AXS25 DigitalGuide V2 04.18 pages - Flipbook - Page 36
Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg 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 de昀椀ciency) with FVIII inhibitors and
hemophilia B (congenital factor IX de昀椀ciency) with FIX inhibitors.
It is time for a new way
to prevent bleeds in
hemophilia with inhibitors
Introducing the[昀椀rst]prophylaxis treatment
in a pre昀椀lled, subcutaneous pen for HBwI and HAwI1
Royal is a Novo Nordisk employee,
who has hemophilia B with
inhibitors and uses Alhemo®.
Learn more
about Alhemo
Needles are provided separately and may
require a prescription in some states.
HAwI=hemophilia A with inhibitors; HBwI=hemophilia B with inhibitors.
Important Safety Information
Contraindications
• Alhemo® is contraindicated in patients with a history of known
serious hypersensitivity to Alhemo® or its components or the inactive
ingredients
Warnings and Precautions
• Thromboembolic Events: Venous and arterial thromboembolic
events were reported in 1.3% of patients (4/320) 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 products or bypassing agents (2 of 4 events).
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
(eg, atherosclerotic disease, crush injury, cancer, disseminated
intravascular coagulation, thrombotic microangiopathy, or septicemia).
Inform patients treated with Alhemo® 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
• Hypersensitivity Reactions: 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 patients treated with Alhemo®. 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
Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey 08536 U.S.A.
Alhemo® is a registered trademark of Novo Nordisk Health Care AG.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2025 Novo Nordisk All rights reserved. US25AHM00081 February 2025
• Increased Laboratory Values of Fibrin D-dimer and Prothrombin
Fragment 1.2: Increased levels of 昀椀brin D-dimer and increased levels
of prothrombin fragment 1.2 were seen in 29 (9.1%) and 18 (5.6%)
of patients, respectively. The plasma concentration of concizumabmtci is positively correlated with 昀椀brin D-dimer and prothrombin
fragments 1.2, indicating a hemostatic e昀昀ect 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
• The most frequently reported adverse reactions (incidence ≥5%) were
injection site reactions and urticaria
Drug Interactions
• Bypassing Agents: Take appropriate precautions when treating
breakthrough bleeding events in hemophilia patients receiving Alhemo®
prophylaxis and a bypassing agent. For mild and moderate bleeds
that require additional treatment with bypassing agents (eg, 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 speci昀椀c product
based on clinical judgment.
An additive and sometimes synergistic increase in thrombin peak, as
quanti昀椀ed 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
Please see a Brief Summary of Prescribing Information on next page.
REFERENCE: 1. Alhemo® [package insert]. Plainsboro, NJ:
Novo Nordisk Inc.
