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THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION

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About the medicine

How to use THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Thyrogen 0.9mg powder for solution for injection

Thyrotropin alfa

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Thyrogen and what is it used for
  2. What you need to know before you use Thyrogen
  3. How to use Thyrogen
  4. Possible side effects
  5. Storage of Thyrogen
  6. Contents of the pack and other information

1. What is Thyrogen and what is it used for

Thyrogen contains the active substance thyrotropin alfa. Thyrogen is a human thyroid-stimulating hormone (TSH) produced by biotechnology processes.

Thyrogen is used for the detection of certain types of thyroid cancer in thyroidectomized patients maintained on thyroid hormones. One of the effects 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 hormones can be measured in the blood.

Thyrogen is also used with radioactive iodine treatment to eliminate (ablate) remaining thyroid tissue after surgical removal of the thyroid gland (remnants) in patients who do not have secondary growths (metastases) and who are receiving thyroid hormone.

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you start using Thyrogen

Do not use Thyrogen:

  • if you are allergic to bovine or human thyroid-stimulating hormone (TSH) or to 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 starting Thyrogen:

  • if you have kidney disease that requires dialysis; your doctor will decide how much Thyrogen to give you, as you may be more likely to suffer from headache and nausea.
  • if your kidney function is reduced; your doctor will decide the amount of radioactive iodine to be given.
  • if your liver function is reduced; you can still receive Thyrogen.

Effect on tumor growth

In patients with thyroid cancer, cases of tumor growth have been reported during withdrawal of thyroid hormones for diagnostic procedures. This was thought to be related to elevated levels of thyroid-stimulating hormone (TSH) for a longer period. It is possible that 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 of these metastases, which may increase in size. If metastases are present in confined spaces, e.g. intracerebral (in the brain) or in the spinal cord, patients may experience symptoms that can 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 patient groups where 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 only be given to children in exceptional circumstances.

Elderly

No special precautions are necessary for elderly 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 you should receive Thyrogen.

Other medicines and Thyrogen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Thyrogen should not be administered to breastfeeding women. Breastfeeding should not be resumed until your doctor tells you to do so.

Driving and using machines

Some patients may feel dizzy or have headaches after administration of Thyrogen that may affect their ability to drive and use machines.

Thyrogen contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per vial; this is essentially "sodium-free".

3. How to use Thyrogen

A doctor or nurse will inject your medicine.

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 medicines 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 injection of Thyrogen.

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

The post-treatment scan may be postponed for a few days to allow the general radioactivity to decrease.

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

Use in children

Your child's doctor will help decide whether Thyrogen should be given to your child.

If you use more Thyrogen than you should

Patient who received too much Thyrogen by accident have described nausea, weakness, dizziness, headache, vomiting, and flushing.

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

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

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following effects have been reported with Thyrogen:

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

  • nausea

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

  • vomiting
  • fatigue
  • dizziness
  • headache
  • weakness

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

  • feeling of heat
  • hives (urticaria)
  • skin rash
  • flu-like symptoms
  • fever
  • chills
  • back pain
  • diarrhea
  • tingling or prickling sensation (paresthesia)
  • neck pain
  • loss of taste (ageusia)
  • distortion of the sense of taste (dysgeusia)
  • flu

Not known(frequency cannot be estimated from the available data):

  • tumor swelling
  • pain (including pain at the site of metastases)
  • tremor
  • stroke
  • palpitations
  • flushing
  • shortness of breath
  • itching (pruritus)
  • excessive sweating
  • muscle or joint pain
  • injection site reactions (including redness, discomfort, itching, pain, or stinging at the injection site, and skin rash with itching)
  • low TSH
  • hypersensitivity (allergic reactions), including hives (urticaria), itching, flushing, difficulty breathing, and skin rash.

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

Reporting of side effects

If you experience 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.

5. Storage of Thyrogen

Keep 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 is the last day of the month shown.

Store in a refrigerator (2°C - 8°C).

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

Thyrogen should be injected within 3 hours of 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 medicine if you notice any visible signs of deterioration, such as particles, turbidity, or color change.

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 protect the environment.

6. Contents of the pack and other information

Composition of Thyrogen

  • The active substance is thyrotropin alfa.

Each vial contains 0.9 mg of thyrotropin alfa when reconstituted with 1.2 ml of water for injectable preparations.

Only 1 ml, equivalent to 0.9 mg of thyrotropin alfa, should be withdrawn.

