Novoeight 2000 IU powder and solvent for solution for injection: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NovoEight250UI powder and solvent for solution for injection

NovoEight500UI powder and solvent for solution for injection

NovoEight1000UI powder and solvent for solution for injection

NovoEight1500UI powder and solvent for solution for injection

NovoEight2000UI powder and solvent for solution for injection

NovoEight3000UI powder and solvent for solution for injection

turoctocog alfa (recombinant human coagulation factor VIII)

Read the entire leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet as you may need to read it again.
If you have any questions, ask your doctor.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

What NovoEight is and what it is used for
What you need to know before using NovoEight
How to use NovoEight
Possible side effects
How to store NovoEight
Contents of the pack and other information

1. What NovoEight is and what it is used for

NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII. Factor VIII is a protein that occurs naturally in the blood and helps it to clot.

NovoEight is used to treat and prevent bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) and can be used in all age groups.

In patients with haemophilia A, factor VIII is missing or does not function properly. NovoEight replaces this missing or non-functioning factor VIII and helps the blood form clots at the site of bleeding.

2. What you need to know before using NovoEight

Do not use NovoEight:

if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6)
if you are allergic to hamster proteins.

Do not use NovoEight in either of these cases. If you are unsure, speak with your doctor before starting to use this medicine.

Warnings and precautions

Talk to your doctor before starting to use NovoEight.

There is a very small chance that an anaphylactic reaction (a sudden and severe allergic reaction) to NovoEight may occur. Early signs of an allergic reaction include rash, hives, urticaria, generalized itching, swelling of the lips and tongue, difficulty breathing, wheezing, chest tightness, general feeling of discomfort, and dizziness.

If any of these symptoms occur, stop the injection immediately and contact your doctor.

Talk to your doctor if you feel that bleeding is not controlled by the dose you are receiving, as there may be several reasons for this. Some people who use this medicine may develop antibodies against factor VIII (also known as factor VIII inhibitors). Factor VIII inhibitors reduce the effectiveness of NovoEight in preventing or controlling bleeding. If this happens, you may need a higher dose of NovoEight or another medicine to control bleeding. Do not increase the total dose of NovoEight to control bleeding without speaking to your doctor. Inform your doctor if you have previously been treated with factor VIII-containing medicines, especially if you have developed inhibitors, as the risk of this happening again is higher.

The development of inhibitors (antibodies) is a known complication that may occur during treatment with all factor VIII-containing medicines. These inhibitors, especially in large amounts, can prevent the treatment from working properly, so you and your child will be carefully monitored for the development of such inhibitors. If your bleeding or your child's bleeding is not being controlled with NovoEight, consult your doctor immediately.

Other medicines and NovoEight

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Driving and use of machines

NovoEight has no influence on the ability to drive or operate machinery.

NovoEight contains sodium

This medicine contains 30.5 mg of sodium (main component of table/cooking salt) per reconstituted vial. This corresponds to 1.5% of the maximum daily recommended sodium intake for an adult.

If you are on a sodium-controlled diet, speak with your doctor.

3. How to use NovoEight

A doctor experienced in treating patients with haemophilia A will initiate treatment with NovoEight. Always follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again.

Your doctor will calculate your dose based on your body weight and the intended use of the medicine.

Prevention of bleeding

The usual dose of NovoEight is 20 to 50 international units (IU) per kg of body weight. The injection is administered every 2 or 3 days. In some cases, especially in younger patients, more frequent injections or higher doses may be required.

Treatment of bleeding

The dose of NovoEight is calculated according to body weight and the desired factor VIII levels. The target factor VIII level depends on the severity and location of the bleeding.

Use in children and adolescents

NovoEight can be used in children of all ages. In children (under 12 years of age), higher doses or more frequent injections may be required. Adolescents (over 12 years of age) may use the same dose as adults.

How NovoEight is administered

NovoEight must be injected into a vein. See “Instructions for use of NovoEight” for further information.

If you use more NovoEight than you should

If you use more NovoEight than you should, contact your doctor or go to a hospital immediately.

