Guía de AlphaNine SD: Cómo funciona, dosificación, riesgos y beneficios

AlphaNine SD injection is a human plasma-derived factor IX preparation. It is used to prevent or control bleeding in patients with Factor IX deficiency caused by hemofilia B. In this article, you will learn about its mechanism of action, dosage, side effects, cost, and more.

AlphaNine SD Introduction and Uses

AlphaNine SD is a brand-name injectable medication used to prevent bleeding in people aged 16 years and older with hemophilia B. It contains the active ingredient “factor IX or Christmas factor”, which is derived from human plasma. This medication belongs to the drug class known as coagulation factors or hemostatics. 

“SD” in the brand name stands for “solvent detergent” treated, which is a virus-inactivation technology. 

AlphaNine SD should not be used to treat patients with other bleeding problems, such as:

• Factor II, VII, or X deficiencies
• Severe bleeding caused by certain blood thinners (anticoagulants)
• Hemophilia A patients with antibodies to Factor VIII

AlphaNine SD Mechanism of Action

AlphaNine SD temporarily replaces deficient factor IX in patients with hemophilia B with working clotting factors, which helps to stop or prevent bleeds. 

AlphaNine SD Dosing

This medication comes as a sterile powder for solution (reconstitution) for intravenous (IV) injection in single-dose vials. It is supplied with a 10-ml vial of “sterile water for injection” and a filter transfer set. 

Las siguientes concentraciones están disponibles en EE. UU.:

• 500 IU factor IX (FIX)/10 ml single-dose vial
• 1,000 IU FIX/10 ml single dose vial
• 1,500 IU FIX/10 ml single dose vial

The amount of AlphaNine SD required to stop or prevent bleeds depends on a patient’s specific needs. Before administering this medication, your healthcare provider will use a specific formula to determine the dose. They will individualize dosing based on:

• Gravedad de la deficiencia del factor IX
• Extent and location of bleeding
• Your clinical status

Then they will prepare the medication according to the instructions in the package insert.

Recommended AlphaNine SD Dosing

Minor bleeding: 20-30 IU per kilogram twice daily until bleeding stops and healing has been achieved. Treatment typically lasts 1 to 2 days. 

Moderate bleeding: 25-50 IU per kilogram twice daily until healing has been achieved. Treatment typically lasts 2 to 7 days. 

Sangrado mayor: 30-50 IU per kilogram twice daily for 3 to 5 days. Then, 20 IU per kilogram twice daily until healing has been achieved. Treatment may last for up to 10 days. 

AlphaNine SD Side Effects

Efectos secundarios comunes

• Náuseas
• Dolor de cabeza
• Mareo
• Altered sense of taste
• Mild skin rash
• Dolor, enrojecimiento o picazón en el lugar de la inyección.

Efectos secundarios graves

• Weight gain, swelling in the waist, hands, or lower legs
• Pérdida de apetito
• Fiebre o escalofríos
• Continued bleeding after treatment
• New or worsened bleeding
• Signs of excessive blood clotting, such as sudden numbness, slurred speech, problems with vision or balance, and coughing up blood

AlphaNine SD Proper Use and Storage

• Use this medication exactly as directed by your prescriber. 
• You will likely receive your first dose in a hospital or clinic setting. Then, your healthcare provider will teach you how to prepare and self-administer this medication at home, if deemed appropriate. 
• Ask your prescriber or pharmacist if you have problems understanding any part of the “Instruction for Use” that comes with the medication.
• After mixing your dose with the liquid, use the prepared medication within 3 hours. Never use expired medication. Contact your prescriber or pharmacy if you need a refill.
• Don’t use the mixture if it looks cloudy or contains particles. 
• Store between 2 and 8°C (36°F to 46°F). You may store the medication at room temperature (not exceeding 30°C or 86°F) for up to 30 days. 

Before Using AlphaNine SD

You should not use this medication if you:

• Have a history of allergic reactions to clotting factor medicines
• Have signs of excessive blood clotting
• Son alérgicos a las proteínas del hámster.

Before you receive your first dose of AlphaNine SD for hemophilia B, inform your healthcare provider if you’ve ever had:

• Kidney or liver disease
• Coronary artery disease (narrowing of the arteries that supply oxygen to the heart)
• A heart attack or stroke

Also, inform your healthcare provider if you:

• ¿Está embarazada o planea quedar embarazada?
• ¿Está amamantando?

Advertencias y precauciones

Disease Transmission Risk

Because this medication is derived from donated human plasma, it may contain viruses or other disease-causing agents. While donated plasma is tested and treated to lower the risk of disease transmission, a small possibility of transmission cannot be ruled out. Ask your healthcare provider about any potential risk.

Reacciones alérgicas

Este medicamento puede causar reacciones alérgicas que pueden ser mortales. Busque atención médica de emergencia si experimenta:

• Urticaria
• dificultad para respirar
• Hinchazón en la cara o la garganta
• Opresión en el pecho
• ritmo cardíaco acelerado

In previously untreated patients, severe allergic reactions are most likely to occur after 11 days of exposure to this medication. 

Inhibitor (Antibody) Formation

In some cases, your body can produce proteins called “factor IX inhibitors”, which can prevent this medication from working as intended.

AlphaNine SD vs. Alprolix

Both products are used to treat people with hemophilia B. AlphaNine SD is a human plasma-derived preparation with a standard half-life. On the other hand, Alprolix is a recombinant product with a long half-life, allowing for less frequent administration.

AlphaNine SD Cost

Cost can vary depending on your insurance plan, location, and pharmacy. Contact your insurance provider to find out whether your plan covers this medication or requires prior authorization.

The manufacturer of AlphaNine SD, Grifols, offers several assistance programs for eligible patients. These include:

• The $0 Copay Assistance Program may cover out-of-pocket expenses not covered or partially covered by insurance. 
• The Free Trial Program for those who are new to AlphaNine SD.
• Benefits investigation and support services that help patients coordinate with their provider. 
• The Patient Assistance Program for patients with no coverage or lapsed coverage.
• Care Coordination to help patients gain access to and remain on AlphaNine SD.

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