PD-1 / PD-L1药物信息更新 | Opdivo（2017-08-01，英文版）

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Classical Hodgkin lymphoma (adult patients) that has relapsed or progressed after:

• autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or

• 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.

• Locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy

• have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

DOSAGE AND ADMINISTRATION ：

Administer as an intravenous infusion over 60 minutes.

• Unresectable or metastatic melanoma

• OPDIVO 240 mg every 2 weeks.

• OPDIVO with ipilimumab: OPDIVO 1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then OPDIVO 240 mg every 2 weeks.

• Metastatic non-small cell lung cancer

• OPDIVO 240 mg every 2 weeks.

• Advanced renal cell carcinoma

• OPDIVO 240 mg every 2 weeks.

• Classical Hodgkin lymphoma

• OPDIVO 3 mg/kg every 2 weeks.

• Recurrent or metastatic squamous cell carcinoma of the head and neck

• OPDIVO 3 mg/kg every 2 weeks.

• Locally advanced or metastatic urothelial carcinoma

• OPDIVO 240 mg every 2 weeks
  

DOSAGE FORMS AND STRENGTHS

• Injection: 40 mg/4 mL and 100 mg/10 mL solution in a single-dose vial.
  

CONTRAINDICATIONS

• None.

WARNINGS AND PRECAUTIONS

• Immune-mediated pneumonitis: Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis.

• Immune-mediated colitis: Withhold OPDIVO when given as a single agent for moderate or severe and permanently discontinue for life-threatening colitis. Withhold OPDIVO when given with ipilimumab for moderate and permanently discontinue for severe or life-threatening colitis.

• Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation.

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