KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:

1.

On-demand treatment and control of bleeding episodes

2.

Perioperative management of bleeding

3.

Routine prophylaxis to reduce the frequency of bleeding episodes

KOVALTRY is not indicated for the treatment of von Willebrand disease.

For intravenous use after reconstitution only.

2.2 Preparation and Reconstitution

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Reconstitute and administer KOVALTRY with the components provided with each package. If any component of the package is opened or damaged, do not use this component.

The procedures below are provided as general guidelines for the reconstitution of KOVALTRY using the sterile vial adapter with a 15 micrometer filter and a prefilled diluent syringe, which together serve as an alternative needleless reconstitution system.

Usability Testing of Vial Adapter

Usability testing was conducted with 60 users, including 15 pediatric hemophilia A patients (between 10-17 years of age), 15 adult hemophilia A patients (≥18 years of age), 15 caregivers, and 15 healthcare providers. To mimic real life, the pediatric and adult patients and the caregivers were given minimal training, which included participants performing a supervised reconstitution and later performing a single unaided reconstitution. Healthcare providers were untrained in this study and could learn the procedure from the provided Instructions for Use. All participants were able to successfully and safely use the vial adapter device for reconstitution.

Reconstitution

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Work on a clean surface and wash hands thoroughly using soap and warm water before performing the procedures.

•

Reconstitute KOVALTRY with the components provided with each package. If any component of the package is opened or damaged, do not use this component.

•

Filter the reconstituted product to remove potential particulate matter in the solution. Filtering is achieved by using the vial adapter.

1. Warm both unopened KOVALTRY vial and prefilled diluent syringe in your hands to a comfortable temperature (do not exceed 37°C or 99°F).
2. Remove the protective cap from the vial (A). Aseptically cleanse the rubber stopper with a sterile alcohol swab, being careful not to handle the rubber stopper.
3. Place the product vial on a firm, non-skid surface. Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Holding the adapter housing, place over the product vial and firmly press down (B). The adapter will snap over the vial cap. Do not remove the adapter housing at this step.
4. Holding the syringe by the barrel, snap the syringe cap off the tip (C). Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use.
5. Now remove and discard the adapter plastic housing (D).
6. Attach the prefilled syringe to the vial adapter thread by turning clockwise (E).
7. Remove the clear plastic plunger rod from the carton. Grasp the plunger rod by the top plate. Avoid touching the sides and threads of the plunger rod. Attach the plunger rod by turning it clockwise into the threaded rubber stopper of the prefilled syringe (F).
8. Inject the diluent slowly by pushing down on the plunger rod (G).
9. Swirl vial gently until all powder on all sides of the vial is dissolved (H). Do not shake vial. Be sure that all powder is completely dissolved. Do not use if solution contains visible particles or is cloudy.
10. Push down on the plunger to push all air back into the vial. Then while holding the plunger down, turn the vial with syringe upside-down (invert) so the vial is now above the syringe (I).
11. Withdraw all the solution into the syringe by pulling the plunger rod back slowly and smoothly (J). Tilt the vial to the side and back to make sure all the solution has been drawn toward the large opening in the rubber stopper and into the syringe. Remove as much air as possible before removing the syringe from the vial by slowly and carefully pushing the air back into the vial.
12. Detach the syringe with plunger rod from the vial adapter by turning counter-clockwise. Attach the syringe to the administration set provided and inject intravenously (K).   Note: follow instructions for infusion set provided.

Pooling

If the dose requires more than one vial, reconstitute each vial as described above with the diluent syringe provided. Use a larger plastic syringe (not provided) to combine the content of the vials into the syringe.

KOVALTRY is available as a lyophilized powder in single-dose glass vials containing nominally 250, 500, 1000, 2000, or 3000 IU of recombinant Factor VIII per vial.

Each vial of KOVALTRY is labeled with actual Factor VIII potency expressed in IU determined using a chromogenic substrate assay. This potency assignment employs a Factor VIII concentrate standard that is referenced to the current WHO International Standard for Factor VIII concentrate, and is evaluated by appropriate methodology to ensure accuracy of the results.

KOVALTRY is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins [see Description (11)].

The most frequently reported adverse reactions in clinical trials (≥3%) were inhibitors in previously untreated patients (PUPs)/minimally treated patients (MTPs), and headache, pyrexia, and pruritus (see Table 3).

KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-dose vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level.

The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method.

KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates.

