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BLEEDING PREVENTION & CONTROL

How well does prophylaxis with NUWIQ prevent bleeds? Could NUWIQ prophylaxis keep me “bleed-free”?

For patients with severe hemophilia A, especially children, the World Federation of Hemophilia (WFH), NBDF (National Bleeding Disorders Foundation), and other hemophilia organizations recommend prophylaxis (or preventive treatment) with factor VIII (FVIII) as the standard of care to prevent joint and other types of spontaneous and breakthrough bleeds.1,2

In studies of adults (n=32) and children (n=59) with severe hemophilia A, NUWIQ prophylaxis (given every other day or 3 times per week for 6 months or more) in adults and children was highly effective at reducing bleeding frequency, with many patients remaining free of spontaneous bleeds (median ABR).3

& Children

rate.

Indications and Usage

NUWIQ® is a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII)] indicated in adults and children with Hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and for routine prophylaxis to reduce the frequency of bleeding episodes. NUWIQ is not indicated for the treatment of von Willebrand Disease.

What if I get a breakthrough bleed while on prophylaxis? How effective is NUWIQ in managing breakthrough bleeds?

Even with regular prophylaxis, breakthrough bleeding can occur, such as on “off” days in between scheduled infusions or from injuries. In studies of NUWIQ prophylaxis in people with severe hemophilia A, breakthrough bleeds were effectively managed 3:

Efficacy with NUWIQ for breakthrough bleeds3

ADULTS

Efficacy rated as “excellent” or “good” in 100% of bleeds

CHILDREN

Efficacy rated as “excellent” or “good” in 82% of bleeds

NUWIQ is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components.

BLEEDING PREVENTION & CONTROL

(continued)

What is personalized prophylaxis, and how effective is it at preventing bleeds?

Personalized prophylaxis is a treatment method where your dose and dosing interval is customized to your body’s pharmacokinetics (or PK), which is how medication is absorbed, broken down (metabolized), and then eliminated. Personalized prophylaxis has the potential to reduce the number of infusions while maintaining bleeding control.

In a study of PERSONALIZED PROPHYLAXIS with NUWIQ, the median ABR for all bleeds was ZERO. More than half of patients were able to extend their dosing interval to twice weekly or less.4

I don’t have many bleeds, so I treat on-demand. How effective is NUWIQ at resolving bleeds?

In clinical studies, on-demand treatment with NUWIQ provided excellent control and resolution of bleeding in people with severe hemophilia A who were treated for 986 spontaneous or traumatic bleeds. Most bleeds resolved with just one infusion.5-7

How well does NUWIQ control bleeding after major and minor surgery?

All patients with hemophilia, regardless of the severity, are at risk of bleeding during or after surgery. NUWIQ was shown to provide highly effective prevention and control of bleeding during and after major and minor surgery. Among 33 surgical procedures conducted in 10 patients 3:

Bleeding control with NUWIQ after surgery3

100%

92%

MINOR SURGERIES

Bleeding control rated as “excellent” in 100% of surgeries

MAJOR SURGERIES

Bleeding control rated as “excellent” or “good” in 92% of surgeries

Warnings and Precautions

Hypersensitivity reactions, including anaphylaxis, are possible with NUWIQ. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, or pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.

Warnings and Precautions (continued)

The formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following the administration of NUWIQ. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests. If the plasma Factor VIII level fails to increase as expected, or if bleeding is not controlled after NUWIQ administration, suspect the presence of an inhibitor (neutralizing antibody).

Please

INHIBITORS & SAFETY

Is the risk of inhibitors with NUWIQ different from other FVIII treatments?

Yes. FVIII products fall into 2 categories: (1) FVIII derived from donated plasma (pdFVIII); or (2) recombinant FVIII (rFVIII) manufactured using DNA technology derived from either a human cell line or hamster cell line. Differences in host cell line among available rFVIII products may impact the risk of inhibitors.8-9 In clinical studies, higher rates of inhibitors were seen with rFVIII products derived from hamster cells than pdFVIII or rFVIII derived from human cell lines.9

NUWIQ is derived from a human cell line and closely resembles the natural FVIII that is produced in the body. No animal or human proteins are added during manufacturing. The body’s immune system may be less likely to see the protein as foreign and make inhibitors against it.3,4,10,11

rFVIII products derived from hamster cell lines may contain small amounts of animal proteins.10 The immune system may see these proteins as foreign and produce inhibitors against them, which can potentially impair the ability of FVIII to control bleeding.

l In a well-known study called SIPPET (Survey of Inhibitors in Plasma-Product Exposed Toddlers), 126 previously untreated patients (or PUPs) were treated with hamster cell line-derived rFVIII and 125 with pdFVIII. The incidence of high-titer inhibitors was 28.4% for rFVIII, and 18.6% for pdFVIII9*

What is the risk of inhibitors with NUWIQ in PUPs?

