Thytropar

In the U.S.

• Thyrogen

In Canada

• Thytropar

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Diagnostic Agent, Thyroid Function

Pharmacologic Class: Thyrotropin

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of thyrotropin alfa injection in children younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of thyrotropin alfa injection in the elderly. However, elderly patients are more likely to have arrhythmia or heart problems which may require caution in patients receiving this medicine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to bovine thyroid stimulating hormone, or history of or
• Heart disease, history of or
• Metastatic cancer (cancer that has already spread to different parts of the body) or
• Nervous system disorder (e.g., hemiparesis, hemiplegia) or
• Significant residual thyroid tissue or
• Stroke, history of—Use with caution. May increase the risk for serious side effects.

• Kidney disease, end stage or
• Patients undergoing dialysis—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

This section provides information on the proper use of a number of products that contain thyrotropin alfa. It may not be specific to Thytropar. 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.

It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Call your doctor right away if you have an inability to move the legs or arms, or paralysis of one side of the body after receiving this medicine.

Tell your doctor right away if you have sudden, rapid, and painful enlargement of thyroid tumors, noisy breathing, shortness of breath, or voice changes. Your doctor may want you to receive glucocorticoids (steroids) before receiving this medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Inability to move the legs or arms
• paralysis of one side of the body

• Faintness
• itching, redness, or swelling at the injection site
• skin rash
• tightness of the throat
• wheezing

• Feeling of warmth
• hives or welts
• itching
• loss of vision
• redness of the face, neck, arms, and occasionally, upper chest
• redness of the skin

• Chills
• confusion
• coughing
• difficult or labored breathing
• difficulty with speaking
• difficulty with swallowing
• dizziness
• double vision
• fast, slow, or irregular heartbeat
• fever
• headache
• hoarseness
• inability to move the facial muscles
• inability to speak
• muscle or joint pain
• noisy breathing
• slow or irregular breathing
• slow speech
• sore throat
• voice changes

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision
• chest pain
• dizziness dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• increased sweating
• irritability
• nausea
• nervousness
• shortness of breath
• sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Flushing of the face
• frequent urge to urinate
• stomach discomfort

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• diarrhea
• fever
• lack or loss of strength
• muscle aches
• sore throat
• stuffy or runny nose
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.