Teprotumumab

Teprotumumab is a prescription medication used to treat the symptoms of Thyroid Eye Disease. 

• Teprotumumab is available under the following different brand names: Tepezza, teprotumumab-trbw

Common side effects of Teprotumumab include:

• Muscle spasms,
• Nausea,
• Diarrhea,
• Headache,
• Tiredness,
• High blood sugar,
• Hair loss,
• Hearing problems,
• Dry skin, and
• Altered sense of taste

Serious side effects of Teprotumumab include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Feeling hot,
• Anxiety,
• Shortness of breath,
• Headache,
• Muscle pain,
• Fast heartbeats,
• Diarrhea (with or without blood),
• Stomach cramps,
• Bowel movements that occur suddenly,
• Loss of bowel control,
• Feeling of incomplete bowel emptying,
• Rectal bleeding,
• Increased thirst,
• Increased urination,
• Dry mouth, and
• Fruity breath odor

Rare side effects of Teprotumumab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 500 mg/single-dose vial

Thyroid Eye Disease

Adult dosage

• 10 mg/kg Intravenous initially, followed by 20 mg/kg Intravenous every 3 weeks for 7 additional infusions

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Teprotumumab has no noted severe interactions with any other drugs.
• Teprotumumab has no noted serious interactions with any other drugs.
• Teprotumumab has no noted moderate interactions with any other drugs.
• Teprotumumab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Teprotumumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Teprotumumab?”

Cautions

• Infusion reactions may occur; if an infusion reaction occurs, interrupt or slow the infusion rate and use appropriate medical management
• May cause exacerbation of preexisting inflammatory bowel disease (IBD); monitor patients with preexisting IBD for a flare of disease; discontinue treatment if IBD worsens
• Hyperglycemia reported; monitor glucose levels in all patients; treat hyperglycemia with glycemic control medications

Pregnancy and Lactation

• Based on findings in animals and their mechanism of action, fetal harm may occur when administered to a pregnant woman
• Adequate and well-controlled studies have not been conducted on pregnant women
• Data are insufficient with use in pregnant women to inform any drug-associated risks for adverse developmental outcomes
• Contraception
  • Advise females of reproductive potential to use effective contraception before initiation, during treatment, and for 6 months following the last dose
• Lactation
  • There is no information regarding the presence of teprotumumab in human milk, the effects on the breastfed infant, or the effects on milk production