NUWIQ has a proven low risk of inhibitors in PUPs.3,8 Inhibitors can impair the effectiveness of FVIII. The risk of inhibitors is related directly to the number of exposure days (EDs) during first-time FVIII treatment, and usually appear during the first 20 EDs. Inhibitors are measured in titers, with high-titer inhibitors associated with a greater loss of FVIII effectiveness.12,13

In the NuProtect trial with NUWIQ, the overall incidence of high-titer inhibitors was among the lowest reported with a rFVIII product—only 16.2% in 105 PUPs treated with NUWIQ.3,8*

*Results from the NuProtect study are presented in parallel to the SIPPET study for context, but please note that these trials were performed under different conditions and in different populations. The observed incidence of inhibitor formation may be influenced by a number of factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Differences in high-titer inhibitor rates between pdFVIII and rFVIII in the SIPPET trial were not found to be statistically significant. The SIPPET authors suggested this may have been due to the small sample size of the study .

Adverse Reactions

The most frequently occurring adverse reactions (>5%) in clinical trials were upper respiratory tract infection, headache, fever, cough, lower respiratory tract infection, rhinitis, chills, abdominal pain, arthralgia, anemia, and pharyngitis.

Have any patients who switched to NUWIQ ever developed an inhibitor?

There are ZERO reports of inhibitors in patients who switched from other FVIII products to NUWIQ.3 In studies that included 135 PTPs, no patients who switched to NUWIQ from other rFVIII products or pdFVIII developed inhibitors after 50 or more exposure days and 6 months of treatment or longer.3

Are all human cell line-derived rFVIII products the same?

No. Although similar, rFVIII products derived from human cell lines are not the same. NUWIQ most closely resembles natural FVIII that is produced by the body. In fact, NUWIQ is the only rFVIII produced in a human cell line without chemical modification or protein fusion.14 That’s why we can call NUWIQ “A Natural Choice.” Other human cell line-derived rFVIII products that are on the market have been chemically modified.14

Also unique to NUWIQ is its high binding affinity (99% bound) to von Willebrand factor (VWF) 10,11,15,16

l VWF is another coagulation protein that’s important for helping the blood to clot

l In normal coagulation, FVIII and VWF bind and circulate together; VWF is like a chaperone for FVIII

l This binding helps protect FVIII and keep it from being eliminated from the body too quickly

Minimizing the amount of unbound FVIII in circulation may also help reduce the risk of inhibitor development11

Have any serious adverse reactions been reported with

NUWIQ?

NUWIQ has been shown to be safe and well tolerated in studies that included 135 PTPs3

l No patients experienced serious adverse reactions or anaphylaxis (a very serious allergic reaction)

l No patients stopped treatment because of an adverse reaction to NUWIQ

FVIII light chain

FVIII heavy chain Human glycan VWF binding site (yellow)

How many vial sizes does NUWIQ offer? Are there larger vial sizes?

NUWIQ offers flexible dosing for children and adults, with a wide range of dosage strength vials.3

l Available in 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 2500 IU, 3000 IU, and 4000 IU vials

Does NUWIQ have low diluent volume?

Yes. NUWIQ offers a low 2.5 mL diluent volume across the entire range of vial strengths. This is the lowest diluent volume among all currently approved FVIII products.3

Does the NUWIQ packaging have all of the infusion supplies I need?

Each NUWIQ box comes with a vial adapter, butterfly needle, and alcohol swabs, in addition to the NUWIQ vial and prefilled syringe.3

Important Safety Information

Contraindications

NUWIQ is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components.

Where can I learn how to reconstitute NUWIQ?

Is there an instructional video?

