Thyrotropin Alfa is an active pharmaceutical ingredient in the Thyrotropin group (H01AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised April 17, 2026[1]
Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST).
Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rhTSH-stimulated Tg levels.
4).
How to take
CACanada· Health Canada
1 product
Uses
CAOfficial regulatory label· revised December 11, 2025[2]
THYROGEN ® (thyrotropin alfa for injection) is indicated for: • use as an adjunctive treatment as pre-therapeutic stimulation for radioiodine ablation of thyroid tissue remnants in patients maintained on thyroid hormone suppression therapy who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer without evidence of distant metastatic thyroid cancer.
• use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing, with or without radioiodine imaging, in the follow-up of patients with well-differentiated thyroid cancer. Potential Clinical Uses: 1. THYROGEN ® treatment may be used in combination with radioiodine (131I) to ablate thyroid remnants following near-total or total thyroidectomy in patients without evidence of distant metastatic thyroid cancer.
2. THYROGEN ® Tg testing may be used in patients with an undetectable Tg on thyroid hormone suppressive therapy, to exclude the diagnosis of residual or recurrent thyroid cancer. 3. THYROGEN ® testing may be used in patients requiring serum Tg testing and radioiodine imaging, who are unwilling to undergo thyroid hormone withdrawal testing.
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised February 19, 2025[3]
Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST).
Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rhTSH-stimulated Tg levels.
4).
How to take
Drug interactions
Known interactions involving Thyrotropin Alfa. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
[1]MHRA (UK) · PLGB044250786 · revised April 17, 2026
[2]Health Canada (DPD) · 02246016 · revised December 11, 2025
[3]European Medicines Agency · EMEA/H/C/000220 · revised February 19, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised April 17, 2026[1]
Therapy should be supervised by physicians with expertise in thyroid cancer. 9 mg thyrotropin alfa administered at a 24-hour interval by intramuscular injection only. Paediatric population Due to a lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances.
Elderly Results from controlled trials indicate no difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those greater than 65 years of age, when Thyrogen is used for diagnostic purposes. 4).
Patients with renal/hepatic impairment Information from post marketing surveillance, as well as published information, suggests that elimination of Thyrogen is significantly slower in dialysis-dependent end stage renal disease (ESRD) patients, resulting in prolonged elevation of thyroid stimulating hormone (TSH) levels for several days after treatment.
This may lead to increased risk of headache and nausea. There are no studies of alternative dose schedules of Thyrogen in patients with ESRD to guide dose reduction in this population. In patients with significant renal impairment the activity of radioiodine should be carefully selected by the nuclear medicine physician.
The use of Thyrogen in patients with reduced liver function does not warrant special considerations. 9 mg thyrotropin alfa) is administered by intramuscular injection to the buttock. 6. For radioiodine imaging or ablation, radioiodine administration should be given 24 hours following the final Thyrogen injection.
Diagnostic scintigraphy should be performed 48 to 72 hours following radioiodine administration, whereas post-ablation scintigraphy may be delayed additional days to allow background activity to decline. For diagnostic follow-up serum thyroglobulin (Tg) testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen.
Use of Thyrogen with Tg testing in follow up of post-thyroidectomy well differentiated thyroid cancer patients should be in accordance with official guidelines.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 17, 2026[1]
Summary of the safety profile The most commonly reported adverse reactions are nausea and headache, occurring in approximately 11%, and 6% of patients, respectively. Tabulated list of adverse reactions The adverse reactions mentioned in the table, combine adverse reactions in the six prospective clinical trials (N=481) and undesirable effects that have been reported to Sanofi after licensure of Thyrogen.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
MedDRA System Organ Class Very Common Common Uncommon Not known Infections and infestations influenza Neoplasm benign, malignant and unspecified (incl. 9 mg has been administered in patients with presence of either partial or entire thyroid gland.
Manifestations of hypersensitivity have been reported uncommonly in both clinical and post-marketing settings. These reactions consisted of urticaria, rash, pruritus, flushing and respiratory signs and symptoms. In clinical trials involving 481 patients, no patients have developed antibodies to thyrotropin alfa either after single or repeated limited (27 patients) use of the product.