The safety and efficacy of KOVALTRY for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis in subjects with severe hemophilia A (<1% Factor VIII) was evaluated in three international (including U.S.) clinical studies. Immunocompetent subjects with severe hemophilia A (Factor VIII activity ≤1%) and no history of Factor VIII inhibitors were eligible for the trials.

Trial 1: a multi-center, open-label, cross-over, uncontrolled, study in adolescent and adult (age ≥12 years to <65 years) PTPs (≥150 EDs) evaluated the pharmacokinetics, efficacy and safety of routine prophylaxis, and perioperative management of bleeding of KOVALTRY (see Table 7). The primary efficacy variable was ABR. The prophylactic regimen was 20 to 50 IU/kg two or three times per week in which the dosing frequency was assigned by the investigator based on the subject’s individual requirements.

Trial 2: a multi-center, open-label, cross-over, uncontrolled, randomized study in adolescent and adult (age ≥12 years to <65 years) PTPs (≥150 EDs) evaluated the superiority of prophylaxis over on-demand treatment with KOVALTRY over a one-year treatment period (see Table 7). The primary efficacy variable was ABR. The prophylactic regimen was 20 to 30 IU/kg two times per week or 30 to 40 IU/kg three times per week and the treatment group was assigned by randomization.

Trial 3: a multi-center, open-label, uncontrolled study in pediatric that evaluated the pharmacokinetics, efficacy and safety of routine prophylaxis, and perioperative management of bleeding of KOVALTRY (see Table 8) in previously treated patients (PTPs; ≥50 EDs) ≤12 years of age (Part A) and previously untreated patients (PUPs) and minimally treated patients (MTPs; ≤3 EDs) <6 years of age (Part B). The primary efficacy variable was annualized number of total bleeds during routine prophylaxis that occurred within 48 hours following previous prophylaxis infusion. ABR during prophylaxis, independent of time of infusion, was also analyzed. In Part A, the prophylactic regimen was 25 to 50 IU/kg at frequencies of either 2 times per week, 3 times per week or every other day and could be adapted to an individual subject’s need by the investigator.

In all studies, treatments of breakthrough bleeds and perioperative management were at the investigator’s discretion based on standard of care.

A total of 204 previously treated subjects (153 subjects ≥12 years of age and 51 subjects <12 years of age) and 43 PUPs/MTPs <6 years of age were treated in the completed clinical trials. Amongst the PTPs, 140 subjects were treated for at least 12 months, and 43 of these subjects were treated for 24 months.

On-demand Treatment and Control of Bleeding Episodes

Adolescents and Adults

A total of 1892 bleeding episodes in 110 subjects were treated with KOVALTRY in Trial 1 and Trial 2 (see Table 9). The majority of the bleeding episodes were spontaneous, localized in joints, and mild to moderate in severity.

In Trial 1 and Trial 2, the treatment responses in a total of 1859 treated bleeds were assessed by the subjects compared to their previous treatment experience.

Children 12 Years of Age and Younger

A total of 97 bleeding episodes in 28 previously treated pediatric subjects and 105 bleeding episodes in 37 PUPs/MTPs were treated with KOVALTRY. Majority (96.9% in PTPs and 97.1% in PUPs/MTPs) of the bleeds were mild to moderate in severity for both groups. Fifty-nine (72.8%) and 62 (59.0%) bleeds were trauma related for the previously treated subjects and PUPS/MTPs, respectively. During the 6 month treatment period, the median dose of KOVALTRY for the treatment of breakthrough bleeds in the previously treated subjects was 36.94 IU/kg per infusion (range 20.8–71.6 IU/kg).

Assessment of response to treatment of bleeds was as follows:

Excellent: Abrupt pain relief and/or improvement in signs of bleeding with no additional infusion administered; Good: Definite pain relief and/or improvement in signs of bleeding but possibly requiring more than one infusion for complete resolution; Moderate: Probable or slight improvement in signs of bleeding with at least one additional infusion for complete resolution; Poor: No improvement at all between infusions or condition worsens.

The hemostatic efficacy in on-demand treatment of bleeds was assessed as either “good” or “excellent” in 90.1% of cases (97.8% in the younger age group and 81.0% in the older age group). Majority of bleeds (89.7%) were successfully treated with ≤2 infusions. Response to treatment was similar for children aged 0 to <6 compared to 6 to 12 years of age (see Table 10).

