Thyrogen
thyrotropin alfa
Thyrotropin alfa
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Thyrogen is and what it is used for
What you need to know before you use Thyrogen
How to use Thyrogen
Possible side effects
How to store Thyrogen
Contents of the pack and other information
Thyrogen contains the active substance thyrotropin alfa. Thyrogen is a human thyroid stimulating hormone (TSH) manufactured using biotechnology processes.
Thyrogen is used to detect certain types of thyroid cancer in patients who have had their thyroid gland removed and who are taking thyroid hormones. One of the effects is that it stimulates any remaining thyroid tissue to take up iodine which is important for radioiodine imaging. It also stimulates the production of thyroglobulin and thyroid hormones if there is any thyroid tissue left. These hormones can be measured in your blood.
Thyrogen is also used with radioiodine treatment to eliminate (ablate) the thyroid tissue left over after surgical removal of the thyroid gland (remnant) in patients who do not have secondary cancer growths (metastases) and who are taking thyroid hormone.
if you are allergic to bovine or human thyroid stimulating hormone (TSH) or any of the other ingredients of this medicine (listed in section 6).
if you are pregnant.
Talk to your doctor or pharmacist before using Thyrogen
if you have kidney disease that requires dialysis and he will decide how much Thyrogen to give to you as you may have more chance of experiencing headache and nausea.
if you have reduced kidney function and he will decide how much radioiodine to give you.
if you have reduced liver function; you should still be able to receive Thyrogen.
Effect on tumour growth
In patients with thyroid cancer, tumour growth has been reported during withdrawal of thyroid hormones for diagnostic procedures. This was thought to be related to the elevated thyroid stimulating hormone (TSH) levels over a longer period. It is possible that Thyrogen may also cause tumour growth. In clinical trials this was not seen.
Due to elevation of TSH levels after Thyrogen, patients with secondary cancer growths (metastases) can experience local swelling or bleeding at the site of these metastases which may become bigger. If the metastases are present in narrow spaces e.g. intracerebral (in the brain) or in the spinal cord, patients could experience symptoms which can occur quickly such as partial paralysis affecting one side of the body (hemiparesis), breathing problems or loss of vision.
Your doctor will decide if you belong to a specific group of patients for which pre-treatment with corticosteroids is to be considered (for example, if you have secondary cancer growths in your brain or spinal cord). Please talk to your doctor about this if you have concerns.
Due to a lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances.
No special precautions for elderly patients are necessary. However if your thyroid gland has not been removed completely and you are also suffering from heart disease, your doctor will help you decide if Thyrogen should
be given to you.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are no known drug interactions with Thyrogen and the thyroid hormones you may be taking. Your doctor will determine the exact activity of radioiodine to use for radioiodine imaging, taking into
consideration the fact that you continue to take thyroid hormones.
Do not take Thyrogen if you are pregnant. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Thyrogen should not be given to breast-feeding women. Breast-feeding should only be resumed following advice from your doctor.
Some patients may feel dizzy or have headaches after administration of Thyrogen which may affect the ability to drive and use machines.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
Your medicine will be injected by a doctor or a nurse.
Your treatment should be supervised by a doctor who has expertise in thyroid cancer. Thyrogen powder must be dissolved in water for injection. Only one vial of Thyrogen is required per injection. Thyrogen should only be administered into the buttock muscle. This solution should never be injected into a vein. Thyrogen must not be mixed with other medicines in the same injection.
The recommended dose of Thyrogen is two doses administered 24 hours apart. Your doctor or nurse will inject
1.0 ml of the Thyrogen solution.
When you undergo radioiodine imaging or elimination (ablation), your doctor will give you radioiodine 24 hours after your final Thyrogen injection.
Diagnostic scanning should be performed 48 to 72 hours after the radioiodine administration (72 to 96 hours after the final injection of Thyrogen).
Post-treatment scanning may be delayed a few days to allow background radioactivity to decline.
For thyroglobulin (Tg) testing, your doctor or nurse will take a serum sample 72 hours after the last injection of Thyrogen.
Your child’s doctor will help you decide if Thyrogen should be given to your child.
Patients who accidentally received too much Thyrogen have reported nausea, weakness, dizziness, headache, vomiting and hot flashes.
A suggested treatment in case of overdose would be the reestablishment of fluid balance and administration of an antiemetic may also be considered.