It is not recommended to perform TSH assays after Thyrogen administration. The occurrence of antibodies which could interfere with endogenous TSH assays performed during regular follow-ups cannot be excluded. Enlargement of residual thyroid tissue or metastases can occur following treatment with Thyrogen.
This may lead to acute symptoms, which depend on the anatomical location of the tissue. For example, hemiplegia, hemiparesis or loss of vision have occurred in patients with CNS metastases. Laryngeal oedema, respiratory distress requiring tracheotomy, and pain at the site of metastasis have also been reported after Thyrogen administration.
It is recommended that pre-treatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system below. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
GBOfficial regulatory label· Warnings and precautions· revised April 17, 2026[1]
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. Thyrogen should not be administered intravenously. When used as an alternative to thyroid hormone withdrawal, the combination of the whole body scintigraphy (WBS) and Tg testing after Thyrogen administration assures the highest sensitivity for detection of thyroid remnants or cancer.
False negative results may occur with Thyrogen. If a high index of suspicion for metastatic disease persists, a confirmatory withdrawal WBS and Tg testing should be considered. The presence of Tg autoantibodies can be expected in 18-40% of patients with differentiated thyroid cancer and may cause false negative serum Tg measurements.
Therefore, both TgAb and Tg assays are needed. g. valvular heart disease, cardiomyopathy, coronary artery disease, and prior or current tachyarrhythmia including atrial fibrillation) and have not undergone thyroidectomy. Thyrogen is known to cause a transient but significant rise in serum thyroid hormone concentration when given to patients who have substantial thyroid tissue still in situ.
Therefore, careful evaluation of individual risk-benefit is necessary for patients with significant residual thyroid tissue. Effect on tumour growth and/or size In patients with thyroid cancer, several cases of stimulated tumour growth have been reported during withdrawal of thyroid hormones for diagnostic procedures which have been attributed to the associated prolonged elevation of TSH levels.
There is a theoretical possibility that Thyrogen, like thyroid hormone withdrawal, may lead to stimulated tumour growth. In clinical trials with thyrotropin alfa, which produces a short-term increase in serum TSH levels, no case of tumour growth has been reported.
Due to elevation of TSH levels after Thyrogen administration patients with metastatic thyroid cancer particularly in confined spaces such as the brain, spinal cord and orbit or disease infiltrating the neck, may experience local oedema or focal haemorrhage at the site of these metastases resulting in increased tumour size.
g. hemiplegia, hemiparesis, loss of vision have occurred in patients with CNS metastases. Laryngeal oedema, respiratory distress requiring tracheotomy, and pain at the site of metastasis have also been reported after Thyrogen administration.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 17, 2026[1]
1. 6).
This is not medical advice. Consult a qualified healthcare professional.
4. THYROGEN ® treatment and testing may be used in patients who are either unable to mount an adequate endogenous TSH response to thyroid hormone withdrawal or in whom withdrawal is medically contraindicated. Considerations in the Use of THYROGEN ®: 1.
Clinicians employ a wide range of 131I activities to achieve remnant ablation. 7 GBq (100 mCi) ± 10% in all patients. Multiple factors contribute to the decision about the activity of 131I that should be administered for a given patient, such as the size of the remnant tissue (a function of aggressiveness of the surgical resection), and the perceived risk of the patient for thyroid cancer recurrence (a function of patient age, primary tumour type and size, extent of disease).
7 GBq (100 mCi) range or above achieve remnant ablation more frequently than do lower activities, but may be associated more often with complications of 131I treatment, such as salivary gland pain and swelling, persistent dry mouth, dry eyes or altered taste.
7 GBq (100 mCi) found that remnant ablation rates were not substantially different between the two radioiodine activities and the THYROGEN ® and thyroid hormone withdrawal methods of TSH stimulation. THYROGEN® (thyrotropin alfa) Product Monograph Page 5 of 51 2.
Even when THYROGEN®-stimulated Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease. Therefore, thyroid hormone withdrawal Tg testing with radioiodine imaging continues to be the standard diagnostic modality to assess the presence, location and extent of thyroid cancer.
