Thyrogen 0.9 mg powder for solution for injectionPatient’s L - United Kingdom[英国药品]

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Thyrogen 0.9 mg powder for solution for injectionPatient’s L

2014-06-23 22:20:38 来源: 作者: 【大中小】浏览:398次评论:0条

For doctors

What is it and how is it used?

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 secondaries (metastases) and who are taking thyroid hormone.

What do you have to consider before using it?

Do not use Thyrogen
Tell your doctor:

Take special care with Thyrogen
Thyrogen should never be injected into a vein.

Tell your doctor if you have:

Elderly patients
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.

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 rapid symptoms 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.

Using other medicines
There are no known drug interactions with Thyrogen and the thyroid hormones you may be taking.

Please tell you doctor if you are taking or have recently taken any other medicines including medicines obtained without prescription.

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.

Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.

Do not take Thyrogen if you are pregnant. Please consult your doctor if you are pregnant or think you may be pregnant.

Thyrogen should not be given to breastfeeding women. Breast-feeding should only be resumed following advice from your doctor.

Driving and using machines
Some patients may feel dizzy or have headaches after administration of Thyrogen which may affect the ability to drive and use machines.

Important information about some of the ingredients of Thyrogen
This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium- free’.

How is it used?

Your doctor, nurse or pharmacist will prepare the injection for you.
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. The injection must be given intra-muscularly. Thyrogen must not be mixed with other medicines in the same injection

Use in children
Your child’s doctor will help you decide if Thyrogen should be given to your child.

Dosage:
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.

Thyrogen should only be administered into the buttock muscle. Thyrogen solution should never be

injected into a vein.

If you have

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.

If you are given more Thyrogen than you should receive
Patients who accidentally received too much Thyrogen have reported nausea, weakness, dizziness, headache, vomiting and hot flashes.

If you have any further questions on the use of this product, ask your doctor.

What are possible side effects?

Like all medicines, Thyrogen can cause side effects although not everybody gets them. The following effects have been reported with Thyrogen:

Very common (affects more than 1 user in 10):

Common (affects 1 to 10 users in 100):

Uncommon (affects 1 to 10 users in 1,000):

Frequency not known
(frequency cannot be estimated from the available data)

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 any of the side effects gets serious, or if any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

Thyrogen is a powder that is made up into a solution for injection. It contains the active substance thyrotropin alfa.

What is it used for?

Thyrogen is used in patients who have had a thyroidectomy (an operation to remove their thyroid gland) because they had cancer. Thyrogen is used with a ‘thyroglobulin test’, with or without a scan using radioactive iodine ( I), to detect any thyroid tissue that might have been left over after surgery. Thyrogen can also be used in combination with higher doses of radioactive iodine to ablate (kill) any remaining thyroid tissue. It is used in patients who have had all or almost all of their thyroid gland removed and whose cancer has not spread to other parts of the body.
The medicine can only be obtained with a prescription.

How is it used?

The use of Thyrogen should be supervised by a doctor with expertise in thyroid cancer. It is given as two injections into the buttock muscle, 24 hours apart. When Thyrogen is used with a radioactive iodine scan, the iodine should be given 24 hours after the final Thyrogen injection, and the scan carried out 48 to 72 hours after this. When Thyrogen is given with higher doses of radioactive iodine in ablation therapy, the iodine is also given 24 hours after the final Thyrogen injection, but the scan is carried out after a longer delay of a few days.

How does it work?

Patients whose thyroid gland has been removed receive replacement therapy with thyroxine (a hormone normally produced by the thyroid gland). This stops the body producing another hormone called thyroid stimulating hormone (TSH), which normally activates the thyroid gland. Stopping the production of TSH causes any thyroid tissue remaining in the body, including any remaining cancer, to become inactive. However, doctors need to use TSH when they are looking for any leftover thyroid tissue after surgery, as the hormone stimulates thyroid tissue and makes it easier to detect. The active substance in Thyrogen, thyrotropin alfa, is a copy of TSH. When Thyrogen is given, it acts like TSH and stimulates all of the remaining tissue in the thyroid, including cancer. Its activity can then be detected by measuring blood levels of a protein called thyroglobulin. It can also be detected using an imaging technique with radioactive iodine, since active thyroid tissue takes up iodine and becomes visible on a scan. At higher doses, the radioactive iodine can also kill the remaining thyroid tissue. Thyrotropin alfa is produced by a method known as ‘recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce the hormone.

How has it been studied?

Thyrogen has been studied in two studies involving a total of 406 patients who had had a thyroidectomy and needed a test to detect any remaining thyroid tissue. Each patient’s production of thyroglobulin and uptake of radioactive iodine were measured twice: once after treatment with Thyrogen while replacement treatment with thyroxine was continued and once after the replacement therapy had been stopped for four to six weeks, which restores the body’s natural production of TSH. The results of the two measurements were compared to see if they were in agreement. The company also presented the results of studies from the published literature looking at Thyrogen’s effect when it was used with a thyroglobulin test, but without a radioactive iodine scan.
Thyrogen has also been studied in the ablation of thyroid tissue in one study involving 63 patients with thyroid cancer. The patients received radioactive iodine either after Thyrogen while replacement treatment with thyroxine was continued, or after replacement therapy was stopped. The main measure of effectiveness was based on a test to see if the patient had any thyroid tissue remaining at eight months after treatment. Following this, 51 of the patients went on to be followed up for an average of three and a half more years. The company also presented the results of 13 studies from the published literature, including one key study that compared the effect of Thyrogen and the effect of stopping thyroxine in 394 patients who were followed up for around two and a half years.

What benefits has it shown during the studies?

In the detection of leftover thyroid tissue, using Thyrogen to stimulate thyroglobulin production and uptake of radioactive iodine was comparable to stopping the patients’ replacement therapy with thyroxine. Using Thyrogen allows patients to remain on their replacement thyroxine therapy before the test is carried out, resulting in a better quality of life. The published studies showed that using Thyrogen was also effective in low-risk patients when leftover tissue was detected only by measuring thyroglobulin levels and that it was not always necessary to do a radioactive iodine scan. For the ablation of thyroid tissue, both treatments were 100% successful after eight months. This finding was confirmed in the follow-up study: all 43 patients whose results could be eva luated after a further three and a half years had successful ablation. This included 25 patients using Thyrogen and 18 whose replacement therapy with thyroxine was stopped while they originally underwent ablation. The larger published studies confirmed that Thyrogen had a similar effect to stopping thyroxine in patients whose cancer had not spread to other parts of the body.

What is the risk associated?

The most common side effect with Thyrogen (seen in more than 1 patient in 10) is nausea (feeling sick). For the full list of all side effects reported with Thyrogen, see the Package Leaflet. Thyrogen should not be used in people who may be hypersensitive (allergic) to bovine (cow) or human TSH or to any of the other ingredients. Thyrogen must not be used during pregnancy.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Thyrogen’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Thyrogen to Genzyme Europe B.V. on 9 March 2000. The marketing authorisation is valid for an unlimited period.

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Name

Thyrogen 0.9 mg powder for solution for injection

Composition

Each vial of Thyrogen contains a nominal value of 0.9 mg thyrotropin alfa. Following reconstitution, each vial of Thyrogen contains 0.9 mg of thyrotropin alfa in 1.0 ml.

For a full list of excipients, see section 6.1.