TEPEZZA (Teprotumumab-trbw)

TEPEZZA

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Important Safety Information

TEPEZZA (teprotumumab-trbw) may increase certain IBD symptoms, such as abdominal cramps, an urgent need to have bowel movements, and blood in your stools. Your physician should monitor you carefully while on TEPEZZA and discontinue if IBD worsens.

TEPEZZA may also increase blood sugar. Prior to starting treatment, tell your doctor if you have diabetes or know your blood sugar is high. It may be necessary to modify your diet during treatment. Tell your doctor or nurse immediately if you experience:

  • Breathing difficulties
  • Rapid heartbeat
  • Headache
  • Muscle pain
  • Redness of the face
  • Feeling hot
  • High blood pressure

What is the most important information I should know about TEPEZZA?

Tell your doctor about all medications you’re taking — whether they’re prescribed or over-the-counter — as well as vitamins and herbal supplements. If you have diabetes, talk to your doctor about following a diet to control glucose levels. While most side effects occur during treatment or up to an hour and a half after the infusion has been completed, some patients have reported experiencing reactions within 24 hours from their most recent infusion. Let your doctor know if you are not feeling well, as it may be necessary to reduce the infusion rate or stop treatment completely.

TEPEZZA Side Effects

As with any prescription medication, TEPEZZA carries a risk of side effects. Reactions have been reported in approximately 4% of patients undergoing infusion treatment with TEPEZZA, and they can occur during treatment, or up to an hour and a half after the infusion has been completed. The most common ones include:

  • Muscle spasms
  • Muscle cramps
  • Nausea
  • Diarrhea
  • Fatigue
  • Hearing impairment
  • Headaches
  • Dry skin
  • Changes in taste
  • Hair loss
  • High blood sugar

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Females Who Can Become Pregnant

  • TEPEZZA may harm your unborn baby.
  • Your healthcare provider should do a pregnancy test before you start treatment with TEPEZZA.
  • You should use an effective method of birth control (contraception) during treatment with TEPEZZA and for at least six months after your last dose of TEPEZZA.
  • Tell your doctor right away if you become pregnant while taking TEPEZZA.
  • Tell your doctor if you are breastfeeding or plan to breast-feed — as t is not known if TEPEZZA may pass into your breast milk.

Indications

TEPEZZA is a prescription infusion medication to treat thyroid eye disease. The recommended dosage is 10 mg/kg for the initial infusion treatment, followed by 20 mg/kg every three weeks for an additional seven infusions. The first two infusions should be administered for 90 minutes. Subsequent infusions could vary between 60 and 90 minutes, depending on how well you tolerate the medication. You should talk to your doctor to determine the right dosage and length of treatment for your needs.

TEPEZZA Prescribing Information

Please refer to TEPEZZA’s full Prescribing Information.