Thyrotropin

Thyrotropin alfa is used 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 who have had thyroidectomy. It is also used as an adjunct for thyroid remnant ablation in well-differentiated thyroid cancer.

• Thyrotropin alfa is available under the following different brand names: Thyrogen

Common side effects of Thyrotropin alfa include:

• Nausea,
• Headache,
• Fatigue,
• Vomiting,
• Dizziness,
• Weakness,
• Temporary flu-like symptoms (fever, chills, shivering, muscle, or joint pain), and
• Hypersensitivity reactions (hives, rash, itching, flushing, and respiratory symptoms).

Serious side effects of Thyrotropin alfa include:

• Throat pain or swelling, trouble breathing.
• Severe headache.
• Severe nausea or vomiting.
• Sudden swelling, pain, numbness, or loss of movement in any part of your body.
• Signs of overactive thyroid--unexplained weight loss, increased appetite, changes in bowel habits, fast or pounding heartbeats, sweating, feeling anxious or irritable; or
• Signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden headache, slurred speech, problems with vision or balance.

Rare side effects of Thyrotropin alfa include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Powder for injection

• 1.1mg/vial

Serum Thyroglobulin Testing

Adult dosage

• 2-dose regimen: 0.9 mg Intramuscular in the buttock, followed by 2nd 0.9 mg Intramuscular injection 24 hours later

Remnant Thyroid Tissue Ablation

Adult dosage

• 2 dose regimens: 0.9 mg Intramuscular in the buttock, followed by 2nd 0.9 mg IM injection 24 hours later

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Thyrotropin alfa has no noted severe interactions with any other drugs.
• Thyrotropin alfa has no noted serious interactions with any other drugs.
• Thyrotropin alfa has no noted moderate interactions with any other drugs.
• Thyrotropin alfa has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Thyrotropin alfa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Thyrotropin alfa?”

Cautions

• Warnings and precautions of radioiodine (RAI) apply if added in combination regimen; see warnings and precautions for RAI when used in combination
• Known to cause a transient (over 7 to 14 days) but significant rise in serum thyroid hormone concentration when given to patients who have substantial thyroid tissue still in situ or functional thyroid cancer metastases
• Sudden, rapid, and painful tumor enlargement reported
• CHF, hypopituitarism, concurrent use of corticosteroids
• An anaphylactic reaction may occur after repeated use of thyrotropin
• Radioiodine testing 24 hours after the final thyrotropin dose
• Reports of death within 24 hours after administration; patients for whom thyrotropin-induced hyperthyroidism could have serious consequences (.g, heart disease, extensive metastatic disease), consider hospitalization for administration and postadministration observation
• Reports of neurologic events, including acute hemiplegia or hemiparesis, occurring 1-3 days after administration to patients with CNS metastases; these events are associated with sudden rapid tumor enlargement
• Postmarketing reports of stroke or unilateral weakness occurring within 72 hours (range 20 minutes to 3 days) of administration to women without known CNS metastases
• Tumor enlargement that is sudden, rapid, and painful is reported within 12-48 hours of administration; symptoms include dyspnea, stridor, or dysphonia; rapid clinical improvement occurs following glucocorticoid therapy (consider pretreatment with glucocorticoids if local tumor expansion may compromise vital anatomic structures)
• Use caution in patients with a known history of heart disease

Pregnancy and Lactation

• Drug may be used in combination with radioiodine (RAI); if the drug is administered with RAI, a combination regimen is contraindicated in pregnant women because fetal exposure to RAI can lead to neonatal hypothyroidism, which in some cases is severe and irreversible; refer to RAI prescribing information for more information on use during pregnancy
• Available data from case reports and postmarketing experience with use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; animal reproduction studies have not been conducted with drug
• Reproductive potential
  • If the drug is administered with RAI, the information for RAI regarding pregnancy testing, contraception, and infertility also applies to the combination regimen; refer to RAI prescribing information for additional information
• Lactation
  • The concomitant use of drug and therapeutic radioiodine (RAI) is contraindicated in lactating women because RAI concentrates in breast tissue and increases the risk of radiation breast toxicity (refer to therapeutic RAI Prescribing Information).
  • If the drug is administered with RAI for diagnostic use, discontinue breastfeeding after RAI administration because of the potential for serious adverse reactions from RAI in the breastfed infant (refer to diagnostic RAI Prescribing Information)
  • If the drug is not administered with RAI, developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child from the drug or underlying maternal condition
  • There are no available data on the presence of thyrotropin alfa in human milk, its effects on the breastfed infant, or milk production