Nuwiq is an FDA-approved product used to treat and control bleeding episodes in children and adults living with hemophilia A. People with hemophilia A have trouble controlling bleeding following injury or surgery; some may have spontaneous bleeding.
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About Copay AssistanceWhat Is Nuwiq?
Nuwiq is a brand-name prescription medication.
The active drug in this product is recombinant clotting factor VIII (rFVIII). rFVIII is also known as recombinant antihemophilic factor. It’s in a class of medicines called antihemophilic factors. The term “recombinant” means Nuwiq is made in a lab using recombinant DNA technology.
Little or no clotting factor VIII is present in the blood of people with hemophilia A. Because clotting factor VIII is essential for clot formation, its deficiency or absence can lead to potentially fatal spontaneous internal bleeding.
Mild hemophilia A may cause trouble controlling bleeding following injury or surgery.
The US FDA initially approved Nuwiq to treat and control bleeding episodes in children and adults with hemophilia A in 2015.
This medication works by replacing factor VIII in people living with hemophilia A.
What Is Nuwiq Used To Treat?
The US FDA has approved Nuwiq for use in children and adults to:
- Control and treat bleeding episodes.
- Prevent bleeding during surgery.
- Reduce the frequency of bleeding episodes.
This product shouldn’t be used to treat another type of bleeding disorder called von Willebrand disease.
What Should You Know Before Using Nuwiq?
Tell your provider if you have ever had inhibitors to factor VIII.
How Is Nuwiq Supplied and Used?
This medicine comes as a white, sterile powder for intravenous infusion in single-use vials. The following strengths (measured in international units/IU) are available in the US:
- 250 IU
- 500 IU
- 1,000 IU
- 1,500 IU
- 2,000 IU
- 2,500 IU
- 3,000 IU
- 4,000 IU
One IU, in this medication, measures the amount of clotting factor VIII that is approximately equal to the level of factor VIII activity in 1 ml of human plasma.
Proper Use
Your provider will perform a blood test to determine if this medication best suits your needs.
Before giving you Nuwiq as an infusion into your vein, your provider will calculate the dose using specific formulas. Then, they will prepare the solution for intravenous injection following instructions on the package.
Factors that determine the dose and duration of treatment include:
- Severity of factor VIII deficiency
- Location and severity of bleeding
- Your body weight and overall health
- Desired factor VIII level
- Condition being treated
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What Are the Side Effects of Nuwiq?
Common Side Effects
- Upper or lower respiratory tract infection
- Headache
- Fever
- Cough
- Inflammation in the nose or throat
- Chills
- Abdominal pain
- Joint pain
- Anemia
- Pain, swelling, itching, or redness at the injection site
Allergic Reactions
Some users may develop allergic reactions. Get emergency medical care if you have:
- Dizziness
- Loss of consciousness
- Difficulty breathing
- Wheezing
- Chest tightness
- Swelling of lips and tongue
- Rash
- Hives
- Fast heartbeat
- Cold sweats
Serious Side Effects
Call your provider immediately if you have:
- Increased bleeding episodes
- Any bleeding that will not stop
- Chest pain
- A feeling like you might faint
Development of Inhibitors
Antibodies (proteins) that make Nuwiq less effective may form in some users. These proteins, also known as inhibitors, neutralize factor VIII. Inhibitors can make it hard to stop bleeding episodes.
You will be monitored for factor VIII activity and the development of inhibitors. If you develop inhibitors, you’ll need special treatment until your body no longer produces them.
Who Shouldn’t Receive Nuwiq?
You shouldn’t use this medication if you have ever had a severe allergic reaction to this product or product components.
Use in Pregnancy and Lactation
There are no human or animal data for use in pregnant women. Likewise, it’s unclear if this medicine is present in breast milk or if it harms the breastfed infant. Tell your provider if you are pregnant or nursing a child.
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Can You Self-Administer Nuwiq?
You may self-administer this medication if you have been trained to do so by your provider. Appropriate training is also available at hemophilia treatment centers.
Find the guidelines for mixing and infusing Nuwiq here.
Before a self-infusion, remember the following:
- Use Nuwiq exactly as instructed.
- Follow all directions on the prescription label.
- Never use this medication in a quantity or duration other than what is recommended.
- Check the strength of the product on the label.
- Never self-administer if you aren’t clear about how to use the injection.
- Always use sterile water and a reconstitution device (available with the product) to prepare the liquid for injection.
- Don’t refrigerate the solution after mixing.
- Use the solution within 3 hours after mixing.
- Before infusing the liquid, visually check the solution for particles. It should be clear and colorless; no visible particles should be there.
- Never use a cloudy solution.
- A single-use vial, as the name suggests, is for one use only.
- Put all the devices and Nuwiq in a puncture-proof sharps container before disposing. Never dispose of any of them in ordinary household trash.
- Your provider may order frequent blood tests to check if the treatment is working or if you need to change your doses.
Nuwiq Storage
- Store Nuwiq in the original container to protect it from sunlight.
- Do not freeze this product.
- You may store it in the refrigerator for up to 24 months at 36°F to 46°F.
- You may store it at room temperature (up to 77°F) for a single period of not more than 90 days (note the date when you removed the medication from the refrigerator).
- After 90 days of storage at room temperature, use or discard the product. Never store it back in the refrigerator.
- Don’t use it after the expiration date. You can find the expiration date printed on the vial.
What Happens if I Miss a Dose?
There may be no dosing schedule because you use this medicine when needed. That said, if you follow a schedule, take the missed dose as soon as you can after you remember. Skip the missed dose if it’s closer to the time for the next scheduled dose. Never use an additional dose to compensate for the missed one.
What Happens if I Overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Nuwiq vs. Advate: What’s the Difference?
Both products are FDA-approved to treat and control bleeding episodes in people with hemophilia A. Likewise, both are made using DNA recombinant technology. However, Nuwiq is a human cell line-derived recombinant factor VIII, while Advate is derived from a hamster cell line.
How Much Does Nuwiq Cost?
Cost can vary depending on your insurance plan, geographical location, and pharmacy. Contact your insurance provider to find out if your plan covers this medicine or if you need prior authorization.
Octapharma, which makes Nuwiq, provides patient support to eligible patients through its NUWIQ Co-Pay & Reimbursement Assistance Program. Contact us if you are interested in exploring financial assistance for Nuwiq.
