ALPROLIX eftrenonacog alfa (rhu) 3000 IU powder for injection vial and diluent pre-filled syringe
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
18-11-2021
Summary of Product characteristics
(SPC)
19-11-2021
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
eftrenonacog alfa, Quantity: 3000 IU
Available from:
Sanofi-Aventis Australia Pty Ltd
INN (International Name):
eftrenonacog alfa
Pharmaceutical form:
Drug delivery system
Composition:
Excipient Ingredients:
Administration route:
Intravenous
Units in package:
1s (vial + diluent)
Prescription type:
exempt from scheduling - Appendix A; prescription medicine
Therapeutic indications:
ALPROLIX is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia B (congenital factor IX deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)
Product summary:
Visual Identification: ; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-05-01
Patient Information leaflet
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
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
te
Read the complete document
Summary of Product characteristics
alp-ccdsv14-piv11-04nov21
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION – ALPROLIX
(EFTRENONACOG ALFA) (RHU) POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
1
NAME OF THE 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 15nm 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
4.1
THERAPEUTIC INDICATIONS
ALPROLIX is a long-acting anti-haemophilic factor (recombinant)
indicated in adults and
children with haemophilia B (congenital factor IX deficiency) for:
•
Control and prevention of bleeding episodes
alp-ccdsv14-piv11-04nov21
Page 2 of 28
•
Routine prophylaxis to prevent or reduce the frequency of bleeding
episodes
•
Perioperative management (surgical prophylaxis)
4.2
DOSE AND METHOD OF ADMINISTRATION
For Intravenous Use Only After Reconstitution.
Treatment should be initiated and supervised by qualified healthcare
professionals experienced in
the d
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