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LABEL: IXINITY (COAGULATION FACTOR IX- RECOMBINANT KIT

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* HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use IXINITY®
safely and effectively. See full prescribing information for IXINITY..
IXINITY [coagulation factor IX (recombinant) ...
These highlights do not include all the information needed to use IXINITY®
safely and effectively. See full prescribing information for IXINITY..

IXINITY [coagulation factor IX (recombinant)]
Lyophilized Powder for Solution for Intravenous Injection
Initial U.S. Approval: 2015

RECENT MAJOR CHANGES

Indications and Usage (1) 09/2020

Dosage and Administration (2.1) 09/2020

Warnings and Precautions (5.1, 5.4) 09/2020

INDICATIONS AND USAGE

IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation
factor indicated for the treatment of:

* Adults and children ≥ 12 years of age with hemophilia B for:
* On-demand treatment and control of bleeding episodes (1)
* Perioperative management (1)
* Adults with hemophilia B for:
* Routine prophylaxis to reduce the frequency of bleeding episodes (1)

IXINITY is not indicated for induction of immune tolerance in patients with
hemophilia B. (1)

DOSAGE AND ADMINISTRATION

For intravenous use after reconstitution only.

On-demand treatment and control of bleeding episodes and perioperative
management of bleeding:

* One international unit (IU) of IXINITY per kg body weight increases the
circulating activity of factor IX by 0.98 IU/dL. (2.1)

Initial dose:

* Required factor IX units (IU) = body weight (kg) x desired factor IX
increase (% of normal or IU/dL) x reciprocal of observed recovery (IU/kg
per IU/dL). (2.1)
* The maintenance dose depends on the type of bleed or surgery, the
intensity of the hemostatic challenge, and number of days until adequate
wound healing is achieved. (2.1)

Routine prophylaxis:

* 40 to 70 IU/kg twice weekly. (2.1)

DOSAGE FORMS AND STRENGTHS

IXINITY is available as a lyophilized white or almost white powder, in
single-use glass vials containing nominally 250, 500, 1000, 1500, 2000, or
3000 international units (IU) per vial (3)

CONTRAINDICATIONS

Do not use in patients with known hypersensitivity to IXINITY or its
excipients, including hamster protein (4)

WARNINGS AND PRECAUTIONS

* Hypersensitivity reactions, including anaphylaxis has occurred. Should
symptoms occur, discontinue IXINITY and administer appropriate treatment.
Patients may also develop hypersensitivity to hamster (CHO) protein, which
is present in trace amounts in the product (5.1)
* Development of neutralizing antibodies (inhibitors) to IXINITY may occur.
If expected factor IX activity plasma levels are not attained, or if
bleeding is not controlled with an appropriate dose, perform an assay that
measures factor IX inhibitor concentration (5.2)
* Nephrotic syndrome has been reported following immune tolerance induction
with factor IX products in hemophilia B patients with factor IX inhibitors
(5.3)
* Thromboembolism has occurred with IXINITY use (5.4)

ADVERSE REACTIONS

The most common adverse reaction observed in > 2% of patients in clinical
trials was headache (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Medexus Pharm, Inc. at
1-844-859-6675 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 9/2021

Close
* Table of Contents
Table of Contents

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 DOSE

2.2 PREPARATION AND RECONSTITUTION

2.3 ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 HYPERSENSITIVITY REACTIONS

5.2 NEUTRALIZING ANTIBODIES

5.3 NEPHROTIC SYNDROME

5.4 THROMBOEMBOLISM

5.5 MONITORING LABORATORY TESTS

6 ADVERSE REACTIONS

6.1 CLINICAL TRIALS EXPERIENCE

6.2 IMMUNOGENICITY

6.3 POSTMARKETING EXPERIENCE

8 USE IN SPECIFIC POPULATIONS

8.1 PREGNANCY

8.2 LACTATION

8.4 PEDIATRIC USE

8.5 GERIATRIC USE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 MECHANISM OF ACTION

12.2 PHARMACODYNAMICS

12.3 PHARMACOKINETICS

13 NONCLINICAL TOXICOLOGY

13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

14 CLINICAL STUDIES

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

* Sections or subsections omitted from the full prescribing information are
not listed. Close
* 1 INDICATIONS AND USAGE
IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation
factor indicated for the treatment of: Adults and children ≥ 12 years of age
with hemophilia B for: On-demand ...

IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation
factor indicated for the treatment of:

* Adults and children ≥ 12 years of age with hemophilia B for:
* On-demand treatment and control of bleeding episodes
* Perioperative management
* Adults with hemophilia B for:
* Routine prophylaxis to reduce the frequency of bleeding episodes

IXINITY is not indicated for induction of immune tolerance in patients with
hemophilia B [see Warnings and Precautions (5.3)].

Close
* 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 ...

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 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) × 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 per IU/kg, calculate the dose as
follows:

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

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

1. 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 × (0.98 IU/dL per IU/kg)/(70 kg) = 64 IU/dL (approximately 60% of
normal)
2. A peak of 70% is required in a 60 kg patient. The appropriate dose would
be
(60 kg × 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)].

On-demand Treatment and Control of Bleeding Episodes and Perioperative
Management of Bleeding

Guides for dosing IXINITY in the on-demand treatment and control 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.

For surgical procedures, initiate treatment with IXINITY early enough
pre-operatively to achieve and maintain the desired factor IX level before
starting the procedure.

Routine Prophylaxis

The dose for previously treated patients (PTPs) is 40 to 70 IU/kg twice
weekly. Adjust the dose based on the individual patient’s bleeding pattern,
and physical activity.

Table 1 Dosing for On-demand Treatment and Control of Bleeding Episodes
Adapted from Srivastava et al. 2013 (1). Type of Bleeding EpisodeDesired Peak
Factor IX Level (%
of normal or IU/dL)Dosing
Interval
(hours)Duration of therapy
(days) Minor
Early bleeds: uncomplicated
hemarthroses and superficial
muscle (except iliopsoas) with no
neurovascular compromise, other
soft tissue30-60241-3, until healing is
achieved Moderate
Hemarthrosis of longer duration,
recurrent hemarthrosis, mucous
membranes, deep lacerations,
hematuria40-60242-7, until healing is
achieved Major or Life Threatening
Iliopsoas, deep muscle with
neurovascular injury, substantial
blood loss, CNS, pharyngeal,
retropharyngeal, retroperitoneal60-10012-242-14, until healing is
achieved

Table 2 Dosing for Perioperative Management Adapted from Srivastava et al.
2013 (1). Type of SurgeryDesired Peak
Factor IX Level (%
of normal or IU/dL)Dosing
Interval
(hours)Duration of
therapy (days) Minor
(including uncomplicated dental
extractions) Pre-op50-80 Post-op30-80241-5, depending on
type of procedure Major Pre-op60-80 Post-op40-60
30-50
20-408-241-3
4-6
7-14

2.2 PREPARATION AND RECONSTITUTION

The procedures below are provided as general recommendations for the
preparation and reconstitution of IXINITY.

