Rixubis (factor IX human recombinant)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Coagulation factor IX (recombinant) is a biosynthetic (recombinant DNA origin) preparation of blood coagulation factor IX.
Coagulation factor IX (recombinant) is a biosynthetic (recombinant DNA origin) preparation of blood coagulation factor IX. Coagulation factor IX is essential for blood clotting and maintenance of hemostasis. Patients with hemophilia B (Christmas disease) have deficient levels of endogenous factor IX, resulting in a hemorrhagic tendency and clinical manifestations such as bleeding into soft tissues, muscles, joints, and internal organs.
The clinical severity and frequency of bleeding in patients with hemophilia B correlate with the degree of deficiency of factor IX activity. Patients with mild hemophilia B generally have >5% of normal activity, those with moderate disease generally have 1-5% of normal activity, and those with severe disease have <1% of normal activity. Administration of coagulation factor IX (recombinant) to patients with hemophilia B results in increased plasma levels of factor IX and temporarily corrects the coagulation defect.
Treatment also may normalize the activated partial thromboplastin time (aPTT), which is typically prolonged in patients with hemophilia B.
Coagulation factor IX (recombinant) is produced by recombinant DNA technology in a mammalian cell expression system and undergoes several purification and virus-inactivating/removal processes (e.g., chromatography, nanofiltration, solvent/detergent). Coagulation factor IX (recombinant) is manufactured without animal or human components. Coagulation factor IX (recombinant) is similar in structure and function to plasma-derived factor IX, but is associated with a substantially reduced risk of transmission of bloodborne human viruses (e.g., human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV)).
In a pharmacokinetic study in previously treated patients (PTPs) receiving BeneFIX(R), in vivo recovery of factor IX following IV administration of 50 units/kg of the drug was approximately 28% lower than that achieved following administration of an equivalent dose of plasma-derived factor IX; the difference is presumably due to structural modifications of coagulation factor IX (recombinant). The half-life of BeneFIX(R) is 22.4 hours at baseline in PTPs and 23.8 hours at 6 months of receiving BeneFIX(R) 75 IU/kg. The half-life of BeneFIX(R) in infants (<=2 years of age), children aged 2 to <6 years, children aged 6 to <12 years, and adolescents and adults is 15.6, 16.7, 16.3, and 23.1 hours, respectively.
Following administration of a single dose of Rixubis(R) (71.3-79.4 units/kg) in PTPs >=12 years of age, half-life of the drug was approximately 26.7 hours. In pediatric patients, the half-life of Rixubis(R) (median dose of 75.3 units/kg) was approximately 23 hours for patients 6-11 years of age and approximately 28 hours for those <6 years of age. Results of single- and repeat-dose pharmacokinetic studies indicate that incremental recovery of Rixubis(R) remains consistent over time in both adult and pediatric populations.
Following administration of a single dose of 75 IU/kg Ixinity(R)in PTPs >=12 years of age, the terminal half-life was 24 hours; repeated dosing did not impact the pharmacokinetics of Ixinity(R). Following administration of 75 IU/kg of Ixinity(R) in PTPs <6 years of age, the terminal half-life was 15.9 hours; 16.8 hours in PTPs age 6 to <12 years. Decreased in vivo recovery has been observed in pediatric patients <=12 years of age compared with older individuals receiving coagulation factor IX (recombinant).
Coagulation factor IX (recombinant) readily diffuses through interstitial fluid and distributes in both intravascular and extravascular compartments. The drug circulates in plasma as a free molecule. Coagulation factor IX (recombinant) binds rapidly and reversibly to vascular endothelium.
Clearance of factor IX correlates with body weight and generally increases through adolescence, then stabilizes during adulthood.
USES: This medication is used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause.
This medication should not be used to treat other types of factor deficiencies (such as factors II, VII, VIII, X) or factor problems (such as inhibitor to factor XIII), to reverse the effects of "blood thinners" (such as warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).
Generic name: factor IX human recombinant
Pronunciation: (FACK-ter nine)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Rixubis
Indications
The following indications are listed for Rixubis:
- Hemophilia B
Also known as: Christmas Disease, Factor Ix Deficiency, Factor Ix Dysfunction, Plasma Thromboplastin Component Deficiency, Ptc Deficiency.
Dosing
No dosing information is available for this tab.
Dosage and duration of therapy should be individualized based on the patient's age, severity and location of bleeding, degree of factor IX deficiency, desired factor IX levels, presence of factor IX inhibitors, and clinical and pharmacokinetic (e.g., half-life, incremental recovery) response.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been performed to date with coagulation factor IX (recombinant).
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Life-threatening, immediate hypersensitivity (e.g., anaphylaxis) or known hypersensitivity reactions to coagulation factor IX (recombinant) or any ingredient in the formulation, including hamster protein.
*Rixubis(R) is also contraindicated in patients with disseminated intravascular coagulation (DIC) and in those with signs of fibrinolysis.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse effects (>5%) reported in previously treated and previously untreated patients receiving BeneFIX(R) in clinical trials were fever, cough, headache, dizziness, nausea, injection site reaction, injection site pain, and skin-related hypersensitivity reactions such as rash and hives.
The most common adverse effects (>1%) reported in previously treated patients receiving Rixubis(R) in clinical trials were dysgeusia, pain in extremity, and positive test for furin antibody.
The most common adverse effect (>2%) reported in patients receiving Ixinity(R)in clinical trials was headache.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Safety, efficacy, and pharmacokinetics of BeneFIX(R) have been evaluated in previously treated and previously untreated pediatric patients <12 years of age.
Safety, efficacy, and pharmacokinetics of Ixinity(R) have been establshed in previously treated pediatric patients. On average, lower recovery of factor IX, shorter half-life, and higher clearance is observed in pediatric patients <12 years of age compared with older individuals; therefore, dosage adjustments may be necessary.
Safety, efficacy, and pharmacokinetics of Rixubis(R) have been evaluated in previously treated pediatric patients <12 years of age, including 11 patients <6 years of age. Incremental recovery in pediatric patients <12 years of age is approximately 22% lower than in older individuals; therefore, dosage adjustments may be necessary. Younger pediatric patients (<6 years of age) appear to have lower mean incremental recovery and higher clearance compared with older pediatric patients (6-12 years of age).
In clinical studies, high-titer inhibitors were detected in several pediatric patients receiving BeneFIX(R) who had no prior exposure to coagulation factor IX preparations; these patients were withdrawn from the study. No inhibitors were detected in pediatric patients receiving Ixinity(R).
There have been rare postmarketing reports of critically ill neonates who have experienced thrombotic events, including life-threatening superior vena cava syndrome, while receiving continuous infusions of BeneFIX(R) through a central venous catheter.
There are no data with coagulation factor IX (recombinant) use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted. It is not known whether coagulation factor IX (recombinant) can cause fetal harm when administered to a pregnant woman or affect reproductive capacity.
It is not known whether coagulation factor IX (recombinant) is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for coagulation factor IX (recombinant) and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.
There is insufficient experience in patients 65 years of age or older to determine whether geriatric patients respond differently than younger patients. Dosage should be individualized in geriatric patients.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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