Alhemo concizumab 40 mg/mL Injection, Solution, 1 syringe
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other systemic hemostatics class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Concizumab-mtci is used to reduce or prevent bleeding episodes in patients with certain types of hemophilia. Concizumab-mtci is in a class of medications called monoclonal antibodies. It works by improving the body's ability to allow blood to clot.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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5.27 mg / 1 mL
UNII 94ZLA3W45F
Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
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5.12 mg / 1 mL
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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3.5 mg / 1 mL
UNII 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
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0.25 mg / 1 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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1.46 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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51.3 mg / 1 mL
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7173 | $86.158 / J7173 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Alhemo 40 mg/mLthis 00169-2084-15 | Novo | 1 syringe | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Dec 20, 2036 |
Is there a biosimilar for ALHEMO 60 MG/1.5 ML PEN?
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00169-2084-15 You're viewing this | 1 SYRINGE, PLASTIC in 1 CARTON (0169-2084-15) / 1.5 mL in 1 SYRINGE, PLASTIC | 2025-02-19 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Alhemo is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors • hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors • hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 )
2.1Recommended 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…
💊 Dosage Forms and Strengths ▾
3 DOSAGE 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 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Alhemo is contraindicated in patients with a history of known serious hypersensitivity to Alhemo or its components or the inactive ingredients [see Warnings and Precautions ( 5.1 )and Description ( 11 )]. Alhemo is contraindicated in patients with a history of known serious hypersensitivity to Alhemo or its components or the inactive ingredients. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Thromboembolic Events: Monitor patients for thromboembolic events. Advise patients to report signs and symptoms, and if they occur discontinue prophylaxis. ( 5.1 ) • Hypersensitivity Reactions: In the event of a severe hypersensitivity reaction, discontinue Alhemo. ( 5.2 ) • Increased Laboratory Values of Fibrin D dimer and Prothrombin Fragment 1.2: Alhemo increases values of fibrin D dimer and prothrombin fragment 1.2. ( 5.3 )
5.1Thromboembolic Events Alhemo may cause thromboembolic events. Venous and arterial thromboembolic events were reported in 1.9% of patients (6/320) in Alhemo clinical trials. These cases occurred in patients with multiple risk factors for thromboembolism, including the use of high doses or prolonged treatment with factor product or bypassing agent (2 of 6 patients).
Risk factors for thromboembolism may include the use of high and/or frequent doses of breakthrough bleed treatments (factor products or bypassing agents) or conditions in which tissue factor is overexpressed (e.g., atherosclerotic disease, crush injury, cancer, disseminated intravascular coagulation, thrombotic microangiopathy, or septicemia). Inform Alhemo treated patients of signs and symptoms of thromboembolic events. Monitor patients for thromboembolic events.
In case of suspicion of thromboembolic events, discontinue Alhemo and initiate further investigations and management strategies.
5.2Hypersensitivity Reactions Alhemo can cause hypersensitivity reaction, including serious cases. Alhemo is contraindicated in patients with a history of known serious hypersensitivity to Alhemo or its components or the inactive ingredients. Hypersensitivity reactions including erythema, rash, pruritus, and abdominal pain have occurred in Alhemo treated patients.
One patient (less than 1% of patients treated in the clinical studies) experienced anaphylaxis which resolved after treatment with antihistamines and corticosteroids. Instruct patients of the signs of acute hypersensitivity reactions. Instruct patients to contact their healthcare provider for mild reactions and to seek urgent medical attention for moderate to severe reactions.
Discontinue Alhemo if severe hypersensitivity symptoms occur and initiate medical management.
5.3 Increased Laboratory Values of Fibrin D-dimer and Prothrombin Fragment
1.2Alhemo can cause increased levels of fibrin D-dimer and prothrombin fragment 1.2. Increased levels of fibrin D-dimer and increased levels of prothrombin fragment 1.2 were seen in 29 (9.1%) and 26 (8.1%) of patients, respectively. The plasma concentration of concizumab-mtci is positively correlated with fibrin D-dimer and prothrombin fragments 1.2 indicating a hemostatic effect of concizumab-mtci.
For patients taking Alhemo, these coagulation biomarkers may not be reliable predictive markers for clinical decision-making with suspicion of thrombosis such as deep vein thrombosis (DVT) and pulmonary embolism (PE).
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
6.1Clinical 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…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Breakthrough Bleeding Treatment: While treatment with all bypassing agents (e.g., rFVIIa or aPCC) can be used for breakthrough bleeds, high and/or frequent doses of FVIII, FIX, or bypassing agents with Alhemo increases the risk of thromboembolism. ( 7.1 )
7.1Breakthrough Bleeding Treatment Take appropriate precautions when treating breakthrough bleeding events in hemophilia patients receiving Alhemo prophylaxis and FVIII or FIX or a bypassing agent [see Dosage and Administration ( 2.1 )] . 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 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. Additive and sometimes synergistic increase in thrombin peak as quantified in the thrombin generation assay has been observed in plasma from hemophilia patients who were on prophylactic treatment with concizumab-mtci with concomitant presence of rFVIII, rFIX or bypassing agents including rFVIIa and aPCC [see Clinical Pharmacology ( 12.2 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Based on its mechanism of action, Alhemo may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on Alhemo use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Alhemo.
