ILLUCCIX Configuration B Kit for the Preparation of Ga-68 Glu-urea-Lys(ahx)-hbed-CC 25 mcg solution for injection Glass Vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Glu-urea-Lys(ahx)-hbed-CC, Quantity: 25 microgram

Available from:

Telix Pharmaceuticals (ANZ) Pty Ltd

Pharmaceutical form:

Injection, diluent for

Composition:

Excipient Ingredients: sodium acetate; hydrochloric acid; water for injections

Administration route:

Intravenous Bolus

Units in package:

1 Kit for the Preparation of Ga-68 prostate specific membrane antigen (PSMA-11) injection

Prescription type:

exempt from scheduling - Appendix A; prescription medicine

Therapeutic indications:

ILLUCCIX, after radiolabelling with Ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging combined with Computerised Tomography (CT) in patients with prostate cancer: who are at risk of metastasis and who are suitable for initial definitive therapy; who have suspected recurrence based on elevated serum prostate specific antigen (PSA) level.

Product summary:

Visual Identification: Clear and colorless solution; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-11-10

Patient Information leaflet

ILLUCCIX
1
ILLUCCIX
Kit for Ga-68 Glu-urea-Lys(ahx)-hbed-CC radiopharmaceutical
preparation
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
ILLUCCIX. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR IF YOU
WOULD LIKE FURTHER INFORMATION OR IF YOU HAVE ANY
CONCERNS OR QUESTIONS ABOUT USING ILLUCCIX.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1.
What ILLUCCIX is used for?
2.
What should you know before you are given
ILLUCCIX?
3.
What if I am taking other medicines?
4.
How ILLUCCIX is given?
5.
When you are given ILLUCCIX?
6.
Are there any side effects?
7.
Product details
1.
WHAT ILLUCCIX IS USED FOR?
ILLUCCIX IS A MULTI-DOSE KIT FOR THE PREPARATION OF GA-68
GA-68 GLU-UREA-LYS(AHX)-HBED-CC FOR INTRAVENOUS USE.
THERE ARE 2 DIFFERENT KIT CONFIGURATIONS, EACH CONTAINING 3
VIALS. ILLUCCIX belongs to a group of medicines called
radiopharmaceutical agents, which are all radioactive.
ILLUCCIX, AFTER RADIOLABELLING WITH GA-68, IS A RADIOACTIVE
DIAGNOSTIC AGENT INDICATED FOR POSITRON EMISSION
TOMOGRAPHY (PET) IMAGING COMBINED WITH COMPUTERISED
TOMOGRAPHY (CT) SCAN IN PATIENTS WITH PROSTATE CANCER:
•
WHO ARE AT RISK OF METASTASIS AND WHO ARE SUITABLE FOR
ANY INITIAL DEFINITIVE THERAPY
•
WHO HAVE SUSPECTED RECURRENCE BASED ON ELEVATED
SERUM PROSTATE SPECIFIC ANTIGEN (PSA) LEVEL.
2.
WHAT SHOULD YOU KNOW BEFORE YOU ARE
GIVEN ILLUCCIX
Before you are given ILLUCCIX, your doctor will explain to
you the procedure you are about to undergo, and the
radioactive medicine you will be given. You must discuss
any concerns you have with your doctor.
WARNINGS
YOU MUST TELL YOUR DOCTOR IF:
•
you have kidney problems.
•
you are allergic to any other medicines.
•
you are allergic to any other substances such as foods,
preservatives or dyes.
CHECK WITH YOUR DOCTOR IF YOU:
•
have any other medical conditions
•
take any medicines for any other condition
During treatment, you may be at risk of developing certain
side effects. It is important you understand these risks and
how to monitor for them. See ad

Summary of Product characteristics

ILLUCCIX (Kit for the Preparation of Ga-68 Glu-urea-Lys(ahx)-hbed-CC)
Injection
Australian Product Information
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION – ILLUCCIX (KIT FOR
THE PREPARATION OF GA-68 GLU-UREA-LYS(AHX)-HBED-CC)
INJECTION
1
NAME OF THE MEDICINE
ILLUCCIX
TM
25 µg, Kit for Ga-68 Glu-urea-Lys(ahx)-hbed-CC radiopharmaceutical
preparation
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ILLUCCIX is supplied as a sterile, multi-dose kit for the preparation
of Ga-68 Glu-urea-Lys(ahx)-
hbed-CC for intravenous use. There are 2 different kit configurations,
each containing 3 vials.
ILLUCCIX Configuration “A” is intended for use with Ga-68 produced
from a cyclotron and purified
via GE FASTlab
TM
or Eckert & Ziegler GalliaPharm
®
Ge 68/Ga-68 generator and includes:
•
Vial 1 (Glu-urea-Lys(ahx)-hbed-CC Vial): contains 25 microgram
Glu-urea-Lys(ahx)-hbed-CC,
10 microgram mannose and water for injections as a lyophilized powder
in a sterile 10 mL vial
with a blue flip-off cap.
•
Vial 2 (Buffer Vial, Configuration A): contains 150 mg sodium acetate,
0.077 mL hydrochloric
acid and water for injections (2.5 mL volume) in a sterile 10 mL vial
with a red flip off cap.
•
Vial 3 (Sterile Vacuumed Vial): an evacuated sterile vial with white
flip off cap used to collect Ga-
68 chloride from generators or cyclotron
ILLUCCIX Configuration “B” is intended for use with Ga-68 produced
from an IRE Galli Eo
®
Ge
68/Ga-68 generator and includes:
•
Vial 1 (Glu-urea-Lys(ahx)-hbed-CC Vial): contains 25 microgram
Glu-urea-Lys(ahx)-hbed-CC,
10 microgram mannose and water for injections as a lyophilized powder
in a sterile 10 mL vial
with a blue flip-off cap.
•
Vial 2 (Buffer Vial, Configuration B): contains 150 mg sodium acetate,
0.15 mL hydrochloric acid
and water for injections (6.4 mL volume) in a sterile 10 mL vial with
a green flip off cap.
•
Vial 3 (Sterile Vacuumed Vial): an evacuated sterile vial with white
flip off cap used to collect Ga-
68 chloride from generator.
The radionuclide is not part of the kit. B