Formulation and specification: Injection: 100mg (4ml)/bottle
Indications: Indicated for the treatment of unresectable or metastatic cutaneous melanoma.
Key points for rational drug use:
1. The recommended dosing regimen for patients with unresectable or metastatic melanoma who have failed first-line therapy is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression or intolerable toxicity occurs. If the patient is clinically stable, continued treatment with this product may be considered until disease progression is confirmed, even if there is preliminary evidence of disease progression, based on a judgment of overall clinical benefit. Depending on the safety and tolerability of individual patients, dosing may need to be suspended or discontinued and no dose increases or decreases are recommended.
2. The major adverse reactions are fatigue, pruritus, diarrhea, and rash. Immune-related adverse reactions, including severe and fatal cases, can occur in patients treated with pablizumab. Immune-related adverse reactions can occur in multiple organ systems at the same time and require adequate evaluation of suspected cases to determine the cause or to rule out other causes. Depending on the severity of the adverse reaction, pabrolizumab should be temporarily discontinued and glucocorticoid therapy applied. When the immune-related adverse reactions improve to ≤ grade 1, the glucocorticoid dosage should be gradually reduced over a period of at least one month until discontinuation. In the event of immune-related adverse reactions not controlled by glucocorticoids, other systemic immunosuppressive agents may be considered. If adverse reactions remain at ≤ grade 1 and the glucocorticoid dose has been reduced to ≤ 10 mg prednisone or equivalent, pabrolizumab therapy may be restarted within 12 weeks of the last dose of pabrolizumab. Pabrolizumab should be permanently discontinued for any recurrent grade 3 immune-related adverse reactions and for any grade 4 immune-related adverse reactions.
3. Patients who experience mild to moderate infusion reactions may continue to receive pabolizumab under close monitoring and may be considered for prophylaxis with antipyretic anti-inflammatory drugs and antihistamines. For severe infusion reactions, the infusion must be stopped and pabrolizumab must be permanently discontinued.
4. Use during pregnancy may cause fetal harm and should not be used during pregnancy unless required by the clinical condition of the pregnant woman. Women of childbearing potential are advised to use a highly effective method of contraception during dosing and to continue contraception for four months after the last dose. The risk to the newborn cannot be ruled out and should be weighed against the benefit of breastfeeding to the fetus and the benefit of treatment with this product to the female patient.
5. The safety and efficacy of this product in children under 18 years of age have not been established, and no dose adjustment is required in the elderly population.
6. No dose adjustment is required in patients with mild hepatic impairment, and no studies have been conducted with this product in patients with moderate to severe hepatic impairment.
7. Avoid the use of systemic glucocorticoids or other immunosuppressive agents prior to the use of this drug.