Before starting reconstitution and administration you will need the following
items that are included in each kit of IXINITY:

* One (or more) vial(s) of IXINITY 250, 500, 1000, 1500, 2000, or 3000 IU
powder
* One (or more) 10 mL syringe(s), pre-filled with 5 mL of Sterile Water for
Injection (pre-filled syringe) with plunger rod attached
* One sterile vial adapter with filter

In addition, you will need the following items that are not included in the
kit:

* One sterile LUER-LOK™ syringe (administration syringe); additional or
larger syringes may be required if pooling multiple vials
* Sterile alcohol swabs
* Sterile infusion set
* Sterile gauze pad
* Sterile bandage

Always work on a clean surface and wash your hands before performing the
following procedures:

1. Use aseptic technique during reconstitution procedure.
2. Allow IXINITY and the pre-filled syringe to reach room temperature
before use.
3. 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, if using, and vial adapter on a clean
flat work surface.
5. Twist off the cap of the pre-filled syringe and place it on the clean
flat surface (See Figure B).

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 clean, flat
surface.
7. Firmly hold the package containing the vial adapter on a clean, flat
surface. 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 the syringe is secured (See Figure C).

Figure C
8. Carefully lift up the combined syringe-and-vial-adapter and remove it
from the plastic package (See Figure D).

Figure D
9. With one hand, continue to hold the combined syringe-and-vial-adapter.
With the other hand, hold the IXINITY vial tightly on a clean, flat
surface. In a continuous motion, place the vial adapter over the IXINITY
vial; firmly push the filter spike of the vial adapter through the
center of IXINITY vial’s rubber circle until the clear plastic cap snaps
onto the IXINITY vial (See Figure E). 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, gently swirl, in a
circular motion, the IXINITY vial until the product is fully
dissolved/reconstituted (See Figure F).

Figure F
11. Remove the pre-filled syringe (now empty) from the vial adapter by
turning it counterclockwise until it is completely detached (See Figure
G).

Figure G
12. Remove the administration syringe from its packaging.
13. Leave the vial adapter attached to the vial and attach the
administration syringe to the vial adapter by turning clockwise until it
is securely attached (See Figure H).

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 the plunger back slowly until all
solution is transferred into the administration syringe (See Figure I).

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 the
other hand firmly grasp the barrel of the administration syringe and
unscrew the syringe from the vial adapter (See Figure J).

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 more vials are required to achieve the required dose, remove the
pre-filled syringe from the vial adapter on the reconstituted second vial by
turning it counterclockwise until it is completely detached. 2. 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 it is securely in place. 3. Turn the IXINITY vial upside down
and slowly pull on the plunger rod to draw the solution into the
administration syringe (see Figure I). 4. Continue with remaining vials, if
required. Once pooling is complete, proceed to administer IXINITY via
intravenous infusion.
* After reconstitution of the lyophilized powder, all dosage strengths
should yield a clear, colorless solution without visible particles.
Discard if visible particulate matter or discoloration is observed.
* 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 clean surface, making sure that the
tip does not touch anything.

2.3 ADMINISTRATION

For intravenous use after reconstitution only.

1. Inspect parenteral drug products visually for particulate matter and
discoloration prior to administration, whenever solution and container
permit.
2. Do not mix IXINITY with other medicinal products for infusion.
3. Attach the administration syringe containing the reconstituted IXINITY
solution to a sterile infusion set.
4. Adapt the infusion rate to the comfort level of each patient, not
exceeding 10 mL per minute.
5. Record the name and batch number of the product in the patient record.

Dispose of any unused product or waste material in accordance with local
requirements.

Close
* 3 DOSAGE FORMS AND STRENGTHS
IXINITY is available as a lyophilized white or almost white powder, in
single-use glass vials containing nominally 250, 500, 1000, 1500, 2000, or
3000 IU per vial.

IXINITY is available as a lyophilized white or almost white powder, in
single-use glass vials containing nominally 250, 500, 1000, 1500, 2000, or
3000 IU per vial.

Close
* 4 CONTRAINDICATIONS(What is this?)
IXINITY is contraindicated in patients who have known hypersensitivity to
IXINITY or its excipients, including hamster protein [see Warnings and
Precautions (5.1)].

IXINITY is contraindicated in patients who have known hypersensitivity to
IXINITY or its excipients, including hamster protein [see Warnings and
Precautions (5.1)].

Close
* 5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions - Hypersensitivity reactions, including
anaphylaxis, has occurred with IXINITY. Signs of allergic reactions, which
can progress to anaphylaxis, include urticaria ...

5.1 HYPERSENSITIVITY REACTIONS

Hypersensitivity reactions, including anaphylaxis, has occurred with IXINITY.
Signs of allergic reactions, which can progress to anaphylaxis, include
urticaria, angioedema, chest or throat tightness, hypotension, lethargy,
nausea, vomiting, dysphagia, paresthesia, restlessness, wheezing and dyspnea.
Immediately discontinue administration and initiate appropriate treatment if
allergic or anaphylactic-type reactions occur. In case of severe allergic
reactions, consider alternative hemostatic measures.

There are literature reports of allergic reactions occurring in close
temporal association with the development of factor IX inhibitors.

IXINITY contains trace amounts of Chinese hamster ovary (CHO) proteins.
Patients treated with this product may develop hypersensitivity to CHO
proteins.

5.2 NEUTRALIZING ANTIBODIES

Development of neutralizing antibodies (inhibitors) to IXINITY may occur. If
expected factor IX activity plasma levels are not attained, or if bleeding is
not controlled as expected with the calculated dose, perform an assay that
measures factor IX inhibitor concentration [see Warnings and Precautions
(5.5)].

Patients with factor IX inhibitors are at an increased risk of severe
hypersensitivity reactions or anaphylaxis if re-exposed to IXINITY.

5.3 NEPHROTIC SYNDROME

Nephrotic syndrome may occur with IXINITY. Nephrotic syndrome has been
reported following attempted immune tolerance induction in hemophilia B
patients with factor IX inhibitors and a history of allergic reactions.

