TEPEZZA Preparation and Administration Overview

Watch a video showing how to prepare TEPEZZA for administration

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How Supplied

TEPEZZA is supplied as a lyophilized powder for reconstitution. Each single-dose vial contains 500 mg of teprotumumab antibody.1

Reconstitute

Reconstitute each TEPEZZA vial with 10 mL of Sterile Water for Injection, United States Pharmacopeia (USP).1

Dilute

Dilute the required volume of reconstituted solution based on the dose in an IV infusion bag containing 0.9% Sodium Chloride Solution, USP1:

  • If dose is <1800 mg, use a 100-mL bag
  • If dose is ≥1800 mg, use a 250-mL bag

Infuse

Infuse for the appropriate duration. Do not administer as an intravenous push or bolus.1
Administer the diluted solution intravenously over 90 minutes for the first 2 infusions1:

  • If well tolerated, the minimum time for subsequent infusions can be reduced to 60 minutes1
  • If not well tolerated, the minimum time for subsequent infusions should remain at 90 minutes1

TEPEZZA should not be infused concomitantly with other agents.1

Image of TEPEZZA packaging and medication

Infusion Guide

For complete instructions, including information about infusion reactions, download the Infusion Guide

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Infusion Checklist

For a step-by-step checklist, download the Infusion Checklist

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Storage instructions

Prior to reconstitution:

Store TEPEZZA inside the box icon

Store inside the box1

Protect TEPEZZA from light when storing icon

Protect from light1

Refrigerate TEPEZZA icon

Refrigerate between
2ºC to 8ºC(36ºF to 46ºF)

Do not freeze TEPEZZA icon

Do not freeze1

After reconstitution:

The combined storage time of reconstituted solution in the vial and diluted solution in the infusion bag is a total of1

Up to

4 hours

at room temperature

20ºC to 25ºC / 68ºF to 77ºF1

Up to 4 hours at room temperature 20ºC to 25ºC (68ºF to 77ºF)

or

OR

Up to

48 hours

in refrigeration

2ºC to 8ºC / 36ºF to 46ºF1

Up to 48 hours in refrigeration 2ºC to 8ºC (36ºF to 46ºF)

  • If not administered immediately, protect from light1

  • If refrigerated, allow the diluted solution to reach room temperature prior to infusion1

IV, intravenous.

Home infusion may be an option for some TEPEZZA patients

Trained nursing staff can provide infusion services for patients in their home, whether for convenience or necessity. Home infusion teams can

  • Provide supplies

  • Help with scheduling, monitoring, and drawing labs

  • Offer patient education

  • Help patients understand the insurance process

  • Coordinate with prescribing HCPs for medications related to TED treatment

Patient Enrollment Form

To get your patient started on TEPEZZA,
complete the Patient Enrollment Form

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It’s just amazing how well this medication has taken care of my eyes. It’s like a miracle. I can’t imagine people having what I had with nothing to help them. I can’t imagine having to live with my eyes like that.

Susan C., real TEPEZZA patient2


INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache, and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, dry skin, and menstrual disorders.

Please see Full Prescribing Information for more information.

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache, and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, dry skin, and menstrual disorders.

Please see Full Prescribing Information for more information.

1. TEPEZZA (teprotumumab-trbw) [prescribing information] Horizon.

2.  Data on File. Horizon, May 2022.