"The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, k"...
(NNO-vo-eyt) Antihemophilic Factor (Recombinant) Lyophilized Powder for Intravenous Injection
Read the Patient Product Information and the Instructions For Use that come with Novoeight® before you start taking this medicine and each time you get a refill. There may be new information.
This Patient Product Information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have questions about Novoeight® after reading this information, ask your healthcare provider.
What is the most important information I need to know about Novoeight®?
Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center.
You must carefully follow your healthcare provider's instructions regarding the dose and schedule for infusing Novoeight® so that your treatment will work best for you.
What is Novoeight®?
Novoeight® is an injectable medicine used to replace clotting factor VIII that is missing in patients with hemophilia A. Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.
Novoeight® is used to control and prevent bleeding in people with hemophilia A.
Your healthcare provider may give you Novoeight® when you have surgery.
Novoeight® is not used to treat von Willebrand Disease.
Who should not use Novoeight®?
You should not use Novoeight® if you
- are allergic to factor VIII or any of the other ingredients of Novoeight
- if you are allergic to hamster proteins
Tell your healthcare provider if you are pregnant or nursing because Novoeight® might not be right for you.
What should I tell my healthcare provider before I use Novoeight®?
You should tell your healthcare provider if you
- Have or have had any medical conditions.
- Take any medicines, including non-prescription medicines and dietary supplements.
- Are nursing.
- Are pregnant or planning to become pregnant.
- Have been told that you have inhibitors to factor VIII.
How should I use Novoeight®?
Treatment with Novoeight® should be started by a healthcare provider who is experienced in the care of patients with hemophilia A.
Novoeight® is given as an injection into the vein.
You may infuse Novoeight® at a hemophilia treatment center, at your healthcare provider's office or in your home. You should be trained on how to do infusions by your hemophilia treatment center or healthcare provider. Many people with hemophilia A learn to infuse the medicine by themselves or with the help of a family member.
Your healthcare provider will tell you how much Novoeight® to use based on your weight, the severity of your hemophilia A, and where you are bleeding.
You may need to have blood tests done after getting Novoeight® to be sure that your blood level of factor VIII is high enough to clot your blood. This is particularly important if you are having major surgery.
Your healthcare provider will calculate your dose of Novoeight® (in international units, IU) depending on your condition and body weight.
Call your healthcare provider right away if your bleeding does not stop after taking Novoeight®.
Development of factor VIII inhibitors
Your body can also make antibodies called “inhibitors” against Novoeight®, which may stop Novoeight® from working properly.
If your bleeding is not adequately controlled, it could be due to the development of factor VIII inhibitors. This should be checked by your healthcare provider. You might need a higher dose of Novoeight® or even a different product to control bleeding. Do not increase the total dose of Novoeight® to control your bleeding without consulting your healthcare provider.
Use in children
Novoeight® can be used in children. Your healthcare provider will decide the dose of Novoeight® you will receive.
If you forget to use Novoeight®
Do not inject a double dose to make up for a forgotten dose. Proceed with the next injections as scheduled and continue as advised by your healthcare provider.
If you stop using Novoeight®
If you stop using Novoeight® you are not protected against bleeding. Do not stop using Novoeight® without consulting your healthcare provider.
If you have any further questions on the use of this product, ask your healthcare provider.
What if I take too much Novoeight®?
Always take Novoeight® exactly as your healthcare provider has told you. You should check with your healthcare provider if you are not sure. If you inject more Novoeight® than recommended, tell your healthcare provider as soon as possible.
What are the possible side effects of Novoeight®?
Common Side Effects Include:
- swelling or itching at the location of injection
- changes in liver tests
Other Possible Side Effects:
You could have an allergic reaction to coagulation factor VIII products. Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction:
- rashes including hives
- difficulty breathing, shortness of breath or wheezing
- tightness of the chest or throat, difficulty swallowing
- swelling of the lips and tongue
- light-headedness, dizziness or loss of consciousness
- pale and cold skin, fast heart beat which may be signs of low blood pressure
- red or swollen face or hands
These are not all of the possible side effects from Novoeight®. Ask your healthcare provider for more information. You are encouraged to report side effects to FDA at 1-800-FDA-1088.