5.4 THROMBOEMBOLISM

Thromboembolism has occurred with IXINITY use. Because of the potential risk
for thromboembolism with the use of factor IX products, monitor for early
signs of thromboembolism and consumptive coagulopathy when administering
IXINITY to patients with liver disease, fibrinolysis, peri-operative status,
or risk for thromboembolic events or disseminated intravascular coagulation.

5.5 MONITORING LABORATORY TESTS

* Monitor patients for factor IX activity levels with the one-stage clotting
assay to confirm that adequate factor IX levels have been achieved and
maintained, when clinically indicated. Factor IX results can be affected
by the type of aPTT reagent used [see Dosage and Administration (2.1)].
* Monitor patients for the development of inhibitors if expected factor IX
activity plasma levels are not attained, or if bleeding is not controlled
with the recommended dose of IXINITY. Assays used to determine if factor
IX inhibitor is present should be titered in Bethesda Units (BUs).

Close
* 6 ADVERSE REACTIONS
The most common adverse reaction (> 2%) reported in clinical trials was
headache. 6.1 Clinical Trials Experience - Because clinical trials are
conducted under widely varying conditions, adverse ...

The most common adverse reaction (> 2%) reported in clinical trials was
headache.

6.1 CLINICAL TRIALS EXPERIENCE

Because clinical trials are conducted under widely varying conditions,
adverse reaction rates observed in the clinical trials of a drug cannot be
directly compared to rates in the clinical trials of another drug and may not
reflect the rates observed in clinical practice.

A total of 14 adverse reactions were reported following IXINITY
administration among 6 of the 77 subjects who received at least one dose of
IXINITY in trials of previously treated patients (PTPs), which included 11
subjects < 18 years of age. A total of 9641 infusions of IXINITY were
administered to the 77 subjects. The adverse reactions that were assessed as
probably or possibly related to study drug are provided in the table below.

Table 3 Summary of Adverse Reactions MedDRA Standard System
Organ ClassAdverse Reaction Number of EventsNumber of
Subjects
(n = 77) (%) Congenital, familial and genetic disordersHemophilia (i.e. lack
of efficacy)11 (1.3%) General disorders and administration site
conditionsAsthenia11 (1.3%) Injection site discomfort11 (1.3%) Infections and
infestationsInfluenza11 (1.3%) Nervous system disordersHeadache52 (2.6%)
Dysgeusia11 (1.3%) Lethargy11 (1.3%) Psychiatric disordersApathy11 (1.3%)
Depression11 (1.3%) Skin and subcutaneous tissue disordersRash pruritic11
(1.3%)

6.2 IMMUNOGENICITY

All subjects participating in the clinical trial were monitored for
inhibitory and non-inhibitory antibodies to factor IX and antibodies for CHO
proteins at the following time points; pre-infusion, after the first 5
exposure days, and then every 3 months thereafter.

No subjects in IXINITY clinical trials developed inhibitors to factor IX,
including 55 subjects with more than 50 exposure days and 45 of those
subjects with more than 100 exposure days. Non-inhibitory factor IX binding
antibodies were detected in 30% (23/77) of subjects, including 5 subjects
positive at baseline. In three of the subjects, the non-inhibitory factor IX
antibodies were persistent, while in the remainder the antibodies were
sporadic and non-persistent. No clinical adverse findings related to
non-inhibitory factor IX antibody formation were identified. 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 subjects tested positive for
antibodies against CHO cell proteins. No clinical adverse findings were
associated with these antibodies. Reports have been published of sporadic
detection of antibodies against CHO cell proteins in subjects treated with
other recombinant coagulation factor products produced in CHO cells, as well
as in non-hemophilic subjects (2). The clinical significance of this is
unknown. The manufacturing process for IXINITY was modified to include an
additional step to ensure increased clearance of CHO proteins to address the
anti-CHO protein response seen in clinical trials. The anti-CHO protein
response status of the clinical trial subjects who transitioned to the
modified product (n = 17) remained negative (n = 10), stable/nonspecific
assay binding (n = 5), or declined (n = 2) after the transition to modified
IXINITY for at least 3 months.

The detection of antibody formation is dependent on the sensitivity and
specificity of the assay. Additionally, the observed incidence of antibody
positivity in an assay may be influenced by several factors including assay
methodology, sample handling, timing of sample collection and concomitant
medications. For these reasons, comparisons of the incidence of antibodies to
IXINITY with the incidence of antibodies to other products may be misleading.

6.3 POSTMARKETING EXPERIENCE

The following adverse reactions have been identified during post approval use
of IXINITY.

Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Anaphylaxis

Vascular Disorders: Deep vein thrombosis

The following class adverse reactions have been seen with another recombinant
factor IX: inadequate factor IX recovery, inhibitor development, angioedema,
hypotension, and thrombosis.

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* 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy - Risk Summary - There are no data with IXINITY use in pregnant
women to inform a drug-associated risk. Animal reproduction studies have not
been conducted with IXINITY. In the ...

8.1 PREGNANCY

Risk Summary

There are no data with IXINITY use in pregnant women to inform a
drug-associated risk. Animal reproduction studies have not been conducted
with IXINITY.

In the U.S. general population, the estimated background risk of major birth
defect and miscarriage in clinically recognized pregnancies is 2-4% and
15-20%, respectively.

8.2 LACTATION

Risk Summary

There is no information regarding the presence of IXINITY in human milk, the
effect on the breastfed infant, or the effects on milk production. The
developmental and health benefits of breastfeeding should be considered along
with the mother’s clinical need for IXINITY and any potential adverse effects
on the breastfed infant from IXINITY or from the underlying maternal
condition.

8.4 PEDIATRIC USE

The safety and effectiveness of IXINITY in pediatric patients below the age
of 12 years have not been established.

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 Dosage and
Administration (2.1)].

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* 11 DESCRIPTION
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 ...

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 250, 500,
1000, 1500, 2000, or 3000 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:

ExcipientConcentration Histidine10 mM Mannitol3% Trehalose Dihydrate1% Sodium
Chloride66 mM Polysorbate 800.0075%

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* 12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action - Hemophilia B is a sex-linked hereditary disorder
of blood coagulation caused by a deficiency in factor IX and results in
bleeding into joints, muscles or internal ...

12.1 MECHANISM OF ACTION

Hemophilia B is a sex-linked hereditary disorder of blood coagulation caused
by a deficiency in factor IX and results in bleeding into joints, muscles or
internal organs, either spontaneously or as a result of accidental or
surgical trauma. Treatment with IXINITY replaces factor IX, thereby enabling
a temporary correction of the factor deficiency and correction of the
bleeding tendencies.

