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In clinical studies, the most common side effects with Thyrogen injections were:
- Nausea
- Headache
- Fatigue
- Vomiting
- Dizziness
- Lack of strength and/or energy
Patients treated with Thyrogen have also reported flu-like symptoms and allergic reactions (hypersensitivity).
Seek immediate medical attention if you experience any severe symptoms.1
What should I tell my doctor before receiving Thyrogen?
Tell your doctor if:
- You are pregnant, planning to become pregnant or breastfeeding
- You have or have had any problems with your kidneys.1
Is there any other important information I should know before receiving Thyrogen?
If you are over 65 years old, you should discuss the risks and benefits of Thyrogen with your physician if:
- You have large amounts of leftover thyroid tissue after surgery.
- You have a history of heart disease.
If you are at risk for complications from Thyrogen administration, you may receive your injections in hospital.
There have been reports of certain central nervous system problems in patients receiving Thyrogen.
These include stroke in young women at a higher risk of stroke, and weakness on one side of the body. If you experience any of these symptoms after receiving Thyrogen, seek immediate medical attention.
Even with a Thyrogen-stimulated Tg test and whole body scan, a risk remains of missing a diagnosis of thyroid cancer or of underestimating the extent of disease.1 If you have any questions or concerns, you should talk with your doctor before or after receiving Thyrogen.
You should remain hydrated prior to treatment with Thyrogen.
Thyrogen is given into the buttock for 2 consecutive days. These injections are given by a health care provider. Please click here to download a copy of Thyrogen Administration Instruction Sheet.
Resources
{ The Patient Kit contains information and resources to help you on your thyroid cancer journey }
{ Learn why your doctor may ask you to avoid certain foods and medicines that contain iodine for a few weeks before your ablation procedure.}
{ Use this resource to help make the most of your next appointment with your endocrinologist }
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Important Safety Information and Indications
Important Safety Information and Indications
IMPORTANT SAFETY INFORMATION
Patients should not use Thyrogen with radioiodine if they have a contraindication to the use of radioiodine. Please consult with your doctor for a list of contraindications for radioiodine.
Thyrogen can cause serious side effects, including:
Thyrogen-Induced Hyperthyroidism:
- There have been reports of events that led to death in patients who have not had surgery to have their thyroid gland removed, and in patients with thyroid cancer cells that have spread to other parts of the body.
- Patients over 65 years old with large amounts of leftover thyroid tissue after surgery, or with a history of heart disease, should discuss with their physicians the risks and benefits of Thyrogen.
- Thyrogen can be administered in the hospital for patients at risk for complications from Thyrogen administration.
Stroke:
- Since Thyrogen was first approved for use, there have been reports of central nervous system problems such as stroke in young women who have a higher chance of having a stroke, and weakness on one side of the body. The relationship between THYROGEN administration and stroke is unknown. Patients should remain hydrated prior to treatment with Thyrogen.
Sudden Rapid Tumor Enlargement:
- Leftover thyroid tissue after surgery and cancer cells that have spread to other parts of the body can quickly grow and become painful after Thyrogen administration. Patients with cancer cells near their windpipe, in their central nervous system, or in their lungs may need treatment with a glucocorticoid (a medication to help prevent an increase in the size of the cancer cells before using Thyrogen.)
Risks Associated with Radioiodine Treatment:
- If THYROGEN is administered with radioiodine (RAI), the serious side effects for RAI apply to this combination regimen. Please consult with your doctor for a list of contraindications for radioiodine.
ADVERSE REACTIONS
In clinical studies, the most common side effects reported were nausea and headache.
USE IN SPECIFIC PATIENT POPULATIONS
Pregnant patients: Notify your healthcare provider immediately in the event of a pregnancy. If THYROGEN is administered with radioiodine, the combination regimen should not be used in pregnant women. Thyrogen should be given to a pregnant woman only if the doctor thinks there is a clear need for it.
Breastfeeding patients: If THYROGEN is administered with radioiodine, the combination regimen should not be used in breastfeeding women. It is not known whether Thyrogen can appear in human milk. Breastfeeding women should discuss the benefits and risks of Thyrogen with their physician.
Children: Safety and effectiveness in young patients (under the age of 18) have not been established.
Elderly: Studies do not show a difference in the safety and effectiveness of Thyrogen between adult patients less than 65 years and those over 65 years of age.
Patients with kidney disease: Thyrogen exits the body much slower in dialysis patients and can lead to longer high TSH levels.
INDICATIONS AND USAGE
Thyrogen (thyrotropin alfa) is used to help identify thyroid disease by testing the blood for a hormone called thyroglobulin in the follow up of patients with a certain type of thyroid cancer known as well differentiated thyroid cancer. It is used with or without a radiology test using a form of iodine.
