Dave was born prematurely and spent the first year of his life in the hospital, later diagnosed with hemophilia A at 15 months of age. Growing up in the southwest with his mother as single parent, Dave describes the biggest challenge of living with hemophilia A as just trying to be a kid and enjoy fun things. “I always wanted to play sports and be active — basketball, baseball, climbing, and bicycling. My Mom didn't like that I played so many sports and participated in other physical activities because it made me more susceptible to injury and it was hard to get me proper treatment.” Despite these challenges, Dave excelled in scholastics and graduated from National American University, earning a Bachelor of Science degree in Business Administration. “I was always a good student, interested in learning. That my Mom did like!”
Before switching to NUWIQ®, Dave was treated with an alternative infusion product, which he received for 10 years. However, he experienced troublesome side effects: rash and irritation as the product was infused. “It just made a hard process even harder and made me much less happy about infusing in general.” After many years of using the first–generation FVIII concentrate, Dave decided to explore other options. “It was time for a change. I wanted to see what else was available – and I did not want a FVIII product that was made from hamster cells.”
Dave did his research. He liked that NUWIQ was expressed in a human cell line with no chemical modifications. So, he made the switch. He worked with his doctor to create a personalized prophylaxis regimen, which only required 2 visits to his HTC for PK testing. “When I finally switched, I had many questions. How will this new product affect me? Will it be better for me? Will there be any side effects?”
“I was on my previous treatment 3 times per week. With NUWIQ, I was able to reduce it to twice per week. I feel like I'm able to do more even though I am infusing less.” Dave appreciates the convenience of NUWIQ when he travels, pointing out that NUWIQ is the only recombinant FVIII that offers 2.5 mL diluent volume across all vial sizes. Finally, Dave reports that with NUWIQ, he is getting the bleeding control he has been looking for.
“I would tell anyone who is thinking about switching their FVIII medication to consider NUWIQ. I'm very satisfied with how it works for me. It gets to the bleed fast, and I no longer have to deal with the rash and irritation when infusing. And everything you need is right there in the box: a pre–filled syringe with 2.5 mL diluent, a vial adapter, a butterfly needle, and even alcohol swabs!”
Today Dave continues his active lifestyle and enjoyment of physical activity, confident in his ability to manage any injuries with prophy or on–demand treatment with NUWIQ when needed. He enjoys his work in business and spending time with his wife and son.
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Indications and Important Safety Information for NUWIQ® [Antihemophilic Factor (Recombinant)].
Please see NUWIQ full Prescribing Information. Instructions For Use
Indications and Usage
NUWIQ® is a recombinant antihemophilic factor [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 routine prophylaxis to reduce the frequency of bleeding episodes. NUWIQ® is not indicated for the treatment of von Willebrand Disease.
Contraindications
NUWIQ is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components.
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.
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).
Adverse Reactions
The most frequently occurring adverse reactions (>0.5%) in clinical trials were paresthesia, headache, injection site inflammation, injection site pain, non-neutralizing anti-Factor VIII antibody formation, back pain, vertigo, and dry mouth.
Please see NUWIQ full Prescribing Information. Instructions For Use
Indications and Important Safety Information for wilate® [von Willebrand Factor/Coagulation Factor VIII Complex (Human)].
Please see wilate full Prescribing Information.
Indications
wilate® is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes and for perioperative management of bleeding. wilate is also indicated in adolescents and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; and for on-demand treatment and control of bleeding episodes.
Contraindications
wilate® is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation, or components of the container.
Warnings and Precautions
Hypersensitivity Reactions
Hypersensitivity reactions may occur with wilate®. Signs and symptoms include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing that may progress to severe anaphylaxis (including shock) with or without fever. Closely monitor patients receiving wilate® and observe for any symptoms throughout the infusion period.
Because inhibitor antibodies may occur concomitantly with anaphylactic reactions, evaluate patients experiencing an anaphylactic reaction for the presence of inhibitors
Neutralizing Antibodies
VWD
Hemophilia A
Transmissible Infectious Agents
wilate® is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent. There is also the possibility that unknown infectious agents may be present in the product. The risk that wilate® will transmit viruses has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and removing certain viruses during manufacture. Despite these measures, it may still potentially transmit disease.
Record the batch number of the product every time wilate® is administered to a patient, and consider appropriate vaccination (against hepatitis A and B virus) of patients in regular/repeated receipt of wilate®. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Octapharma USA, Inc., at 1-866-766-4860.
Monitoring and Laboratory Tests
Adverse Reactions
The most common adverse reactions to treatment with wilate (≥ 1%) in patients with VWD were hypersensitivity reactions, urticaria, and dizziness. The most common adverse reactions to treatment with wilate (≥ 1%) in previously treated patients with hemophilia A was pyrexia (fever).
Please see wilate full Prescribing Information.
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