Description
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 injection 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 product is available in the following dosage forms:
- Powder for Solution
Before Using
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. 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 thyroid problems (eg, hyperthyroidism) which may require caution in patients receiving this medicine.
Breastfeeding
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.
Drug Interactions
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.
Other Interactions
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:
- Heart disease, history of or
- Metastatic thyroid cancer (cancer that has already spread to different parts of the body) or
- Migraine headaches, history of or
- Nerve problems or
- Patients who did not undergo thyroidectomy (surgery to remove thyroid gland) or
- Residual thyroid tissue, significant 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.
Proper Use
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 medical facility. This medicine is given as a shot into a muscle of the buttocks.
Drink extra fluids before treatment with this medicine.
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.
Precautions
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.
Thyrotropin alfa may be given together with radioiodine. You will be exposed to radiation while receiving radioiodine. Talk with your doctor about precautions that you should take for yourself and for the people around you.
This medicine may increase you risk of having a stroke. 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 if you smoke or take birth control pills.
Tell your doctor right away if you have sudden, rapid, and painful enlargement of thyroid tumors, loss of vision, troubled breathing, or voice changes. Your doctor may want you to receive glucocorticoids (steroids) before receiving this medicine.
Side Effects
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:
More common
- Inability to move the legs or arms
- paralysis of one side of the body
Rare
- Faintness
- feeling of warmth
- skin rash, hives, welts, itching, or redness
- itching, redness, or swelling at the injection site
- loss of vision
- redness of the face, neck, arms, and occasionally, upper chest
- tightness of the throat
Incidence not known
- 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
- muscle or joint pain
- sore throat
- voice changes
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred vision
- chest pain
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast or irregular heartbeat
- increased sweating
- irritability
- nausea
- nervousness
- 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:
More common
- Frequent urge to urinate
- stomach discomfort
Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- diarrhea
- lack or loss of strength
- stuffy or runny nose
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site
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.
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