Data from FDA - Curated by Toby Galbraith - Last updated 18 April 2017
FDA (Food and Drug Administration, USA)
To report SUSPECTED
6.1 Clinical Trials Experience Because clinical trials are conducted under widely
A total of 14
A total of 9641 infusions of IXINITY were administered to the 77 subjects.
Table 3 Summary of
familial and genetic
Non-inhibitory factor IX binding antibodies were detected in 30 % (23/77) of subjects, including
In three of the subjects,
Detection of non-inhibitory antibodies against factor IX has been reported following administration of other factor IX products.
The clinical significance of this finding is unknown.
In IXINITY clinical trials, 29 % (20/68) of
Reports have been published of
CHO cell proteins in subjects treated with other recombinant coagulation factor products produced in CHO cells, as well as in non-hemophilic subjects ().
The clinical significance of this is unknown.
The anti-CHO protein response status of the clinical trial subjects who transitioned to the modified product (n = 17) remained
The detection of antibody formation is dependent on the sensitivity and specificity of the assay.
Additionally, the observed incidence of antibody
For these reasons, comparisons of the incidence of
2 DOSAGE AND ADMINISTRATION For intravenous use after reconstitution only.
For intravenous use after reconstitution only.
One international unit (IU) of
Maintenance dose: Depends upon the type of bleed or surgery, clinical response, and the
Dosage and duration of treatment for all factor IX products depend on the
Initial Dose Calculate the initial dose of IXINITY based on the empirical finding that one international unit (IU) of
12 years of age.
Initial Dose = body weight (kg) x
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
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
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
For surgical procedures, initiate treatment with IXINITY early enough pre-operatively to achieve and maintain the desired factor IX level before starting the procedure.
Table 1 Dosing for Control and Prevention of Bleeding Episodes Adapted from Srivastava et al. 2013 (1).
Type of Bleeding Episode
Type of Surgery
pre-filled with 5 mL of Sterile Water for Injection (Pre-filled Syringe) with plunger rod attached One
Allow IXINITY and the Pre-filled Syringe to reach room temperature before use.
Remove cap from the vial (See Figure A).
Peel back the cover of the vial adapter package (leave the vial adapter in the package).
Figure A 4.
Place the Administration Syringe and vial adapter on a
Twist off the cap of the Pre-filled Syringe and place it on the
Figure B 6.
Wipe the top of the
IXINITY vial with an alcohol swab (or similar germicidal solution) and allow it to dry.
Place on a
Connect the Pre-filled Syringe to the vial adapter by pushing the syringe tip down onto the LUER-LOK in the center of the vial adapter, and screw until
Figure C 8.
Figure D 9.
With one hand,
With the other hand, hold
In a continuous motion, place the vial adapter over the IXINITY vial;
Push the plunger down to complete the transfer of all liquid from the syringe to the IXINITY vial.
Figure E 10.
With the syringe and the vial still attached,
Figure F 11.
Remove the Pre-filled Syringe (now empty) from the vial adapter by turning it counterclockwise until
Figure G 12.
Remove the Administration Syringe (
Leave the vial adapter attached to the vial and attach the Administration Syringe to the vial adapter by turning clockwise until
Figure H 14.
Keeping the Administration Syringe plunger pressed, turn the IXINITY vial upside down.
Draw the solution from the vial through the filter spike in the vial adapter by pulling
Figure I 15.
Keep the Administration Syringe plunger facing downwards and prevent it from moving.
With one hand hold the vial-and-vial-adapter, and with
Figure J 16.
If only dosing with a single vial, proceed to administer IXINITY via intravenous infusion; otherwise proceed to Pooling Instructions.
POOLING INSTRUCTIONS 1.
If two or
Leave the vial adapter attached to the vial and attach the Administration Syringe containing the reconstituted IXINITY from the first vial by turning it clockwise until
Turn the IXINITY vial upside down and
The Administration Syringe provided with IXINITY may be used to pool up to three (3) vials.
If more than three
After reconstitution of the lyophilized powder, all dosage strengths should yield a
Infuse reconstituted solution immediately or within 3 hours of storage at room temperature after reconstitution.
Do not refrigerate after reconstitution.
Do not touch the syringe tip or the inside of the cap.
Place the syringe containing the IXINITY solution on the
Dosing Figure A-1 Dosing Figure A-2 Dosing Figure B
Dosing Figure C Dosing
Figure D Dosing Figure E \Dosing Figure F Dosing Figure G Dosing Figure H Dosing Figure I Dosing Figure J 2.3 Administration For intravenous use after reconstitution only.
Inspect parenteral drug products visually for particulate matter and
Do not mix IXINITY with other medicinal products for infusion.
Attach the Administration Syringe containing the reconstituted IXINITY solution to a
Adapt the infusion rate to the
Dispose of any unused product or
8 USE IN SPECIFIC POPULATIONS Pregnancy:
Use only if clearly needed (8.1).
8.1 Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with IXINITY.
It is also not known whether IXINITY can cause fetal
IXINITY should be given to a pregnant woman only if clearly needed.
8.3 Nursing Mothers It is not known whether IXINITY is excreted into human milk.
Because many drugs are excreted into human milk,
8.4 Pediatric Use The
8.5 Geriatric Use Clinical studies of IXINITY did not include subjects aged 65 and over.
It is not known whether elderly patients respond differently than younger patients.
Individualize dose selection for elderly patients [see
|Date Last Revised||24-09-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Cangene BioPharma|