Thyrotropin alfa (intramuscular route)

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.

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.

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.

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.

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.

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.

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.

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

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

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