Applies to thyrotropin alpha: intramuscular powder for solution.

Serious side effects of Thyrotropin alpha

Along with its needed effects, thyrotropin alpha 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 while taking thyrotropin alpha:

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 while taking thyrotropin alpha:

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

Other side effects of Thyrotropin alpha

Some side effects of thyrotropin alpha 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

For Healthcare Professionals

Applies to thyrotropin alpha: intramuscular powder for injection.

Hypersensitivity

Postmarketing reports: Hypersensitivity (including urticaria, rash, pruritus, flushing, respiratory signs/symptoms)

Other

Common (1% to 10%): Fatigue

Postmarketing reports: Stroke, transient influenza-like symptoms (less than 48 hours, including fever over 100F, chills/shivering, myalgia/arthralgia, fatigue/asthenia/malaise, respiratory signs/symptoms), enlargement of residual thyroid tissue or metastases

Gastrointestinal

Very common (10% or more): Nausea (11%)

Common (1% to 10%): Vomiting^[Ref]

Local

Postmarketing reports: Injection site reactions (including pain, erythema, bruising, pruritus)

Nervous system

Common (1% to 10%): Headache^[Ref]