Sycume Teprotumumab N01 Injection

1. Indications and Usage
Thyroid-Related Ophthalmopathy (TAO): Indicated for the treatment of adults with active thyroid-related ophthalmopathy.
Treatment Goal: To reduce proptosis and improve clinical activity scores.
2. Dosage and Administration
Route of Administration: Intravenous infusion ONLY.
Recommended Dosage: 10 mg/kg administered every 3 weeks for a total of 3 doses.
Critical Administration Instructions:
Pre-medication: Pre-medication with corticosteroids is recommended prior to each infusion to minimize infusion-related reactions.
Infusion Rate: The initial infusion should be administered at a rate of 300 mg over 90 minutes. If tolerated, subsequent infusions may be administered over 60 minutes.
Missed Dose: If a dose is missed, administer as soon as possible, then resume the original schedule.
3. Mechanism of Action
IGF-1R Binding: Teprotumumab binds to the insulin-like growth factor-1 receptor (IGF-1R).
Pathway Inhibition: It inhibits the activation of IGF-1R, blocking the downstream signaling pathways involved in the proliferation of fibroblasts and the synthesis of glycosaminoglycans in orbital tissues.
4. Safety and Warnings
Infusion-Related Reactions: Common reactions include flushing, nausea, pyrexia, and chills. Severe hypersensitivity reactions may occur.
Hypertension: Significant increases in blood pressure have been reported. Blood pressure should be monitored before each infusion.
Hyperglycemia: May cause elevated blood glucose levels. Patients with diabetes or at risk of hyperglycemia require close monitoring.
Hearing and Ototoxicity: Cases of hearing impairment, hearing loss, tinnitus, and otalgia have been reported. Auditory function should be evaluated periodically.
Muscle Spasms: Myalgia and muscle spasms are common adverse events.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Muscle spasms, fatigue, nausea, dysgeusia, and alopecia.
Clinical Research Highlights: Phase III clinical trials demonstrated significant improvements in proptosis and clinical activity scores compared to placebo, establishing it as a first-line targeted therapy for active TAO.
6. Drug Interactions
Antidiabetic Medications: Teprotumumab may alter glycemic control. Dose adjustments of antidiabetic agents may be necessary.
Antihypertensive Medications: Due to the risk of hypertension, concomitant use with antihypertensive medications should be monitored closely.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Teprotumumab.
Appearance: Clear to slightly opalescent, colorless to pale yellow liquid.
Packaging: Available in single-dose vials or pre-filled syringes.
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Protect from light.