Although there are no data on concizumab-mtci, monoclonal antibodies can be actively transported across the placenta, and concizumab-mtci may cause fetal harm. It is unknown whether Alhemo can affect reproductive capacity. Alhemo should only be used during pregnancy if the potential benefit for the mother outweighs the potential risk to the fetus.
The estimated background risk of birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
8.2Lactation Risk Summary There is no information regarding the presence of Alhemo in either human or animal milk, the effect on the breastfed child, or the effects on milk production. Clinical Considerations Human IgGs are known to be excreted in breast milk during the first few days after birth, decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, Alhemo could be used during breast-feeding if clinically needed.
8.3Females and Males of Reproductive Potential Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential. Contraception Women of childbearing potential should use a highly effective form of contraception during treatment with Alhemo and for 7 weeks after ending treatment. The benefits and thromboembolic risks of the type of contraceptives used should be evaluated by the treating physician.
8.4Pediatric Use 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.
8.5Geriatric Use 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.
8.6Body Weight The exposure of concizumab-mtci increased with increasing body weight [see Clinical Pharmacology ( 12.3 )] . However, patients should receive the approved recommended Alhemo dosage titration and concizumab-mtci plasma concentration monitoring regardless of body weight [see Dosage and Administration ( 2.1 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on its mechanism of action, Alhemo may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on Alhemo use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Alhemo.
Although there are no data on concizumab-mtci, monoclonal antibodies can be actively transported across the placenta, and concizumab-mtci may cause fetal harm. It is unknown whether Alhemo can affect reproductive capacity. Alhemo should only be used during pregnancy if the potential benefit for the mother outweighs the potential risk to the fetus.
The estimated background risk of birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use 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.
🧓 Geriatric Use ▾
8.5Geriatric Use 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Concizumab-mtci is a monoclonal antibody antagonist of endogenous Tissue Factor Pathway Inhibitor (TFPI). Through the inhibition of TFPI, concizumab-mtci acts to enhance FXa production during the initiation phase of coagulation which leads to improved thrombin generation and clot formation with the goal of achieving hemostasis in patients with Hemophilia A or B regardless of their inhibitor status. The effect of concizumab-mtci is not influenced by the presence of inhibitory antibodies to FVIII or FIX.
There is no structural relationship or sequence homology between concizumab-mtci and FVIII or FIX and, as such, treatment with concizumab-mtci does not induce or enhance the development of direct inhibitors to FVIII or FIX.
12.2Pharmacodynamics Increasing concizumab-mtci dose levels resulted in decreased levels of free TFPI (plasma TFPI not bound to concizumab-mtci) and increased duration of free TFPI suppression. In hemophilia patients with inhibitors, free TFPI plasma levels predose decreased from a geometric mean (CV%) of 88.3 (20%) ng/mL at baseline to 10.7 (105%) ng/mL at week 24 in patients on Alhemo prophylaxis, while the geometric mean (CV%) was 76 (18%) ng/mL at week 24 for patients treated on-demand. In hemophilia patients without inhibitors, free TFPI plasma levels predose decreased from a geometric mean (CV%) of 84.2 (19%) ng/mL at baseline to 11.1 (102%) ng/mL at week 24 in patients on Alhemo prophylaxis, while the geometric mean (CV%) was 80.6 (18%) ng/mL at week 24 for patients treated on-demand.
Mean thrombin peak within the range of normal plasma reflected that concizumab‑mtci re‐established thrombin generation capacity. Drug Interaction In vitro studies Additive and sometimes synergistic increase in thrombin peak as quantified in the thrombin generation assay has been observed in plasma from hemophilia patients who were on prophylactic treatment with concizumab-mtci with concomitant presence of rFVIII, rFIX or bypassing agents including rFVIIa and aPCC. Depending on concentrations of concizumab-mtci and hemostatic agents, the impact on thrombin peak ranged from being additive with all hemostatic agents to an extra 40% effect with rFVIIa, an extra 33% effect with aPCC, an extra 22% with rFVIII and less than 13% with rFIX.
12.3Pharmacokinetics Peak and trough geometric mean plasma concizumab-mtci concentrations at steady state are shown in Table 3 . Following a single Alhemo loading dose of 1 mg/kg, the steady state concentrations were reached around Day 4 and remained within a stable exposure range with daily maintenance doses. Concizumab-mtci AUC and C max increased with increasing dose in a greater than dose-proportional manner following subcutaneous administration.
