Formulation and specifications: Powder injection: 200mg/vial
Indications: This product is indicated for the treatment of patients with relapsed or refractory classic Hodgkin’s lymphoma who have undergone at least second-line systemic chemotherapy.
Key points for rational drug use:
1. A clear diagnosis of classic Hodgkin’s lymphoma must be made prior to drug administration.
2. Baseline evaluation should be done prior to treatment in accordance with relevant disease guidelines, and treatment response and toxicity should be monitored regularly during treatment.
3. This product is administered by intravenous infusion. The recommended dose of intravenous infusion is 200 mg, administered every 2 weeks until disease progression or intolerable toxicity occurs.
4. It is possible that atypical reactions may be observed. If patients have stable or persistent clinical symptoms, 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; it is not recommended for patients with moderate to severe hepatic impairment. It should be used with caution under medical supervision in patients with mild hepatic impairment and no dose adjustment is required 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 medical supervision in patients with mild renal impairment and no dose adjustment is necessary if used.
8. The most common adverse reactions (≥10%) in patients with Hodgkin’s lymphoma treated with this drug include skin reactive capillary hyperplasia, fever, hypothyroidism, upper respiratory tract infection, anemia, infusion-related reactions, cough, oral reactive capillary hyperplasia, nasopharyngitis, and pruritus. The most common grade 3 or higher adverse reactions (≥ 2%) include decreased lymphocyte count, decreased white blood cell count, decreased neutrophil count, elevated gamma-glutamyl transferase, herpes zoster, and inflammation of the lungs.
9. No safety and efficacy data are available for this product in children and adolescents under 18 years of age.
10. 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.
11. The use of this product for treatment during pregnancy is not recommended.
12. 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.
Management of reactive capillary hyperplasia: Reactive capillary hyperplasia may occur in approximately 70% of patients treated with this product. Reactive capillary hyperplasia occurs mostly in the skin of the body, and to a lesser extent in the oral mucosa, nasal mucosa, and eyelid conjunctiva. Reactive capillary hyperplasia occurs in the skin and initially appears as bright red dots on the body surface with a diameter of ≤2 mm, but with the increase in the number of doses, the lesions may gradually increase in extent, mostly nodular, but also patchy, bright red or dark red in color, and clinical symptoms and signs need to be observed.
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 complications of infection, anti-infective treatment should be given. Reactive capillary hyperplasia may occur in tissues other than the skin (including internal organs), and appropriate medical tests such as fecal occult blood, endoscopy and imaging should be performed if necessary (see the Reactive Capillary Hyperplasia Information Collection and Risk Management Plan for details).