WARNINGS
What is the most important information I should know about TEPEZZA?
Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.
Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with TEPEZZA:
High blood pressure
Fast heartbeat
Redness of the face/Feeling hot
Difficulty breathing
Headache
Muscle pain
TEPEZZA may worsen inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis, even if you don’t have a diagnosis of IBD before starting TEPEZZA treatment. Tell your doctor right away if you have worsening IBD symptoms, which may include diarrhea with stomach pain or cramps, blood in your stools, sudden urgency to have a bowel movement, or feeling like you need to have a bowel movement even when there’s little or no stool to pass.
TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.
TEPEZZA may cause severe hearing problems including hearing loss, which in some cases may be permanent. Tell your doctor if you have any signs or symptoms of hearing problems or changes in hearing.
USES
TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.
HOW TO USE
For Doctors:
1. Recommended Dosing
The recommended dose of TEPEZZA is an intravenous infusion of 10 mg/kg for the initial dose followed by an intravenous infusion of 20 mg/kg every three weeks for 7 additional infusions.
2. Reconstitution and Preparation
Step 1: Calculate the dose (mg) and determine the number of vials needed for the 10 or 20 mg/kg dosage based on patient weight. Each TEPEZZA vial contains 500 mg of the teprotumumab antibody.
Step 2: Using appropriate aseptic technique, reconstitute each TEPEZZA vial with 10 mL of Sterile Water for Injection, USP. Ensure that the stream of diluent is not directed onto the lyophilized powder, which has a cake-like appearance. Do not shake, but gently swirl the solution by rotating the vial until the lyophilized powder is dissolved. The reconstituted solution has a volume of 10.5 mL. Withdraw 10.5 mL of reconstituted solution to obtain 500 mg. After reconstitution, the final concentration is 47.6 mg/mL.
Step 3: The reconstituted TEPEZZA solution must be further diluted in 0.9% Sodium Chloride Injection, USP prior to infusion. To maintain a constant volume in the infusion bag, a sterile syringe and needle should be used to remove the volume equivalent to the amount of the reconstituted TEPEZZA solution to be placed into the infusion bag. Discard the 0.9% Sodium Chloride, USP volume withdrawn.
Step 4: Withdraw the required volume from the reconstituted TEPEZZA vial(s) based on the patient’s weight (in kg) and transfer into an intravenous bag containing 0.9% Sodium Chloride Solution, USP to prepare a diluted solution with a total volume of 100 mL (for less than 1800 mg dose) or 250 mL (for 1800 mg and greater dose). Mix diluted solution by gentle inversion. Do not shake.
The product does not contain any preservative. The combined storage time of reconstituted
TEPEZZA solution in the vial and the diluted solution in the infusion bag containing 0.9% Sodium Chloride Injection, USP is a total of 4 hours at room temperature 20-degrees C to 25-degrees C (68-degrees F to 77-degrees F) or up to 48 hours under refrigerated conditions 2-degrees C to 8-degrees C (36-degrees F to 46-degrees F) protected from light. If refrigerated prior to administration, allow the diluted solution to reach room temperature prior to infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Upon reconstitution, TEPEZZA is a colorless or slightly brown, clear to opalescent solution which is free of foreign particulate matter. Discard the solution if any particulate matter or discoloration are observed.
Do not freeze the reconstituted or diluted solution.
Discard vial(s) and all unused contents.
No incompatibilities between TEPEZZA and polyethylene (PE), polyvinyl chloride (PVC), polyurethane (PUR) or polyolefin (PO) bags and intravenous administration sets have been observed.
3. Administration
Administer the diluted solution intravenously over 90 minutes for the first two infusions. If well tolerated, the minimum time for subsequent infusions can be reduced to 60 minutes. If not well tolerated, the minimum time for subsequent infusions should remain at 90 minutes.
Do not administer as an intravenous push or bolus. TEPEZZA should not be infused concomitantly with other agents.
What are the possible side effects of TEPEZZA?
The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, weight loss, nail problems, and changes in menstruation.
This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.
None
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Refrigerate at 2-degrees C to 8-degrees C (36-degrees F to 46-degrees F) in original carton until time of use to protect from light. Do not freeze.
NOTES
Medication Guide: revision date N/A
Prescribing Information: 11/2025
Please call your healthcare provider for more information.
Before receiving TEPEZZA, tell your doctor if you:
Have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Are currently being treated for diabetes, have been diagnosed with diabetes, or know your blood sugar is high.
Are pregnant or plan to become pregnant. TEPEZZA may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with TEPEZZA.
Women who are able to become pregnant should use an effective form of birth control (contraception) prior to starting treatment, during treatment and for at least 6 months after the final dose of TEPEZZA.
Are breastfeeding or plan to breastfeed. It is not known if TEPEZZA passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with TEPEZZA.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
