500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection nonakog
beta pegol
What Refixia is and what it is used for
What Refixia is
Refixia contains the active substance nonakog beta pegol. It is a long-acting version of factor IX. Factor IX is a protein found naturally in the blood that helps stop bleeding.
What Refixia is used for
Refixia is used to treat and prevent bleeding in patients 12 years of age or older with hemophilia B (congenital factor IX deficiency).
In patients with hemophilia B, factor IX is missing or does not work properly. Refixia replaces the factor IX that is malfunctioning or missing and helps the blood to form a clot (clotted blood) where it bleeds.
What you need to know before using Refixia
Do not use Refixia
- 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.
If you are not sure if any of the above applies to you, talk to your doctor before using this medicine.
Warnings and cautions
Traceability
You must keep track of the Lot number on your Refixia. Each time you receive a new package with Refixia, make a note of the date and Lot number (which is on the package after Lot) and keep this information in a safe place.
Allergic reactions and development of inhibitors
There is a risk, although it is rare, that you will have a sudden and severe allergic reaction (eg anaphylactic reaction ) to Refixia. Discontinue injection and contact your doctor or emergency department immediately if you show signs of an allergic reaction such as skin rash, hives, itching over large areas of skin, red and/or swollen lips, tongue, face, or hands, difficulty swallowing or breathing, shortness of breath, wheezing, tightness in the chest, pale and cold skin, palpitations and/or dizziness.
Your doctor may need to treat these reactions immediately. Your doctor may also take a blood test to check if you have developed factor IX inhibitors (neutralizing antibodies ) against your medicine, as inhibitors may develop along with allergic reactions. If you have such inhibitors, you may have a higher risk of sudden and severe allergic reactions (eg anaphylactic reaction ) during future factor IX treatments.
Due to the risk of allergic reactions with factor IX, the first treatment with Refixia should be given in a clinic or the presence of healthcare professionals with access to appropriate medical treatment for allergic reactions if needed.
Contact your doctor immediately if your bleeding does not stop as expected or if you need to significantly increase the amount of Refixia you need to stop bleeding. Your doctor will take a blood test to check if you have developed inhibitors (neutralizing antibodies ) against Refixia. The risk of developing inhibitors is highest in people who have not previously been treated with factor IX drugs, especially young children.
Blood clots
Tell your doctor if any of the following apply to you, as there is an increased risk of blood clots during treatment with Refixia:
- you have recently had surgery
- you have another serious illness, e.g. liver disease, heart disease, or cancer
- you have risk factors for heart disease, e.g. high blood pressure, obesity, or smoking.
Kidney disease ( nephrotic syndrome )
There is a risk, although rare, of developing a specific kidney disease called “nephrotic syndrome” after high doses of factor IX in patients with hemophilia B with factor IX inhibitors and allergic reactions in the history of the disease.
Catheter-related problems
If you have aid for central intravenous administration, infections or blood clots may occur where the catheter is located.
Other medicines and Refixia
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using Refixia.
Driving and using machines
Refixia does not affect your ability to drive or use machines.
Refixia contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, ie essentially ‘sodium-free’. it is next to “sodium-free”.
How to use Refixia
Treatment with Refixia is started by a doctor who has experience in treating patients with hemophilia B. Always use this medicine exactly as your doctor has told you. Ask your doctor if you are not sure how to use Refixia.
Your doctor will calculate the correct dose for you. Dose one depends on your weight and what the medicine is used for.
Prevention of bleeding
The usual dose of Refixia is 40 International Units (IU) per kg body weight. It is given as an injection every week. Your doctor may choose a different dose or how often the injections should be given based on your needs.
Treatment of bleeding
The usual dose of Refixia is 40 International IU per kg body weight. Depending on where the bleeding is and the severity of the bleeding, you may need a higher dose (80 IU per kg) or extra injections. Talk to your doctor about what dose and how many injections you need.