12.2 PHARMACODYNAMICS

The administration of IXINITY increases plasma levels of factor IX and can
temporarily correct the coagulation defect in these patients, as reflected by
decrease in the aPTT.

12.3 PHARMACOKINETICS

Pharmacokinetic studies with IXINITY were conducted in 32 previously treated
patients (PTPs) ≥ 12 years of age with severe to moderately severe hemophilia
B (factor IX ≤ 2 IU/dL). Intravenous administration of 75 ± 5 IU/kg of
IXINITY to 32 PTPs showed an initial recovery ranging from 51 to 113% (median
70%). The results of pharmacokinetic studies are summarized below in Table 4.

Table 4 Pharmacokinetic Parameters for IXINITY (n = 32) ParametersMean (± SD)
(Range) AUC0–∞ (IU/dL/hr)1573 (± 451)
(862-2643) Incremental Recovery (IU/dL per IU/kg)0.98 (± 0.21)
(0.67-1.50) Terminal Half-life (hours)24 (± 7)
(13-43) Cmax (IU/dL)73 (± 17)
(51-113) Mean Residence Time (hours)32 (± 6)
(19-47) VDss (mL/kg)175 (± 57)
(102-314) Clearance [mL/(kg·hr)]5.1 (± 1.3)
(2.8-7.7)

Pharmacokinetic parameters were re-assessed in a subset of 14 subjects after
routine treatment with IXINITY for a median of 5.8 months (range 3.1 to 18.6
months) as summarized in Table 5 below.

Table 5 Pharmacokinetic Parameters for IXINITY Following Repeat-Dosing (n =
14) ParametersInitial
Mean (± SD)Repeat-Dosing
PK
Mean (± SD) AUC0–∞ (IU/dL/hr)1438 (± 409)1530 (± 435) Incremental Recovery
(IU/dL per IU/kg)0.96 (± 0.22)0.95 (± 0.18) Terminal Half-life (hours)24 (±
7)24 (± 6) Cmax (IU/dL)73 (± 16)73 (± 15) Mean Residence Time (hours)30 (±
6)31 (± 5) VDss (mL/kg)193 (± 62)185 (± 70) Clearance [mL/(kg·hr)]5.6 ±
(1.3)5.3 (± 1.5)

Repeat dosing did not impact the pharmacokinetics of IXINITY.

The PK data were divided into two subgroups of subjects with a BMI ≤ 30 (n =
26) or BMI > 30 (n = 6). The AUC(0-∞) and Cmax values of IXINITY were 40% and
34% higher, respectively, in subjects with BMI > 30.

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* 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No macroscopic or
microscopic pathologies in reproductive organs were observed in repeated dose
toxicity studies of IXINITY in ...

13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

No macroscopic or microscopic pathologies in reproductive organs were
observed in repeated dose toxicity studies of IXINITY in animals. Animal
studies regarding impairment of fertility were not conducted.

No nonclinical investigations of genotoxicity, carcinogenicity, or toxicity
to reproduction and development have been conducted with IXINITY.

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* 14 CLINICAL STUDIES
The efficacy of IXINITY was evaluated in a prospective, open-label,
uncontrolled multicenter study in which a total of 77 subjects (76 male, 1
female carrier in surgery study) were exposed to ...

The efficacy of IXINITY was evaluated in a prospective, open-label,
uncontrolled multicenter study in which a total of 77 subjects (76 male, 1
female carrier in surgery study) were exposed to IXINITY for treatment of
hemophilia B or for perioperative management. All male subjects either had
severe or moderately severe (factor IX level ≤ 2 IU/dL) hemophilia B, or had
factor IX levels between 2-8 IU/dL and clinically severe hemophilia B with
recurrent hemarthroses and required surgery (n = 3 in surgery study, 1
continued to treatment phase). Previously treated patients (PTPs) were
defined as patients with a minimum of 150 exposures to another factor IX
preparation. Of the 77 subjects, 68 PTPs between 7 and 64 years of age
received IXINITY either as routine prophylaxis or on-demand treatment.
Routine prophylaxis treatment was defined as PTPs who received a starting
dose of 40-70 international units (IU) per kg twice weekly. Excluded from the
study were patients with a history of a detectable factor IX inhibitor (≥ 0.6
BU), a history of hypersensitivity reactions following exposure to factor
IX-containing products, a known allergic reaction to hamster proteins,
evidence of severe liver impairment, evidence of impaired renal function, CD4
count < 400 cells/mm3, or any coagulation defect other than hemophilia B. In
addition, there was a prospective, open-label, uncontrolled, multicenter
substudy where 17 subjects (16 male, 1 female carrier) underwent surgeries
(19 major procedures in males) receiving IXINITY for perioperative
management; some of the surgery subjects also participated in the treatment
trial.

Of the 68 PTPs in the treatment group, subjects were primarily prescribed a
routine prophylaxis (n = 58) or an on-demand regimen (n = 9); one subject was
not assigned a regimen. Subjects were allowed to switch regimens during the
course of the study. As a result, 61 subjects were treated at some point with
routine prophylaxis treatment and 12 were treated at some point with an
on-demand regimen. Subjects in the routine prophylaxis therapy group received
mean intravenous doses of 55 ± 12.8 IU/kg of IXINITY twice weekly. Subjects
in the on-demand therapy group received mean doses of 60 ± 18.2 IU/kg (median
59.3, interquartile range 49.9, 71.8) for bleeding episodes. The mean number
of exposure days (ED) was 138.2 (median 127.5), including 45 subjects with ≥
100 ED and 55 subjects with ≥ 50 ED. Median duration on study for the
on-demand group was 14.1 months (range 2.3-36.9).

Prophylaxis and Reduction of Bleeding Episodes

In the prophylaxis arm, the mean annualized bleed rate (ABR) was 3.55 (Table
6).

Table 6 Efficacy of Prophylaxis with IXINITY (N=61) Total ABR Mean ±
SD3.55 ± 7.19 Median (IQR)1.52 (0 – 3.47) Spontaneous ABR Mean ±
SD1.07± 3.06 Median (IQR)0.00 (0 – 1.22) Subjects with zero bleeding
episodes % (n)31.1% (19)

Control of Bleeding Episodes

A total of 508 bleeding episodes were treated with IXINITY, of which 286
bleeds were recorded for subjects treated with the routine prophylaxis
treatment regimen and 222 with the on-demand regimen. Bleeding resolved in
360 episodes (70.9%) after a single infusion of IXINITY and in 66 (13.0%)
episodes after two infusions. For 24 bleeding episodes (4.7%), five or more
infusions were required; these 24 bleeding episodes were predominantly
related to trauma, target joints, or muscle bleeds.

