ELOCTATE efmoroctocog alfa (rhu) 1000 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)
04-03-2022
Public Assessment Report
(PAR)
19-10-2017
Active ingredient:
efmoroctocog alfa, Quantity: 1000 IU
Available from:
Sanofi-Aventis Australia Pty Ltd
INN (International Name):
efmoroctocog alfa
Pharmaceutical form:
Drug delivery system
Composition:
Excipient Ingredients:
Administration route:
Intravenous
Units in package:
1s (vial + diluent syringe)
Prescription type:
exempt from scheduling - Appendix A; prescription medicine
Therapeutic indications:
ELOCTATE is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia A (congenital factor VIII deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis). ELOCTATE does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease.
Product summary:
Visual Identification: ; Container Type: Multiple containers; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Authorization status:
Registered
Authorization date:
2014-06-27
Patient Information leaflet
ELOCTATE
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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 ELOCTATE?
ELOCTATE contains the active ingredient efmoroctocog alfa.
Efmoroctocog alfa is a factor VIII protein necessary for forming clots
in
the blood and helps to control or prevent bleeding. ELOCTATE is used
for the management of haemophilia A (congenital factor VIII
deficiency).
For more information, see Section 1. Why am I using ELOCTATE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ELOCTATE?
Do not use if you have ever had an allergic reaction to ELOCTATE,
efmoroctocog alfa or other factor VIII 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, TAKE 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
ELOCTATE? in the full CMI.
3.
WHAT IF I AM TAKING OR USING 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 or using
other medicines? in the full CMI.
4.
HOW DO I USE ELOCTATE?
•
Your doctor will decide what dose you will receive. Do not use more
than the recommended dose.
•
ELOCTATE is administered by slow injection directly into your vein.
•
ELOCATE comes in a vial of sterile powder to cake and a pre-filled
syringe containing solvent. These need to be mixed before
use.
MORE INSTRUCTIONS AND HOW TO USE ELOCTATE CAN BE FOUND IN SECTION 4.
How do I use ELOCTATE? IN THE FULL CMI.
5.
WHAT SHOULD I KNOW WHILE USING ELOCTATE?
THINGS YOU
SHOULD DO
•
Tell your doctor immediately if bleeding is not controlled after using
ELOCTATE.
•
Tell your doctor immediately if you become
Read the complete document
Summary of Product characteristics
elo-ccdsv12-piv10-03mar22
Page 1 of 32
AUSTRALIAN PRODUCT INFORMATION – ELOCTATE
(EFMOROCTOCOG ALFA) (RHU) POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Efmoroctocog alfa
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use vial contains nominally 250, 500, 750, 1000, 1500,
2000, or 3000 International
Units (IU) of efmoroctocog alfa.
Each pre-filled syringe contains 3 mL of solvent.
Efmoroctocog 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
efmoroctocog alfa into a defined cell culture medium that does not
contain any proteins derived
from animal or human sources. The purification process utilises a
series of chromatography and
multiple viral clearance steps. The viral clearance steps include
affinity chromatography, 15nm
virus-retaining nano-filtration step, and detergent viral
inactivation. No human or animal derived
additives are used in the 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.
ELOCTATE 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 water for injections) is in a pre-filled
syringe.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ELOCTATE is a long-acting antihaemophilic factor (recombinant)
indicated in adults and
children with haemophilia A (congenital factor VIII deficiency) for:
•
Control and prevention of bleeding episodes.
elo-ccdsv12-piv10-03mar22
Page 2 of 32
•
Routine prophylaxis to prevent or reduce the frequency of bleeding
episodes.
•
Perioperative management (surgical prophylaxis).
ELOCTATE does not contain von Willebrand factor, and therefore is not
indicated in patients
with von Willebrand’s disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
For Intravenous Us
Read the complete document
