RX ITEM-Ixinity 2000 Unit coagulation factor IX Vial By Aptevo Pharma

IXINITY- coagulation factor ix (recombinant)
Cangene BioPharma

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

For intravenous use after reconstitution only.

2.1 Dose
Each vial of IXINITY has the recombinant factor IX (rFIX) potency in international units (IU) stated on the vial.
Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, the patient�s clinical condition, age, and pharmacokinetic parameters of factor IX, such as incremental recovery and half-life.


Initial Dose

Calculate the initial dose of IXINITY based on the empirical finding that one international unit (IU) of IXINITY per kg body weight increases the circulating level of factor IX by 0.98 international units/dL (IU/dL) of plasma in adults and children ? 12 years of age.

Initial Dose = body weight (kg) x desired factor IX increase (% of normal or IU/dL)
x reciprocal of observed recovery (IU/kg per IU/dL)

Incremental Recovery in Previously Treated Patients (PTPs)

Base calculation of the dose on the patient�s individual incremental recovery using serial factor IX activity assays, to account for the wide range of inter-individual differences in incremental recovery and the type of aPTT reagent used for the assay. Titrate the dose based on the patient�s clinical response and individual pharmacokinetics, in particular incremental recovery and half-life.

For an incremental recovery of 0.98 IU/dL, the dose is calculated as follows:

Dose (IU) = body weight (kg) x desired factor IX increase (% of normal or IU/dL) x 1.02 dL/kg

Examples (assuming patient�s baseline factor IX level is < 1% of normal):

A dose of 4550 international units (IUs) of IXINITY administered to a 70 kg patient should be expected to result in a peak post-infusion factor IX increase of 4550 IU x (0.98 IU/dL per IU/kg)/(70 kg) = 64 IU/dL (approximately 60% of normal)
A peak of 70% is required in a 60 kg patient. The appropriate dose would be (60 kg x 70 IU/dL)/(0.98 IU/dL per IU/kg) = 4286 IU
Monitor factor IX activity to ensure that the desired factor IX activity level has been achieved [see Warnings and Precautions (5.5) ].
Titrate doses using factor IX activity and pharmacokinetic parameters such as half-life and incremental recovery, as well as by taking the clinical situation into consideration, to adjust the dose and frequency of repeated infusions as appropriate.
Factor IX activity measurements in the clinical laboratory may be affected by the type of activated partial thromboplastin time (aPTT) reagent or laboratory standard used [see Warnings and Precautions (5.5) ].Control and Prevention of Bleeding and Perioperative Management
Control and Prevention of Bleeding and Perioperative Management

Guides for dosing IXINITY in the control and prevention of bleeding episodes (Table 1) and perioperative management (Table 2) are provided in the tables below. Individual patients may vary in their response to factor IX, and may demonstrate different levels of in vivo recovery and different half-lives.

RX ITEM-Ixinity 1000 Unit Vial By ASD He
NDC 53270-0271-05 UPC/GTIN No.3-53270-27105-3 Mfg.Part No.44916

Ixinity 1000 Unit Vial By ASD Healthcare
BRAND: IXINITY NDC: 53270-0271-05,53270027105 UPC: 3-53270-27105-3,353270271053 ASD Specialty Healthcare-Special Order

FACTOR IX HUMAN RECOMB,TH
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.