Tell your healthcare provider about any side effect that bothers you or that does not go away.
What are the Novoeight® dosage strengths?
Novoeight® comes in six different dosage strengths. The actual number of international units (IU) of factor VIII in the vial will be imprinted on the label and on the box. The six different strengths are as follows:
Dosage strength of approximately 250 IU per vial
Dosage strength of approximately 500 IU per vial
Dosage strength of approximately 1000 IU per vial
Dosage strength of approximately 1500 IU per vial
Dosage strength of approximately 2000 IU per vial
Dosage strength of approximately 3000 IU per vial
Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your doctor.
How should I store Novoeight®?
Prior to Reconstitution:
Store in original package in order to protect from light. Do not freeze Novoeight®.
Novoeight® vials can be stored in the refrigerator (36–46°F [2°C–8°C]) for up to 30 months or up to the expiration date, or at room temperature (up to 86°F [30°C]) for a single period not exceeding 12 months.
If you choose to store Novoeight® at room temperature:
- Note the date that the product is removed from refrigeration on the box.
- The total time of storage at room temperature should not exceed 12 months. Do not return the product to the refrigerator.
- Do not use after 12 months from this date or the expiration date listed on the vial, whichever is earlier.
Do not use this medicine after the expiration date which is on the outer carton and the vial.
The expiration date refers to the last day of that month.
After Reconstitution (mixing the dry powder in the vial with the diluent):
The reconstituted Novoeight® should appear clear to slightly unclear without particles.
The reconstituted Novoeight® should be used immediately.
If you cannot use the Novoeight® immediately after it is mixed, it should be used within 4 hours when stored at ≤ 86°F (30°C). Store the reconstituted product in the vial.
Keep this medicine out of the sight and out of reach of children.
What else should I know about Novoeight® and hemophilia A?
Medicines are sometimes prescribed for purposes other than those listed here. Do not use Novoeight® for a condition for which it is not prescribed. Do not share Novoeight® with other people, even if they have the same symptoms that you have.
Instructions on how to use
READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT®.
Novoeight® is supplied as a powder. Before injection (administration) it must be mixed (reconstituted) with the liquid diluent supplied in the syringe. The liquid diluent is a sodium chloride solution. The mixed Novoeight® must be injected into your vein (intravenous injection). The equipment in this package is designed to mix and inject Novoeight®.
You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads, and bandages.
Don't use the equipment without proper training from your doctor or nurse.
Always wash your hands and ensure that the area around you is clean.
When you prepare and inject medication directly into the veins, it is important to use a clean and germ free (aseptic) technique. Improper technique can introduce germs that can infect the blood.
Don't open the equipment until you are ready to use it.
Don't use the equipment if it has been dropped, or if it is damaged. Use a new package instead.
Don't use the equipment if it is expired. Use a new package instead. The expiration date is printed on the outer carton and on the vial, the vial adapter and the pre-filled syringe.
Don't use the equipment if you suspect it is contaminated. Use a new package instead.
Don't dispose of any of the items until after you have injected the mixed solution.
The equipment is for single use only.
The package contains:
- Vial with Novoeight® powder
- Vial adapter
- Pre-filled syringe with diluent
- Plunger rod (placed under the syringe)
1. Prepare the vial and the syringe
- Take out the number of Novoeight®packages you need.
- Check the expiry date.
- Check the name and the color of the package, to make sure it contains the correct product.
- Wash your hands and dry them properly using a clean towel or air dry.
- Take the vial, the vial adapter and the pre-filled syringe out of the carton. Leave the plunger rod untouched in the carton.
- Bring the vial and the pre-filled syringe to room temperature. You can do this by holding them in your hands until they feel as warm as your hands.
- Remove the plastic cap from the vial. If the plastic cap is loose or missing, don't use the vial.
- Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible.
- Don't touch the rubber stopper with your fingers as this can transfer germs.
2. Attach the vial adapter
- Remove the protective paper from the vial adapter.
- Don't take the vial adapter out of the protective cap with your fingers. If you touch the spike on the vial adapter germs from your fingers can be transferred.
- If the protective paper is not fully sealed or if it is broken, don't use the vial adapter.
- Place the vial on a flat and solid surface.