Hemostatic efficacy to resolve a bleed was rated by subjects as excellent or
good in 84% of treated bleeding episodes. Excellent was defined as a dramatic
response with abrupt pain relief and clear reduction in joint or hemorrhage
site size, and good was defined as pain relief or reduction in hemorrhage
size that may have required an additional infusion for resolution.

Perioperative Management

The efficacy analysis of IXINITY in perioperative management included 19
major surgeries performed in 16 male PTPs between 12 and 56 years of age
(female carrier not included in efficacy analysis). Efficacy of IXINITY for
support of major surgery was based on the surgeon’s assessment of efficacy
including: a) at the time of surgery as estimation of blood loss as ‘less
than expected’, ‘expected’, or ‘more than expected’; and b) at 12 and 24
hours post-surgical assessments of hemostasis as ‘adequate’, ‘better than
adequate’, or ‘poorly controlled’. Transfusion requirements to support
surgery were also monitored. There were no transfusions required during the
procedures.

IXINITY was administered during major surgical procedures as bolus (n = 13)
or continuous infusion (n = 6). IXINITY was rated as adequate or better in
controlling hemostasis post-surgery as assessed by the surgeon when used in
various procedures, including, knee arthroplasty (n = 8), elbow arthroplasty
(n = 2), knee amputation (n = 1), percutaneous Achilles tendon lengthening (n
= 1), open inguinal hernia repair (n = 1), tibiotalar fusion (n = 1),
arthroscopic synovectomy (n = 2), and debridement (ankle, knee) (n = 3). In
all instances, blood loss at surgery was ‘expected’ or ‘less than expected’
as assessed by the surgeon.

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* 15 REFERENCES
Srivastava A, et al. World Federation of Hemophilia, Guidelines for the
management of hemophilia. Haemophilia. 2013; 19:e1–e47. Ingerslev J,
Christiansen K, Ravn HB, et al. Antibodies to ...

1. Srivastava A, et al. World Federation of Hemophilia, Guidelines for the
management of hemophilia. Haemophilia. 2013; 19:e1–e47.
2. Ingerslev J, Christiansen K, Ravn HB, et al. Antibodies to heterologous
proteins in hemophilia A patients receiving recombinant factor VIII
(Recombinate™). Thromb Haemost. 2002; 87:626–634.

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* 16 HOW SUPPLIED/STORAGE AND HANDLING
IXINITY is supplied as a lyophilized powder in single-use glass vials
containing the labeled amount of factor IX activity, expressed in
international units (IU). The actual factor IX activity in ...

IXINITY is supplied as a lyophilized powder in single-use glass vials
containing the labeled amount of factor IX activity, expressed in
international units (IU). The actual factor IX activity in IU is stated on
the label of each vial.

Kits include one single-use vial (containing nominally 250, 500, 1000, 1500,
2000, or 3000 IU per vial), a 10 mL syringe pre-filled with 5 mL of Sterile
Water for Injection with plunger rod attached, and a vial adapter with
filter. None of the kit components are made with natural rubber latex.

Color CodeNominal StrengthKit NDC Number Yellow250 IU59137-287-05 Blue500
IU59137-282-05 Green1000 IU59137-283-05 Orange1500 IU59137-284-05 Red2000
IU59137-288-05 Brown3000 IU59137-289-05

250 IU strength only; store at 2 to 8°C (36 to 46°F).

500, 1000, 1500, 2000, and 3000 IU strengths: store at 2 to 25°C (36 to
77°F).

Do not freeze.

Keep the vial in the carton and protect from light.

Infuse reconstituted solution immediately or within 3 hours of storage at
room temperature after reconstitution. Do not refrigerate after
reconstitution.

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* 17 PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient
Information and Instructions for Use). Inform patients of the early signs of
hypersensitivity reactions (including hives ...

* Advise patients to read the FDA-approved patient labeling (Patient
Information and Instructions for Use).
* Inform patients of the early signs of hypersensitivity reactions
(including hives, generalized urticaria, chest tightness, wheezing, and
hypotension) and anaphylaxis. Instruct patients to discontinue use of the
product and contact their physician if these symptoms occur.
* Advise patients to contact their physician or treatment facility for
further treatment and/or assessment if they experience a lack of clinical
response to factor IX replacement therapy, as in some cases this may be a
manifestation of an inhibitor.

Manufactured by:
Medexus Pharma, Inc.
Chicago, IL 60606
U.S. License No. 2220

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* Patient Information
IXINITY® [coagulation factor IX (recombinant)] This leaflet summarizes
important information about IXINITY. Please read it carefully before using
this medicine. This information does not take ...

IXINITY® [coagulation factor IX (recombinant)]

This leaflet summarizes important information about IXINITY. Please read it
carefully before using this medicine. This information does not take the
place of talking with your healthcare provider, and it does not include all
of the important information about IXINITY. If you have any questions after
reading this, ask your healthcare provider.

What is IXINITY?

IXINITY is a medicine used to replace clotting factor (factor IX) that is
missing in people with hemophilia B. Hemophilia B is also called congenital
factor IX deficiency or Christmas disease. Hemophilia B is an inherited
bleeding disorder that prevents clotting.

Your healthcare provider may give you IXINITY when you have surgery.

Who should not use IXINITY?

You should not use IXINITY if you:

* Are allergic to hamsters
* Are allergic to any ingredients in IXINITY

Tell your healthcare provider if you are pregnant or breastfeeding because
IXINITY may not be right for you.

What should I tell my healthcare provider before using IXINITY?

You should tell your healthcare provider if you:

* Have or have had any medical problems
* Take any medicines, including prescription and non-prescription medicines,
such as over-the-counter medicines, supplements, or herbal remedies
* Have any allergies, including allergies to hamsters
* Are breastfeeding. It is not known if IXINITY passes into your milk and if
it can harm your baby
* Are pregnant or planning to become pregnant. It is not known if IXINITY
may harm your baby
* Have been told that you have inhibitors to factor IX (because IXINITY may
not work for you)

How should I infuse IXINITY?

IXINITY is given directly into the bloodstream. IXINITY should be
administered as ordered by your healthcare provider. You should be trained on
how to do infusions by your healthcare provider or hemophilia treatment
center. Many people with hemophilia B learn to infuse their IXINITY by
themselves or with the help of a family member.

See the step-by-step guide (Instructions for Use) provided at the end of this
leaflet.