If you forget to use NovoEight

If you have missed a dose and do not know how to make up for it, contact your doctor.

If you stop using NovoEight

If you stop treatment with NovoEight, you will no longer be protected against bleeding, or an existing bleed may not stop. Do not stop treatment with NovoEight without first talking to your doctor.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine.

If serious and sudden allergic reactions (anaphylactic reactions) occur (rarely), the injection must be stopped immediately. If you experience any of the following symptoms, contact your doctor immediately:

difficulty breathing, shortness of breath, or wheezing
chest tightness
swelling of the lips and tongue
rashes, hives, welts, or widespread itching
feeling dizzy or loss of consciousness
low blood pressure (cold, pale skin, palpitations).

Severe symptoms, including difficulty swallowing or breathing and redness and swelling of the face or hands, require immediate emergency treatment.

If you experience a severe allergic reaction, your doctor may switch your medication.

In children who have not previously been treated with Factor VIII-containing medicines, inhibitor antibodies (see section 2) may develop very frequently (more than 1 in 10 patients); however, in patients who have previously received Factor VIII treatment (more than 150 days of treatment), the risk is uncommon (less than 1 in 100 patients). If this happens to you or your child, treatment may no longer work properly, and you or your child may experience persistent bleeding. If this occurs, contact your doctor immediately.

Frequent adverse effects (may affect up to 1 in 10 people)

blood test results indicating changes in liver function
reactions (redness and itching) at the injection site.

Frequent adverse effects (may affect up to 1 in 10 people) in patients not previously treated with Factor VIII-containing medicines

skin redness
vein inflammation
joint bleeding
muscle tissue bleeding
cough
redness around the catheter insertion site
vomiting.

Uncommon adverse effects (may affect up to 1 in 100 people)

feeling tired
headache
dizziness
difficulty sleeping (insomnia)
palpitations
increased blood pressure
rash
fever
feeling of warmth
muscle stiffness
muscle pain
pain in arms and legs
swelling of arms and legs
joint disease
bruising
myocardial infarction.

Adverse effects in children and adolescents

The adverse effects observed in children and adolescents are the same as those observed in adults.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of NovoEight

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, vial label, and pre-filled syringe label following EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Keep the vial in the outer packaging to protect it from light.

Before reconstitution, NovoEight powder may be stored at:

room temperature (≤30°C) for a single period not exceeding 9 months

above room temperature (from 30°C to 40°C) for a single period not exceeding 3 months.

Once the product has been removed from refrigeration, it must not be refrigerated again.

Please record the date and temperature when storage at room temperature begins on the product packaging.

After reconstitution, NovoEight must be used immediately. If immediate use is not possible, the reconstituted NovoEight solution must be used within:

24 hours when stored between 2°C and 8°C
4 hours when stored at ≤30°C, for product previously stored for a single period not exceeding 9 months at room temperature (≤30°C)
4 hours when stored up to 40°C, for product previously stored for a single period not exceeding 3 months above room temperature (from 30°C to 40°C)

If the reconstituted medicine is not used immediately, store it in the vial. Otherwise, it will no longer remain sterile and may cause infection. Do not store the solution unless advised by your doctor.

The powder in the vial is white or slightly yellow. Do not use if the powder has changed colour.

The reconstituted solution will be clear to slightly opalescent. Do not use this medicine if it appears cloudy or contains visible particles.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of NovoEight

The active substance is turoctocog alfa (recombinant human coagulation factor VIII). Each vial of NovoEight contains 250, 500, 1000, 1500, 2000 or 3000 IU of turoctocog alfa.
The other components are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
The components of the solvent are sodium chloride and water for injections.

After reconstitution with the supplied solvent (injection solution containing sodium chloride 9 mg/ml (0.9%)), the prepared injection solution contains 62.5, 125, 250, 375, 500 or 750 IU of turoctocog alfa per ml, respectively (based on the concentration of turoctocog alfa, i.e., 250, 500, 1000, 1500, 2000 or 3000 IU).