Perioperative Management

A total of 14 major and 46 minor surgeries were performed in 44 previously treated subjects (43 adults and adolescents and 1 child under 12 years of age) with severe hemophilia A. Seven of the 14 major surgeries in PTPs were orthopedic procedures, including joint replacement. Approximately 51% of the minor surgeries in PTPs were dental extractions. All subjects received KOVALTRY as bolus infusions. In the adolescent and adult subjects, the initial KOVALTRY doses administered ranged between 3000–5000 IU. The median total dose on the day of surgery was 107.5 IU/kg (range 60–207 IU/kg). In a single previously treated subject younger than 12 years of age who underwent a major surgery, the total initial KOVALTRY dose administered was 2500 IU (108.7 IU/kg).

The blood loss, during and after surgery, was within expected ranges. Hemostatic control was assessed by surgeons as “good” (perioperative bleeding slightly but not clinically significantly increased over expectations for the non-hemophilic patient; treatment similar to non-hemophilic patient) or “excellent” (perioperative blood loss similar to the non-hemophilic patient).

Routine Prophylaxis

Adolescents and Adults

A total of 140 subjects were treated with KOVALTRY for at least 12 months with median (range) 157 EDs (25-178) in Study 1, [305 EDs (25-355) inclusive of extension phase], and 153 EDs (103-187) in Study 2 (see Table 11). In both studies, subjects in the Intent-to-Treat (ITT) population received 95% to 100% of the prescribed number of prophylaxis infusions.

The mean and median ABR for the ITT population in Study 1 was 3.8 ± 5.2 and 1 bleed/year, respectively. In Study 2, comparison of the bleeding rates between subjects receiving on-demand therapy versus prophylaxis in an ANOVA demonstrated a statistically significant difference (p<0.0001) in the median ABR in subjects receiving on-demand therapy (60 bleeds per year) as compared to subjects receiving prophylaxis (2 bleeds per year). In Study 2, mean ABR in subjects receiving on-demand therapy was 57.7 ± 24.6 versus 4.9 ± 6.8 in the subjects receiving prophylaxis.

The ABR for subjects (n=21) receiving on-demand therapy in Study 2 [median (IQR Q1; Q3)] for all bleeds: 60 (41.7; 76.3); spontaneous bleeds: 42.1 (24.3; 61.3); joint bleeds: 38.8 (24.3; 60.0).

Children 12 Years of Age and Younger

In Part A, a total of 51 PTPs were treated with KOVALTRY for at least 6 months with median (range) 73 EDs (37-103) (see Table 13). Subjects received >95% of the prescribed number of prophylaxis infusions.

In children 12 years of age and younger (n=51), the median (IQR Q1; Q3) ABR within 48 hours after prophylactic infusion was 0 (0; 4) for all bleeds, and 0 (0; 0) for spontaneous and joint bleeds. The median (IQR Q1; Q3) ABR during prophylactic treatment independent of time of infusion was 1.9 (0; 6) for all bleeds, 0 (0; 0) for spontaneous bleeds and 0 (0; 2) for joint bleeds. The mean ABR within 48 hours after prophylactic infusion was 2.04 ± 2.91. The mean ABR at any time during the prophylaxis regimen was 3.75 ± 4.98.

In both age groups (0 to <6 years and 6 to 12 years), the ABR for spontaneous bleeds and joint bleeds within 48 hours after prophylactic treatment [ABR median (IQR Q1; Q3)] was 0 (0; 0). The median (IQR Q1; Q3) annualized number of spontaneous bleeds during prophylactic treatment independent of time of infusion was 0 (0; 0). The median (IQR Q1; Q3) annualized number of joint bleeds during prophylactic treatment independent of time of infusion was 0 (0; 1.9) in 0 to <6 years age group and 0 (0; 2.1) in 6 to 12 years age group (see Table 14).

The majority (32/53) of bleeds that occurred within 48 hours after a previous prophylaxis infusion were trauma related. Twenty-three (45.1%) subjects reported no bleeds during the six-month prophylaxis period.

How Supplied

KOVALTRY is available as a lyophilized powder in single-dose glass vials, one vial per carton. It is supplied with a sterile vial adapter with 15-micrometer filter and a prefilled diluent glass barrel syringe, which together serve as a needleless reconstitution system. The prefilled diluent syringe contains Sterile Water for Injection, USP. An administration set is also provided in the package. Available sizes:

Actual Factor VIII activity in IU is stated on the label of each KOVALTRY vial.

The product vial and diluent syringe are not made with natural rubber latex.