Your healthcare provider will tell you how much IXINITY to use based on your
weight, the severity of you hemophilia B, and where you are bleeding. You may
have to have blood tests done after getting IXINITY to be sure that your
blood level of factor IX is high enough to stop the bleeding. Call you
healthcare provider right away if your bleeding does not stop after taking
IXINITY.

What are the possible side effects of IXINITY?

Allergic reactions may occur with IXINITY. Call your healthcare provider or
get emergency treatment right away if you get any of the following symptoms:
rash, hives, itching, tightness of the throat, chest pain or tightness,
difficulty breathing, lightheadedness, dizziness, nausea, or fainting.

Tell your healthcare provider about any side effect that bothers you or does
not go away.

The most common side effect of IXINITY in clinical trials was headache.

These are not all the side effects possible with IXINITY. You can ask your
healthcare provider for information that is written for healthcare
professionals.

Call your healthcare provider for medical advice about side effects. You may
report side effects to the FDA at 1-800-FDA-1088.

What are the IXINITY dosage strengths?

IXINITY comes in vials containing six different dosage strengths: 250, 500,
1000, 1500, 2000 and 3000 international units (IU). The actual strength will
be printed on the label of the vial and on the box. The six different
strengths in the vials are color coded as follows:

Color CodeNominal Strength Yellow250 IU Blue500 IU Green1000 IU Orange1500 IU
Red2000 IU Brown3000 IU

Always check the actual dosage strength printed on the label to make sure you
are using the strength prescribed by your healthcare provider.

How should I store IXINITY?

250 IU strength only; store at 2 to 8°C (36 to 46°F). Do not freeze.

500, 1000, 1500, 2000, and 3000 IU strengths; store at 2 to 25°C (36 to
77°F). Do not freeze.

Do not use IXINITY after the expiration date printed on the label. Throw away
any unused IXINITY and diluents after it reaches this date.

Reconstituted product (after mixing dry product with Sterile Water for
Injection) must be used within 3 hours and cannot be stored or refrigerated.
Discard any IXINITY left in the vial at the end of your infusion.

What else should I know about IXINITY?

Your body may form inhibitors to factor IX. An inhibitor is part of the
body’s immune system. If you form inhibitors, it may stop IXINITY from
working properly. Consult with your healthcare provider to make sure you are
carefully monitored with blood tests to check for the development of
inhibitors to factor IX. Consult your doctor promptly if bleeding is not
controlled with IXINITY as expected.

Medicines are sometimes prescribed for purposes other than those listed here.
Do not use IXINITY for a condition for which it is not prescribed. Do not
share IXINITY with other people, even if they have the same symptoms as you.

Resources available to patients

For information on patient assistance programs that may be available to you,
please call our IXINITY Patient Care Center at 1-855-IXINITY
(1-855-494-6489).

Manufactured by:
Medexus Pharma, Inc.
Chicago, IL 60606
U.S. License No. 2220

Part Number: 1000973.01

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* Instructions for Use
IXINITY [coagulation factor IX (recombinant)] For intravenous use after
reconstitution only - Do not attempt to do an infusion to yourself unless you
have been taught how by your healthcare ...

IXINITY [coagulation factor IX (recombinant)]

For intravenous use after reconstitution only

Do not attempt to do an infusion to yourself unless you have been taught how
by your healthcare provider or hemophilia center.

Always follow the specific instructions given by your healthcare provider.
The steps listed below are general guidelines for using IXINITY. If you are
unsure of the procedures, please call your healthcare provider before using
IXINITY. Your healthcare provider will prescribe the dose that you should
take.

Before starting reconstitution and administration you will need the following
items that are included in each kit of IXINITY:

* One (or more) vial(s) of IXINITY 250, 500, 1000, 1500, 2000, or 3000 IU
powder, as prescribed by your healthcare provider
* One (or more) 10 mL syringe(s), pre-filled with 5 mL of Sterile Water for
Injection (pre-filled syringe) with plunger rod attached
* Sterile vial adapter with filter

In addition, you will need the following items that are not included in the
kit:

* One sterile LUER-LOK syringe (administration syringe); additional or
larger syringes may be required if pooling multiple vials
* Sterile alcohol swabs
* Sterile infusion set
* Sterile gauze pad
* Sterile bandage

IXINITY is supplied in kits that include single-use vials which contain vials
of IXINITY (250, 500, 1000, 1500, 2000, or 3000 IU of powder), a 10 mL
syringe pre-filled with 5 mL of Sterile Water for Injection with plunger rod
attached (to be used for reconstitution only), and a sterile vial adapter
with filter.

RECONSTITUTION INSTRUCTIONS

Wash your hands and then clean a flat area before starting the steps for
reconstituting IXINITY. Use an aseptic technique during reconstitution.

1. Remove the pre-filled syringe and IXINITY vial from storage and allow them
to reach room temperature before use. Check the expiration date on the
IXINITY vial.

2. Remove the plastic cap from the IXINITY vial and place the vial top up on
the clean surface. You will see a rubber circle on the top of the vial.

3. Wipe the top of the IXINITY vial with a sterile alcohol swab and allow it
to dry. After cleaning, do not touch the rubber circle with your hands or
allow it to touch another object.

4. Peel back the paper cover of the vial adapter package. Be careful not to
touch the LUER-LOK (tip) in the center of the vial adapter. Do not remove the
adapter from the package.

5. Leave the vial adapter in the package and place it open end up on the
clean surface with the LUER-LOK pointing up.

6. Twist off the tip cap counterclockwise from the pre-filled syringe. Do not
touch the inside of the cap or the syringe tip.

7. While firmly holding the package containing the adapter with one hand and
the barrel of the pre-filled syringe with the other, 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, turning clockwise until the syringe is
secured.

8. Carefully lift up the combined syringe-and-vial-adapter and remove it from
the plastic package and discard packaging.

9. With one hand, continue to hold the combined syringe-and-vial-adapter.
With the other hand, hold the IXINITY vial tightly on the clean, flat
surface. Do not touch the top of the IXINITY vial or the filter spike of the
combined syringe and vial adapter.

10. Place the vial adapter over the IXINITY vial on the table; firmly push
the filter spike of the vial adapter through the center of the IXINITY vial
rubber circle until the clear plastic cap snaps onto the IXINITY vial.

11. Slowly push the plunger rod down to transfer all of the liquid from the
syringe into the IXINITY vial.

* With the syringe and the vial still attached, gently swirl, in a circular
motion, the IXINITY vial until the product is fully dissolved. IXINITY is
a clear, colorless solution without visible particles. Inspect the final
solution for specks before administration. Do not use contents of vial if
specks or particles persist after proper reconstitution.

