Label: information for the user

Thyrogen 0.9 mg powder for injectable solution

Tirotropina alfa

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

1.What is Thyrogen and how is it used

2.What you need to know before using Thyrogen

3.How to use Thyrogen

4.Possible adverse effects

5.Storage of Thyrogen

6.Contents of the package and additional information

Thyrogen contains the active ingredient recombinant human thyrotropin (rhTSH). Thyrogen is a human thyroid-stimulating hormone (TSH) manufactured through biotechnology processes.

Thyrogen is used for the detection of certain types of thyroid cancer in patients who have undergone thyroidectomy and are being maintained on thyroid hormone replacement therapy. One effect is that it stimulates any remaining thyroid tissue to take up iodine, which is important for imaging with radioactive iodine. It also stimulates the production of thyroglobulin and thyroid hormones if there is any residual thyroid tissue. These hormonescan be measured in the blood.

Thyrogen is also used with radioactive iodine treatment to eliminate (ablate) any remaining thyroid tissue after surgical removal of the thyroid gland (remnants) in patients without secondary growths (metastases) and who are receiving thyroid hormone replacement therapy.

No use Thyrogen:

• If you are allergic to bovine or human thyroid-stimulating hormone (TSH) or to any of the other components of this medication (listed in section 6).
• If you are pregnant.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Thyrogen::

• If you have kidney disease that requires dialysis; your doctor will decide how much Thyrogen to administer, as you may be more likely to experience headaches and nausea.
• If your renal function is decreased; your doctor will decide the amount of radioactive iodine to be administered.
• If your liver function is decreased; you will still be able to receive Thyrogen.

Effect on tumor growth

In patients with thyroid cancer, cases of tumor growth have been reported during the withdrawal of thyroid hormones for diagnostic procedures. It was thought that this was related to elevated levels of thyroid-stimulating hormone (TSH) for a longer period. Thyrogen may also cause tumor growth. This was not seen in clinical trials.

Due to the elevation of TSH levels after administration of Thyrogen, patients with secondary tumor growth (metastases) may experience local swelling or bleeding at the site where these metastases are located, which may increase in size. If metastases are present in narrow spaces, e.g., intracerebral (in the brain) or in the spinal cord, patients may experience symptoms that may manifest rapidly, such as partial paralysis affecting one side of the body (hemiparesis), respiratory problems, or loss of vision.

Your doctor will decide if you belong to one of the specific groups of patients for whom prior treatment with corticosteroids should be considered (e.g., if you have secondary tumor growth in the brain or spinal cord). If you have any doubts, consult your doctor.

Children

Due to the lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances.

Older patients

No special precautions are necessary for older patients. However, if the thyroid gland has not been completely removed and you also suffer from heart disease, your doctor will help you decide whether to receive Thyrogen.

Other medications and Thyrogen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

No interactions with Thyrogen and thyroid hormones you may be taking are known.

Your doctor will determine the exact activity of radioactive iodine to be used for imaging, taking into account the fact that you continue to take thyroid hormones.

Pregnancy and breastfeeding

Do not take Thyrogen if you are pregnant.If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Thyrogen should not be administered to women who are breastfeeding. Do not resume breastfeeding until your doctor tells you to.

Driving and operating machinery

Some patients may experience dizziness or headaches after administration of Thyrogen that may affectyour ability to drive and operate machinery.

Thyrogen contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per vial; it is essentially “sodium-free”.

A doctor or nurse will inject your medication.

Your treatment should be supervised by a doctor with experience in thyroid cancer. The Thyrogen powder must be dissolved in water for injectable preparations. Only one vial of Thyrogen is required per injection. Thyrogen should only be administered in the buttocks. This solution should never be injected into a vein.Thyrogen should not be mixed with other medications in the same injection.

The recommended dose of Thyrogen consists of two doses administered with a 24-hour interval between them. Your doctor or nurse will inject 1.0 ml of the Thyrogen solution.

For ablation or imaging with radioactive iodine, your doctor will administer the radioactive iodine 24 hours after the last Thyrogen injection.

Diagnostic examination should be performed 48 to 72 hours after administration of radioactive iodine (72 to 96 hours after the last Thyrogen injection).

