coagulation (DIC) with Alhemo treatment.
• Hypersensitivity:
• Inform patients of the early signs of hypersensitivity reactions, including rash, redness, hives, and itching, facial swelling, tightness of the chest, and wheezing as well the signs of an anaphylactic reaction such as itching on large areas of skin; redness and/or swelling of lips, tongue, face, or hands; difficulty swallowing; shortness of breath; wheezing; tightness of the chest; pale and cold skin; fast heartbeat; or dizziness/low blood pressure. Advise patients to discontinue use of Alhemo immediately and contact their healthcare provider if any signs or symptoms occur [see Warnings and Precautions ( 5.2 )] . Advise patients on the importance of adherence to daily dosing and to speak with their healthcare provider before discontinuing treatment with Alhemo as patients who are not adhering to daily dosing or stop treatment with Alhemo may no longer be protected against bleeding. Advise patients to follow the recommendations regarding proper sharps disposal provided in the FDA-approved Instructions for Use. Patent Information :
• http://novonordisk-us.com/products/product-patents.html Alhemo ® is a registered trademark of Novo Nordisk Health Care AG. NovoFine ® , NovoFine ® Plus, and Novo Nordisk ® are registered trademarks of Novo Nordisk A/S. For information about Alhemo contact:
• Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 1-844-668-6732 Manufactured by:
• Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 U.S. License No. 1261 At:
• Novo Nordisk A/S Novo Allé 1 2880 Bagsvaerd Denmark © 2025 Novo Nordisk

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Alhemo injection is a clear to slightly opalescent and colorless to slightly yellow solution that may contain translucent to white particles, available in the following presentations:
• 60 mg/1.5 mL (40 mg/mL) in a single-patient-use prefilled pen
• 150 mg/1.5 mL (100 mg/mL) in a single-patient-use prefilled pen
• 300 mg/3 mL (100 mg/mL) in a single-patient-use prefilled pen Injection:
• 60 mg/1.5 mL (40 mg/mL) in a single-patient-use prefilled pen ( 3 )
• 150 mg/1.5 mL (100 mg/mL) in a single-patient-use prefilled pen ( 3 )
• 300 mg/3 mL (100 mg/mL) in a single-patient-use prefilled pen ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• How Supplied Alhemo (concizumab-mtci) injection is a clear to slightly opalescent, colorless to slightly yellow liquid, that may contain translucent to white particles.
• Alhemo is available as one single-patient-use prefilled pen per carton in the following presentations (see Table 4 ):
• Table 4.
• Alhemo Presentations Presentation Label NDC Number 60 mg/1.5 mL (40 mg/mL) Brown 0169-2084-15 150 mg/1.5 mL (100 mg/mL) Gold 0169-2080-15 300 mg/3 mL (100 mg/mL) White 0169-2081-03 Storage and Handling Before first use:
• Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
• Do not freeze.
• After first use:
• Store in a refrigerator at 36℉ to 46˚F (2℃ to 8˚C) or at room temperature below 86˚F (30˚C) for up to 28 days.
• Write the date of first use in the space provided on the carton.
• Discard the unused portion of the pen 28 days after first opening.
• Store Alhemo with the cap on and in the original carton to protect from light.
• Alhemo should not be stored in direct sunlight, and the Alhemo pen should be kept away from direct heat.
• Do not freeze or store it close to a cooling element in a refrigerator (the part that cools the refrigerator).
• Do not use Alhemo if it has been frozen or stored at temperatures above 86˚F (30˚C).

Quoted from the official label, section “How Supplied”.

What is in it

• Concizumab-mtci, is a humanized IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells with an approximate molecular weight of 149 kDa.
• Alhemo (concizumab-mtci) injection is a clear to slightly opalescent, and colorless to slightly yellow solution that may contain translucent to white particles.
• Alhemo is supplied as a single-patient-use prefilled pen for subcutaneous injection.
• Each 1 mL of Alhemo single-patient-use prefilled pen (60 mg/1.5 mL) contains 40 mg active ingredient concizumab-mtci.
• Each 1 mL of Alhemo single-patient-use prefilled pen (150 mg/1.5 mL) contains 100 mg active ingredient concizumab-mtci.
• Each 1 mL of Alhemo single-patient-use prefilled pen (300 mg/3 mL) contains 100 mg active ingredient concizumab-mtci.
• Each 1 mL of Alhemo single-patient-use prefilled pen contains the following excipients:
• arginine hydrochloride (5.27 mg), histidine (5.12 mg), phenol (3.5 mg), polysorbate 80 (0.25 mg), sodium chloride (1.46 mg), sucrose (51.3 mg), and water for injection.
• Hydrochloric acid and sodium hydroxide may be added to adjust the pH to 6.0.

Quoted from the official label, section “Description”.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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