Use for children and adolescents
Refixia should only be used in adolescents (12 years of age or older). Dose one for adolescents is also calculated based on body weight and is the same dose as for adults.
How Refixia is given
Refixia is available as a powder and diluent that is mixed into a solution ( preparation ) and given as an injection into a vein. See “Refixia Instructions for Use” for more information.
If you use more Refixia than you should
If you have used too much Refixia, contact your doctor.
If you need to significantly increase the amount of Refixia you need to stop bleeding, contact your doctor immediately. For more information, see section 2 “Allergic reactions and development of inhibitors”.
If you forget to use Refixia
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. Consult a doctor if you are unsure.
If you stop using Refixia
If you stop using Refixia, it is possible that you are no longer protected against bleeding or that ongoing bleeding does not stop. Do not stop using Refixia without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions may occur with this medicine.
If sudden and severe allergic reactions (eg anaphylactic reactions) occur, the injection must be stopped immediately. You must contact a doctor or an emergency department immediately if you experience an early symptom of a severe allergic reaction ( anaphylactic reaction ), such as:
- difficulty swallowing or breathing
- shortness of breath or wheezing
- tightness in the chest
- red and/or swollen lips, tongue, face, or hands
- skin rash, hives, or itching
- pale and cold skin, rapid heartbeat, and/or dizziness (low blood pressure ).
The following side effects have been observed with Refixia:
Common side effects ( may affect up to 1 in 10 people)
- itching
- skin reactions at the injection site
- nausea
- extreme fatigue.
Uncommon side effects ( may affect up to 1 in 100 people)
- allergic reactions (hypersensitivity). They can be serious and potentially life-threatening (anaphylactic reactions)
- palpitation
- hemorrhage.
Has been reported (occurs in an unknown number of users)
- neutralizing antibodies (inhibitors).
- anaphylactic reactions
How to store Refixia
Keep this medicine out of the sight and reach of children.
Use Refixia before the expiry date which is stated after “EXP” on the carton and the label of the vial and pre-filled syringe. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C-8 ° C). Do not freeze. Store in the original package. Sensitive to light.
Refixia can be removed from the refrigerator for a period of up to 6 months and stored at room temperature (maximum 30 ° C). Write down the date on the box when Refixia is taken out of the refrigerator and placed at room temperature. The new expiry date should never exceed the original expiry date which is stated on the outer carton. If the medicine has not been used before the new expiry date, it must be discarded. After storage at room temperature, the medicine must not be put back in the refrigerator.
Use injection one immediately after you have made the ordering solution (berdningen). If it can not be used immediately, use it within 24 hours if stored in a refrigerator at 2 ° C-8 ° C or within 4 hours if stored outside the refrigerator at a temperature of up to 30 ° C.
The powder in the vial is white to off-white. Do not use the powder if the color has changed.
The prepared solution should be clear and colorless. Do not use the reconstituted solution if you see particles in the solution or if the solution is discolored.
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.
Contents of the pack and other information
Content declaration
- The active substance is nonacog beta pegol (pegylated human coagulation factor IX (rDNA)). Each vial of Refixia contains a nominal 500 IU, 1,000 IU, or 2,000 IU nonacog beta pegol equivalent to approximately 125 IU / ml, 250 IU / ml, and 500 IU / ml respectively after reconstitution with histidine diluent.
- The other ingredients in the powder are sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide, and hydrochloric acid.
- Ingredients in the sterile diluent are histidine, water for injections, sodium hydroxide, and hydrochloric acid.
What the medicine looks like and the contents of the pack
- Refixia is supplied as a powder and solvent for solution for injection (500 IU, 1,000 IU, or 2,000 IU powder in a vial and 4 ml of diluent in a pre-filled syringe, a plunger rod with a vial adapter – pack size 1 pc).
- The powder is white to off-white and the diluent is clear and colorless.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A / S
Novo Allé
DK-2880 Bagsværd, Denmark