Consumer medicine information

Alprolix 500 IU Powder for infusion

Eftrenonacog alfa

BRAND INFORMATION

Brand name

Alprolix

Active ingredient

Eftrenonacog alfa

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Alprolix 500 IU Powder for infusion.

1. Why am I using ALPROLIX?


ALPROLIX contains the active ingredient eftrenonacog alfa (recombinant coagulation factor IX fusion protein). ALPROLIX is used for the management of haemophilia B (congenital factor IX deficiency). For more information, see Section 1. Why am I using ALPROLIX? in the full CMI.

2. What should I know before I use ALPROLIX?


Do not use if you have ever had an allergic reaction to ALPROLIX or other factor IX replacement factors, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, use any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use ALPROLIX? in the full CMI.

3. What if I am taking other medicines?


Tell your doctor or Haemophilia Treatment Centre if you are taking or using any other medicines including any that you get without a prescription from your pharmacy, supermarket, or health food shop. For more information see Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ALPROLIX?

  • Your doctor will decide how much ALPROLIX you use. This will depend on your individual need for replacement factor IX therapy. Your doctor may change the dose you use during your treatment.
  • ALPROLIX is given by slow injection directly into your veins.
  • ALPROLIX comes in a vial of sterile powder to cake and a pre-filled syringe containing solvent, also known as diluent. These need to be mixed before use. More instructions can be found in Section 4. How do I use ALPROLIX? in the full CMI.

5. What should I know while using ALPROLIX?

Things you should do
  • Tell your doctor immediately if bleeding is not controlled after using ALPROLIX.
  • If you become pregnant while on treatment with ALPROLIX, immediately tell your doctor.
  • Tell any other doctors, dentist, or pharmacist you visit that you are using ALPROLIX.
  • Keep all your appointments with your doctor and any blood tests.
Things you should not do
  • Do not give your medicine to anyone else, even if they appear to have the same condition as you.
  • Do not stop using your medicine or change the dosage without checking with your doctor.
Looking after your medicine
  • Keep your ALPROLIX in the pack until it is time to use it.
  • This medicine should be protected from light.
  • Keep ALPROLIX in the refrigerator at 2°C to 8°C.

For more information, see Section 5. What should I know while using ALPROLIX? in the full CMI.

6. Are there any side effects?


Some common side effects are headache, tingling or numbness in your mouth (paraesthesia), breath odour, fatigue, dizziness, taste disturbance or loss of taste (dysgeusia), pain or redness at site of infusion, easily bruising or bleeding due to factor IX inhibition, low blood pressure (symptoms include dizziness or feeling lightheaded), fast or irregular heartbeats, also called palpitations, pain in your side with blood in your urine (obstructive uropathy).
A serious side effect is an allergic reaction with symptoms of shortness of breath, wheezing or difficulty breathing, chest pain or discomfort, swelling of the face, lips tongue or other parts of the body rash or hives.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Alprolix

Active ingredient

Eftrenonacog alfa

Schedule

Unscheduled

 

1 Name of Medicine

Eftrenonacog alfa.

2 Qualitative and Quantitative Composition

Each single-use vial contains nominally 250, 500, 1000, 2000, 3000, or 4000 International Units (IU) of eftrenonacog alfa.
Each pre-filled syringe contains 5 mL of solvent.
Eftrenonacog alfa is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line, which has been extensively characterised. The HEK cell line expresses eftrenonacog alfa into a defined cell culture medium that does not contain any proteins derived from animal or human sources. Eftrenonacog alfa is purified by a series of chromatography steps that does not require use of a monoclonal antibody. The process includes multiple viral clearance steps including 15 nanometre virus-retaining nano-filtration. No human or animal additives are used in the cell culture, purification, and formulation processes.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder and solvent for solution for injection.
Alprolix is formulated as a sterile, preservative-free, non-pyrogenic, lyophilised, white to off-white powder to cake, for intravenous (IV) administration in a single-use vial.
The liquid diluent (sterile sodium chloride solution 0.325%) is in a pre-filled syringe.

4 Clinical Particulars

4.9 Overdose

No symptoms of overdose have been reported. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Alprolix has not been evaluated in mutagenicity or chromosomal aberration assays since it is a replacement protein factor for coagulation.
Carcinogenicity. No animal studies investigating carcinogenicity effects of Alprolix have been conducted since it is a replacement factor for coagulation activity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Alprolix (eftrenonacog alfa) (rhu) is a long-acting, fully recombinant, fusion protein consisting of human coagulation factor IX (FIX) covalently linked to the Fc domain of human immunoglobulin G1 (IgG1). The factor IX portion of eftrenonacog alfa has a primary amino acid sequence that is identical to the Thr148 allelic form of plasma derived factor IX and has structural and functional characteristics similar to endogenous factor IX. The Fc domain of eftrenonacog alfa contains the hinge, CH2 and CH3 regions of IgG1. Eftrenonacog alfa contains 867 amino acids with a molecular weight of approximately 98 kilodaltons.
CAS number. 1270012-74-2.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

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