THYROGEN thyrotropin alfa-rch 0.9 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Thyrotropin alfa, Quantity: 1.1 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: nitrogen; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate; sodium chloride; mannitol

Administration route:

Intramuscular

Units in package:

2 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Thyrogen is indicated for use with serum thyroglobulin (Tg) testing, with or without radioactive iodine imaging and undertaken for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy. Therapeutic use in post-thyroidectomy patients maintained on hormone suppression therapy in the ablation of thyroid remnant tissue in combination with radioactive iodine.

Product summary:

Visual Identification: White/off-white cake (lyophilised powder); Container Type: Vial; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2001-08-14

Patient Information leaflet

THYROGEN
®
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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 THYROGEN?
Thyrogen contains the active ingredient thyrotropin alfa. Thyrogen is
used to help in the detection of thyroid cancer cells. Thyrogen
is also used in the treatment of thyroid cancer in combination with
radioactive iodine. For more information, see Section 1. Why am I
using Thyrogen? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE THYROGEN IS GIVEN?
Do not use if you have ever had an allergic reaction to thyrotropin
alfa 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
Thyrogen? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Thyrogen and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE THYROGEN?
•
Your treating physician will decide on the dose that is most suitable.
•
Your treating physician will give you two injections of Thyrogen into
the muscle of your buttock. The second injection will be
given to you a day after the first one.
More instructions can be found in Section 4. How is Thyrogen given? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING THYROGEN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Thyrogen.
•
Keep appointments with your treating physician.
•
Have tests when your treating physician says to.
THINGS YOU
SHOULD NOT DO
•
Do not use Thyrogen if you have a known, severe allergic reaction to
Thyrogen or any of its ingredients
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how Thyrogen
affects you.
LOOKING AFTER
YOUR MEDICIN

Summary of Product characteristics

thyrogen-ccdsv2-piv3-12apr21
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION – THYROGEN
(THYROTROPIN ALFA) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Thyrotropin alfa.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Thyrotropin alfa 1.1 mg
3
PHARMACEUTICAL FORM
THYROGEN is supplied as a sterile, non - pyrogenic, white to off -
white, lyophilised
product, intended for intramuscular (IM) administration after
reconstitution with Sterile
Water for Injection. Each vial of THYROGEN contains 1.1 mg thyrotropin
alfa.
After reconstitution with 1.2 mL of Sterile Water for Injection, the
thyrotropin alfa
concentration is 0.9 mg/mL. The pH of the reconstituted solution is
approximately 7.0.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
THYROGEN is indicated for:
1. use with serum thyroglobulin (Tg) testing, with or without
radioactive iodine imaging,
undertaken for the detection of thyroid remnants and well -
differentiated thyroid cancer in
post - thyroidectomy patients maintained on hormone suppression
therapy.
2. therapeutic use in post - thyroidectomy patients maintained on
hormone suppression
therapy in the ablation of thyroid remnant tissue in combination with
radioactive iodine.
4.2
DOSE AND METHOD OF ADMINISTRATION
A two - injection regimen is recommended for THYROGEN administration.
The two - injection regimen is THYROGEN 0.9 mg intramuscularly (IM),
followed by a
second 0.9 mg IM injection 24 hours later.
After reconstitution with 1.2 mL Sterile Water for Injection, 1.0 mL
solution (0.9 mg
thyrotropin alfa) is administered by intramuscular injection to the
buttock.
thyrogen-ccdsv2-piv3-12apr21
Page 2 of 15
Each vial, after reconstitution with 1.2 mL of Sterile Water for
Injection, should be inspected
visually for particulate matter or discolouration, before use. Any
vials exhibiting particulate
matter or discolouration should not be used.
For radioiodine imaging or treatment, radioiodine administration
should be given 24 hours
following the final T