Formulation and specifications: Injection: 100mg (20ml)/vial
Indications: This product is used for the treatment of squamous cell carcinoma of the head and neck: in combination with platinum and fluorouracil chemotherapy for the first-line treatment of recurrent and/or metastatic disease.
Key points for rational drug use:
1. This product must be used under the guidance of a physician experienced in the use of antineoplastic drugs. The patient’s condition needs to be closely monitored during and for 1 hour after the end of dosing and must be equipped with resuscitation equipment.
2. This product should be stored at 2~8℃, and should be used immediately after opening, freezing is prohibited. Please keep out of reach of children.
3. Patients must receive prophylactic dosing with antihistamines and/or glucocorticoids at least 1 hour prior to the first dose of this product. It is recommended that this prophylactic medication be given to the patient prior to each dose of this product in subsequent therapy.
4. For all indications, this product should be administered once weekly. The initial dose is 400 mg/m2 of body surface area, followed by a weekly dose of 250 mg/m2 of body surface area.
5. This product should be used in combination with platinum-based chemotherapeutic agents for the treatment of recurrent and/or metastatic head and neck squamous cell carcinoma, followed by continued maintenance therapy with this product until disease progression. The administration of chemotherapeutic agents must be started 1 hour after the end of the drip of this product.
6. Clinical benefit was confirmed for all efficacy endpoints, regardless of EGFR expression status. There is no evidence that testing for relevant markers such as EGFR expression predicts the efficacy of this product in patients with squamous cell carcinoma of the head and neck.
7. The global study (EXTREME) is a multicenter phase III study enrolling 442 patients with locally recurrent and/or metastatic head and neck squamous cell carcinoma. The China study (CHANGE2) is a phase III study of the efficacy and safety of first-line treatment in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. the efficacy results of CHANGE2 were consistent with the EXTREME results.
8. This product can be administered intravenously using an infusion pump, gravity drip or syringe pump. The first dose should be administered slowly at a titration rate of no more than 5 mg/min. The recommended titration time is 120 minutes, followed by weekly dosing at a titration time of 60 minutes at a titration rate of no more than 10 mg/min.
9. The main adverse reactions of this product are skin reactions, the incidence is about 80% or more, about more than 10% of patients occur hypomagnesemia, more than 10% of patients occur mild to moderate infusion reactions, more than 1% of patients will occur severe infusion reactions.
10. There is no experience with pediatric patients, and the effectiveness of this product in patients under 18 years of age has not been established. Dose adjustment is not required in elderly patients. there is limited experience with dosing in patients over 75 years of age.
The pharmacokinetic properties of this product are not affected by race, age, sex, or hepatic or renal status. To date, this product has only been studied in patients with normal hepatic and renal function.