TEPEZZA Dosing and Administration

TEPEZZA is given once every 3 weeks for a total of 8 IV infusions1

Infographic showing how TEPEZZA is administered and the infusion schedule Infographic showing how TEPEZZA is administered and the infusion schedule Infographic showing how TEPEZZA is administered and the infusion schedule
  • TEPEZZA dosing is based on the patient's actual weight 1
  • The initial dose is 10 mg/kg. The dose for Infusions 2 to 8 is 20 mg/kg 1

Other considerations1:

  • Educate and counsel females of reproductive potential about the need to use effective contraception prior to initiation, during treatment with TEPEZZA, and for 6 months after the last dose 1
  • Patient’s glucose levels should be monitored for hyperglycemic reactions 1
  • Patients with preexisting diabetes or impaired glucose tolerance should be under appropriate glycemic control before receiving TEPEZZA 1

Find your patient’s dose

This tool is intended to provide dose calculations for patients ranging from 40 kg - 170 kg. For additional information about dosing and administration, please refer to the Full Prescribing Information.

Enter Patient’s Weight
OR
Infusion 1 (10 mg/kg)
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mg

vials

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mL of reconstituted TEPEZZA to be withdrawn

Infusions 2 to 8 (20 mg/kg)
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mg

vials

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mL of reconstituted TEPEZZA to be withdrawn

*Rounded to the nearest whole number.

Rounded to the nearest tenth.

Preparation and administration overview

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

Image of TEPEZZA box next to 500mg TEPEZZA

Reconstitution and Dilution of TEPEZZA

Watch a video showing how to prepare TEPEZZA for administration

Read transcript

Storage Instructions

Prior to reconstitution:

Box icon

Store inside the box1

Lightbulb icon

Protect from light1

Refrigerator icon

Refrigerate between 2°C to 8°C
(36°F to 46°F)1

Do not freeze icon

Do not freeze1

  • Store inside the box 1
  • Protect from light 1
  • Refrigerate between 2ºC to 8ºC (36ºF to 46ºF) 1
  • Do not freeze 1

After reconstitution:

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

Store TEPEZZA up to 4 hours at room temperature or up to 48 hours in refrigeration Store TEPEZZA up to 4 hours at room temperature or up to 48 hours in refrigeration Store TEPEZZA up to 4 hours at room temperature or up to 48 hours in refrigeration
  • Up to 4 hours at room temperature 20°C to 25°C (68°F to 77°F)1

OR

  • Up to 48 hours in refrigeration 2°C to 8°C (36°F to 46°F)1
  • If not administered immediately, protect from light 1
  • If refrigerated, allow the diluted solution to reach room temperature prior to infusion 1

IV, intravenous; USP, United States Pharmacopeia.

INDICATION AND IMPORTANT SAFETY INFORMATION

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, and dry skin.

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

Please see Full Prescribing Information for more information.

INDICATION AND IMPORTANT SAFETY INFORMATION

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, and dry skin.

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

Please see Full Prescribing Information for more information.

REFERENCE:

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