Storage and Handling

Product as Packaged for Sale

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Store KOVALTRY at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Do not freeze. Within this period, KOVALTRY may be stored for a single period of up to 12 months at temperatures up to +25°C or 77°F.

•

Record the starting date of room temperature storage on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature for 12 months, or after the expiration date on the product vial, whichever is earlier.

•

Do not use KOVALTRY after the expiration date indicated on the vial.

•

Protect KOVALTRY from extreme exposure to light and store the vial with the lyophilized powder in the carton prior to use.

Product After Reconstitution

•

Administer reconstituted KOVALTRY as soon as possible. If not, store at room temperature for no longer than 3 hours.

•

Do not use KOVALTRY if the reconstituted solution is cloudy or has particulate matter.

•

Use the administration set provided.

•

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

•

Hypersensitivity reactions are possible with KOVALTRY [see Warnings and Precautions (5.1)]. Warn patients of the early signs of hypersensitivity reactions (including tightness of the chest or throat, dizziness, mild hypotension and nausea during infusion) which can progress to anaphylaxis. Advise patients to discontinue use of the product if these symptoms occur and seek immediate emergency treatment with resuscitative measures such as the administration of epinephrine and oxygen.

•

Inhibitor formation may occur at any time in the treatment of a patient with hemophilia A [see Warnings and Precautions (5.2)]. Advise patients to contact their physician or treatment center for further treatment and/or assessment, if they experience a lack of clinical response to Factor VIII replacement therapy, as this may be a manifestation of an inhibitor.

FDA-Approved Patient Labeling

Patient Information

KOVALTRY (KOH-vahl-tree)

Antihemophilic Factor (Recombinant)

This leaflet summarizes important information about KOVALTRY with vial adapter. 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 KOVALTRY. If you have any questions after reading this, ask your healthcare provider.

Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.

What is KOVALTRY?

KOVALTRY is a medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.

KOVALTRY is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you KOVALTRY when you have surgery. KOVALTRY can reduce the number of bleeding episodes in adults and children with hemophilia A when used regularly (prophylaxis).

KOVALTRY is not used to treat von Willebrand Disease.

Who should not use KOVALTRY?

You should not use KOVALTRY if you

•

are allergic to rodents (like mice and hamsters).

•

are allergic to any ingredients in KOVALTRY.

What should I tell my healthcare provider before I use KOVALTRY?

•

Tell your healthcare provider about all of your medical conditions.

•

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies.

•

Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

•

Tell your healthcare provider if you have been told that you have inhibitors to Factor VIII (because KOVALTRY may not work for you).

What are the possible side effects of KOVALTRY?

The common side effects of KOVALTRY are headache, fever and itchy rash, in addition to inhibitors in patients who were not previously treated or minimally treated with Factor VIII products.

Your body may make antibodies, called “inhibitors” against KOVALTRY, which may stop KOVALTRY from working properly. If your bleeding is not adequately controlled, it could be due to the development of Factor VIII inhibitors. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

Allergic reactions may occur with KOVALTRY. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, and nausea.

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

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

What are the KOVALTRY dosage strengths?

KOVALTRY with 2.5 mL or 5 mL Sterile Water for Injection (SWFI) comes in five different dosage strengths labeled as International Units (IU): 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU. The five different strengths are color-coded as follows:

How do I store KOVALTRY?

Do not freeze KOVALTRY.

Store KOVALTRY at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, KOVALTRY may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F.

Record the starting date of room temperature storage clearly on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature for 12 months, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light.

Administer reconstituted KOVALTRY as soon as possible. If not, store at room temperature for no longer than 3 hours.

Throw away any unused KOVALTRY after the expiration date.

Do not use reconstituted KOVALTRY if it is not clear.

What else should I know about KOVALTRY and hemophilia A?

Finding veins for injections may be difficult in young children. When frequent injections are required, your healthcare provider may propose to have a device surgically placed under the skin to facilitate access to the bloodstream. These devices may result in infections.

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

This leaflet summarizes the most important information about KOVALTRY. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about KOVALTRY that was written for healthcare professionals.

Instructions for Use

KOVALTRY (KOH-vahl-tree)

Antihemophilic Factor (Recombinant)

Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.

You should always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using KOVALTRY. If you are unsure of the procedures, please call your healthcare provider before using.

Call your healthcare provider right away if bleeding is not controlled after using KOVALTRY.

Your healthcare provider will prescribe the dose that you should take.

Your healthcare provider may need to take blood tests from time to time.