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following effects have been reported with Thyrogen:
nausea
vomiting
fatigue
dizziness
headache
weakness
feeling hot
hives (urticaria)
rash
flu symptoms
fever
chills
back pain
diarrhoea
prickling or tingling sensation (paraesthesia),
neck pain
inability to taste (ageusia)
impaired sense of taste (dysgeusia)
influenza
swelling of the tumour
pain (including pain at the site of metastases (secondary cancer growths))
tremor
stroke
palpitations
flushing
shortness of breath
itching (pruritus)
excessive sweating
muscle or joint pain
injection site reactions (including: redness, discomfort, itching, local pain or stinging, and an itchy rash)
low TSH
hypersensitivity (allergic reactions), these reactions include hives (urticaria), itching, flushing, difficulty in breathing and rash.
Very rare cases of hyperthyroidism (increased activity of the thyroid gland) or atrial fibrillation have been reported when Thyrogen was administered to patients who had not undergone total or partial removal of the thyroid gland.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Keep the vial in the outer carton in order to protect from light.
It is recommended that the Thyrogen solution be injected within three hours after reconstitution.
The reconstituted solution can be stored for up to 24 hours in a refrigerator (2°C - 8°C) under protection from light, while avoiding microbial contamination.
Do not use this medicine if you notice foreign particles, cloudiness or discoloration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is thyrotropin alfa.
Each vial contains 0.9 mg/ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection. Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.
The other ingredients are: Mannitol
Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Sodium chloride.
Thyrogen contains sodium, see section 2.
Powder for solution for injection. White to off-white lyophilised powder. Pack sizes: one or two vials of Thyrogen per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Genzyme Europe B.V. Paasheuvelweg 25
1105 BP Amsterdam The Netherlands
Manufacturer:
Genzyme Ireland Limited IDA Industrial Park
Old Kilmeaden Road
Waterford Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Tél/Tel: + 32 (0)2 710 54 00
Swixx Biopharma EOOD
Tел: +359 (0)2 4942 480
Sanofi S.r.l.
Tel: +39 02 39394275
Genzyme Europe B.V. Tel: +31 20 245 4000
Sanofi A/S
Tlf: +45 45 16 70 00
sanofi-aventis Norge AS Tlf: + 47 67 10 71 00
Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 996
Tel: aus dem Ausland:+49 69 305 70 13
sanofi-aventis GmbH Tel: + 43 1 80 185 - 0
Swixx Biopharma OÜ Tel. +372 640 10 30
sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
sanofi-aventis AEBE
Τηλ: +30 210 900 16 00
Sanofi – Produtos Farmacêuticos, Lda. Tel: +351 21 35 89 400
sanofi-aventis, S.A. Tel: +34 93 485 94 00
Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Sanofi-aventis France Tél: 0 800 222 555
Appel depuis l’étranger: +33 1 57 63 23 23
Swixx Biopharma d.o.o. Tel: +386 1 235 51 00
Swixx Biopharma d.o.o. Tel: +385 1 2078 500
sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00
Vistor hf.
Sími: +354 535 7000
Sanofi Oy
Puh/Tel: + 358 (0) 201 200 300
Sanofi S.r.l. Tel: 800536389
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741
Sanofi AB
Tel: +46 (0)8 634 50 00
Swixx Biopharma SIA Tel: +371 6 616 47 50
Swixx Biopharma UAB Tel. +370 5 236 91 40
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The following information is intended for healthcare professionals only:
The recommended dose regimen of Thyrogen is two intramuscular injections of 0.9 mg thyrotropin alfa administered at a 24-hour interval.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Use aseptic technique.
Add 1.2 ml water for injection to the Thyrogen powder in the vial. Swirl the contents of the vial gently until all material is dissolved. Do not shake the solution. When the powder is dissolved the total volume in the vial is
1.2 ml. The pH of the Thyrogen solution is approximately 7.0.
Visually inspect the Thyrogen solution in the vial for foreign particles and discoloration. The Thyrogen solution should be a clear, colourless solution. Do not use vials exhibiting foreign particles, cloudiness or discoloration.
Withdraw 1.0 ml of the Thyrogen solution from the product vial. This equals 0.9 mg thyrotropin alfa to be injected.
Thyrogen does not contain preservatives. Dispose of any unused solution immediately. No special requirements for disposal.
After reconstitution, the solution should be injected within three hours. The reconstituted solution can be stored for up to 24 hours in a refrigerator (2°C - 8°C) under protection from light, while avoiding microbial contamination. It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution.