Teprotumumab N01 injection Application Scope

Teprotumumab N01 injection (also known as Tepezza) is approved for the treatment of Thyroid Eye Disease (TED). Specifically, its application scope is for adult patients with moderate to severe active Thyroid Eye Disease.

teprotumumab N01 injection

Teprotumumab N01 injection Characteristics

Ingredients: Teprotumumab, a recombinant human monoclonal antibody that binds to the insulin-like growth factor 1 receptor (IGF-1R).
Properties: A sterile, clear to slightly brownish, slightly opalescent liquid.
Packaging Specification: 500 mg (10 mL) per vial.
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
Expiry Date: Refer to the expiration date printed on the product packaging.
Executive Standard: As per the latest standards approved by the drug regulatory authorities.
Approval Number: Refer to the approval number printed on the product packaging.
Date of Revision: Refer to the revision date printed on the product insert.
Manufacturer: Innovent Biologics (Suzhou) Inc.

Guidelines for the Use of Teprotumumab N01 injection

Dosage and Administration:
- Recommended Dose:
  - The initial dose is 10 mg/kg, administered via intravenous infusion.
  - Subsequent 7 infusions are 20 mg/kg, administered every 3 weeks.
  - A complete course of treatment consists of 8 infusions.
- Administration:
  - Intravenous infusion.
  - Infusions 1 and 2 should be infused over 90 minutes.
  - If tolerated, subsequent infusions can be infused over 60 minutes.
  - Do not administer as an intravenous push or bolus injection.
- Missed Dose: If a dose is missed, it should be rescheduled as soon as possible. Subsequent infusions should continue on the original every-3-weeks schedule.
Adverse Reactions:
- Common Adverse Reactions: Muscle spasms, hyperglycemia, nausea, alopecia, diarrhea, fatigue, dysgeusia, headache, hearing impairment, etc.
- Serious Adverse Reactions:
  - Infusion-related reactions: May include fever, tachycardia, dyspnea.
  - Hyperglycemia: May lead to elevated blood glucose levels in patients with prediabetes or diabetes.
  - Hearing impairment: Can lead to serious hearing loss, which in some cases may be permanent.
Contraindications:
- Hypersensitivity to teprotumumab or any of its excipients.
- Pregnant women, breastfeeding women, women intending to become pregnant, and women of childbearing potential who are not using effective contraception.
- Use with caution in patients with a history of inflammatory bowel disease (IBD), as it may exacerbate IBD.
Precautions:
- Infusion-Related Reactions: Monitor patients closely for infusion-related reactions during the infusion. If a reaction occurs, interrupt or slow the infusion rate and provide appropriate medical management.
- Hyperglycemia: Monitor blood glucose levels before and during treatment, especially in patients with diabetes.
- Hearing Impairment: Assess hearing before, during, and after treatment, and inform patients of the risk of hearing changes.
- Inflammatory Bowel Disease: Assess for a history of IBD before treatment and counsel patients on the risk of exacerbation.
- Fertility: Women of childbearing potential should use effective contraception during treatment and for at least 6 months after the last dose.

Teprotumumab N01 injection Interactions

Currently, there is no detailed information on drug interactions with Teprotumumab N01 injection. Before starting treatment, be sure to inform your doctor about all medications you are currently taking, including prescription drugs, over-the-counter medications, and herbal products.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.