  • The other ingredients are:

Mannitol

Sodium phosphate monobasic monohydrate

Sodium phosphate dibasic heptahydrate

Sodium chloride.

Thyrogen contains sodium, see section 2.

Appearance and pack contents

Powder for solution for injection. White lyophilized powder.

Presentation: Packs of 1 or 2 vials of Thyrogen.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Sanofi Winthrop Industrie

82 Avenue Raspail

94250 Gentilly

France

Manufacturer:

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Belgium/Belgique/Belgien/Luxembourg/Luxemburg

Sanofi Belgium

Tel: +32 (0)2 710 54 00

Hungary

SANOFI-AVENTIS Zrt.

Tel: +36 1 505 0050

Text indicating Bulgaria, Swixx Biopharma EOOD, and phone number +359 (0)2 4942 480

Malta

Sanofi S.r.l.

Tel: +39 02 39394275

Czech Republic

Sanofi s.r.o.

Tel: +420 233 086 111

Netherlands

Sanofi B.V.

Tel: +31 20 245 4000

Denmark

Sanofi A/S

Tel: +45 45 16 70 00

Norway

sanofi-aventis Norge AS

Tel: +47 67 10 71 00

Germany

Sanofi-Aventis Deutschland GmbH

Tel: 0800 52 52 010

Tel: from abroad: +49 69 305 21 131

Austria

sanofi-aventis GmbH

Tel: +43 1 80 185 - 0

Estonia

Swixx Biopharma OÜ

Tel: +372 640 10 30

Poland

Sanofi Sp. z o.o.

Tel: +48 22 280 00 00

Greece

Sanofi-Aventis Μονοπρ?σωπη AEBE

Tel: +30 210 900 16 00

Portugal

Sanofi – Produtos Farmacêuticos, Lda. Tel: +351 21 35 89 400

Spain

sanofi-aventis, S.A.

Tel: +34 93 485 94 00

Romania

Sanofi Romania SRL

Tel: +40 (0)21 317 31 36

France

Sanofi Winthrop Industrie

Tel: 0 800 222 555

Call from abroad: +33 1 57 63 23 23

Slovenia

Swixx Biopharma d.o.o.

Tel: +386 1 235 51 00

Croatia

Swixx Biopharma d.o.o.

Tel: +385 1 2078 500

Slovakia

Swixx Biopharma s.r.o.

Tel: +421 2 208 33 600

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +353 (0)1 403 56 00

Iceland

Vistor hf.

Tel: +354 535 7000

Finland

Sanofi Oy

Tel: +358 (0)201 200 300

Italy

Sanofi S.r.l.

Tel: 800536389

Cyprus

C.A. Papaellinas Ltd.

Tel: +357 22 741741

Sweden

Sanofi AB

Tel: +46 (0)8 634 50 00

Latvia

Swixx Biopharma SIA

Tel: +371 6 616 47 50

United Kingdom (Northern Ireland)

sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +44 (0)800 035 2525

Lithuania

Swixx Biopharma UAB

Tel: +370 5 236 91 40

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu.

This information is intended only for healthcare professionals:

The recommended dose of Thyrogen is two intramuscular injections of 0.9 mg of thyrotropin alfa administered with a 24-hour interval between them.

Traceability

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

Use of an aseptic technique.

Add 1.2 ml of water for injectable preparations to the vial containing the Thyrogen powder. Gently swirl the vial until all the contents are dissolved. Do not shake 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 particulate matter and color change. The Thyrogen solution should be clear and colorless. Do not use vials containing particulate matter, or that are turbid or discolored.

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

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

The solution should be injected within 3 hours of 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. It is important to note that microbiological safety will depend on the aseptic conditions used during preparation of the solution.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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Dr. Lokchiri’s professional training includes:

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

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Additional care areas:

  • Preventive consultations and check-up planning.
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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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She also provides:

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
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  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
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  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Frequently Asked Questions

Is a prescription required for THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION?
THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION?
The active ingredient in THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION is thyrotropin. This information helps identify medicines with the same composition but different brand names.
Who manufactures THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION?
THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION is manufactured by Sanofi Winthrop Industrie. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to THYROGEN 0.9 mg POWDER FOR INJECTABLE SOLUTION?
Other medicines with the same active substance (thyrotropin) include ANTICUDE, APULCO ACOMETH 0.3%/0.3%/0.3% MEDICINAL COMPRESSED GAS, APULCO COHE 0.28%/9.5% MEDICINAL COMPRESSED GAS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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