Nature of the product and pack contents

NovoEight is a powder and solvent for solution for injection. Each NovoEight pack contains one vial with white or slightly yellow powder, one pre-filled syringe with 4 ml of a colourless and clear solution, one plunger rod and one vial adapter.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd, Denmark

Date of the latest revision of this leaflet:

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for Use of NovoEight

READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT.

NovoEight is supplied as a powder. Prior to injection (administration), it must be reconstituted with the solvent provided in the syringe. The solvent is a 9 mg/ml (0.9%) sodium chloride solution. Reconstituted NovoEight should be injected into a vein (intravenous injection). The components in this package are designed to reconstitute and inject NovoEight.

You will also need an infusion set (tubing and butterfly needle), sterile alcohol wipes, gauze, and adhesive bandages. These items are not included in the NovoEight package.

Do not use the equipment without proper training from your doctor or nurse.

Always wash your hands and ensure the area around you is clean.

When preparing and injecting medication directly into veins, it is important to use a clean, germ-free (aseptic) technique. Inadequate technique may introduce germs capable of causing blood infections.

Do not open the equipment until you are ready to use it.

Do not use the equipment if it has been dropped or damaged. Use a new package instead.

Do not use the equipment if it has expired. Use a new package instead. The expiration date is printed on the outer packaging, vial, vial adapter, and pre-filled syringe after "EXP."

Do not use the equipment if you suspect contamination. Use a new package instead.

Do not discard any components until the reconstituted solution has been injected.

The equipment is for single use only.

Contents

The package contains:

1 vial of NovoEight powder
1 vial adapter
1 pre-filled syringe with solvent
1 syringe plunger rod (placed beneath the syringe)

Diagram of a vial with NovoEight powder showing labels for plastic cap and underlying rubber stopper Diagram of a vial adapter with labels indicating protective cover, spike beneath protective paper, and protective paper

Diagram of a pre-filled syringe with labels indicating tip, cap, graduated scale, and plunger Technical diagram of a syringe with Spanish labels indicating Rosca thread and plunger

1. Prepare the vial and syringe

Prepare the number of NovoEight packages you need.

Check the expiration date.

Verify the name, concentration, and color on the packaging to confirm it contains the correct product.

Wash your hands thoroughly and dry them with a clean towel or air dry.

Remove the vial, vial adapter, and pre-filled syringe from the package. Leave the plunger rod untouched in the package.

Allow the vial and pre-filled syringe to reach room temperature. You can do this by holding both in your hands until they feel the same temperature as your hands.

Do not use any other method to warm the vial and pre-filled syringe.

Two hands holding a vial and a small bottle respectively, on a light blue background with a letter A in a blue box at the top left

Remove the plastic cap from the vial. If the plastic cap is loose or missing, do not use the vial.

Clean the rubber stopper with a sterile alcohol wipe and allow it to air dry for a few seconds before use to ensure it is as germ-free as possible.

Do not touch the rubber stopper with your fingers, as this may transfer germs.

A hand holding a small glass vial tilted upward

2. Attach the vial adapter

Remove the protective paper from the vial adapter.

If the protective paper is not fully sealed or is torn, do not use the vial adapter.

Do not remove the vial adapter from its protective cover with your fingers. If you touch the spike of the vial adapter, you may transfer germs from your fingers.

Two hands lifting a transparent medical device upward

Place the vial on a flat, hard surface.

Turn the protective cover of the vial adapter upside down and press the adapter firmly onto the vial.

Once attached, do not remove the vial adapter from the vial.

A hand pressing a medical device downward onto a small glass vial indicated by a blue downward arrow

Gently squeeze the protective cover between your thumb and index finger as shown.

Remove the protective cover from the vial adapter.

Do not remove the vial adapter when removing the protective cover.

A hand removing a protective cap from a glass vial placed on a flat surface, with a blue upward-pointing arrow

3. Assemble the plunger rod and syringe

Hold the plunger rod by the wide end and remove it from the package. Do not touch the sides or threads of the plunger rod. Touching them may transfer germs from your fingers.

Immediately attach the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.

