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nuwiq patient assistance

by Mr. Walker Farrell Published 2 years ago Updated 1 year ago
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Patient Assistance & Copay Programs for Nuwiq Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or discounted medicines and copay programs to low income or uninsured and under-insured people who meet specific guidelines. Eligibility requirements vary for each program.

Full Answer

Can nuwiq be used for hemophilia A?

Nuwiq can reduce the number of bleeding episodes in children and adults when used regularly (prophylaxis). Usually, Hemophilia A treatment is life-long. Your healthcare provider may also give you Nuwiq when you have surgery. Nuwiq is NOT used to treat von Willebrand disease. Who should not use Nuwiq ?

Is nuwiq safe for pediatric patients?

The safety and efficacy of Nuwiq were assessed in a study in 59 previously treated pediatric patients (58 patients 2 to 11 years old) who received at least one dose of Nuwiq for routine prophylaxis.

How much nuwiq do you give for a bleeding episode?

The mean dose per injection used to treat a bleeding episode was 32 IU/kg. Hemostatic efficacy in response to Nuwiq treatment was rated as excellent or good in 94% and as moderate in 6% of the bleeds.

How much does nuwiq cost?

The cost for Nuwiq intravenous kit (recombinant albumin-free) is around $11 for a supply of 1 kits, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.

How much does a free drug card save?

What is Nuwiq used for?

How many IUs is Nuwiq Factor My Way free trial?

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How much does a free drug card save?

The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.

What is Nuwiq used for?

Nuwiq (antihemophilic factor) is a member of the miscellaneous coagulation modifiers drug class and is commonly used for Hemophilia A.

How many IUs is Nuwiq Factor My Way free trial?

Nuwiq Factor My Way Free Trial Program: Eligible patients may receive free trial treatment at no cost (not to exceed 6 doses or not exceed approximately 20,000 IUs); for additional information contact the program at 866-830-6541.

How long does it take for Nuwiq to work?

A total of 1124 bleeding episodes in 69 subjects (35 adults, 2 adolescents, and 32 children) were treated with Nuwiq. Response to each treatment was assessed by the patients using an ordinal scale of excellent (abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion), good (definite pain relief and/or improvement in signs of bleeding within approximately 8–12 hours after an infusion requiring up to 2 infusions for complete resolution), moderate (probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution), or none (no improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution).

What is hemophilia A?

Hemophilia A is a bleeding disorder characterized by a deficiency of functional coagulation Factor VIII, resulting in a prolonged plasma clotting time as measured by the activated partial thromboplastin time (aPTT) assay. Treatment with Nuwiq normalizes the aPTT over the effective dosing period.

What is Nuwiq recombinant?

Nuwiq, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-use vials containing nominal Factor VIII potencies of 250, 500, 1000, 2000, 2500, 3000 or 4000 IU. When reconstituted with 2.5 mL of solvent (Sterile Water for Injection), the respective nominal concentrations are 100, 200, 400, 800, 1000, 1200 or 1600 IU/mL. The reconstituted product contains the following excipients per mL: 18 mg sodium chloride, 5.4 mg sucrose, 5.4 mg L-arginine hydrochloride, 0.3 mg calcium chloride dihydrate, 1.2 mg poloxamer 188, and 1.2 mg sodium citrate dihydrate. The concentration of each of the excipients is the same for all potencies. Nuwiq contains no preservatives. Each vial of Nuwiq is labeled with the actual Factor VIII potency expressed in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for Factor VIII concentrates. One IU, as defined by the WHO standard for human Factor VIII concentrates, is approximately equal to the level of Factor VIII activity in 1 mL of fresh pooled, normal, human plasma. The mean specific activity of Nuwiq is 8124 IU/mg total protein.

How safe is Nuwiq?