12. NOTE: If you use more than one vial of IXINITY per infusion, reconstitute
each vial as per the previous instructions.

13. Remove the diluent syringe from the vial adapter by turning syringe
counterclockwise until it is completely detached. Do not touch the luer tip
of the vial adapter.

14. Remove the LUER-LOK syringe (administration syringe) from its sterile
packaging, taking care to not touch the luer tip of the syringe. Attach to
the reconstituted vial and vial adapter by turning syringe clockwise until it
is securely attached.

15. Press and keep the plunger down and turn the IXINITY vial/vial
adapter/administration syringe upside down to transfer the solution. Draw up
the solution into the administration syringe slowly until all solution is
transferred into the syringe. Inspect the vial to confirm as much liquid as
possible has been extracted into the administration syringe. NOTE: If you use
more than one vial of IXINITY per infusion, extract reconstituted liquid from
each vial, as per the previous instructions.

16. Hold onto the vial adapter with one hand and firmly grasp the
administration syringe with the other and unscrew the administration syringe
from the vial adapter turning either counterclockwise. Do not touch the tip
of the syringe to any object or surface. NOTE: If multiple reconstituted
vials are required for infusion, do not detach the large LUER-LOK
administration syringe from the first vial until you are ready to attach the
next vial (with vial adapter attached).

17. Prior to administering the solution, invert the administration syringe so
that the tip is pointed toward the ceiling and express any air in the
syringe. Place the administration syringe containing the IXINITY solution on
the clean surface, making sure that the tip does not touch anything.

The reconstituted solution should be infused immediately or within 3 hours of
storage at room temperature after reconstitution. NOTE: The luer tip of the
syringe must not be touched by any objects or surfaces, when disconnecting
the syringe from the vial adapter, and when transferring the administration
syringe to the infusion set.

If you are using more than one vial, stop here and proceed to the Pooling
Instructions.

POOLING INSTRUCTIONS

POOLING is the process of combining two or more reconstituted vials into a
larger administration syringe prior to intravenous administration.

Do not detach the large LUER-LOK administration syringe until you are ready
to attach the next vial (with vial adapter attached).

Follow the instructions above for reconstitution of the second vial.

1. Remove the administration syringe from the first vial adapter by turning
it counter clockwise until it is completely detached.
2. Attach the administration syringe to the second reconstituted vial by
turning clockwise until it is securely attached.
3. Turn the IXINITY vial/vial adapter/administration syringe upside down,
slowly pull on the plunger rod to draw the solution into the
administration syringe (see Step 15 above).

Repeat this POOLING procedure with each vial you will be using.

Once you have pooled the required dose, proceed to administration using the
administration syringe.

ADMINISTRATION INSTRUCTIONS

For intravenous use after reconstitution only.

IXINITY is administered by intravenous (IV) infusion after reconstitution
with diluent (Sterile Water for Injection) supplied in the pre-filled
syringe.

IXINITY must not be mixed with other medicinal products for infusion.

Reconstituted IXINITY must be pulled into an administration syringe prior to
infusion.

IXINITY is normally administered intravenously over about 5 minutes at a
maximum infusion rate of 10 mL per minute. The infusion rate should be
adapted to the comfort level of each patient.

1. Attach the administration syringe containing the reconstituted IXINITY
solution to the luer end of the sterile infusion set. Inspect for and
remove any air bubbles in the infusion set and administration syringe.
NOTE: The luer tip of the administration syringe and the luer connection
of the infusion set must not be touched by any object or surface, prior
to connection of the administration syringe.
2. Transfer IXINITY solution into the tube by pressing the syringe plunger
until the tubing is completely filled. Once again, inspect for and remove
any air bubbles in the infusion set and administration syringe.
3. Perform venipuncture as directed by your healthcare provider.
4. Limit the amount of blood entering the tubing. Blood must never enter the
syringe. If blood is observed in the tubing or syringe, discard all
material and resume administration with a new package.
5. Following completion of the infusion, remove the infusion set, press the
sterile gauze on the infusion site until bleeding has stopped, then apply
a sterile bandage. The amount of drug product remaining in the infusion
set should be minimal. Log the batch number of the IXINITY used; it is
located on the container.

Dispose of all unused solution, empty vials, and used needles and syringes in
an appropriate container for throwing away medical waste as it may hurt
others if not handled properly.

Contact your healthcare provider or local hemophilia treatment center if you
experience any problems.

IXINITY® coagulation factor IX (recombinant) and any and all Medexus Pharma,
Inc. brand, product, service and feature names, logos, and slogans are
trademarks or registered trademarks of Medexus Pharma, Inc. in the United
States or other countries. All rights reserved.

LUER-LOK™ is a trademark of Becton, Dickinson and Company. All other brand,
product, service and feature names or trademarks are the property of their
respective owners.

Manufactured by:
Medexus Pharma, Inc.
Chicago, IL 60606
U.S. License No. 2220

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* PRINCIPAL DISPLAY PANEL - NDC: 59137-275-01 - 250 IU Single-Use Vial
Label(What is this?)

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* PRINCIPAL DISPLAY PANEL - NDC: 59137-287-05 - 250 IU Kit Carton

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-270-01 - 500 IU Single-Use Vial Label

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-282-05 - 500 IU Kit Carton

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-271-01 - 1000 IU Single-Use Vial Label

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-283-05 - 1000 IU Kit Carton

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-272-01 - 1500 IU Single-Use Vial Label

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-284-05 - 1500 IU Kit Carton

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-276-01 - 2000 IU Single-Use Vial Label

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-288-05 - 2000 IU Kit Carton

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-277-01 - 3000 IU Single-Use Vial Label

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-289-05 - 3000 IU Kit Carton

Close
* PRINCIPAL DISPLAY PANEL - NDC: 59137-280-01 - Water for Injection 5 mL
Single-Use Syringe Label

Close
INGREDIENTS AND APPEARANCE
Product Information

IXINITY coagulation factor ix (recombinant) kit

Product Information Product TypeHUMAN PRESCRIPTION DRUGItem Code
(Source)NDC:59137-287

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-287-051 in 1 CARTON07/01/2021

Quantity of Parts Part #Package QuantityTotal Product Quantity Part 11 VIAL
5 mL Part 21 SYRINGE 5 mL

Part 1 of 2 IXINITY coagulation factor ix (recombinant) injection, powder,
lyophilized, for solution

Product Information Item Code (Source)NDC:59137-275 Route of
AdministrationINTRAVENOUS

