NovoEight
turoctocog alfa
turoctocog alfa (human coagulation factor VIII (rDNA))
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What NovoEight is and what it is used for
What you need to know before you use NovoEight
How to use NovoEight
Possible side effects
How to store NovoEight
Contents of the pack and other information
NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII. Factor VIII is a protein naturally found in the blood that helps it to clot.
NovoEight is used to treat and prevent bleeding episodes in patients with haemophilia A (inborn factor VIII deficiency) and can be used for all age groups.
In patients with haemophilia A, factor VIII is missing or not working properly. NovoEight replaces this faulty or missing ‘factor VIII’ and helps blood to form clots at the site of bleeding.
if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to hamster proteins.
Do not use NovoEight if either of the above applies to you. If you are not sure, talk to your doctor before using this medicine.
Talk to your doctor before using NovoEight.
There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to NovoEight. Early signs of allergic reactions are rash, hives, weals, generalised itching,
swelling of lips and tongue, difficulty in breathing, wheezing, tightness of the chest, general feeling of being unwell, and dizziness.
If any of these symptoms occur, stop the injection immediately and contact your doctor.
Talk to your doctor if you think that your bleed is not being controlled with the dose you receive, as there can be several reasons for this. Some people using this medicine can develop antibodies to factor VIII (also known as factor VIII inhibitors). Factor VIII inhibitors make NovoEight less effective in preventing or controlling bleeding. If this happens you may need a higher dose of NovoEight or a different medicine to control your bleed. Do not increase the total dose of NovoEight to control your bleed without talking to your doctor. You should tell your doctor if you have been previously treated with factor VIII products, especially if you developed inhibitors, since there might be a higher risk that it happens again.
The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. If you or your child´s bleeding is not being controlled with NovoEight, tell your doctor immediately.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
If you are pregnant or breastfeeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
NovoEight has no influence on your ability to drive and use machines.
This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial. This is equivalent to 1.5% of the recommended maximum dietary intake of sodium for an adult.
Talk to your doctor if you are on a controlled sodium diet.
Treatment with NovoEight will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Your doctor will calculate your dose for you. This will depend on your weight and what the medicine is being used for.
The usual dose of NovoEight is 20 to 50 international units (IU) per kg of body weight. The injection is given every 2 to 3 days. In some cases, especially in younger patients, more frequent injections or higher doses may be needed.
The dose of NovoEight is calculated depending on your body weight and the factor VIII levels to be achieved. The target factor VIII levels will depend on the severity and location of the bleeding.
NovoEight can be used in children of all ages. In children (below the age of 12) higher doses or more frequent injections may be needed. Adolescents (above the age of 12) can use the same dose as adults.
NovoEight is given as an injection into a vein. See ‘Instructions on how to use NovoEight’ for more information.
If you use more NovoEight than you should, tell your doctor or go to a hospital straight away.
You should contact your doctor if you have missed a dose and do not know how to compensate for this.
If you stop using NovoEight you may no longer be protected against bleeding or a current bleed may not stop. Do not stop using NovoEight without talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.
If severe, sudden allergic reactions (anaphylactic reactions) occur (very rare), the injection must be stopped immediately. You must contact your doctor immediately if you have one of the following early symptoms:
difficulty in breathing, shortness of breath or wheezing
chest tightness
swelling of the lips and tongue
rash, hives, weals or generalised itching
feeling dizzy or loss of consciousness
low blood pressure (having pale and cold skin, fast heartbeat).
Severe symptoms, including difficulty in swallowing or breathing and red or swollen face or hands, require prompt emergency treatment.
If you have a severe allergic reaction, your doctor may change your medicine.
For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients). If this happens to you or your child´s medicines may stop working properly and you or your child may experience persistent bleeding. If this happens, you should contact your doctor immediately.
blood tests showing changes in the way the liver functions
reactions (redness and itching) around the site where you injected the medicine.
blushing of the skin
inflammation of vein
bleeding into joint spaces
bleeding in muscle tissue
cough
redness around the site where you placed catheter
vomiting.
feeling tired
headache
feeling dizzy
difficulty sleeping (insomnia)
fast heartbeat
increased blood pressure
rash
fever
feeling hot
stiffness of muscles
pain in muscles
pain in legs and arms
swelling of legs and feet
joint disease
bruising
heart attack.
The side effects observed in children and adolescents are the same as observed in adults.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated after ‘EXP’ on the carton and on the vial and the pre-filled syringe labels. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Before the NovoEight powder is reconstituted it may be kept at:
room temperature (≤ 30°C) for a single period no longer than 9 months
above room temperature (30°C up to 40°C) for a single period no longer than 3 months.
Once the product has been taken out of the refrigerator, the product must not be returned to the refrigerator.
Please record the beginning of storage and the storage temperature on the product carton. Once you have reconstituted NovoEight it should be used right away. If you cannot use the
reconstituted NovoEight solution immediately, it should be used within:
24 hours stored at 2°C – 8°C
4 hours stored at ≤ 30°C, for product which has been kept for a single period no longer than 9 months at room temperature (≤30°C)
4 hours stored up to 40°C, for product which has been kept for a single period no longer than 3 months at above room temperature (30°C up to 40°C).
Store the reconstituted product in the vial. If not used straight away the medicine may no longer be sterile and could cause infection. Do not store the solution without your doctor’s advice.
The powder in the vial appears as a white or slightly yellow powder. Do not use the powder if the colour has changed.
The reconstituted solution will be clear to slightly opalescent. Do not use this medicine if you notice that it is cloudy or contains visible particles.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is turoctocog alfa (human coagulation factor VIII (rDNA)). Each vial of NovoEight contains nominally 250, 500, 1000, 1500, 2000 or 3000 IU turoctocog alfa.
The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
The ingredients in the solvent are sodium chloride and water for injections.
After reconstitution with the supplied solvent (sodium chloride 9 mg/ml (0.9%) solution for injection), the prepared solution for injection contains 62.5, 125, 250, 375, 500 or 750 IU turoctocog alfa per ml,
respectively, (based on the strength of turoctocog alfa, i.e. 250, 500, 1000, 1500, 2000 or 3000 IU).
NovoEight is a powder and solvent for solution for injection. Each pack of NovoEight contains a vial with white or slightly yellow powder, a 4 ml pre-filled syringe with a clear colourless solution, a plunger rod and a vial adapter.
Novo Nordisk A/S Novo Allé
DK-2880 Bagsværd, Denmark This leaflet was last revised in
Instructions on how to use NovoEight READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT. NovoEight is supplied as a powder. Before injection (administration) it must be reconstituted with the solvent supplied in the syringe. The solvent is a sodium chloride 9 mg/ml (0.9%) solution. The reconstituted NovoEight must be injected into your vein (intravenous injection). The equipment in this package is designed to reconstitute and inject NovoEight. You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and plasters. These devices 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 that the area around you is clean. When you prepare and inject medicine 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. Do not open the equipment until you are ready to use it. Do not use the equipment if it has been dropped, or if it is damaged. Use a new package instead. Do not use the equipment if it is expired. Use a new package instead. The expiry date is printed after ‘EXP’ on the outer carton, on the vial, on the vial adapter, and on the pre-filled syringe. Do not use the equipment if you suspect it is contaminated. Use a new package instead. Do not dispose of any of the items until after you have injected the reconstituted solution. The equipment is for single use only. |
Contents The package contains:
|
Overview Vial with NovoEight powder Vial adapter Plastic cap Protective cap Rubber stopper (under plastic cap) Spike Protective (under protective paper) paper | |
Pre-filled syringe with solvent Syringe tip Plunger Plunger rod (under syringe cap) Scale Thread Wide top end Syringe cap | |
1. Prepare the vial and the syringe
| A |
vial and pre-filled syringe. | |
If the plastic cap is loose or missing, do not use the vial. | B |
2. Attach the vial adapter
If the protective paper is not fully sealed or if it is broken, do not use the vial adapter. Do not 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. | C |
Once attached, do not remove the vial adapter from the vial. | D |
Remove the protective cap from the vial adapter. Do not lift the vial adapter from the vial when removing the protective cap. | E |
3. Attach the plunger rod and the syringe
| F |
into the plunger inside the pre-filled syringe until resistance is felt. | |
If the syringe cap is loose or missing, do not use the pre-filled syringe. | G |
| H |
4. Reconstitute the powder with the solvent
| I |
powder is dissolved. Do not shake the vial as this will cause foaming. | J |
NovoEight is recommended to be used immediately after it has been reconstituted. This is because if left, the medicine may no longer be sterile and could cause infections. If you cannot use the reconstituted NovoEight solution immediately, it should be used within 4 hours when stored at room temperature or up to 40°C and within 24 hours when stored at 2°C – 8°C. Store the reconstituted product in the vial. Do not freeze reconstituted NovoEight solution or store it in syringes. Do not store the solution without your doctor’s advice. Keep reconstituted NovoEight solution out of direct light. |
If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose. | |
If, at any point, there is too much air in the syringe, inject the air back into the vial. | K |
| L |
5. Inject the reconstituted solution NovoEight is now ready to be injected into your vein.
Injecting NovoEight via needleless 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 needleless connectors with an internal spike are incompatible with the pre-filled syringe. This incompatibility may prevent administration of the medicine and/or result in damage to the needleless connector. Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
| |
Disposal
Do not throw it out with the ordinary household waste. | M |
Do not disassemble the equipment before disposal. Do not reuse the equipment. |