3. 1% uptake of radioactive tracer within the thyroid bed at 24 hours in a study of postsurgical thyroid remnant ablation, long-term clinical outcome data are limited. Due to the relatively small clinical experience with THYROGEN ® in remnant ablation, it is not possible to conclude whether long-term thyroid cancer outcomes would be equivalent after use of THYROGEN ® or use of thyroid hormone withholding for TSH elevation prior to remnant ablation.
4. THYROGEN ® Tg levels are generally lower than Tg levels after thyroid hormone withdrawal. The extent to which THYROGEN ® Tg levels correlate with Tg levels after thyroid hormone withdrawal has not been adequately studied. 5. A newly detectable Tg level or a Tg level rising over time after THYROGEN ®, or a high index of suspicion of metastatic disease, even in the setting of a negative or low-stage THYROGEN ® radioiodine scan, should prompt further evaluation such as thyroid hormone withdrawal to definitively establish the location and extent of thyroid cancer.
5 ng/mL) had metastatic disease. Therefore, an undetectable THYROGEN ® Tg level suggests the absence of clinically significant disease. 6. The decisions whether to perform a THYROGEN ® radioiodine scan in conjunction with a THYROGEN ® serum Tg test and whether and when to withdraw a patient from thyroid hormone are complex.
Pertinent factors in these decisions include the sensitivity of the Tg assay used, the THYROGEN ® Tg level obtained, and the index of suspicion of recurrent or persistent local or metastatic disease. In the clinical trials combination Tg and scan testing did enhance the diagnostic accuracy of THYROGEN ® in some cases.
7. The signs and symptoms of hypothyroidism which accompany thyroid hormone withdrawal are avoided with THYROGEN ®(see PART II: SCIENTIFIC INFORMATION, CLINICAL TRIALS, Hypothyroid Signs and Symptoms and Quality of life). 1 Pediatrics Pediatrics (< 18 years of age): Safety and effectiveness in patients below the age of 18 years have not been established.
2 Geriatrics Geriatrics (> 65 years of age): Results from controlled trials indicate no difference in the safety and efficacy of Thyrogen® between adult patients less than 65 years and those greater than 65 years of age. e. valvular heart disease, THYROGEN® (thyrotropin alfa) Product Monograph Page 6 of 51 cardiomyopathy, coronary artery disease, and prior or current […]
How to take
CAOfficial regulatory label· revised December 11, 2025[2]
1 Dosing Considerations • Thyrogen® (thyrotropin alfa for injection) injections should be supervised by a healthcare professional knowledgeable in the management of thyroid cancer. • Thyrogen® should be administered intramuscularly only.
It should not be administered intravenously. 2 Recommended Dose and Dosage Adjustment A two-injection regimen is recommended for Thyrogen® administration. 9 mg IM injection 24 hours later. 9 mg thyrotropin alfa), Thyrogen® is administered by intramuscular injection in the gluteal muscle.
No pediatric data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 3 Reconstitution Thyrogen® has to be reconstituted with Sterile Water for Injection. Only one vial of Thyrogen® is required per injection.
2 mL of Sterile Water for Injection, USP, to the Thyrogen® powder in the vial. Swirl the contents of the vial gently until all material is dissolved. Do not shake the solution. 9 mg thyrotropin alfa per mL. Reconstituted Thyrogen® solution should be a clear, colourless solution.
Do not use vials exhibiting foreign particles, cloudiness or discoloration. 5. 0 mL of the Thyrogen® solution from the product vial. 9 mg thyrotropin alfa to be injected. Thyrogen® does not contain preservatives. The Thyrogen® solution should be injected within three hours, however the Thyrogen® solution will stay chemically stable for up to 24 hours, if kept in a refrigerator (between 2-8oC).
It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution. Each vial of Thyrogen® and each vial of diluent is intended for single use. Discard unused materials. Thyrogen® injection material should not be mixed with other substances.
4 Administration Thyrogen® (thyrotropin alfa for injection) should be administered intramuscularly only. 5 Missed Dose Not applicable. 6 Image Acquisition and Interpretation The following parameters were utilized in the second Phase 3 study and these parameters are recommended for radioimaging scanning: • For radioiodine imaging or treatment, radioiodine administration should be given 24 hours following the final Thyrogen® injection.