Active Ingredient/Active Moiety Ingredient NameBasis of StrengthStrength
COAGULATION FACTOR IX RECOMBINANT HUMAN (UNII: 382L14738L) (COAGULATION
FACTOR IX RECOMBINANT HUMAN - UNII:382L14738L) COAGULATION FACTOR IX
RECOMBINANT HUMAN250 [iU] in 5 mL

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-275-015 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Part 2 of 2 WATER water liquid

Product Information Item Code (Source)NDC:59137-280 Route of
AdministrationINTRAVENOUS

Inactive Ingredients Ingredient NameStrength WATER (UNII: 059QF0KO0R) 1 mL
in 1 mL HISTIDINE (UNII: 4QD397987E) MANNITOL (UNII: 3OWL53L36A)
TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4) SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-280-015 mL in 1 SYRINGE; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA12542605/12/2017

IXINITY coagulation factor ix (recombinant) kit

Product Information Product TypeHUMAN PRESCRIPTION DRUGItem Code
(Source)NDC:59137-282

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-282-051 in 1 CARTON07/01/2021

Quantity of Parts Part #Package QuantityTotal Product Quantity Part 11 VIAL
5 mL Part 21 SYRINGE 5 mL

Part 1 of 2 IXINITY coagulation factor ix (recombinant) injection, powder,
lyophilized, for solution

Product Information Item Code (Source)NDC:59137-270 Route of
AdministrationINTRAVENOUS

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-270-015 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Part 2 of 2 WATER water liquid

Product Information Item Code (Source)NDC:59137-280 Route of
AdministrationINTRAVENOUS

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-280-015 mL in 1 SYRINGE; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA12542605/12/2017

IXINITY coagulation factor ix (recombinant) kit

Product Information Product TypeHUMAN PRESCRIPTION DRUGItem Code
(Source)NDC:59137-283

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-283-051 in 1 CARTON07/01/2021

Quantity of Parts Part #Package QuantityTotal Product Quantity Part 11 VIAL
5 mL Part 21 SYRINGE 5 mL

Part 1 of 2 IXINITY coagulation factor ix (recombinant) injection, powder,
lyophilized, for solution

Product Information Item Code (Source)NDC:59137-271 Route of
AdministrationINTRAVENOUS

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-271-015 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Part 2 of 2 WATER water liquid

Product Information Item Code (Source)NDC:59137-280 Route of
AdministrationINTRAVENOUS

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-280-015 mL in 1 SYRINGE; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA12542605/12/2017

IXINITY coagulation factor ix (recombinant) kit

Product Information Product TypeHUMAN PRESCRIPTION DRUGItem Code
(Source)NDC:59137-284

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-284-051 in 1 CARTON07/01/2021

Quantity of Parts Part #Package QuantityTotal Product Quantity Part 11 VIAL
5 mL Part 21 SYRINGE 5 mL

Part 1 of 2 IXINITY coagulation factor ix (recombinant) injection, powder,
lyophilized, for solution

Product Information Item Code (Source)NDC:59137-272 Route of
AdministrationINTRAVENOUS

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-272-015 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Part 2 of 2 WATER water liquid

Product Information Item Code (Source)NDC:59137-280 Route of
AdministrationINTRAVENOUS

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-280-015 mL in 1 SYRINGE; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA12542605/12/2017

IXINITY coagulation factor ix (recombinant) kit

Product Information Product TypeHUMAN PRESCRIPTION DRUGItem Code
(Source)NDC:59137-288

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-288-051 in 1 CARTON07/01/2021

Quantity of Parts Part #Package QuantityTotal Product Quantity Part 11 VIAL
5 mL Part 21 SYRINGE 5 mL

Part 1 of 2 IXINITY coagulation factor ix (recombinant) injection, powder,
lyophilized, for solution

Product Information Item Code (Source)NDC:59137-276 Route of
AdministrationINTRAVENOUS

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-276-015 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Part 2 of 2 WATER water liquid

Product Information Item Code (Source)NDC:59137-280 Route of
AdministrationINTRAVENOUS

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-280-015 mL in 1 SYRINGE; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA12542605/12/2017

IXINITY coagulation factor ix (recombinant) kit

Product Information Product TypeHUMAN PRESCRIPTION DRUGItem Code
(Source)NDC:59137-289

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-289-051 in 1 CARTON07/01/2021

Quantity of Parts Part #Package QuantityTotal Product Quantity Part 11 VIAL
5 mL Part 21 SYRINGE 5 mL

Part 1 of 2 IXINITY coagulation factor ix (recombinant) injection, powder,
lyophilized, for solution

Product Information Item Code (Source)NDC:59137-277 Route of
AdministrationINTRAVENOUS

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-277-015 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Part 2 of 2 WATER water liquid

Product Information Item Code (Source)NDC:59137-280 Route of
AdministrationINTRAVENOUS

Packaging #Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59137-280-015 mL in 1 SYRINGE; Type 0: Not a Combination Product

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA125426

Marketing Information Marketing CategoryApplication Number or Monograph
CitationMarketing Start DateMarketing End Date BLABLA12542605/12/2017

Labeler - Medexus Pharma, Inc. (078811131)

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IXINITY (COAGULATION FACTOR IX- RECOMBINANT KIT

NUMBER OF VERSIONS: 2

Published Date (What is this?) Version Files Nov 17, 2021 2 (current) download
Sep 27, 2021 1 download

RXNORM

IXINITY (COAGULATION FACTOR IX- RECOMBINANT KIT

RxCUI RxNorm NAME RxTTY 1 1666311 coagulation factor IX (recombinant human) 1
UNT Injection PSN 2 1666311 nonacog alfa 1 UNT Injection SCD 3 1666328 IXINITY 1
UNT Injection PSN 4 1666328 nonacog alfa 1 UNT Injection [Ixinity] SBD 5 1666328
Ixinity (coagulation factor IX (recombinant human)) 1 UNT Injection SY

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NDC CODES

IXINITY (COAGULATION FACTOR IX- RECOMBINANT KIT

IF THIS SPL CONTAINS INACTIVATED NDCS LISTED BY THE FDA INITIATED COMPLIANCE
ACTION, THEY WILL BE SPECIFIED AS SUCH.

NDC 1 59137-270-01 2 59137-271-01 3 59137-272-01 4 59137-275-01 5 59137-276-01 6
59137-277-01 7 59137-280-01 8 59137-282-05 9 59137-283-05 10 59137-284-05 11
59137-287-05 12 59137-288-05 13 59137-289-05

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