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AlphaNine SD

AlphaNine^® SD, or Coagulation Factor IX (Human), is a purified, solvent detergent-treated, virus-filtered preparation of factor IX obtained from human plasma. It contains a minimum of 150 IU of factor IX protein per milligram, as well as undetectable quantities of factor VII (proconvertin), factor II (prothrombin), and factor X (Stuart-Prower factor).¹ AlphaNine SD is used to control and prevent bleeding caused by factor IX deficiency (hemophilia B).² Each vial contains a pure, lyophilized preparation to be administered intravenously as a single dose. The US Food and Drug Administration (FDA) approved AlphaNine SD in 1996. It is marketed by Grifols and indicated for the treatment of hemophilia B.^1,3

Mechanism of Action

Factor IX is a vitamin K-dependent coagulation factor that is produced in the liver. Purified human plasma-derived factor IX (AlphaNine SD) temporarily replaces deficient clotting factor IX to stop and/or prevent bleeds.⁴ When 1 IU of AlphaNine SD is infused per kilogram of body weight, the recipient’s plasma factor level is raised by 1%.⁵ The half-life of AlphaNine SD is 11 to 28 hours.⁴

Get full prescribing information for AlphaNine SD at MPR

Efficacy in Trials and Trial Results

In a randomized crossover trial that enrolled 11 patients with hemophilia B, the level of activation of the coagulation cascade was lower after infusion of a highly purified factor IX concentrate such as AlphaNine than after infusion of a factor IX complex concentrate such as Profilnine Heat-Treated.⁶

The efficacy of the heptane heat-treated product AlphaNine in maintaining hemostasis during and after surgery was evaluated in 13 patients with hemophilia B. Preoperative doses varied from 30.1 to 65.0 IU of factor IX per kilogram. Postoperative replacement doses ranged from 9.4 to 52.0 IU of factor IX per kilogram. No bleeding events occurred, and hemostasis was maintained throughout the postoperative period. Various hematologic parameters, including the hematocrit, platelet count, partial thromboplastin time, prothrombin time, and levels of fibrinogen, fibrin degradation products, fibrin monomers, and D-dimers, did not indicate a thrombogenic effect of AlphaNine.⁷

Warnings, Precautions, and Adverse reactions

When patients with known liver illness undergo surgery, careful monitoring for signs and symptoms of disseminated intravascular coagulation is required after the administration of AlphaNine SD.⁸

All factor IX products, including AlphaNine SD, can cause allergy-type hypersensitivity reactions, including anaphylaxis. Nausea, chills, reactions at the injection site, thrombosis, and disseminated intravascular coagulation may also occur.^2,9

In patients with hemophilia B and a history of severe allergic reactions to factor IX, nephrotic syndrome has occurred after attempts to induce immune tolerance with factor IX products. The safety and efficacy of using AlphaNine SD to induce immune tolerance have yet to be determined.⁸

AlphaNine SD has not been evaluated in reproduction studies in animals. Its teratogenic potential is unclear. AlphaNine SD should not be given to a pregnant woman unless clearly indicated.¹

AlphaNine SD should not be administered at a rate faster than 10 mL/min. Vasomotor responses may develop if the medication is given too quickly.²

Drug-Drug Interactions

Co-administration of prothrombin complex concentrate with factor IX is contraindicated because the risk for thrombosis is increased. Factor IX increases the effects of prothrombin complex concentrate in humans through pharmacodynamic synergism.⁴

Tranexamic acid, given orally or injected, exaggerates the effects of factor IX through pharmacodynamic synergism. Co-administration with factor IX increases the risk for thrombosis and is contraindicated, and the use of alternative drugs is advised.⁴

References

ALPHANINE SD (Coagulation Factor IX- Human kit. DAILYMED. US National Library Of Medicine. Updated February 1, 2021. Accessed December 9, 2021.
AlphaNine® SD (Coagulation Factor IX [Human]). Grifols. Accessed December 9, 2021.
AlphaNine SD for hemophilia B. Hemophilia News Today. Accessed December 9, 2021.
Factor IX (Rx). Brand and other names: AlphaNine SD, Mononine. Medscape. Accessed December 9, 2021.
Coagulation factor IX (human), AlphaNine® SD solvent detergent treated/virus filtered. Grifols USA. Accessed December 7, 2021
Mannucci PM, Bauer KA, Gringeri A, et al. Thrombin generation is not increased in the blood of hemophilia B patients after the infusion of a purified factor IX concentrate. Blood. 1990;76(12):2540-2545.
Goldsmith JC, Kasper CK, Blatt PM, et al. Coagulation factor IX: successful surgical experience with a purified factor IX concentrate. Am J Hematol. 1992;40(3):210-215. doi:10.1002/ajh.2830400310
Alphanine SD. Drugs.com. Accessed December 9, 2021.
ALPHANINE SD Rx. MPR. Accessed December 9, 2021.

Reviewed by Hasan Avcu, MD, on 12/13/2021.

Harshi Dhingra, MD

Harshi Dhingra is a licensed medical doctor with specialization in Pathology. She is currently employed as faculty in a medical school with a tertiary care hospital and research center in India. Dr. Dhingra has over a decade of experience in diagnostic, clinical, research, and teaching work, and has written several publications and citations in indexed peer reviewed journals. She holds medical degrees for MBBS and an MD in Pathology.

Hemophilia