Formulation and specifications: Powder injection: 200mg/vial
Indications:
1. Treatment of patients with locally advanced or metastatic esophageal squamous carcinoma whose disease has progressed or is intolerable after prior first-line chemotherapy.
2. Treatment of patients with advanced hepatocellular carcinoma who have received prior sorafenib therapy and/or oxaliplatin-containing systemic chemotherapy.
Key points for rational drug use:
1. This product is administered by intravenous infusion at the recommended dose of 200 mg administered every 2 or 3 weeks until disease progression or intolerable toxicity occurs.
2. Carelizumab therapy should be continued as long as clinical benefit is observed until the patient is intolerant and an atypical response is likely to be observed. If the patient has stable or persistently decreasing clinical symptoms, continued treatment with this product may be considered until disease progression is confirmed, even if the possibility of disease progression is considered, based on the judgment of overall clinical benefit.
3. Depending on the degree of individual patient safety and tolerability, dosing may be suspended or discontinued and no dose adjustment is recommended.
Baseline tests including thyroid function and cardiac enzymes are recommended prior to treatment and regular follow-up during treatment for early detection of immune-related adverse reactions. It should also be noted that immune-related adverse reactions may also occur after the end of treatment. In the event of immune-related adverse reactions, dosing may need to be suspended or permanently discontinued depending on the safety and tolerability of the individual patient. Dose increases or reductions are not recommended. The occurrence of Grade 4 or recurrent Grade 3 adverse reactions and the persistence of Grade 2 or 3 adverse reactions despite therapeutic modifications should result in permanent discontinuation of carrilizumab. Severe cases or those with doubtful diagnosis can be consulted by MDT of immune adverse reactions composed of gastroenterology, rheumatology, dermatology, respiratory medicine, oncology, etc.
5. There are limited data on the use of this product in elderly patients ≥ 65 years of age, and caution is advised under the guidance of a physician; no dose adjustment is necessary if it is needed. Treatment with this product during pregnancy is not recommended. No data are available on this product in patients with moderate to severe renal impairment. It is not recommended for use in patients with moderate to severe renal impairment and should be used with caution under the guidance of a physician in patients with mild renal impairment. There are no data from studies on patients with moderate to severe hepatic impairment, and it is not recommended for use in patients with moderate to severe hepatic impairment, and no dose adjustment is necessary in patients with mild hepatic impairment.
6. Systemic glucocorticoids or other immunosuppressive agents should be avoided prior to the use of this product because they may affect the pharmacodynamic activity and efficacy of this product. However, systemic glucocorticoids or other immunosuppressive agents may be used to treat immune-mediated adverse reactions after the administration of this product has been initiated.
7. Management of reactive capillary hyperplasia: Reactive capillary hyperplasia occurs in 70% to 80% of patients treated with this product. Reactive capillary hyperplasia occurs mostly on the skin of the body surface, and a few are seen in the oral mucosa, nasal mucosa, and eyelid conjunctiva. Reactive capillary hyperplasia that occurs in the skin is initially manifested as bright red dots on the body surface, ≤2mm in diameter, and the lesions may gradually increase in extent with the increase in the number of doses, mostly nodular, but also patchy, bright red or dark red in color, requiring observation of clinical symptoms and signs.
When the patient experiences this adverse reaction, scratching or rubbing should be avoided and the easily rubbed area can be protected with gauze to avoid bleeding. For rupture and bleeding, local compression may be used to stop bleeding or local treatment such as laser or surgical excision; for complicated infection, anti-infection treatment should be given. Reactive capillary hyperplasia may occur in tissues other than the skin (including the lid conjunctiva, inner and outer canthus, oral mucosa, pharynx, and other mucous membranes or other organs), and appropriate medical tests such as fecal occult blood, endoscopy, and imaging should be performed as necessary based on self-examination of signs and symptoms (see the Reactive Capillary Hyperplasia Information Collection and Risk Management Plan for details).