Limitations of Use:
- The effect of Thyrogen on long term thyroid cancer outcomes has not been determined.
- When Thyrogen is used to help detect thyroid cancer, there is still a chance all or parts of the cancer could be missed.
Thyrogen is also used to help patients prepare for treatment with a form of iodine, called radioiodine, to remove leftover thyroid tissue in patients who have had surgery to take out the entire thyroid gland for patients with well differentiated thyroid cancer who do not have signs of thyroid cancer which has spread to other parts of the body.
Limitations of Use:
- In a study of people being prepared for treatment with a form of iodine after thyroid surgery, results were similar between those who received Thyrogen and those who stopped taking their thyroid hormone for up to 5 years after treatment. Researchers do not know if results would be similar over a longer period of time.
Click here for full Prescribing Information.
References
1) Thyrogen (thyrotropin alfa) Package Insert. Cambridge, MA. Genzyme Corporation, March 2020
Important Safety Information and Indications
IMPORTANT SAFETY INFORMATION
Patients should not use Thyrogen with radioiodine if they have a contraindication to the use of radioiodine. Please consult with your doctor for a list of contraindications for radioiodine.
Thyrogen can cause serious side effects, including:
Thyrogen-Induced Hyperthyroidism:
- There have been reports of events that led to death in patients who have not had surgery to have their thyroid gland removed, and in patients with thyroid cancer cells that have spread to other parts of the body.
- Patients over 65 years old with large amounts of leftover thyroid tissue after surgery, or with a history of heart disease, should discuss with their physicians the risks and benefits of Thyrogen.
- Thyrogen can be administered in the hospital for patients at risk for complications from Thyrogen administration.
Stroke:
- Since Thyrogen was first approved for use, there have been reports of central nervous system problems such as stroke in young women who have a higher chance of having a stroke, and weakness on one side of the body. The relationship between THYROGEN administration and stroke is unknown. Patients should remain hydrated prior to treatment with Thyrogen.
Sudden Rapid Tumor Enlargement:
- Leftover thyroid tissue after surgery and cancer cells that have spread to other parts of the body can quickly grow and become painful after Thyrogen administration. Patients with cancer cells near their windpipe, in their central nervous system, or in their lungs may need treatment with a glucocorticoid (a medication to help prevent an increase in the size of the cancer cells before using Thyrogen.)
Risks Associated with Radioiodine Treatment:
- If THYROGEN is administered with radioiodine (RAI), the serious side effects for RAI apply to this combination regimen. Please consult with your doctor for a list of contraindications for radioiodine.
ADVERSE REACTIONS
In clinical studies, the most common side effects reported were nausea and headache.
USE IN SPECIFIC PATIENT POPULATIONS
Pregnant patients: Notify your healthcare provider immediately in the event of a pregnancy. If THYROGEN is administered with radioiodine, the combination regimen should not be used in pregnant women. Thyrogen should be given to a pregnant woman only if the doctor thinks there is a clear need for it.
Breastfeeding patients: If THYROGEN is administered with radioiodine, the combination regimen should not be used in breastfeeding women. It is not known whether Thyrogen can appear in human milk. Breastfeeding women should discuss the benefits and risks of Thyrogen with their physician.
Children: Safety and effectiveness in young patients (under the age of 18) have not been established.
Elderly: Studies do not show a difference in the safety and effectiveness of Thyrogen between adult patients less than 65 years and those over 65 years of age.
Patients with kidney disease: Thyrogen exits the body much slower in dialysis patients and can lead to longer high TSH levels.
INDICATIONS AND USAGE
Thyrogen (thyrotropin alfa) is used to help identify thyroid disease by testing the blood for a hormone called thyroglobulin in the follow up of patients with a certain type of thyroid cancer known as well differentiated thyroid cancer. It is used with or without a radiology test using a form of iodine.
Limitations of Use:
- The effect of Thyrogen on long term thyroid cancer outcomes has not been determined.
- When Thyrogen is used to help detect thyroid cancer, there is still a chance all or parts of the cancer could be missed.
Thyrogen is also used to help patients prepare for treatment with a form of iodine, called radioiodine, to remove leftover thyroid tissue in patients who have had surgery to take out the entire thyroid gland for patients with well differentiated thyroid cancer who do not have signs of thyroid cancer which has spread to other parts of the body.
Limitations of Use:
- In a study of people being prepared for treatment with a form of iodine after thyroid surgery, results were similar between those who received Thyrogen and those who stopped taking their thyroid hormone for up to 5 years after treatment. Researchers do not know if results would be similar over a longer period of time.
Click here for full Prescribing Information.
References
1) Thyrogen (thyrotropin alfa) Package Insert. Cambridge, MA. Genzyme Corporation, March 2020