The safety and efficacy of Nuwiq were assessed in a study in 59 previously treated pediatric patients (58 patients 2 to 11 years old) who received at least one dose of Nuwiq for routine prophylaxis. The safety and efficacy in routine prophylaxis and on-demand treatment of bleeding episodes are comparable between children and adults [see Clinical Trial Experience (6) and Clinical Studies (14) ] . The pediatric pharmacokinetic data of Nuwiq were obtained in 29 children between 2 and 5 years of age and 30 children between 6 and ≤12 years of age. Half-life (T 1/2 ) and incremental in vivo recovery (IVR) are lower in children than in adults and systemic drug clearance is substantially higher in the pediatric age group 2 to 5 yrs compared to adults [see Clinical Pharmacology (12.3) ] . Higher doses and/or a more frequent dosing schedule for prophylactic treatment should be considered in pediatric patients aged 2 to 5 yrs.

What age group is PK?

PK of pediatric patients is presented in Table 5 for the age groups 2 to 5 years and 6 to 12 years. They were based on plasma Factor VIII activity measured by the one-stage clotting assay after a single intravenous infusion of 50 IU/kg dose. Compared to adults and adolescents, IVR and T 1/2 were lower and systemic drug clearance (based on per kg bodyweight) was substantially higher in children 2 to 5 yr of age.

How often is Nuwiq used in clinical trials?

All clinical trial subjects (N = 190) were monitored for neutralizing antibodies (inhibitors) to Factor VIII by the modified Bethesda assay using blood samples obtained prior to the first infusion of Nuwiq in all studies, at defined intervals (at ED 10 to 15, at three months , and every further three months) in five studies, and every three months in one study and at the completion visit in all studies. No subject developed neutralizing antibodies to Factor VIII.

What is the % of bleeds in adults?

Severity of bleeds (% of bleeds) in the adults were major 16 (36.4% ), minor – 28 (63.6%), life threatening 0. Severity of bleeds in the children was moderate or major 64 (42.6%), minor 61 (56.5%), unknown 1 (0.9%), life threatening 0. * Based on a negative binomial model.

How do I apply for the Nuwiq patient assistance program?

NiceRx makes it as easy as possible to apply for the Nuwiq patient assistance program. All you need to do is fill in our enrollment application. Tell us about any medications you’re taking, including Nuwiq. We’ll ask for details about your healthcare provider, insurance, and your household income, as this is required by the pharmaceutical manufacturers who ship your medication.

Can NiceRx help me get Nuwiq if I have insurance?

At NiceRx we help eligible individuals access the medications they need through patient assistance programs. You may be eligible in a range of scenarios including if you have insurance, but your insurance company won’t pay for your Nuwiq medication. We may also be able to help if you have a high copay or coinsurance responsibility, or no insurance in place at all.

How to report a WILATE batch?

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.

How to withdraw factor my way?

You may withdraw Your participation or revoke this authorization at any time by notifying Octapharma Customer Service, either via email at [email protected] or by calling 1-201-604-1130 stating that You no longer wish to participate in Factor My Way. You understand that if You do not accept this authorization, or if You revoke it, Your health care provider will still treat You for Your condition and You will still be eligible to receive an Octapharma treatment; however You will not be eligible for enrollment in the Program and You may not receive all the services.

What are the most common adverse reactions to wilate?

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).

What is the purpose of Wilate?

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.

What is Bethesda Units?

Use Bethesda Units (BU) to report inhibitor levels. 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.

Does VWF cause thromboembolic events?

In VWD, continued treatment using a FVIII-containing VWF product may cause an excessive rise in F VIII activity, which may increase the risk of thromboembolic events. Monitor plasma levels of VWF:RCo and FVIII activities in patients receiving wilate to avoid sustained excessive VWF and FVIII activity levels.

What is NUWIQ for?

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.

How much does a free drug card save?

The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.

What is Nuwiq used for?

Nuwiq (antihemophilic factor) is a member of the miscellaneous coagulation modifiers drug class and is commonly used for Hemophilia A.

How many IUs is Nuwiq Factor My Way free trial?

Nuwiq Factor My Way Free Trial Program: Eligible patients may receive free trial treatment at no cost (not to exceed 6 doses or not exceed approximately 20,000 IUs); for additional information contact the program at 866-830-6541.

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