250, 500, 1000, 2000, and 3000 IU powder and solvent for injection, solution
eftrenonacog alpha (alpha eftrenonacogum) recombinant coagulation factor IX Fc fusion protein
1. What ALPROLIX is and what it is used for
ALPROLIX contains the active substance eftrenonacog alfa, a recombinant coagulation factor IX Fc fusion protein. Factor IX is a protein that is produced naturally in the body and which is necessary for the blood to be able to clot and stop bleeding.
ALPROLIX is a medicine used to treat and prevent bleeding in patients of all ages with hemophilia B (hereditary hemophilia due to factor IX deficiency).
ALPROLIX is manufactured using recombinant technology without the addition of any human or animal components in the manufacturing process.
How ALPROLIX works
Patients with hemophilia B do not have factor IX or the factor does not work properly. ALPROLIX is used to replace the missing or missing factor IX. ALPROLIX increases the level of factor IX in the blood and temporarily corrects the bleeding tendency. The Fc fusion protein in ALPROLIX prolongs the duration of action of the drug.
2. What you need to know before using ALPROLIX
Do not use ALPROLIX
- if you are allergic to eftrenonacog alfa or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using ALPROLIX.
- There is a small risk of an anaphylactic reaction (a severe, sudden allergic reaction ) to ALPROLIX. Signs of allergic reactions include itching all over the body, hives, pressure on the chest, difficulty breathing and low blood pressure. If any of these symptoms occur, stop the injection immediately and consult a doctor.
- Talk to your doctor if you think your bleeding is not being controlled with the dose you are given, as there may be several reasons for this. For example, the formation of antibodies (also called inhibitors) to factor IX is a known complication that may occur during the treatment of hemophilia B. The antibodies prevent the treatment from having the intended effect. In this case, the doctor checks this. Do not increase the total dose of ALPROLIX to control bleeding without consulting a doctor.
Patients with factor IX inhibitors may be at increased risk of developing anaphylactic reactions during future factor IX treatment. Therefore, you should be tested for the presence of an inhibitor if you get allergic reactions such as those described above.
Factor IX products can increase the risk of unwanted blood clots in your body, especially if you have risk factors for blood clot development. Symptoms of a possible unwanted blood clot can be: pain and/or tenderness along a vein, unexpected swelling of an arm or leg or sudden shortness of breath, or sudden difficulty breathing.
Catheter-related complications
If you need a central venous catheter (CVK) device, the risk of CVK-related complications in the form of local infections, the presence of bacteria in the blood, and blood clots at the site of the catheter should be considered.
Documentation
It is strongly recommended that the product name and batch number be noted each time ALPROLIX is given.
Other medicines and ALPROLIX
Tell your doctor or pharmacist 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 or pharmacist for advice before taking this medicine.
Driving and using machines
ALPROLIX has no effect on the ability to drive and use machines.
ALPROLIX contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
3. How to use ALPROLIX
Treatment with ALPROLIX is started by a doctor who has experience in the treatment of patients with hemophilia. Always use this medicine exactly as your doctor has told you (see section 7). If you are not sure, talk to your doctor, pharmacist, or nurse.
ALPROLIX is given as an injection to a friend. You or someone else can give ALPROLIX after receiving appropriate training. Your doctor will prescribe a dose of ALPROLIX (in international units or “IU”) that you should receive. Dose one depends on your individual needs for replacement factor IX, and whether the drug is used to prevent or treat bleeding. Talk to your doctor if you think your bleeding is not being controlled with the dose you are given.
How often you need an injection depends on how well ALPROLIX works for you. Your doctor will take appropriate laboratory tests to make sure you have enough factor IX in your blood.
Treatment of bleeding
Dose one of ALPROLIX is calculated based on your body weight and the level of factor IX to be achieved. The target level for factor IX depends on how severe the bleeding is and where it occurs.
Prevention of bleeding
If you are using ALPROLIX to prevent bleeding, your doctor will calculate your dose.
The usual dose of ALPROLIX is 50 IU per kg body weight, given once a week or 100 IU per kg body weight given every 10 days. Your doctor may adjust the dose range. In some cases, especially in younger patients, shorter dosing intervals or higher doses may be necessary.
Use for children and adolescents
ALPROLIX can be used for children and adolescents of all ages. In children under 12 years of age, higher doses or more frequent injections may be needed and the usual dose is 50‑60 IU per kg body weight given every 7 days.