Talk to your healthcare provider before traveling. You should plan to bring enough KOVALTRY for your treatment during this time.

See the step-by-step instructions below for reconstituting KOVALTRY with vial adapter. Follow the specific infusion instruction leaflet included with the infusion set provided.

Carefully handle KOVALTRY. Dispose of all materials, including any leftover reconstituted KOVALTRY product, in an appropriate container.

Reconstitution

Always work on a clean surface and wash your hands before performing the following procedure. Use only the components for reconstitution and administration that are provided with each package of KOVALTRY. If a package is opened or damaged, do not use this component. If these components cannot be used, please contact your healthcare provider.

Prepare a clean flat surface and gather all the materials needed for the infusion.

1. Warm the unopened diluent syringe and the concentrate vial to a temperature not to exceed 37°C or 99°F.
2. Remove protective cap from the vial (A). Aseptically cleanse the rubber stopper with a sterile alcohol swab, being careful not to handle the rubber stopper.
3. Place product vial on a firm, non-skid surface. Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Holding the adapter housing, place over the product vial and firmly press down (B). The adapter will snap over the vial cap. Do not remove the adapter housing at this step.
4. Holding the syringe by the barrel, snap the syringe cap off the tip (C). Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use.
5. Now remove and discard the adapter plastic housing (D).
6. Attach the prefilled syringe to the vial adapter thread by turning clockwise (E).
7. Remove the clear plastic plunger rod from the carton. Grasp the plunger rod by the top plate. Avoid touching the sides and threads of the plunger rod. Attach the plunger rod by turning it clockwise into the threaded rubber stopper of the prefilled syringe (F).
8. Inject the diluent slowly by pushing down on the plunger rod (G).
9. Swirl vial gently until all powder on all sides of the vial is dissolved (H). Do not shake vial. Be sure that all powder is completely dissolved. Do not use if solution contains visible particles or is cloudy.
10. Push down on the plunger to push all air back into the vial. Then while holding the plunger down, turn the vial with syringe upside-down (invert) so the vial is now above the syringe (I).
11. Withdraw all the solution into the syringe by pulling the plunger rod back slowly and smoothly (J). Tilt the vial to the side and back to make sure all the solution has been drawn toward the large opening in the rubber stopper and into the syringe. Remove as much air as possible before removing the syringe from the vial by slowly and carefully pushing the air back into the vial.
12. Detach the syringe with plunger rod from the vial adapter by turning counter-clockwise. Attach the syringe to the administration set provided and inject intravenously (K). NOTE: follow instructions for infusion set provided.

Pooling

If the dose requires more than one vial, reconstitute each vial as described above with the diluent syringe provided. To combine the content of the vials, use a larger plastic syringe (not provided) to pool the solution into the syringe and administer as usual.

Rate of Administration

The entire dose of KOVALTRY can usually be infused within 1 to 15 minutes. Your healthcare provider will determine the rate of administration that is best for you.

Resources at Bayer available to the patient:

For Adverse Reaction Reporting, contact Bayer Medical Communications 1-888-84-BAYER (1-888-842-2937)

To receive more product information, contact KOVALTRY Customer Service 1-888-606-3780

Bayer Reimbursement HELPline 1-800-288-8374

For more information, visit www.KOVALTRY-us.com

Bayer HealthCare LLC
Whippany, NJ 07981 USA

U.S. License No. 8

 

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Revised: 01/2021

NDC 0026-3821-25
Kovaltry 250 IU Range
Antihemophilic Factor (Recombinant)
Recombinant Factor VIII

with Vial Adapter

For Intravenous Use Only

Needleless Reconstitution Set

NDC 0026-3822-25
Kovaltry 500 IU Range
Antihemophilic Factor (Recombinant)
Recombinant Factor VIII

with Vial Adapter

For Intravenous Use Only

Needleless Reconstitution Set

NDC 0026-3824-25
Kovaltry 1000 IU Range
Antihemophilic Factor (Recombinant)
Recombinant Factor VIII

with Vial Adapter

For Intravenous Use Only

Needleless Reconstitution Set

NDC 0026-3826-50
Kovaltry 2000 IU Range
Antihemophilic Factor (Recombinant)
Recombinant Factor VIII

with Vial Adapter

For Intravenous Use Only

Needleless Reconstitution Set

NDC 0026-3828-50
Kovaltry 3000 IU Range
Antihemophilic Factor (Recombinant)
Recombinant Factor VIII

with Vial Adapter

For Intravenous Use Only

Needleless Reconstitution Set