- Turn over the protective cap, and snap the vial adapter onto the vial. Once attached, don't remove the vial adapter from the vial.
Lightly squeeze the protective cap with your thumb and index finger as shown. Remove the protective cap from the vial adapter. Don't lift the vial adapter from the vial when removing the protective cap.
3. Attach the plunger rod and the syringe
- Grasp the plunger rod by the wide top end and take it out of the carton. Don't touch the sides or the thread of the plunger rod. If you touch the sides or the thread germs from your fingers can be transferred.
- Immediately connect the plunger rod to the syringe by turning it clockwise into the rubber plunger inside the pre-filled syringe until resistance is felt.
- Remove the syringe cap from the pre-filled syringe by bending it down until the perforation breaks.
Don't touch the syringe tip under the syringe cap. If you touch the syringe tip germs from your fingers can be transferred.
If the syringe cap is loose or missing, don't use the pre-filled syringe.
- Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
4. Mix the powder with the diluent
- Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
- Push the plunger rod to inject all the diluent into the vial.
- Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved. Don't shake the vial as this will cause foaming.
- Check the mixed solution. It must be clear to slightly opalescent (slightly unclear). If you notice visible particles or discoloration, don't use it. Use a new package instead.
Novoeight® is recommended to be used immediately after it is mixed. This is because if left, the medicine may no longer be sterile and could cause infections.
If you cannot use the mixed Novoeight® solution immediately, it should be used within 4 hours when stored at ≤ 86°F (30°C). Store the reconstituted product in the vial.
Do not freeze mixed Novoeight®solution or store it in syringes.
- Keep mixed Novoeight®solution out of direct light.
- If your dose requires more than one vial, repeat step A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
- Keep the plunger rod pushed completely in.
- Turn the syringe with the vial upside down.
- Stop pushing the plunger rod and let it move back on its own while the mixed solution fills the syringe.
- Pull the plunger rod slightly downwards to draw the mixed solution into the syringe.
- In case you only need part of the entire vial, use the scale on the syringe to see how much mixed solution you withdraw, as instructed by your doctor or nurse.
- While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
- Push the plunger rod slowly until all air bubbles are gone.
- Unscrew the vial adapter with the vial.
Don't touch the syringe tip. If you touch the syringe tip germs from your fingers can be transferred.
Caution: The pre-filled diluent syringe is made of glass with an internal tip diameter of 0.037 inches, and is compatible with a standard Luer-lock connector.
Some needleless connectors for intravenous catheters are incompatible with the glass diluent syringes (for example, certain connectors with an internal spike, such as Clave®/MicroClave®, InVision-Plus®, InVision- Plus CS®, Invision-Plus Junior®, Bionector®).
The use of these needleless connectors can damage the connector and affect administration.
To administer Novoeight®through incompatible needleless connectors, withdraw reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe.
If you have encountered any problems with attaching the pre-filled sodium chloride diluent syringe to any Luer-lock compatible device, please contact Novo Nordisk at (844) 303-4448.
5. Inject the mixed solution
Novoeight® is now ready to inject into your vein.
- Do not mix Novoeight® with any other intravenous infusions or medications.
- Inject the mixed solution slowly over 2 to 5 minutes as instructed by your doctor or nurse.
- Use a clean and germ free (aseptic) technique. Follow the instructions for proper use for your connector and central venous access device in consultation with your doctor or nurse.
- Injecting into a CVAD may require using a sterile 10 mL plastic syringe for withdrawal of the mixed solution and injection.
- If necessary, use 0.9% Sodium Chloride Injection, USP to flush the CVAD line before or after Novoeight® injection.
The peel-off label found on the Novoeight® vial can be used to record the lot number.
- After injection, safely dispose of all unused Novoeight® solution, the syringe with the infusion set, the vial with the vial adapter, and other waste materials in an appropriate container for throwing away medical waste.
Don't throw it out with the ordinary household trash.
Don't disassemble the vial and vial adapter before disposal.
Don't reuse the equipment.
Contact your healthcare provider or local hemophilia treatment center if you experience any problems.
For full Prescribing Information please read the other insert included in this package.
Last reviewed on RxList: 4/5/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Novoeight Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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