Ixinity
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
IXINITY is a coagulation factor IX (recombinant) indicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management.
IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B
History
There is currently no drug history available for this drug.
Other Information
IXINITY [coagulation factor IX (recombinant)] is a purified protein that has 415 amino acids. It has an amino acid sequence that is comparable to the Thr148 allelic form of plasma-derived factor IX. Coagulation factor IX (recombinant) is a single-chain glycoprotein with a molecular mass of about 55,000 Dalton that is secreted by a genetically engineered mammalian cell line derived from Chinese hamster ovary (CHO) cells. No human or animal proteins are added during any stage of manufacturing or formulation of IXINITY. The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain hormones. The recombinant factor IX is purified by a chromatography purification process. The process includes three validated steps for virus inactivation and removal, namely, solvent/detergent treatment, a chromatographic step, and nanofiltration. The process also includes a validated step to reduce the presence of CHO proteins in the final drug product.
IXINITY is formulated as a sterile, nonpyrogenic lyophilized powder to be reconstituted with Sterile Water for Injection for intravenous administration. It does not contain any preservatives and is available in single-use vials containing the labeled amount of factor IX activity, expressed in international units (IU). Each vial contains nominally 500, 1000, or 1500 IU of recombinant coagulation factor IX. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, colorless solution. The concentrations of excipients are:
| Excipient | Concentration |
|---|---|
| Histidine |
10 mM |
| Mannitol |
3% |
| Trehalose Dihydrate |
1% |
| Sodium Chloride |
66 mM |
| Polysorbate 80 |
0.0075% |
Sources
Ixinity Manufacturers
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Cangene Biopharma
![Ixinity (Coagulation Factor Ix (Recombinant)) Kit [Cangene Biopharma]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ixinity | Breckenridge Pharmaceutical, Inc.
Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS).
Carbinoxamine maleate should be taken on an empty stomach with water.
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.
Carbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient. The drug is well tolerated in adults in doses as high as 24 mg daily, in divided doses, over prolonged periods. On the other hand, some patients respond to as little as 4 mg daily.
Clinical experience suggests the following dosage schedules:
Tablets
Usual Adult Dosage:
1 or 2 tablets (4 to 8 mg) 3 to 4 times daily
Usual Child’s Dosage:
Six to eleven years – 1/2 to 1 tablet (2 to 4 mg) 3 to 4 times daily
Oral Solution
Usual Adult Dosage:
1 or 2 teaspoonfuls (4 to 8 mg) 3 to 4 times daily
Usual Child's Dosage (approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 doses)
Six to eleven years - ½ to 1 teaspoonful (2 to 4 mg) 3 to 4 times daily
Dosing for children 2 to 5 years of age should be based on weight whenever possible. The usual dosage for children 2 to 5 years of age is approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 daily doses. In general, this corresponds to a dose of 1/4 to 1/2 teaspoonful (1 to 2 mg) 3 to 4 times daily.
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