Thyrogen

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• throat pain or swelling, trouble breathing;
• 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 severe headache, slurred speech, problems with vision or balance.

Common side effects may include:

• nausea, vomiting, diarrhea;
• headache, dizziness;
• weakness, tired feeling;
• sleep problems (insomnia); or
• numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Thyrotropin alfa is a manmade form of a protein similar to thyroid-stimulating hormone (TSH), which is normally produced by your thyroid. Thyrotropin alfa keeps your TSH levels steady while you undergo thyroid tests or treatments that can reduce TSH and cause symptoms of low thyroid (hypothyroidism).

Thyrotropin alfa is used together with radioactive iodine ablation (a procedure to remove thyroid tissue that was not removed with surgery) in people with thyroid cancer.

Thyrotropin alfa is also used during medical testing to check for certain types of thyroid cancer that has returned after treatment. Thyrotropin alfa may not help your doctor find all signs of cancer, and there is still a chance that some of your cancer could be missed.

Thyrotropin alfa will not treat cancer that has spread to other parts of the body.

Thyrotropin alfa may also be used for purposes not listed in this medication guide.

Carefully follow your doctor's instructions about the timing of your medications, scans, and other treatments. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Thyrotropin alfa injection is a form of human thyroid stimulating hormone (TSH). It is used with or without radioactive iodine imaging to test the presence of thyroglobulin (Tg) in patients with thyroid cancer.

Thyrotropin alfa is also used with radioactive iodine to remove any remaining diseased thyroid tissue in patients with thyroid cancer who have had most or all of their thyroid gland removed.

This medicine is to be given only by or under the immediate supervision of your doctor.

This section provides information on the proper use of a number of products that contain thyrotropin alfa. It may not be specific to Thyrogen. Please read with care.

Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given as a shot into a muscle of the buttocks.

For your doctor to properly treat your medical condition, you must receive 2 doses of this medicine. After the last dose, your doctor may want to perform certain tests that are very important.

Your doctor may have special instructions for you to get ready for your treatment. If you have not received such instructions or you do not understand them, check with your doctor ahead of time.

• If you have an allergy to thyrotropin alfa or any other part of Thyrogen (thyrotropin alfa).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Thyrogen (thyrotropin alfa) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Thyrogen. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Adverse Reactions

• Inform patients that the most common adverse events from clinical experience were nausea and headache.
• Advise patients to seek immediate medical attention should they experience severe symptoms.

Important Information

• Prior to Thyrogen administration, counsel patients to seek care immediately for any neurologic symptoms occurring after administration of the drug.
• Inform patients for whom Thyrogen induced hyperthyroidism could have serious consequences, hospitalization for administration of Thyrogen and post-administrative observation should be considered.

Dosing and Administration

• Patients should be instructed that Thyrogen is for intramuscular administration into the buttock only. Thyrogen should not be administered intravenously.
• Inform patients the treatment regimen is two doses of Thyrogen administered at a 24 hour interval.
• Encourage patients to remain hydrated prior to treatment with Thyrogen.

Schedule of Procedures

• Inform patients that if diagnostic scanning will be performed, radioiodine will be given 24 hours after the second injection of Thyrogen, and patients should return for the scan 48 hours after radioiodine administration.
• Inform patients that if serum Tg testing is performed, blood will be drawn 72 hours or later after the second injection of Thyrogen.
• Inform patients that if remnant ablation is performed radioiodine will be administered 24 hours after the second injection of Thyrogen.

Thyrogen is manufactured and distributed by:

Genzyme Corporation
500 Kendall Street
Cambridge, MA, U.S.A. 02142
(800) 745-4447

Thyrogen is a registered trademark of Genzyme Corporation.

Package Label - Principal Display Panel – 4 vial Carton

NDC 58468-1849-4

Thyrogen®

thyrotropin alfa for injection

0.9 mg/mL after reconstitution

For intramuscular injection only

Carton contains 2 vials of Thyrogen® 

and 2 vials of diluent.

genzyme

Package Label - Principal Display Panel – 2 vial Carton

NDC 58468-0030-2

Thyrogen®

thyrotropin alfa for injection

0.9 mg/mL after reconstitution

For intramuscular injection only

Carton contains 2 vials of Thyrogen®

Dilute only with Sterile Water for Injection, USP.

genzyme

There are no data on the excretion of thyrotropin alfa into human milk. The manufacturer recommends that caution be used when administering thyrotropin alfa to nursing women.