Table 3. Steady State Concizumab-mtci Concentrations During 24-hour Dosing Interval at Week 24 Parameters Hemophilia A and B without inhibitors All maintenance doses N=127 a HAwI and HBwI All maintenance doses N=99 a C max,ss (ng/mL), geometric mean (CV%) N 893.4 (144.5%) N=103 1167.1 (128%) N=69 C trough,ss (ng/mL), geometric mean (CV%) N 647.3 (178.8%) N=116 665.4 (221%) N=94 C max / C trough ratio, mean (SD) N 1.5 (0.5) N=103 2.2 (5.2) N=69 Abbreviations: C max,ss, maximum plasma concentration at steady state; C trough,ss, trough plasma concentration at steady state; HAwI, hemophilia A with inhibitors; HBwI, hemophilia B with inhibitors. a On concizumab-mtci dosing regimen.
Absorption Concizumab-mtci time to maximum plasma concentration ranged from 8 hours to 99 hours (4.1 days) following a single Alhemo subcutaneous dose of 0.05 to 3 mg/kg in healthy and hemophilia subjects. Distribution Concizumab-mtci volume of distribution for a typical 70 kg patient is about 3 L. Elimination Concizumab-mtci is cleared via linear and nonlinear mechanisms.
Concizumab-mtci exhibited nonlinear pharmacokinetics due to target-mediated drug disposition (TMDD) which occurs when it forms concizumab-mtci/TFPI comple…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Concizumab-mtci is a monoclonal antibody antagonist of endogenous Tissue Factor Pathway Inhibitor (TFPI). Through the inhibition of TFPI, concizumab-mtci acts to enhance FXa production during the initiation phase of coagulation which leads to improved thrombin generation and clot formation with the goal of achieving hemostasis in patients with Hemophilia A or B regardless of their inhibitor status. The effect of concizumab-mtci is not influenced by the presence of inhibitory antibodies to FVIII or FIX.
There is no structural relationship or sequence homology between concizumab-mtci and FVIII or FIX and, as such, treatment with concizumab-mtci does not induce or enhance the development of direct inhibitors to FVIII or FIX.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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).
📋 Description ▾
11 DESCRIPTION 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.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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
💬 Medication Guide ▾
Medication Guide MEDICATION GUIDE Alhemo ® (al-HEE-mo) (concizumab-mtci) injection, for subcutaneous use What is the most important information I should know about Alhemo? • It is important to follow the daily dosing schedule of Alhemo to stay protected against bleeding. This is especially important during the first 4 weeks of treatment to make sure a correct maintenance dose is established. Use Alhemo exactly as prescribed by your healthcare provider.
Do not stop using Alhemo without talking to your healthcare provider. If you miss doses, or stop using Alhemo, you may no longer be protected against bleeding. • Your healthcare provider may prescribe factor VIII, factor IX or bypassing agents during treatment with Alhemo. Carefully follow your healthcare provider’s instructions regarding when to use on-demand factor VIII, factor IX or bypassing agents, and the recommended dose and schedule for breakthrough bleeds.
See “How should I use Alhemo?” for more information on how to use Alhemo. What is Alhemo? Alhemo is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with: • hemophilia A with or without factor VIII inhibitors • hemophilia B with or without factor IX inhibitors It is not known if Alhemo is safe and effective in people while receiving ongoing Immune Tolerance Induction (ITI).
It is not known if Alhemo is safe and effective for hemophilia A and B with and without inhibitors in children younger than 12 years of age. Do not use Alhemo if you are allergic to concizumab-mtci or any of the ingredients in Alhemo. See the end of this Medication Guide for a complete list of ingredients in Alhemo.
Before using Alhemo, tell your healthcare provider about all of your medical conditions, including if you: • have a planned surgery. Your healthcare provider may stop treatment with Alhemo before your surgery. Talk to your healthcare provider about when to stop using Alhemo and when to start it again if you have a planned surgery. • are pregnant or plan to become pregnant.
It is not known if Alhemo may harm your unborn baby. Females who are able to become pregnant: o Your healthcare provider may do a pregnancy test before you start treatment with Alhemo. o You should use an effective birth control (contraception) during treatment with Alhemo and for 7 weeks after ending treatment. Talk to your healthcare provider about birth control methods that you can use during this time. • are breastfeeding or plan to breastfeed.
It is not known if Alhemo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Alhemo. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use Alhemo?
Read the Instructions for Use that comes with Alhemo for information about how to prepare and inject a dose of Alhemo, and how to properly throw away (dispose of) used Alhemo pens and needles. • Use Alhemo exactly as prescribed by your healthcare provider. • Your healthcare provider will provide instructions for stopping (discontinuing) your current treatment when switching to Alhemo. • Inject Alhemo 1 time a day. • Your healthcare provider should show you or your caregiver how to use Alhemo before you use it for the first time. • Alhemo is given as an injection under the skin (subcutaneous injection) by you or a caregiver. • Ask your healthcare provider if you need to use a different injection technique.
For example, children and people who are lean may need to inject into a pinched fold of skin to avoid injecting too deep (into the muscle). • Change (rotate) your injection site with each injection. Do not use the same site for each injection. • You will inject a l…