Features & Benefits

Consistent Pharmacokinetic Profile

One IU of AlphaNine SD infused per kg of body weight raises the recipient's plasma factor IX level by 1%.

Summary of the pharmacokinetic parameters of AlphaNine SD¹

Parameter

Recovery (IU dL⁻¹ per IU kg⁻¹

PK1 Mean (±SD) (n = 25): 1.01 ± 0.19

NDC PK2 Mean (±SD) (n = 23): 1.23 ± 0.34

Terminal half-life (t½) (h)*

PK1 Mean (±SD) (n = 25): 34.5 ± 6.2

NDC PK2 Mean (±SD) (n = 23): 33.7 ± 5.4

Area under the curve (AUC_0-74h) (IU x h dL⁻¹)

PK1 Mean (±SD) (n = 25): 1351.8 ± 260.7

NDC PK2 Mean (±SD) (n = 23): 1442.0 ± 246.1

Area under the curve (AUC_0-∞) (IU x h dL⁻¹)

PK1 Mean (±SD) (n = 25): 1601.6 ± 312.1

NDC PK2 Mean (±SD) (n = 23): 1643.7 ± 360.0

Clearance (CL) (dL min⁻¹)

PK1 Mean (±SD) (n = 25): 0.076 ± 0.02

NDC PK2 Mean (±SD) (n = 23): 0.071 ± 0.01

Mean residence time (MRT) (h)

PK1 Mean (±SD) (n = 25): 35.76 ± 5.4

NDC PK2 Mean (±SD) (n = 23): 34.63 ± 5.2

AUC, area under the curve; MRT, mean residence time; PK1, A baseline PK assessment; PK2, A second PK assessment.
*Half-life is variable based on the population studied. Mean half-life reported in prescribing information is approximately 21 hours.

AUC, area under the curve; MRT, mean residence time; PK1, A baseline PK assessment; PK2, A second PK assessment.
*Half-life is variable based on the population studied. Mean half-life reported in prescribing information is approximately 21 hours.
Parameter	PK1 Mean (±SD) (n = 25)	NDC PK2 Mean (±SD) (n = 23)
Recovery (IU dL⁻¹ per IU kg⁻¹	1.01 ± 0.19	1.23 ± 0.34
Terminal half-life (t½) (h)*	34.5 ± 6.2	33.7 ± 5.4
Area under the curve (AUC_0-74h) (IU x h dL⁻¹)	1351.8 ± 260.7	1442.0 ± 246.1
Area under the curve (AUC_0-∞) (IU x h dL⁻¹)	1601.6 ± 312.1	1643.7 ± 360.0
Clearance (CL) (dL min⁻¹)	0.076 ± 0.02	0.071 ± 0.01
Mean residence time (MRT) (h)	35.76 ± 5.4	34.63 ± 5.2

Results from a pharmacokinetic, efficacy and safety study in 25 patients with severe hemophilia B treated with AlphaNine SD, which compared the first AlphaNine SD pharmacokinetics with a second assessment after 6 months of treatment.¹

AlphaNine SD was infused at a single dose of 65-76 IU/kg and FIX activity was determined at pre-infusion and different times until 74 hours post-infusion.¹

Efficacy & Safety

AlphaNine SD offers patients with hemophilia B an effective replacement therapy option.

93% of infusions rated as excellent/good¹

Pharmacokinetic, efficacy, and safety study in 25 patients with severe hemophilia B treated with AlphaNine SD (1.6M IU used in 889 infusions).¹

The 7 reported cases of no efficacy were explained by an insufficient initial dose compared to what was recommended by the study protocol. Six of 7 bleedings were resolved with additional infusions.¹

89% of bleedings resolved with 1 infusion¹

Twenty-one adverse events were reported in 8 patients, none of which was considered related to the study medication. After 12 month follow-up, no evidence of inhibitor formation in treated subjects. No clinical or lab evidence of allergic reactions or thrombotic events throughout the entire study period.¹

AlphaNine SD infused pre- and post-operatively is an effective treatment for patients with hemophilia B undergoing major surgery²

n = 29 major surgeries (90% orthopedic and 10% abdominal)²

Study of 20 patients with hemophilia B undergoing major surgery treated with AlphaNine SD – a single infusion retrospective analysis.²

Response to AlphaNine SD was monitored throughout the hospital stay and the dose was adjusted accordingly with a target peak level at 100% (with continuous infusion or bolus).²

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Indication
AlphaNine® SD (coagulation factor IX [human]) is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B.

Important Safety Information

AlphaNine SD is made from human plasma. Plasma products carry a risk of transmitting infectious agents, including viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

Incidences of thrombosis or disseminated intravascular coagulation (DIC) have been reported following administration of Factor IX Complex concentrates which contain high amounts of Factor II, VII, and X. AlphaNine SD contains low, nontherapeutic levels of Factor II, VII, and X.

Following administration in surgery patients and individuals with known liver disease, the physician should closely observe the patient for signs and symptoms of potential disseminated intravascular coagulation.

Allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. The administration of plasma preparations may cause allergic reactions, mild chills, nausea or stinging at the infusion site.

Nephrotic syndrome has been reported following attempted immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of severe allergic reactions to Factor IX.

In order to minimize the possibility of thrombogenic complications, dosing guidelines should be strictly followed.

AlphaNine SD should not be administered at a rate exceeding 10 mL/ minute. Rapid administration may result in vasomotor reactions.

Please see full Prescribing Information for AlphaNine SD.

References

1. Lissitchkov T, Matysiak M, Zavilska K, et al. A clinical study assessing the pharmacokinetics, efficacy and safety of AlphaNine(®) , a high-purity factor IX concentrate, in patients with severe haemophilia B. Haemophilia. 2011;17(4):590-596. 2. Quon DV, Logan L. Safety and efficacy of plasma-derived coagulation factor IX concentrate (AlphaNine® SD) in patients with haemophilia B undergoing surgical intervention: a single institution retrospective analysis. Haemophilia. 2011 Jan;17(1):e196-201.