If you use more ALPROLIX than you should
Talk to your doctor as soon as possible. You should always use ALPROLIX exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
If you forget to use ALPROLIX
Do not take a double dose to make up for a forgotten dose. Take a dose as soon as you remember and then return to your normal dosing schedule. Ask your doctor, pharmacist, or nurse if you are not sure what to do.
If you stop using ALPROLIX
Do not stop using ALPROLIX without consulting a doctor. If you stop using ALPROLIX, you may no longer be protected against bleeding or ongoing bleeding will not stop.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If severe, sudden allergic reactions ( anaphylactic reaction ) occur, injection must be stopped immediately. You must contact a doctor immediately if you experience any of the following symptoms of allergic reactions: swelling of the face, skin rash, itching over the body, hives, pressure on the chest, difficulty breathing, burning and tingling at the injection site, chills, hot flushes, headache, general malaise, nausea, restlessness, fast heart rate, and low blood pressure.
In children not previously treated with factor IX drugs, it is common (in up to 1 in 10 users) for inhibitors to form (see section 2). If this happens, the medicine may stop working properly and your baby may experience persistent bleeding. Contact a doctor immediately if this occurs.
The following side effects may occur with this medicine.
Common side effects (may affect up to 1 in 10 people): headache, numbness or tingling in the mouth, pain in the side with blood in the urine (obstructive uropathy), and redness at the injection site.
Children not previously treated with factor IX drugs: factor IX inhibitors, hypersensitivity.
Uncommon side effects (may affect up to 1 in 100 people): dizziness, taste change, bad breath, feeling tired, injection site pain, fast heartbeat, blood in the urine ( haematuria ), side pain ( renal colic ), low blood pressure and decreased appetite.
Reporting of side effects
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store ALPROLIX
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 ° C ‑ 8 ° C). Do not freeze. Store in the original package. Sensitive to light.
Alternatively, ALPROLIX can be stored at room temperature (maximum 30 ° C) for a maximum continuous period of 6 months. Make a note of the date when ALPROLIX is removed from the refrigerator to room temperature on the carton. After storage at room temperature, the medicine must not be set in the refrigerator again.
Do not use this medicine after the expiry date which is stated on the carton and vial label after “EXP”. The expiration date is the last day of the specified month. Do not use this medicine if it has been stored at room temperature for more than 6 months.
Prepared ALPROLIX should be used immediately. If you can not use the reconstituted solution with ALPROLIX immediately, it should be used within 6 hours when stored at room temperature. Do not set the solution in the refrigerator after preparation. Protect the solution from direct sunlight.
The reconstituted solution will be ready to slightly pearlescent and colorless. Do not use this medicine if you notice that it is cloudy or contains visible particles.
This product is for single use only.
Dispose of any remaining solution appropriately. 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
Powder :
- The active substance is eftrenonacog alfa ( recombinant coagulation factor IX Fc fusion protein). One vial of ALPROLIX contains nominally 250, 500, 1,000, 2,000 or 3,000 IU eftrenonacog alfa.
- The other ingredients are sucrose, L ‑ histidine, mannitol, polysorbate 20, sodium hydroxide, and hydrochloric acid. If you are on a low-salt diet, see section 2.
Liquid :
5 ml of sodium chloride and water for injections.
What the medicine looks like and the contents of the pack
ALPROLIX is supplied as a powder and solvent for solution for injection. The powder is a white to off-white powder or cake. The liquid provided for the preparation of the solution for injection is a clear, colorless liquid. After reconstitution, the liquid to be injected is clear to slightly pearlescent and colorless.
One pack of ALPROLIX contains 1 vial of powder, 5 ml of a pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 patches, and 1 gauze swab.
Marketing Authorization Holder and Manufacturer
This leaflet was last modified 10/2020. Further information on this medicine is available on the European Medicines Agency web site: http://ema.europa.eu. There are also links to other websites regarding rare diseases and treatments.
7. Instructions for preparation and administration
The procedure below describes the preparation and administration of ALPROLIX.
ALPROLIX is administered as an intravenous (iv) injection after the powder for solution for injection has been dissolved in the liquid provided in the pre-filled syringe. The package with ALPROLIX contains:
ALPROLIX should not be mixed with other liquids for injection or infusion.
Wash your hands before opening the package.
Preparation:
Administration ( intravenous injection )
ALPROLIX should be administered with the infusion set (E) included in the package.