0.9 mg powder for solution for injection.
Thyrotropin alfa
What Thyrogen is and what it is used for
Thyrogen contains the active substance thyrotropin alfa. Thyrogen is a human thyroid-stimulating (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 removed and 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 scintigraphy. It also stimulates the production of thyroglobulin and thyroid hormones if there is any thyroid tissue left. These hormones can be measured in the blood.
Thyrogen is also used together with radioiodine treatment to remove (ablate) the thyroid tissue that is left behind (residue) after the thyroid gland has been surgically removed in patients who do not have secondary tumor growth ( metastases ) and who are taking thyroid hormone.
What you need to know before using Thyrogen
Do not use Thyrogen
- if you are allergic to bovine (from cows) or human thyroid-stimulating hormone ( TSH ) or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant.
Warnings and precautions
Talk to your doctor or pharmacist before using Thyrogen
if you have:
- a kidney disease that needs to be treated with dialysis so the doctor can decide how much Thyrogen you can get because you may be at a greater risk of headaches and nausea.
- if you have impaired kidney function so that the doctor can decide how much radioiodine you can receive.
- if you have impaired liver function. You should still be able to get Thyrogen.
Effect on tumor growth
In patients with thyroid cancer, tumor growth has been reported during the withdrawal of thyroid hormones for diagnostic procedures. This was thought to be related to the elevated levels of thyroid-stimulating hormone ( TSH ) over a longer period. It is possible that Thyrogen can also cause tumor growth. This has not been seen in clinical trials.
Due to elevated TSH levels after Thyrogen, patients with secondary cancer tumors ( metastases ) may experience local swelling or bleeding where these metastases are located. Metastases can also grow. If the metastases are in tight places, e.g. intracerebrally (in the brain) or in the spinal cord, patients may have symptoms that may occur acutely, e.g. in the form of partial paralysis affecting one side of the body (hemiparesis), breathing problems or vision loss.
Your doctor will decide whether you belong to the special group of patients for whom pretreatment with corticosteroids may be considered (for example, if you have secondary cancerous tumors in the brain or spinal cord). Please discuss this with your doctor if you have any questions.
Children
Since there is no data on the use of Thyrogen in children, Thyrogen should only be given to children in exceptional cases.
Older
No special precautions are needed for the elderly. If your thyroid gland has not been completely removed and you also have heart disease, your doctor will help you decide whether you should receive Thyrogen.
Other medicines and Thyrogen
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
There are no known drug interactions with Thyrogen and the thyroid hormones you may be taking.
Your doctor will assess the exact activity of radioiodine to be used for radioiodine scintigraphy taking into account that you continue to take thyroid hormones.
Pregnancy and breastfeeding
Do not take Thyrogen if you are pregnant. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Thyrogen must not be given to breastfeeding women. Breastfeeding should only be resumed after you have spoken to your doctor.
Driving ability and use of machinery
Some patients may experience dizziness or headache after administration of Thyrogen which may affect the ability to drive and use machines.
Thyrogen contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. it is almost “sodium-free”.
How to use Thyrogen
Your medicine will be injected by a doctor or nurse.
Your treatment should be supervised by doctors with extensive experience in thyroid cancer. Thyrogen powder must be dissolved in water intended for injection. Only one vial of Thyrogen is needed per injection. Thyrogen may only be injected into the buttock. The solution must 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 given 24 hours apart. The doctor or nurse injects 1.0 ml of the Thyrogen solution.
When you are going to undergo radioiodine scintigraphy or removal (ablation), the doctor will give you radioiodine 24 hours after your last Thyrogen injection.
Diagnostic scintigraphy should be performed 48 to 72 hours after receiving radioiodine (72 to 96 hours after the last injection of Thyrogen).
Scintigraphy after the treatment can be postponed for a few days so that the background radioactivity is reduced.
For thyroglobulin (Tg) testing, the doctor or nurse takes a serum sample 72 hours after the last injection of Thyrogen.
Use in children
Your child’s doctor will help you decide if Thyrogen should be given to your child.
If you have received too much Thyrogen
Patients who have accidentally taken too much Thyrogen have reported nausea, weakness, dizziness, headache, vomiting, and hot flashes.
A suggestion for treatment in case of overdose could be to restore the fluid balance. Administration of antiemetics may also be considered.
If you have any further questions about this medicine, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported in connection with Thyrogen:
Very common (may affect more than 1 in 10 users):
- nausea
Common (may affect up to 1 in 10 users):
- vomiting
- fatigue
- dizziness
- headache
- weakness
Uncommon (may affect up to 1 in 100 users):
- feeling of warmth
- hives ( urticaria )
- rash
- flu-like symptoms
- fever
- overindulge
- back pain
- diarrhea
- tingling or crawling sensation ( paresthesia )
- neck pain
- inability to taste ( ageusia )
- impaired sense of taste ( dysgeusia )
- influenza
Has been reported (occurring in an unknown number of users)
- tumor a swells
- pain (including pain where there are metastases [secondary cancer tumors])
- tremor
- stroke
- palpitation
- hot flush
- shortness of breath
- itching (pruritis)
- profuse sweating
- pain in muscles or joints
- reactions at the injection site ( redness, discomfort, itching, local pain or burning, and itchy rash)
- low TSH value
- hypersensitivity reaction ( allergic reaction ). These reactions may include hives ( urticaria ), itching, hives, difficulty breathing, and skin rash.
Very rare cases of hyperthyroidism (increased activity of the thyroid gland) or atrial fibrillation have been reported when Thyrogen has been administered to patients who have not had a total or partial thyroidectomy.
How Thyrogen should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C – 8 °C).
Store the vial in the outer carton. Light sensitive.
The hydrogen solution should be injected within three hours of preparation.
The prepared solution can be stored for up to 24 hours in a refrigerator (2 °C–8 °C), provided it is protected from light and microbial contamination is avoided.
Do not use this medicine if the solution contains foreign particles, is cloudy, or discolored.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is thyrotropin alfa. Each vial contains 0.9 mg/ml thyrotropin alfa when reconstituted with 1.2 ml water for injection. Only 1ml should be withdrawn, corresponding to 0.9 mg of thyrotropin alfa.
- Other ingredients are: MannitolSodium phosphate, monobasic, monohydrate sodium phosphate, dibasic, heptahydrateSodium chloride
Thyrogen contains sodium, see section 2.
Appearance and package sizes of the medicine
Powder for solution for injection. White to off-white freeze-dried powder.
Pack size: One or two vials of Thyrogen per carton. Not all pack sizes may be marketed.
Marketing Authorization Holder :
Genzyme Europe BV
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands
Manufacturer:
Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
Contact the representative of the holder of the marketing authorization if you want to know more about this medicine:
Sanofi AB
Phone: +46 (0)8 634 50 00