500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU powder and solvent for injection, solution
turoktokog alpha pegol (pegylated human coagulation factor VIII) (rDNA))
1. What Esperoct is and what it is used for
What Esperoct is
Esperoct contains the active substance turoktokog alfa pegol and is a long-acting recombinant coagulation factor VIII product. Factor VIII is a protein found in the blood that helps prevent and stop bleeding.
What Esperoct is used for
Esperoct is used for treating and preventing bleeding in people 12 years of age or older with hemophilia A (congenital factor VIII deficiency).
In people with hemophilia A, factor VIII is missing or not working properly. Esperoct replaces the missing or missing factor VIII and helps the blood to coagulate where it bleeds.
2. What you need to know before using Esperoct
Do not use Esperoct
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to hamster protein.
Do not use Esperoct if any of the above apply to you. If you are not sure, talk to your doctor before using this medicine.
Warnings and cautions
Previous use of factor VIII drugs
Tell your doctor if you have used factor VIII medicines before, especially if you have developed inhibitors ( antibodies ) to the medicine, as there may be a risk of it happening again.
Allergic reactions
There is a risk that you may experience a severe and sudden allergic reaction (eg anaphylactic reaction ) to Esperoct.
Discontinue injection and contact your doctor or emergency department immediately if you have early signs of an allergic reaction. These early signs may include rash, hives, streaks, itching over large areas of skin, redness and/or swelling of the lips, tongue, face, or hands, difficulty swallowing or breathing, wheezing, tightness of the chest, pale and cold skin, rapid heartbeat or dizziness, headache, nausea, and vomiting.
Development of “FVIII inhibitors” ( antibodies )
Inhibitors ( antibodies ) can be developed during treatment with any factor VIII drug
- These inhibitors, especially at high levels, prevent the treatment from working properly
- You will be closely monitored for the development of these inhibitors
- If your bleeding does not get under control with Esperoct, tell your doctor immediately
- Do not increase the total dose one of Esperoct to control the bleeding without talking to your doctor.
Catheter-related problems
If you have a catheter that allows drugs to be injected into the bloodstream (central valve delivery device), infections or blood clots may occur where the catheter is located.
Heart disease
Tell your doctor or pharmacist if you have a heart condition or are at risk of developing a heart condition.
Children
Esperoct can not be used in children under 12 years.
Other medicines and Esperoct
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Esperoct does not affect your ability to drive or use machines.
Esperoct contains sodium
This medicine contains 30.5 mg sodium (the main constituent of cooking/table salt) per reconstituted vial. This corresponds to 1.5% of the recommended maximum daily intake of sodium for an adult.
3. How to use Esperoct
Treatment with Esperoct will be started by a doctor who has experience in the treatment of people with hemophilia A.
Always use this medicine exactly as your doctor has told you. Ask your doctor if you are not sure how to use Esperoct.
How Esperoct is given
Esperoct is given as an injection into a vein ( intravenously ), see “Esperoct Instructions for Use” for more information.
How much to use
Doctors will calculate your dose for you. This will depend on your body weight and whether it is used to prevent or treat bleeding.
Prevention of bleeding
Adults and adolescents (12 years and older): The recommended dose is 50 IU Esperoct per kg body weight every 4 days. Your doctor may choose a different dose or how often the injections should be given based on your needs.
Treatment of bleeding
Dos en Esperoct is calculated based on your body weight and the levels of factor VIIIto be achieved. The target value for the factor VIII level depends on the severity of the bleeding and where it is bleeding. If you have the impression that the effect of Esperoct is insufficient, talk to your doctor.
Use for children and adolescents
Adolescents (12 years and older) can use the same dose as adults.
If you use more Esperoct than you should
If you use more Esperoct than you should, contact your doctor immediately.
If you have to significantly increase your use of Esperoct to stop bleeding, talk to your doctor immediately. For further information, see “Development of“ FVIII inhibitors ”( antibodies )” in section 2.
If you forget to use Esperoct
If you miss a dose, inject the missed dose as soon as you remember. Do not inject a double dose to make up for a forgotten dose. Proceed with the next injection as planned and continue as your doctor has told you. If you are not sure, talk to your doctor.