Post-treatment examination may be postponed for a few days to allow for a reduction in overall radioactivity.

To analyze thyroglobulin (Tg), your doctor or nurse will take a serum sample 72 hours after the last Thyrogen injection.

Use in children

Your child's doctor will help you decide if Thyrogen should be administered to your child.

If you use more Thyrogen than you should

Patients who received too much Thyrogen accidentally have described nausea, weakness, dizziness, headaches, vomiting, and flushing.

In case of overdose, it is recommended to restore fluid balance, as well as administration of an antiemetic.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported with Thyrogen:

Very common(may affect more than 1 in 10people):

• nausea

Common(may affect up to 1 in 10people):

• vomiting
• fatigue
• dizziness
• headache
• weakness

Uncommon(may affect up to 1 in 100people):

• sensation of heat
• hives (urticaria)
• skin rash
• flu-like symptoms
• fever
• chills
• back pain
• diarrhea
• sensation of itching or tingling (paresthesia)
• neck pain
• loss of taste (ageusia)
• alteration of taste (dysgeusia)
• flu

Unknown(cannot be estimated from available data):

• tumor swelling
• pain (including pain at the site of metastases (secondary tumor growth))
• tremor
• stroke
• palpitations

• flushing

• shortness of breath
• itching (pruritus)
• excessive sweating
• muscle or joint pain
• reactions at the injection site (including: redness, discomfort, itching, pain, or burning, and skin rash with itching)
• low TSH
• hypersensitivity (allergic reactions), these reactions include hives (urticaria), itching, flushing, difficulty breathing, and skin rash.

In very rare cases, cases ofhyperthyroidism(increased activity of the thyroid gland) oratrial fibrillationhave been reported when Thyrogen has been administered to patients who have not undergone a total or partial removal of the thyroid gland.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after “CAD.” The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C).

Keep the vial within the outer packaging to protect it from light.

It is recommended that Thyrogen be injected within 3 hours following reconstitution.

The reconstituted solution can be stored for up to 24 hours at a temperature between 2°C and 8°C, protected from light and avoiding bacterial contamination.

Do not use this medication if you observe foreign particles, turbidity, or color alteration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Thyrogen

• The active ingredient is recombinant human thyrotropin.

Each vial contains 0.9 mg of recombinant human thyrotropin when reconstituted with 1.2 ml of water for injection.

Only 1 ml equal to 0.9 mg of recombinant human thyrotropin should be withdrawn.

• The other components are:

Manitol

Sodium phosphate monobasic monohydrate

Sodium phosphate dibasic heptahydrate

Sodium chloride.

Thyrogen contains sodium, see section 2.

Appearance of the product and contents of the pack

Lyophilized powder for solution for injection. White powder.

Presentation: Vials of one and two vials of Thyrogen.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sanofi Winthrop Industrie

82 Avenue Raspail

94250 Gentilly

France

Manufacturer:

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.

This information is intended for healthcare professionals only:

The recommended dose of Thyrogen is two intramuscular injections of 0.9 mg of recombinant human thyrotropin administered with an interval of 24 hours.

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the medicinal product administered must be clearly recorded.

Use of aseptic technique.

Add 1.2 ml of water for injection to the vial containing the Thyrogen powder. Gently shake the vial until the contents are dissolved. Do not agitate the solution. When the powder is dissolved, the total volume of the vial will be 1.2 ml. The pH of the Thyrogen solution is approximately 7.0.

Visually inspect the Thyrogen solution in each vial for the presence of foreign particles and changes in color. The Thyrogen solution must be clear and colorless. Do not use the vials that contain foreign particles, that are turbid or have a change in color.

Withdraw 1.0 ml of the Thyrogen solution from the vial.This is equivalent to 0.9 mg of recombinant human thyrotropin.

Thyrogen does not contain preservatives. Discard unused solution immediately. No special requirements for disposal.

The solution must be injected within three hours of reconstitution. The reconstituted solution can be stored for up to 24 hours at a temperature between 2°C and8°C, protected from light and avoiding bacterial contamination. It is essential to note that the microbiological safety will depend on the aseptic conditions used during the preparation of the solution.