Idelvion is an injectable drug that is typically prescribed to children and adult patients with Hemophilia B (also called congenital Factor IX deficiency or Christmas disease). This drug contains a recombinant version of clotting factor IX, which helps to control and prevent bleeding episodes in hemophilia B patients.
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About Copay AssistanceIdelvion, also known by its generic name, “Coagulation Factor IX (Recombinant), Albumin Fusion Protein,” was approved by the U.S. Food and Drug Administration in 2016. This drug can only be obtained through a doctor’s prescription.
If your doctor has prescribed Idelvion to you or someone you care about, you should know how it works in the body, the side effects it may cause, and what precautionary measures need to be taken.
Idelvion: Usage or Indication
Idelvion is normally prescribed to hemophilia B patients (children and adults) who either lack coagulation factor IX or have a lower-than-normal level. Coagulation factor IX helps clot the blood, and if you have hemophilia B, your blood takes longer to clot, thus creating a bleeding episode.
Bleeding episodes can happen after an injury or surgery, or sometimes without any obvious cause. Idelvion is used to manage these situations, including:
- Treating bleeding episodes when they occur
- Managing excessive bleeding before, during, or after a surgical procedure
- For routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Idelvion should NOT be used to induce immune tolerance in patients with Hemophilia B. Immune tolerance induction is a treatment that is used to get the immune system used to the clotting factor so that it no longer rejects the factor.
Composition and Mechanism of Action
Idelvion is made up of a genetically fused recombinant coagulation factor IX and recombinant albumin. This fusion extends the length of time it lasts in the body, which means it stays longer and can be given less frequently than other factor products.
In terms of its mechanism of action, the active substance, albutrepenonacog alfa, in Idelvion works the same way as a human coagulation factor and helps the blood to clot more efficiently. It replaces the missing factor IX, thus giving temporary control of bleeding in hemophilia B patients.
Idelvion: Dosage Forms and Strengths
Idelvion comes as a lyophilized powder in a single-dose vial reconstituted in the diluent (sterile water) provided. Currently, this drug is available in five different strengths:
- 250 international units (IU)
- 500 IU
- 1,000 IU
- 2,000 IU
- 3,500 IU
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Idelvion: Dosage and Administration
Your doctor will prescribe an Idelvion dose based on your clinical condition, age, body weight (kg), severity of factor IX deficiency, and location and extent of bleeding. The dose is mixed with diluent and administered intravenously (an injection into a vein).
1. Dosage for Routine Prophylaxis
The recommended dosing range of Idelvion for patients (≥12 years of age) is 20 – 45 IU per kg body weight, administered every 7 days. Patients who are well-controlled on a 7-day regimen may be switched to a 14-day interval at 50 – 75 IU per kg body weight.
For children under age 12, a dose of 40 – 55 IU per kg is administered every 7 days.
2. Dosage for On-Demand Treatment
When a bleed happens, a single dose of Idelvion is often enough to stop it. The exact dose of Idelvion depends on how serious the bleeding is and where it’s happening. For example:
- For mild to moderate bleeds (like in the joints or muscles), Idelvion is administered every 48 to 72 hours to achieve factor IX levels of 30 – 60 IU/dl until the bleeding stops.
- For severe bleeds (like in the brain or stomach), Idelvion is administered every 48 to 72 hours for the first week to achieve factor IX levels of 60 – 100 IU/dl, followed by 7 to 14 days of treatment to heal properly.
3. Dosage to Control Bleeding Surrounding Surgery
To control bleeding during or after surgery, Idelvion is used to maintain the factor IX activity levels at or above the target range. For example:
- For minor surgical procedures (e.g., tooth extraction), to keep factor IX activity levels between 50 – 80 IU/dl, Idelvion is administered every 48-72 hours for at least a day until healing is complete.
- For major surgical procedures (e.g., hip replacement surgery or brain surgery), to keep factor IX activity levels between 60 – 100 IU/dl, Idelvion is administered every 48 to 72 hours for the first week, followed by 7 – 14 days until recovery is complete.
Common Side Effects
All medicines can have side effects. Some side effects are minor and temporary, while some could be severe and require immediate medical attention. The most common side effects reported by >1% of people during prophylaxis trials include:
- Headache
- Dizziness
- Hypersensitivity (allergic reaction)
- Rash, eczema
Always consult your doctor or hemophilia treatment center if you experience any side effects after taking Idelvion.
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Contraindications and Warnings
Patients who have had a history of anaphylactic or severe hypersensitivity reactions to Idelvion, human coagulation factor IX recombinant, albumin fusion protein, or any of the inactive ingredients in the vial should not take this drug.
When using Factor IX-containing products, patients may develop thromboembolism (e.g., pulmonary embolism, venous thrombosis, and arterial thrombosis).
Precautionary Measures You Should Take
Always consult your healthcare provider before taking Idelvion if you are/have:
- Pregnant or plan to become pregnant (because Idelvion may harm your unborn baby)
- Breastfeeding or plan to breastfeed
- Had an allergic reaction to any of the Factor IX products before taking Idelvion
- Taking any over-the-counter medications or other coagulation factors like carfilzomib, efgartigimod alfa, or rozanolixizumab, supplements, or herbal products
- Had any medical problems
- Inhibitors against coagulation factor IX (because Idelvion may not work for you)
Estimated Cost
The price of one Idelvion recombinant albumin fusion protein intravenous kit may vary depending on your insurance coverage. Copay assistance programs are available through the manufacturer. Contact us if you want to explore financial assistance options.
REFERENCES:
- US Food and Drug Administration (FDA). Idelvion Prescribing Information: https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/idelvion
- European Medical Agency (EMC). Idelvion Prescribing Information: https://www.ema.europa.eu/en/medicines/human/EPAR/idelvion
- Escobar, M., Mancuso, M. E., Hermans, C., Leissinger, C., Seifert, W., Li, Y., McKeand, W., & Oldenburg, J. (2022). IDELVION: A Comprehensive Review of Clinical Trial and Real-World Data. Journal of Clinical Medicine, 11(4), 1071. https://doi.org/10.3390/jcm11041071
- Lyseng-Williamson, K. A. (2016). Coagulation factor IX (Recombinant), albumin fusion protein (Albutrepenonacog alfa; idelvion®): A review of its use in haemophilia b. Drugs, 77(1), 97–106. https://doi.org/10.1007/s40265-016-0679-8
- Roberts, J., Fosser, C., Tortorici, M., Veldman, A., Jacobs, I. C., & Sidhu, J. (2016). Bleeding Risk Reduction in Relation to Predicted Factor IX Levels in Hemophilia B Patients Receiving Idelvion (rIX-FP). Blood, 128(22), 1411. https://doi.org/10.1182/blood.V128.22.1411.1411
