Formulation and Specifications: Powder injection: 200 mg/vial
Indications: Carrilizumab in combination with pemetrexed and carboplatin is indicated for the first-line treatment of EGFR mutation-negative and ALK-negative, non-surgically resectable locally advanced or metastatic non-squamous cell NSCLC.
Key points for rational drug use:
1. The diagnosis of EGFR mutation-negative and ALK-negative nonsquamous cell NSCLC must be clearly established before drug administration.
2. Baseline evaluation should be done before treatment and treatment response and toxicity should be monitored regularly during treatment in accordance with relevant disease guidelines.
3. This product is administered by intravenous infusion. The recommended dose of intravenous infusion is 200 mg for 30-60 minutes, administered every 3 weeks until disease progression or intolerable toxicity occurs. When cariolizumab is administered in combination with chemotherapy, cariolizumab should be given first as an intravenous infusion, with an interval of at least 30 minutes before chemotherapy is given.
4. Atypical reactions are likely to be observed. If the patient has stable or persistent clinical symptoms in remission, even with preliminary evidence of disease progression, continued treatment with this product may be considered based on the judgment of overall clinical benefit until disease progression is confirmed.
5. 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.
6. There are no study data available for this product in patients with moderate to severe hepatic impairment and it is not recommended for patients with moderate to severe hepatic impairment. Patients with mild hepatic impairment should use this product with caution under the guidance of a physician and without dose adjustment if needed.
7. There are no data from studies in patients with moderate to severe renal impairment and it is not recommended for use in patients with moderate to severe renal impairment. This product should be used with caution under the guidance of a physician in patients with mild renal impairment and no dose adjustment is necessary if used.
8. No safety and efficacy data are available for this product in children and adolescents under 18 years of age.
9. Limited data are available on the use of this product in elderly patients ≥65 years of age. Use with caution under the guidance of a physician is recommended, and no dose adjustment is necessary if used.
10. The use of this product for treatment during pregnancy is not recommended.
11. Systemic glucocorticoids and other immunosuppressive agents should be avoided prior to initiating treatment with this product because of possible interference with its pharmacodynamic activity. However, systemic glucocorticoids and other immunosuppressive agents may be used after initiation of treatment for immune-related adverse reactions.
12. Carrilizumab is a humanized monoclonal antibody, and pharmacokinetic interaction studies with other drugs have not been performed. Because the monoclonal antibody is not metabolized by CYP450 enzymes or other drug metabolizing enzymes, inhibition or induction of these enzymes by the combined drugs is not expected to affect the pharmacokinetic properties of karelixumab.
13. Management of reactive capillary hyperplasia: Reactive capillary hyperplasia occurred in 1023 (77.4%) of patients treated with this product, with grade 1 in 827 (62.6%), grade 2 in 182 (13.8%), and grade 3 in 14 (1.1%). All reactive capillary hyperplasia occurred on the body surface, with 3.9% (52/1321) in the oral cavity, 1.1% (14/1321) in the nasal mucosa, 0.5% (7/1321) in the eyelids, and 0.5% (6/1321) in the eyes; 16.5% had combined bleeding and 1.1% had combined infection. The median time to onset of reactive capillary hyperplasia was 0.9 months (range: 0.0 to 8.1 months) and the median time to duration was 6.3 months (range: 0.2 to 32.8 months). Reactive capillary hyperplasia occurring in the skin, initially mostly manifested as bright red dots on the body surface, ≤2 mm in diameter, with increasing dosing, the lesions may gradually increase in extent, mostly nodular, but also patchy, bright red or dark red in color, requiring observation of clinical signs and symptoms.
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. Recurrent bleeding can be stopped by local pressure, and recurrent bleeding can be treated by dermatological consultation or local treatment such as laser or surgical excision. Reactive capillary hyperplasia may occur in tissues other than the skin (including the lid conjunctiva, inner and outer canthus, oral mucosa, mucosa of the digestive tract such as the pharynx, or other organs), and appropriate medical tests such as fecal occult blood, endoscopy, and imaging should be performed when necessary (see the Information Collection and Risk Management Plan for Reactive Capillary Hyperplasia for details).