Diagnostic scanning should be performed 48 hours after radioiodine administration whereas post-therapy scanning may be delayed additional days to allow background activity to decline. • A diagnostic activity of 148 MBq (4mCi) 131I should be used.
• Whole body images should be acquired for a minimum of 30 minutes and/or should contain a minimum of 140,000 counts. e. 60,000 for a large field of view camera, 35,000 counts for a small field of view). For radioiodine ablation of thyroid tissue remnants, the activity of 131I is carefully selected at the discretion of the nuclear medicine physician.
For serum Tg testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen®.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised December 11, 2025[2]
1 Adverse Reaction Overview Adverse reaction data were derived from post-marketing surveillance and clinical trials. Table 3 below represents adverse reactions experienced by 62 thyroid cancer patients who participated in the clinical trials for Thyrogen® supporting the ablation indication (THYR-008-00 and THYR01605).
Table 4 below represents adverse reactions experienced by 381 thyroid cancer patients who participated in the clinical trials for Thyrogen® supporting the diagnostic indication (TSH92-0601 and TSH95-0101). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Three patients enrolled in clinical trials and/or the Compassionate Use Program developed thromboembolism. Amongst 152 patients in the diagnostic study TSH92-0601, one patient with extensive metastases had a fatal Pulmonary Embolism 8 days after receiving Thyrogen®.
Amongst 115 advanced cancer patients treated in the Compassionate Use Program, 2 had Deep Vein Thrombosis (DVT) AEs. There are several reports in the post-marketing database of DVT and/or Pulmonary Embolism in patients who received Thyrogen®.
One patient was on concomitant oral contraceptive therapy, and the other patients had prolonged hospitalization and/or extensive metastatic disease prior to the thromboembolic event. Remnant Ablation Indication Adverse reaction data for the remnant ablation indication are derived from 62 patients who received Thyrogen® as adjunctive treatment for radioiodine ablation of thyroid tissue remnants in THYR-008-00 and follow-up study THYR01605.
In the THYR-008-00 study, patients were randomized to either the hypothyroid or euthyroid group after thyroidectomy. 7 GBq ± 10%; 100 mCi) administered on the following day. Patients randomised to the Hypothyroid Group did not receive Thyrogen® prior to ablation.
7 GBq ± 10%; 100 mCi) was administered. 9 mg IM once a day x 2 days for diagnostic purposes. Adverse events were collected in the Euthyroid group for the entire 8-month period including 5 days after the diagnostic dose of Thyrogen®. 4 years) following radioiodine ablation.
Therefore, the study has limited long-term safety data. 1%). All adverse events reported in the THYR01605 trial occurred in only one patient. 7%. Events reported in patients in the trials are summarized in Table 3. 0) […]
CAOfficial regulatory label· Warnings and precautions· revised December 11, 2025[2]
, General). For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Thyrogen® (thyrotropin alfa for injection) should be administered intramuscularly only.
It should not be administered intravenously (see 7 WARNINGS AND PRECAUTIONS, General). 1 Dosing Considerations • Thyrogen® (thyrotropin alfa for injection) injections should be supervised by a healthcare professional knowledgeable in the management of thyroid cancer.
• Thyrogen® should be administered intramuscularly only. It should not be administered intravenously. 2 Recommended Dose and Dosage Adjustment A two-injection regimen is recommended for Thyrogen® administration. 9 mg IM injection 24 hours later.
9 mg thyrotropin alfa), Thyrogen® is administered by intramuscular injection in the gluteal muscle. No pediatric data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 3 Reconstitution Thyrogen® has to be reconstituted with Sterile Water for Injection.
Only one vial of Thyrogen® is required per injection. 2 mL of Sterile Water for Injection, USP, to the Thyrogen® powder in the vial. Swirl the contents of the vial gently until all material is dissolved. Do not shake the solution. 9 mg thyrotropin alfa per mL.
Reconstituted Thyrogen® solution should be a clear, colourless solution. Do not use vials exhibiting foreign particles, cloudiness or discoloration. 5. 0 mL of the Thyrogen® solution from the product vial. 9 mg thyrotropin alfa to be injected.
