coagulation factor IX complex [IV]

Adult Dosing

Bebulin VH

Hemophilia B

Estimated dose (units) = [wt (kg) x desired factor IX level (%) x 1.2
Minor bleeding

Initial dose: 25-35 IU/kg IV
Individualize dose IV x 1, may repeat in 24 hrs if necessary
Desired factor IX level: 20%

Moderate bleeding

Initial dose: 40-55 IU/kg IV
Individualize dose IV q24 hrs x 2 days or until adequate wound healing
Desired factor IX level: 40%

Major bleeding

Initial dose: 60-70 IU/kg IV
Individualize dose IV q24 hrs x 2-3 days or until adequate wound healing
Desired factor IX level: 60%

Major surgery

70-95 IU/kg IV 1 hr prior to surgery; desired factor IX level: 60%
Postop: 70-35 IU/kg IV q12 hrs x 1-2 wks; desired factor IX level: 60-20%
Late postop: 35-25 IU/kg IV q24 hrs until adequate wound healing; desired factor IX level: 20%

Minor surgery

50-60 IU/kg IV 1 hr prior to surgery; desired factor IX level: 40-60%
Postop: 55-25 IU/kg IV q12 hrs x 1-2 wks; desired factor IX level: 40-20%

Dental extractions

50-60 IU/kg IV 1 hr prior to surgery; desired factor IX level: 40-60%
In case of multiple extractions, administer 55-25 IU/kg IV postop q12 hrs x 1 wk; desired factor IX level: 40-20%

Long-term prophylaxis

Administer 20-30 IU/kg IV 1-2 times/wk

Notes:

Therapy indicated for IV administration only
1 IU/kg will increase the plasma level of factor IX by 0.8%
Dosage and duration of treatment for all factor IX products depend on the severity of factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age and recovery of factor IX

Profilnine SD

Hemophilia B

Estimated dose (units) = [wt (kg) x desired factor IX level (%) x 1.0
Minor-moderate bleeding

Individualize dose IV x 1
Desired factor IX level: 20-30%

Major bleeding

Individualize dose IV q24 hrs
Desired factor IX level: 30-50%

Surgery

Desired factor IX level: 30-50% for at least 1 wk postop

Dental extractions

Desired factor IX level: up to 50% immediately prior to the procedure; additional dose may be given if bleeding recurs

Notes:

1 IU/kg will increase the plasma level of factor IX by 0.1%
Dosage and duration of treatment for all factor IX products depend on the severity of factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age and recovery of factor IX

Pediatric Dosing

Bebulin VH

Hemophilia B

Estimated dose (units) = [wt (kg) x desired factor IX level (%) x 1.2
Minor bleeding

Initial dose: 25-35 IU/kg IV
Individualize dose IV x 1, may repeat in 24 hrs if necessary
Desired factor IX level: 20%

Moderate bleeding

Initial dose: 40-55 IU/kg IV
Individualize dose IV q24 hrs x 2 days or until adequate wound healing
Desired factor IX level: 40%

Major bleeding

Initial dose: 60-70 IU/kg IV
Individualize dose IV q24 hrs x 2-3 days or until adequate wound healing
Desired factor IX level: 60%

Major surgery

70-95 IU/kg IV 1 hr prior to surgery; desired factor IX level: 60%
Postop: 70-35 IU/kg IV q12 hrs x 1-2 wks; desired factor IX level: 60-20%
Late postop: 35-25 IU/kg IV q24 hrs until adequate wound healing; desired factor IX level: 20%

Minor surgery

50-60 IU/kg IV 1 hr prior to surgery; desired factor IX level: 40-60%
Postop: 55-25 IU/kg IV q12 hrs x 1-2 wks; desired factor IX level: 40-20%

Dental extractions

50-60 IU/kg IV 1 hr prior to surgery; desired factor IX level: 40-60%
In case of multiple extractions, administer 55-25 IU/kg IV postop q12 hrs x 1 wk; desired factor IX level: 40-20%

Long-term prophylaxis

Administer 20-30 IU/kg IV 1-2 times/wk

Notes:

Therapy indicated for IV administration only
1 IU/kg will increase the plasma level of factor IX by 0.8%
Dosage and duration of treatment for all factor IX products depend on the severity of factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age and recovery of factor IX

Profilnine SD

Hemophilia B

Estimated dose (units) = [wt (kg) x desired factor IX level (%) x 1.0
Minor-moderate bleeding

Individualize dose IV x 1
Desired factor IX level: 20-30%

Major bleeding

Individualize dose IV q24 hrs
Desired factor IX level: 30-50%

Surgery

Desired factor IX level: 30-50% for at least 1 wk postop

Dental extractions

Desired factor IX level: up to 50% immediately prior to the procedure; additional dose may be given if bleeding recurs

Notes:

1 IU/kg will increase the plasma level of factor IX by 0.1%
Dosage and duration of treatment for all factor IX products depend on the severity of factor IX deficiency, the location and extent of bleeding, and the patient’s clinical condition, age and recovery of factor IX

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Prevention and control of hemorrhagic episodes in patients with factor IX deficiency due to hemophilia B

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Caution advised; dose adjustments not defined

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

Coagulation factor IX complex is prepared from human plasma; products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Also, it may carry a risk of transmitting infectious agents such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent
The risk of transmission may be reduced by screening plasma donors for prior exposure to certain viruses, testing for the presence of certain current viral infections, and by inactivating and/or removing certain viruses during manufacture. Despite these measures, these products may still contain human pathogenic agents, including those not yet known or identified. Discuss the risks and benefits of this product with the patient
Thromboembolic complications including DIC and hyperfibrinolysis have been associated with the use of Factor IX Complex concentrates, particularly in the postoperative period and in patients with risk factors predisposing to thrombosis
Individuals receiving blood or plasma products may develop signs and/or symptoms of certain viral infections, particularly non-A, non-B hepatitis. All patients with hemophilia should be vaccinated with hepatitis B and A vaccinations at birth or diagnosis
Monitor patients with risk factors predisposing to thrombosis and those requiring high doses of factor IX due to major surgical interventions for the possible development of DIC and/or thrombosis
Administer coagulation factor IX complex slowly not exceeding 10 mL/minute, as rapid administration may cause vasomotor reactions
Nursing personnel and others who administer this material should exercise appropriate caution in handling due to the risk of exposure to viral infection

Cautions: Use cautiously in

Liver disease
Post-operative patients
Neonates
Risk of thromboembolic phenomena
DIC
Fibrinolysis

Supplemental Patient Information

Inform patients of the early signs and symptoms of hypersensitivity reactions such as hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia, and anaphylaxis. Advise patients to discontinue the drug and immediately contact their clinician for appropriate emergency care, depending on the severity of reaction, if such symptoms occur

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Safety unknown.

Adverse Reactions ⬆ ⬇

CNS: Headache, tingling, somnolence
CV: Thromboembolism, hypotension, BP changes
GI: Nausea, vomiting
DERM: Urticaria, rash, hives, flushing
HEMA: DIC
LOCAL: Injection site reaction
HYPERSENSITIVITY: Anaphylactoid or anaphylactic reactions
MISC: Fever, chills, lethargy, viral transmission risk

Clinical Pharmacology ⬆ ⬇

Coagulation factor/thrombotic agent; increases plasma levels of factor IX, thus temporarily correcting the coagulation defect seen in factor IX deficiency
Metabolism: Unknown
Excretion: Unknown
Half-life

Bebulin VH: 19.4-24.6 hrs
Profilnine SD: 24.68+/-8.29 hrs

Brands and Availability ⬆ ⬇