Thyrotropin alfa Injection

Thyrotropin alfa injection is used in patients with thyroid cancer to help prepare for radioactive iodine treatment after surgery. It is also used to see if thyroid cancer has returned or has spread after surgery. Thyrotropin alfa is in a class of medications called thyroid stimulating hormone (TSH). It works by increasing TSH in the body, which helps thyroid cells take-up radioactive iodine which can find and remove any remaining cancer cells.

Thyrotropin alfa comes as a powder to be mixed with liquid and injected intramuscularly (into a muscle) by a doctor or nurse. It is injected into the muscles of the buttocks as 2 doses, given 24 hours apart (2 days in a row).

Your doctor may tell you to drink plenty of fluids before you receive treatment with thyrotropin alfa injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving thyrotropin alfa injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you smoke or have ever smoked or if you have or have ever had a stroke, migraine headaches, or heart or kidney problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving thyrotropin alfa injection, call your doctor immediately.

If your doctor tells you to eat a low-iodine diet, follow these instructions carefully. Ask your doctor if you have any questions about a low-iodine diet.

Thyrotropin alfa injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• unusual tiredness or weakness
• dizziness
• headache
• itching, pain, bruising, or redness at the injection site
• hot flashes

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash, hives, itching, flushing, or difficulty breathing or swallowing
• fever, chills, or flu-like symptoms
• slow or difficult speech; sudden weakness or numbness of the face, arm or leg; sudden headache; sudden vision problems; or sudden difficulty walking
• fast, pounding, or irregular heartbeat; sensitivity to heat; nervousness; increased sweating; uncontrollable shaking of a part of the body; difficulty falling asleep or staying asleep; anxiety; or irritability

Thyrotropin alfa injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• weakness
• dizziness
• headache
• vomiting
• hot flashes

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to thyrotropin alfa injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you have received thyrotropin alfa injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Thyrogen ^®