Thyrogen® does not contain preservatives. The Thyrogen® solution should be injected within three hours, however the Thyrogen® solution will stay chemically stable for up to 24 hours, if kept in a refrigerator (between 2-8oC). It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution.
Each vial of Thyrogen® and each vial of diluent is intended for single use. Discard unused materials. Thyrogen® injection material should not be mixed with other substances. 4 Administration Thyrogen® (thyrotropin alfa for injection) should be administered intramuscularly only.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised December 11, 2025[2]
Thyrogen® (thyrotropin alfa for injection) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container or component of the container (see 7 WARNINGS AND PRECAUTIONS, General).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
This is not medical advice. Consult a qualified healthcare professional.
EUOfficial regulatory label· revised February 19, 2025[3]
Therapy should be supervised by physicians with expertise in thyroid cancer. 9 mg thyrotropin alfa administered at a 24-hour interval by intramuscular injection only. Paediatric population Due to a lack of data on the use of Thyrogen in children, Thyrogen should be given to children only in exceptional circumstances.
Elderly Results from controlled trials indicate no difference in the safety and efficacy of Thyrogen between adult patients less than 65 years and those greater than 65 years of age, when Thyrogen is used for diagnostic purposes. 4).
3 Patients with renal/hepatic impairment Information from post marketing surveillance, as well as published information, suggests that elimination of Thyrogen is significantly slower in dialysis-dependent end stage renal disease (ESRD) patients, resulting in prolonged elevation of thyroid stimulating hormone (TSH) levels for several days after treatment.
This may lead to increased risk of headache and nausea. There are no studies of alternative dose schedules of Thyrogen in patients with ESRD to guide dose reduction in this population. In patients with significant renal impairment the activity of radioiodine should be carefully selected by the nuclear medicine physician.
The use of Thyrogen in patients with reduced liver function does not warrant special considerations. 9 mg thyrotropin alfa) is administered by intramuscular injection to the buttock. 6. For radioiodine imaging or ablation, radioiodine administration should be given 24 hours following the final Thyrogen injection.
Diagnostic scintigraphy should be performed 48 to 72 hours following radioiodine administration, whereas post-ablation scintigraphy may be delayed additional days to allow background activity to decline. For diagnostic follow-up serum thyroglobulin (Tg) testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen.
Use of Thyrogen with Tg testing in follow up of post-thyroidectomy well differentiated thyroid cancer patients should be in accordance with official guidelines.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised February 19, 2025[3]
Summary of the safety profile The most commonly reported adverse reactions are nausea and headache, occurring in approximately 11%, and 6% of patients, respectively. Tabulated list of adverse reactions The adverse reactions mentioned in the table, combine adverse reactions in the six prospective clinical trials (N=481) and undesirable effects that have been reported to Sanofi after licensure of Thyrogen.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
MedDRA System Organ Class Very Common Common Uncommon Not known Infections and infestations influenza Neoplasm benign, malignant and unspecified (incl. 9 mg has been administered in patients with presence of either partial or entire thyroid gland.
Manifestations of hypersensitivity have been reported uncommonly in both clinical and post-marketing settings. These reactions consisted of urticaria, rash, pruritus, flushing and respiratory signs and symptoms. In clinical trials involving 481 patients, no patients have developed antibodies to thyrotropin alfa either after single or repeated limited (27 patients) use of the product.
It is not recommended to perform TSH assays after Thyrogen administration. The occurrence of antibodies which could interfere with endogenous TSH assays performed during regular follow-ups cannot be excluded. Enlargement of residual thyroid tissue or metastases can occur following treatment with Thyrogen.
This may lead to acute symptoms, which depend on the anatomical location of the tissue. For example, hemiplegia, hemiparesis or loss of vision have occurred in patients with CNS metastases. Laryngeal oedema, respiratory distress requiring tracheotomy, and pain at the site of metastasis have also been reported after Thyrogen administration.
It is recommended that pre-treatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised February 19, 2025[3]
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. Thyrogen should not be administered intravenously. When used as an alternative to thyroid hormone withdrawal, the combination of the whole-body scintigraphy (WBS) and Tg testing after Thyrogen administration assures the highest sensitivity for detection of thyroid remnants or cancer.
