ALPROLIX contains the active substance eftrenonacog alfa, recombinant coagulation factor IX, Fc fusion protein. Factor IX is a protein produced naturally in the body necessary for the blood to form clots and stop bleeding.

ALPROLIX is a medicine used for the treatment and prevention of bleeding in all age groups of patients with haemophilia B (inherited bleeding disorder caused by factor IX deficiency).

ALPROLIX is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.

How ALPROLIX works

In patients with haemophilia B, factor IX is missing or not working properly. This medicine is used to replace the missing or deficient factor IX. ALPROLIX increases factor IX level in the blood and temporarily corrects the bleeding tendency. The Fc fusion protein in this medicine increases the length of time that the medicine works.

Do not use ALPROLIX

·             if you are allergic to eftrenonacog alfa or any other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using ALPROLIX.

·             There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ALPROLIX. Signs of allergic reactions may include, generalised itching, hives, tightness of the chest, difficulty breathing and low blood pressure. If any of these symptoms occur, stop the injection immediately and contact your doctor. Because of the risk of allergic reactions with factor IX, your initial administrations of ALPROLIX should be performed under medical observation where proper medical care for allergic reactions can be provided.

·             Talk to your doctor if you think that your bleeding is not being controlled with the dose you receive, as there can be several reasons for this. For example, the formation of antibodies (also known as inhibitors) to factor IX is a known complication that can occur during the treatment of haemophilia B. The antibodies prevent the treatment from working properly. This would be checked by your doctor. Do not increase the total dose of ALPROLIX to control your bleed without talking to your doctor.

Patients with a factor IX inhibitor may be at an increased risk of anaphylaxis during future treatment with factor IX. Therefore, if you experience allergic reactions such as those described above, you should be tested for the presence of an inhibitor.

Factor IX products may increase the risk of unwanted blood clots in your body, especially if you have risk factors for developing blood clots. Symptoms of a possible unwanted blood clot may include: pain and/or tenderness along a vein, unexpected swelling of an arm or leg or sudden shortness of breath or difficulty breathing.

Cardiovascular events

If you have been told you have heart disease or are at risk for heart disease, take special care when using factor IX and talk to your doctor.

Catheter-related complications

If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site blood clots should be considered.

Documentation

It is strongly recommended that every time ALPROLIX is given, the name and batch number of the product are recorded.

Other medicines and ALPROLIX

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

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 influence on the ability to drive and use machines.

ALPROLIX contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial that is to say essentially “sodium free”. In case of treatment with multiple vials, the total sodium content should be taken into consideration.

Treatment with ALPROLIX will be started by a doctor who is experienced in the care of patients with haemophilia. Always use this medicine exactly as your doctor has told you (see section 7). Check with your doctor, pharmacist or nurse if you are not sure.

ALPROLIX is given as an injection into a vein. You or somebody else may administer it after receiving adequate training. Your doctor will decide the dose (in International Units or “IU”) you will receive. The dose will depend on your individual needs for replacement factor IX therapy and on whether it is used for prevention or treatment of bleeding. Talk to your doctor if you think that your bleeding is not being controlled with the dose you receive.

How often you need an injection will depend on how well the medicine is working for you. Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor IX levels in your blood.

Treatment of bleeding

The dose of ALPROLIX is calculated depending on your body weight and the factor IX levels to be achieved. The target factor IX levels will depend on the severity and location of the bleeding.

Prevention of bleeding

If you are using ALPROLIX to prevent bleeding, your doctor will calculate the dose for you.

The usual dose of ALPROLIX is 50 IU per kg of body weight, given once a week or 100 IU per kg of body weight, given once every 10 days. The dose or interval may be adjusted by your doctor. In some cases, especially in younger patients, shorter dosing intervals or higher doses may be necessary.

Use in children and adolescents

ALPROLIX can be used in children and adolescents of all ages. In children below the age of 12 years, higher doses or more frequent injections may be needed and the usual dose is 50 to 60 IU per kg of body weight, given once every 7 days.

If you use more ALPROLIX than you should

Tell your doctor as soon as possible. You should always use ALPROLIX exactly as your doctor has told you, check with your doctor, pharmacist or nurse if you are not sure.

If you forget to use ALPROLIX

Do not take a double dose to make up for a forgotten dose. Take your dose as soon as you remember and then resume your normal dosing schedule. If you are not sure what to do, ask your doctor, pharmacist or nurse.

If you stop using ALPROLIX

Do not stop using ALPROLIX without consulting your doctor. If you stop using ALPROLIX you may no longer be protected against bleeding or a current bleed may not stop.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

7.       Instructions for preparation and administration

The procedure below describes the preparation and administration of ALPROLIX.

ALPROLIX is administered by intravenous (IV) injection after dissolving the powder for injection with the solvent supplied in the pre-filled syringe. ALPROLIX pack contains:

			A) 1 Powder vial B) 5 mL Solvent in pre-filled syringe C) 1 Plunger rod D) 1 Vial adapter E) 1 Infusion set F) 2 Alcohol swabs G) 2 Plasters H) 1 Gauze pad

ALPROLIX should not be mixed with other solutions for injection or infusion.

Wash your hands before opening the pack.

Preparation:

Administration (Intravenous Injection):

ALPROLIX should be administered using the infusion set (E) provided in this pack.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If severe, sudden allergic reactions (anaphylactic reaction) occur, the injection must be stopped immediately. You must contact your doctor immediately if you experience any of the following symptoms of allergic reactions: swelling of the face, rash, generalised itching, hives, tightness of the chest, difficulty breathing, burning and stinging at the injection site, chills, flushing, headache, general feeling of being unwell, nausea, restlessness, fast heartbeat, and low blood pressure.

For children not previously treated with factor IX medicines, inhibitors (see section 2) may form commonly (up to 1 in 10 patients). If this happens, the medicine may stop working properly and your child may experience persistent bleeding. If this happens, you should contact your doctor immediately.

The following side effects may occur with this medicine.

Common side effects (may affect up to 1 in 10 people): headache, mouth numbness or tingling, pain in your side with blood in your urine (obstructive uropathy) and injections site redness. Children not previously treated with factor IX medicines: factor IX inhibitors, hypersensitivity.

Uncommon side effects (may affect up to 1 in 100 people): dizziness, taste alteration, bad breath, feeling tired, pain at the injection site, rapid heartbeat, blood in the urine (haematuria), pain in your side (renal colic), low blood pressure, and decreased appetite.

Reporting of side effects

Reporting of suspected adverse reactions

To report any side effect(s):
· Saudi Arabia

Y

· UAE

· Other GCC States:

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the vial label, listed after “EXP”. The expiry date refers to the last day of that month. Do not use this medicine if it has been stored at room temperature for longer than 6 months.

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original pack in order to protect from light.

Alternatively, ALPROLIX may be stored at room temperature (up to 30 °C) for a single period not exceeding 6 months. Please record on the carton the date that ALPROLIX is removed from the refrigerator and set at room temperature. After storage at room temperature, the product must not be put back in the refrigerator.

Once you have prepared ALPROLIX it should be used right away. If you cannot use the prepared solution immediately, it should be used within 6 hours when stored at room temperature. Do not refrigerate the solution after preparation. Protect the solution from direct sunlight.

The prepared solution will be clear to slightly pearl-like (opalescent) and colourless. Do not use this medicine if you notice that it is cloudy or contains visible particles.

This product is for single use only.

Discard any unused solution appropriately. 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.