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*If not well tolerated, the minimum infusion duration should remain at 90 minutes.1
This tool is intended to provide dose calculations for patients ranging from 40 kg to 170 kg (88 lbs to 375 lbs). For additional information about dosing and administration, please refer to the Full Prescribing Information.
mg
vials
mL of reconstituted TEPEZZA to be withdrawn‡
mg
vials
mL of reconstituted TEPEZZA to be withdrawn‡
†Rounded to the nearest whole number.
‡Rounded to the nearest tenth.
TEPEZZA is supplied as a lyophilized powder for reconstitution. Each single-dose vial contains 500 mg of teprotumumab antibody.1
Reconstitute each TEPEZZA vial with 10 mL of Sterile Water for Injection, United States Pharmacopeia (USP).1
Dilute the required volume of reconstituted solution based on the dose in an IV infusion bag containing 0.9% Sodium Chloride Solution, USP1:
Infuse for the appropriate duration. Do not administer as an intravenous push or bolus.1
Watch a video showing how to prepare TEPEZZA for administration
Store inside the box1
Protect from light1
Refrigerate between 2°C to 8°C
(36°F to 46°F)1
Do not freeze1
The combined storage time of reconstituted solution in the vial and diluted solution in the infusion bag is a total of:
OR
IV, intravenous; USP, United States Pharmacopeia.
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TEPEZZA is indicated for the treatment of Thyroid Eye Disease.
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.
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.
TEPEZZA is indicated for the treatment of Thyroid Eye Disease.
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.
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.
1. TEPEZZA (teprotumumab-trbw) [prescribing information] Horizon.