False negative results may occur with Thyrogen. If a high index of suspicion for metastatic disease persists, a confirmatory withdrawal WBS and Tg testing should be considered. The presence of Tg autoantibodies can be expected in 18-40% of patients with differentiated thyroid cancer and may cause false negative serum Tg measurements.
Therefore, both TgAb and Tg assays are needed. g. valvular heart disease, cardiomyopathy, coronary artery disease, and prior or current tachyarrhythmia including atrial fibrillation) and have not undergone thyroidectomy. Thyrogen is known to cause a transient but significant rise in serum thyroid hormone concentration when given to patients who have substantial thyroid tissue still in situ.
Therefore, careful evaluation of individual risk-benefit is necessary for patients with significant residual thyroid tissue. Effect on tumour growth and/or size In patients with thyroid cancer, several cases of stimulated tumour growth have been reported during withdrawal of thyroid hormones for diagnostic procedures which have been attributed to the associated prolonged elevation of TSH levels.
There is a theoretical possibility that Thyrogen, like thyroid hormone withdrawal, may lead to stimulated tumour growth. In clinical trials with thyrotropin alfa, which produces a short-term increase in serum TSH levels, no case of tumour growth has been reported.
Due to elevation of TSH levels after Thyrogen administration patients with metastatic thyroid cancer particularly in confined spaces such as the brain, spinal cord and orbit or disease infiltrating the neck, may experience local oedema or focal haemorrhage at the site of these metastases resulting in increased tumour size.
g. hemiplegia, hemiparesis, loss of vision have occurred in patients with CNS metastases. Laryngeal oedema, respiratory distress requiring tracheotomy, and pain at the site of metastasis have also been reported after Thyrogen administration.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised February 19, 2025[3]
1. 6).
This is not medical advice. Consult a qualified healthcare professional.
It is recommended that pre- treatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures. e. essentially ‘sodium- free’.
5 Missed Dose Not applicable. 6 Image Acquisition and Interpretation The following parameters were utilized in the second Phase 3 study and these parameters are recommended for radioimaging scanning: • For radioiodine imaging or treatment, radioiodine administration should be given 24 hours following the final Thyrogen® injection.
Diagnostic scanning should be performed 48 hours after radioiodine administration whereas post-therapy scanning may be delayed additional days to allow background activity to decline. • A diagnostic activity of 148 MBq (4mCi) 131I should be used.
• Whole body images should be acquired for a minimum of 30 minutes and/or should contain a minimum of 140,000 counts. e. 60,000 for a large field of view camera, 35,000 counts for a small field of view). For radioiodine ablation of thyroid tissue remnants, the activity of 131I is carefully selected at the discretion of the nuclear medicine physician.
For serum Tg testing, the serum sample should be obtained 72 hours after the final injection of Thyrogen®. 5 OVERDOSAGE Data on exposure above the recommended dose is limited to clinical studies and a special treatment program. Three patients in clinical trials, and one patient in the special treatment program experienced symptoms after receiving Thyrogen® (thyrotropin alfa for injection) doses higher than those recommended.
7 mg IM dose, and in one of these patients, the event was accompanied by weakness, dizziness and headache. 6 mg IM dose. 9 mg over 6 days, developed atrial fibrillation, cardiac decompensation and terminal myocardial infarction 2 days later.
3 mg Thyrogen® as a single IV bolus, experienced severe nausea, vomiting, diaphoresis, hypotension (BP decreased from 115/66 mm Hg to 81/44 mm Hg) and tachycardia (pulse increased from 75 to 117 bpm) 15 minutes after injection. When necessary, symptomatic treatment should be considered for potential cardiac symptoms.
In case of overdose, assessment of fluid balance and administration of fluids and/or an antiemetic may be considered. For management of a suspected drug overdose, contact your regional poison control centre. THYROGEN® (thyrotropin alfa) Product Monograph Page 9 of 51 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Thyrogen® (thyrotropin alfa for injection) is supplied as a sterile, non-pyrogenic lyophilized product.
It is recommended that pre-treatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures. e. essentially ‘sodium- free’.