You can watch a step-by-step instructional video on the reconstitution and infusion of NUWIQ at NUWIQUSA.com/Taking NUWIQ or scan the QR code.

How do I store NUWIQ? How long can I keep it outside the refrigerator (at room temperature)?

Keep NUWIQ in its original box in the refrigerator to protect it from exposure to light.3

l Store NUWIQ in the refrigerator for up to 24 months at 36-46°F (2-8°C)

l NUWIQ can be kept at room temperature (up to 77°F [25°C]) for a single period not exceeding 3 months

l After being stored at room temperature, NUWIQ must not be put back into the refrigerator

SUPPORT & SERVICES

Does Octapharma offer patient support services for NUWIQ? Is there a free trial and co-pay program? Will my health insurance cover NUWIQ?

Factor My Way is Octapharma’s patient support program for people living with bleeding disorders, offering comprehensive resources for patients and caregivers, support services for those navigating care, reliable educational materials, and uplifting community connections.

Free Trial and Co-Pay Assistance

l Eligible patients can receive up to 6 doses of NUWIQ (not to exceed 20,000 IUs) at no cost

l Potential annual savings of up to $12,000 per year on the out-of-pocket costs associated with NUWIQ

Broad Regional & National Coverage: NUWIQ is covered in over 91% of commercial and Medicaid plans

A comprehensive, personalized patient support program for people living with bleeding disorders

Factor My Way Assistance

Financial assistance programs and real world insurance know-how all at your fingertips.

Factor My Way Connection

Meet experts and join our online support community to help you access resources and build relationships.

Factor My Way Events

Join scheduled live and on-demand digital information programs and events.

Factor My Way Learning

Learn-as-you-go, practical information about bleeding disorders, treatment, and lifestyle management.

To join the program, visit www.factormyway.com, call 1-855-498-4260, or scan the QR code.

Membership in Factor My Way is complimentary and open to anyone over the age of 18 in the USA.

Warnings and Precautions

Warnings and Precautions (continued)

see accompanying

Prescribing Information.

Octapharma USA, Inc.

117 W. Century Road Paramus, NJ 07652

Tel: 201-604-1130

Free Trial, Co-Pay Assistance, and Reimbursement

usreimbursement@octapharma.com

Tel: 800-554-4440

Medical Affairs

usmedicalaffairs@octapharma.com

For all inquiries relating to drug safety, or to report adverse events, please contact our local Drug Safety Officer: Tel: 201-604-1137 | Cell: 201-772-4546 | Fax: 201-604-1141 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Important Safety Information

Adverse Reactions

References: 1. Carcao M, et al. Carcao MD, et al. Blood. 2013;121(19):3946-3952. 2. MASAC Recommendation concerning prophylaxis for hemophilia A and B with and without Inhibitors. MASAC Document 267. https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document267-masac-recommendation-concerning-prophylaxis-for-hemophilia-a-and-b-with-and-without-inhibitors 3. NUWIQ full Prescribing Information. Paramus, NJ: Octapharma USA, Inc.; rev 2021. 4. Lissitchkov T, et al. Haemophilia. 2017;23:697-704. 5. Valentino LA, et al. Haemophilia. 2014;20(suppl 1):1–9. 6. Kessler C, et al. Haemophilia. 2015;21(suppl 1):1–12. 7. Lissitchkov T, et al. Haemophilia. 2016;22:225-231. 8. Liesner RJ, et al. Thromb Haemost. 2021;121:1400–1408. 9. Peyvandi F, et al. N Engl J Med. 2016;374:2054-2064. 10. Cafuir LA, Kempton CL. Ther Adv Hematol. 2017;8(10):303–313. 11. Sandberg H, et al. Thromb Res. 2012;130:808-817. 12. Carcao M, Goudemand J. Inhibitors in Hemophilia: A Primer. 5th ed. World Federation of Hemophilia. 2019. 13. Hemophilia Federation of America. Inhibitors. https://www.hemophiliafed.org/understanding-bleeding-disorders/complications/inhibitors 14. Altuviiio full Prescribing Information. Waltham, MA; Bioverativ Therapeutics Inc.; rev 2023. 15. Casademunt E, et al. Eur J Haematol. 2012;89:165-176. 16. Kannicht C, et al. Thromb Res. 2013;131:78-88.

www.NUWIQUSA.com

Please see accompanying full Prescribing Information.