What is it prescribed for?
Alhemo is used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children 12 years and older with hemophilia A (factor VIII deficiency) with inhibitors and hemophilia B (factor IX deficiency) with inhibitors. Alhemo was approved on December 2024.
What is the name of the drug and what does it do?
The drug is called Alhemo (pronounced al-HEE-mo), with the generic name concizumab-mtci. It is an injectable medication that works as a Tissue Factor Pathway Inhibitor (TFPI) antagonist. This medication enhances blood clotting in patients with hemophilia who have inhibitors, reducing the risk of bleeding episodes.
How does it work?
Alhemo blocks the activity of TFPI, a protein that interferes with the blood-clotting process. By inhibiting TFPI, Alhemo helps increase the production of thrombin, a key protein needed for forming blood clots. This leads to improved clot formation and helps prevent excessive bleeding in patients with hemophilia.
What did the research discover?
Clinical trials demonstrated that Alhemo significantly reduces bleeding episodes compared to no prophylactic treatment. Patients on Alhemo had an 86% reduction in annualized bleeding rates. The average number of treated bleeds per year dropped from 11.8 in untreated patients to 1.7 in those using Alhemo.
What are some of the side effects?
Some side effects of Alhemo include:
- Injection site reactions (redness, bruising, or itching)
- Hives (urticaria)
- Elevated levels of certain blood clotting markers, such as fibrin D-dimer
- Rarely, serious complications like blood clots or hypersensitivity reactions
Patients should inform their doctor if they experience symptoms such as chest pain, shortness of breath, swelling, or severe allergic reactions.
What are the dosage recommendations and how is it prescribed?
Alhemo is administered by subcutaneous injection into the abdomen or thigh. The treatment begins with a loading dose of 1 mg/kg on the first day, followed by a daily maintenance dose of 0.2 mg/kg. After four weeks, the dose is adjusted based on the patient’s blood levels of the medication. Alhemo is available in prefilled pens with multiple dosage strengths to match the prescribed dose.
Source:
Novo Nordisk. Highlights of prescribing information for Alhemo. 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761315s000lbl.pdf