If you stop using Esperoct
Do not stop using Esperoct without talking to your doctor.
If you stop using Esperoct, it is possible that you are no longer protected against bleeding or that ongoing bleeding does not stop. If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (hypersensitivity)
Discontinue injection immediately if you experience severe and sudden allergic reactions (anaphylactic reactions). You must contact your doctor or an emergency department immediately if you have signs of an allergic reaction such as:
• difficulty swallowing or breathing
• wheezing
• tightness in the chest
• redness and/or swelling of the lips, tongue, face, or hands
• skin rash, hives, streaks, or itching
• pale and cold skin, rapid heartbeat, or dizziness (low blood pressure )
• headache, nausea, or vomiting.
Development of “FVIII inhibitors” ( antibodies )
If you have previously received more than 150 days of factor VIII treatment, inhibitors ( antibodies ) may develop (may affect up to 1 in 100 people). If this happens, your medicine may stop working properly and you may experience persistent bleeding. If this happens, contact your doctor immediately. See “Development of“ FVIII inhibitors ”( antibodies )” in section 2.
The following side effects have been observed with Esperoct
Common side effects are (may affect up to 1 in 10 people)
• skin reactions at the injection site
• itching ( pruritus )
• reddening of the skin ( erythema )
• rash.
Less common side effects are (may affect up to 1 in 100 people)
• allergic reactions (hypersensitivity). These can be serious and can be life-threatening, see “Allergic reactions (hypersensitivity)” above for more information
• factor VIII inhibitors ( antibody s) in patients previously treated with factor VIII.
5. How to store Esperoct
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 the vial and pre-filled syringe label. The expiration date is the last day of the specified month.
Before reconstitution (before mixing the powder with the diluent):
Store in a refrigerator (2 ° C – 8 ° C). Esperoct can be stored
- at room temperature (≤ 30 ° C) for a single continuous period not exceeding 12 months within the shelf life of the product or
- above room temperature (> 30 ° C up to 40 ° C) for a single continuous period of not more than 3 months within the shelf life of the product.
When you start storing Esperoct outside the refrigerator, make a note of the date and storage temperature in the box on the carton. Once you have removed the product from the refrigerator for storage, do not store it in the refrigerator again.
Do not freeze. Store in the original package. Sensitive to light.
After reconstitution (after mixing the powder with the diluent):
Once you have prepared Esperoct, it should be used immediately. If you can not use the reconstituted solution immediately, use it within
- 24 hours when stored in a refrigerator (2 ° C – 8 ° C) or
- 4 hours at ≤30 ° C or
- 1 hour between> 30 ° C and 40 ° C, only if the product is stored above room temperature (> 30 ° C up to 40 ° C) before reconstitution for a maximum of 3 months.
The powder in the vial is white to off-white. Do not use the powder if the color has changed.
The reconstituted solution must be clear and colorless. Do not use the reconstituted solution if you notice any particles or discoloration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is turoctococcal alpha pegol (pegylated human coagulation factor VIII (rDNA)). Each vial of Esperoct nominally contains 500, 1000, 1500, 2000, or 3000 IU turoctococcal alpha pegol.
- The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide, and hydrochloric acid.
- The constituents of the diluent are sodium chloride 9 mg/ml (0.9%) solution for injection and water for injections.
After reconstitution with the supplied diluent (sodium chloride 9 mg / ml (0.9%) solution for injection ), the reconstituted solution contains 125, 250, 375, 500 and 750 IU turoctocog alfa pegol per ml, respectively (based on the strength of turoctococcal alpha pegol , i.e. 500, 1000, 1500, 2000 or 3000 IU).
What the medicine looks like and the contents of the pack
Esperoct is available in packs of 500 IU, 1000 IU, 1500 IU, 2000 IU, or 3000 IU. Each pack of Esperoct contains a vial of white to off-white powder, a 4 ml pre-filled syringe with a clear colorless diluent, a plunger rod, and a vial adapter.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A / S
Novo Allé
DK ‑ 2880 Bagsværd, Denmark