TEPEZZA 500 mg/1
teprotumumab · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Horizon Therapeutics USA, Inc.
TEPEZZA is a injection, powder, lyophilized, for solution containing teprotumumab at 500 mg/1, taken intravenous. Manufactured by Horizon Therapeutics USA, Inc..
Key Facts
- Brand Name
- TEPEZZA
- Generic Name
- teprotumumab
- NDC Code (Product)
75987-130- Manufacturer
- Horizon Therapeutics USA, Inc.
- Strength
- 500 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761143
- Drug Class
- Insulin-like Growth Factor-1 Receptor Inhibitor [EPC]
- Marketing Start
- 01/21/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration. TEPEZZA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of Thyroid Eye Disease ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Initiate dosing with 10 mg/kg for first infusion, followed by 20 mg/kg every 3 weeks for 7 additional infusions ( 2.1 ) Administer TEPEZZA by intravenous infusion over 60 to 90 minutes ( 2.3 ) 2.1 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. 2.2 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 total 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 recons…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Inflammatory Bowel Disease [see Warnings and Precautions (5.2) ] Hyperglycemia [see Warnings and Precautions (5.3) ] Hearing Impairment Including Hearing Loss [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence greater than 5%) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dry skin, dysgeusia, headache, weight decreased, and nail disorder ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TEPEZZA was evaluated in two premarketing randomized, double-masked, placebo-controlled clinical trials (Study 1 [NCT01868997] and Study 2 [NCT03298867]) c…
Frequently Asked Questions
What is TEPEZZA used for?
TEPEZZA contains teprotumumab. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is TEPEZZA a controlled substance?
TEPEZZA is not classified as a controlled substance by the DEA.
What is the generic name for TEPEZZA?
The generic name for TEPEZZA is teprotumumab. There are no other listed brand versions of teprotumumab.
What is the NDC code for TEPEZZA 500 mg/1?
The NDC (National Drug Code) for TEPEZZA 500 mg/1 is 75987-130, listed by Horizon Therapeutics USA, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)