Two gloved hands holding a syringe while a curved blue arrow indicates rotational movement or withdrawal of the plunger upward

Remove the syringe cap by bending it downward until the perforation breaks.

Do not touch the tip of the syringe below the syringe cap. Touching it may transfer germs from your fingers.

If the syringe cap is loose or missing, do not use the pre-filled syringe.

Two hands removing a protective cap from an injection pen with a curved blue arrow indicating the motion

Screw the pre-filled syringe firmly onto the vial adapter until resistance is felt.

Two hands holding and rotating a cylindrical medical device with a curved blue arrow indicating clockwise rotation

4. Reconstitute the powder with the solvent

Hold the pre-filled syringe at a slight angle with the vial pointing downward.

Press the plunger rod to inject all the solvent into the vial.

A hand holding a tilted syringe with a blue arrow indicating downward pressure on the plunger

Keep the plunger rod pressed and gently swirl the vial until the powder is completely dissolved.

Do not shake the vial, as this may cause foaming.

Inspect the reconstituted solution. It should be clear or slightly opalescent (slightly less transparent). If the solution appears cloudy or contains visible particles, do not use it. Use a new package instead.

A hand holding a syringe ready to be screwed onto a small glass vial, with a circular arrow indicating rotational movement

It is recommended to use NovoEight immediately after reconstitution, as delays may compromise sterility and could lead to infections.

If you cannot use the reconstituted NovoEight solution immediately, it should be used within 4 hours if stored at room temperature or up to 40°C, or within 24 hours if stored between 2°C and 8°C. Store the reconstituted product in the vial.

Do not freeze the reconstituted NovoEight solution or store it in syringes.

Do not store the solution without consulting your doctor.

Store the reconstituted NovoEight solution away from direct light.

If your dose requires more than one vial, repeat steps A through J with additional vials, vial adapters, and pre-filled syringes until the required dose is achieved.

Keep the plunger rod fully pressed inward.

Turn the syringe with the vial upside down.

Stop pushing the plunger rod and allow it to retract on its own as the reconstituted solution fills the syringe.

Pull the plunger rod slightly downward to draw the reconstituted solution into the syringe.

If only part of the vial is needed, use the syringe scale to measure the amount of reconstituted solution withdrawn, as directed by your doctor or nurse.

If there is excess air in the syringe at any point, inject the air back into the vial.

While holding the vial upside down, gently tap the syringe to allow any bubbles to rise to the top.

Slowly push the plunger rod to remove all air bubbles.

A hand holding a syringe vertically with a blue downward arrow indicating plunger movement downward

Unscrew the vial adapter from the vial.

Do not touch the tip of the syringe. Touching it may transfer germs from your fingers.

Two hands holding a medical device and rotating it to the right following the direction of a curved blue arrow on a light background

5. Inject the reconstituted solution

NovoEight is now ready to be injected into a vein.

Inject the reconstituted solution according to your doctor’s or nurse’s instructions.

Inject slowly over 2 to 5 minutes.

Do not mix NovoEight with any other intravenous infusion or medication.

Injection of NovoEight through needle-free connectors for intravenous (IV) catheters

Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections. Some needle-free connectors with internal spikes are incompatible with the pre-filled syringe. This incompatibility may prevent medication delivery and/or damage the needle-free connector.

Injection of the solution through a central venous access device (CVAD), such as a central venous catheter or subcutaneous port:

Use a clean, germ-free (aseptic) technique. Follow instructions for proper use of your connector and CVAD as advised by your doctor or nurse.
Injection via a CVAD may require transferring the reconstituted solution into a sterile 10 ml plastic syringe. This should be done immediately after step J.
If flushing the CVAD line is required before or after NovoEight injection, use 9 mg/ml sodium chloride injection solution.

Disposal

After injection, safely dispose of all unused NovoEight solution, the syringe with infusion set, the vial with vial adapter, and all other waste according to your pharmacist’s instructions.

Do not dispose of them as ordinary household waste.

Medical diagram showing a syringe with needle, a vial, and a blue arrow indicating the transfer of liquid

Do not disassemble the equipment before disposal.

Do not reuse the equipment.