Ryan was diagnosed with severe hemophilia A when he was 9 months old. Today, in his 40's, he lives in Maryland, near Baltimore, with his wife and two children. “I guess you could say that treatment for hemophilia and I matured right alongside each other. Since I'm considered part of the ‘older generation’ of people with a bleeding disorder, and because I work with a specialty pharmacy serving people who have hemophilia, a lot of people ask me questions on the state of treatment. It has really evolved! I'm much happier for the younger generation and people coming of age today because they've been doing FVIII prophylaxis since they were very young – with products like NUWIQ ® – and it's provided them with much better lives in the long run.”
Growing up, Ryan took various kinds of treatments to manage his bleeds but wasn't really satisfied until he discovered FVIII therapy. “I've become a big believer in FVIII. It is very safe, very effective, and there are different variations to fit everyone's needs.” Today Ryan is a strong advocate for FVIII therapy as the standard of care in hemophilia A, especially as the use of non–FVIII medications increases. “I see that some doctors and HTCs are pushing non–FVIII treatment. I wonder about the risks. Can you develop a clot? How will your system react? I haven't really gotten straight answers to these questions. And as someone who works in the bleeding disorders community, I've seen the non–FVIII products first–hand. I'm not really comfortable with switching from a FVIII product.” Ryan suggests that if you're being advised to switch medications, you do your own research, and get information from sources you trust.
“I am very concerned about what goes into my body, so a product based on a human cell line was of particular interest to me. It just seems more natural.” Ryan learned about NUWIQ through his work, and he was impressed. He switched to NUWIQ prophylaxis and it has been a good fit for him. Currently Ryan takes NUWIQ 3 times per week, self–infusing at home. “I could probably go to 2 times a week but I'm pretty active. I prefer the extra coverage, and I'm pretty much a pro at doing my own infusions!” Since switching to NUWIQ, Ryan reports that he has had zero bleeds. “I also feel better. With NUWIQ, I've been able to go back to the gym and exercise more.”
Ryan has done extensive outreach with the hemophilia community for over 15 years, having served as VP for Hemophilia Foundation of Maryland as well as through his work with a specialty pharmacy. His advice to patients? “Don't let your condition hold you back, but always keep safety in mind. Every product has pluses and minuses, and it may not work in your body the same way as another. You are in charge of your body, your treatment, and your life.”
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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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