250, 500, 1000, 2000, and 3000 IU powder and solvent for injection, solution 
eftrenonacog alpha (alpha eftrenonacogum) recombinant coagulation factor IX Fc fusion protein

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What ALPROLIX is and what it is used for 
2. What you need to know before using ALPROLIX 
3. How to use ALPROLIX 
4. Possible side effects 
5. How to store ALPROLIX 
6. Contents of the packaging and other information 

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:

The package with ALPROLIX contains:
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:

1. Check the name and strength of the package to make sure it contains the correct medicine. Check the expiry date on the carton with ALPROLIX. Do not use if the expiration date has passed.
If ALPROLIX has been stored in a refrigerator, allow the vial of ALPROLIX (A) and the syringe of liquid (B) to reach room temperature before use. Do not add external heat.
3. Place the vial on a clean, level surface. Remove the plastic snap-off cap from the ALPROLIX vial.
Wipe the top of the vial with one of the alcohol swabs (F) included in the package and allow it to air dry. Do not touch the top of the vial and do not allow anything else to touch it after wiping it.
5. Tear off the protective paper from the clear plastic adapter for vials (D). Do not remove the adapter from the protective cover. Do not touch the inside of the vial adapter with the vial adapter.
6. Place the vial on a flat surface. Hold the vial adapter in the cap and place it directly over the top of the vial. Push the adapter down with a determined motion until it snaps onto the top of the vial so that the tip of the adapter penetrates the stopper of the vial.
Attach the plunger rod (C) to the syringe with liquid by inserting the tip of the plunger rod into the opening on the syringe plunger. Turn the piston rod clockwise with a determined movement until it is firmly seated in the syringe plunger.
8. Break the white, tamper-proof plastic cap from the syringe with liquid by bending at the perforation cap until it breaks off. Lay the lid aside with the top side down on a flat surface. Do not touch the inside of the cap or syringe tip.
9. Lift the protective cover off the adapter and discard it.
10. Connect the syringe of liquid to the vial adapter by inserting the tip of the syringe into the opening on the adapter. Push in and turn the syringe clockwise with a determined motion until it is firmly seated.
11. Slowly push the plunger rod in so that all the liquid is injected into the vial of ALPROLIX.
12. Leave the syringe in the adapter with the plunger rod depressed and gently swirl the vial until the powder has dissolved. Do not shake.
13. The finished solution must be inspected visually before administration . The solution should be ready to slightly pearlescent and colorless. Do not use the solution if it is cloudy or contains visible particles.
14. Check that the syringe plunger is still fully depressed and turn the vial upside down. Slowly pull out the plunger rod to pull out any solution through the vial adapter into the syringe.
15. Detach the syringe from the vial adapter by gently pulling and turning the vial counterclockwise.
Note! If you use more than one vial with ALPROLIX per injection, each vial prepared separately according to the previous instructions (step 1 to 13), and the syringe with the liquid is removed while the adapter for vials is left in place. A single large Luer-lock syringe can be used to draw up the reconstituted contents of the individual vials.
16. Discard the vial and adapter.Note! If the solution is not to be used immediately, carefully put the syringe cap back on the syringe tip. Do not touch the syringe tip or the inside of the lid.After preparation can ALPROLIX stored at room temperature for up to 6 hours prior to administration . After this time, the reconstituted ALPROLIX should be discarded. Protect from direct sunlight.

Administration ( intravenous injection )

ALPROLIX should be administered with the infusion set (E) included in the package.

Open the package with the infusion set and remove the cap at the end of the tube. Connect the syringe of reconstituted ALPROLIX solution to the end of the infusion set tubing by turning clockwise.
If necessary, attach a stasis tube and prepare the injection site by washing the skin thoroughly with the other spirit compress included in the package.
3. Remove any air in the infusion set tubing by slowly pushing in the plunger rod until the liquid has reached the infusion set needle. Do not push the solution through the needle. Remove the transparent plastic protective cap from the needle.
Insert the needle of the infusion set into a vein according to the doctor’s or nurse’s instructions and remove the stasis tube. If you want, you can use one of the patches (G) included in the package to attach the plastic wings of the needle to the injection site. The reconstituted product should be injected intravenously over several minutes. Your doctor may change the recommended injection rate to make it more comfortable for you.
5. When the injection is finished and the needle is pulled out, fold the needle cover over the needle and snap it on.
Dispose of the used needle, any remaining solution, the syringe and the empty vial in a suitable container for medical waste as these objects may harm others if not disposed of properly. Do not reuse any equipment.

Muhammad Nadeem

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