INDICATIONS AND USAGE（适应症）

Unresectable or Metastatic Melanoma

OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma.

Adjuvant Treatment of Melanoma

OPDIVO is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Metastatic Non-Small Cell Lung Cancer

OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO is indicated for the treatment of patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

Malignant Pleural Mesothelioma

OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

Advanced Renal Cell Carcinoma

OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of patients with intermediate or poor risk advanced RCC.

OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced RCC.

OPDIVO as a single agent is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Classical Hodgkin Lymphoma

OPDIVO is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) 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.

Squamous Cell Carcinoma of the Head and Neck

OPDIVO is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

Urothelial Carcinoma

OPDIVO is indicated for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO is indicated for the treatment of patients with 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.

Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer

OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

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

Hepatocellular Carcinoma

OPDIVO, in combination with ipilimumab, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma

OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

DOSAGE（服用剂量）

Your healthcare provider will give you OPDIVO into your vein through an intravenous (IV) line over 30 minutes.

When OPDIVO is used alone, it is usually given every 2 weeks or 4 weeks depending on the dose you are receiving.

When OPDIVO is used in combination with ipilimumab (except for treating NSCLC), OPDIVO is usually given every 3 weeks, for a total of 4 doses. Ipilimumab will be given on the same day. After that, OPDIVO will be given alone every 2 weeks or 4 weeks depending on the dose you are receiving.

For NSCLC that has spread to other parts of your body, when OPDIVO is used in combination with ipilimumab, OPDIVO is given either every 2 weeks or every 3 weeks, and ipilimumab is given every 6 weeks for up to 2 years. Your healthcare provider will determine if you will also need to receive chemotherapy every 3 weeks for 2 cycles.

For malignant pleural mesothelioma, OPDIVO is given every 3 weeks and ipilimumab is given every 6 weeks for up to 2 years.

For RCC, when used in combination with cabozantinib, OPDIVO is usually given every 2 weeks or 4 weeks depending on the dose you are receiving. Cabozantinib is given once daily by mouth.

For gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, when used in combination with fluoropyrimidine and platinum-containing chemotherapy, OPDIVO is given every 2 weeks or 3 weeks depending on the dose you are receiving. Chemotherapy will be given on the same day.

Your healthcare provider will decide how many treatments you need.

Your healthcare provider will do blood tests to check you for side effects.

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

ADVERSE REACTIONS（不良反应）

OPDIVO can cause serious side effects, including:

Severe infusion reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of OPDIVO:

chills or shaking

itching or rash

flushing

shortness of breath or wheezing

dizziness

feel like passing out

fever

back or neck pain

Complications of stem cell transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

The most common side effects of OPDIVO when used alone include:

feeling tired

rash

pain in muscles, bones, and joints

itchy skin

diarrhea

nausea

weakness

cough

vomiting

shortness of breath

constipation

decreased appetite

back pain

upper respiratory tract infection

fever

headache

stomach-area (abdominal) pain

urinary tract infection

The most common side effects of OPDIVO when used in combination with ipilimumab include:

feeling tired

diarrhea

rash

itching

nausea

pain in muscles, bones, and joints

fever

cough

decreased appetite

vomiting

stomach-area (abdominal) pain

shortness of breath

upper respiratory tract infection

headache

low thyroid hormone levels (hypothyroidism)

decreased weight

dizziness

The most common side effects of OPDIVO when used in combination with ipilimumab and chemotherapy include:

feeling tired

pain in muscles, bones, and joints

nausea

diarrhea

rash

decreased appetite

constipation

itching

The most common side effects of OPDIVO when used in combination with cabozantinib include:

diarrhea

feeling tired or weak

liver problems

rash, redness, pain, swelling or blisters on the palms of your hands or soles of your feet

mouth sores

rash

high blood pressure

low thyroid hormone levels

pain in muscles, bones, and joints

decreased appetite

nausea

change in the sense of taste

stomach-area (abdominal) pain

cough

upper respiratory tract infection

The most common side effects of OPDIVO when used in combination with fluoropyrimidine and platinum-containing chemotherapy include:

numbness, pain, tingling, or burning in your hands or feet

nausea

feeling tired

diarrhea

vomiting

decreased appetite

stomach-area (abdominal) pain

constipation

pain in muscles, bones, and joints

These are not all the possible side effects of OPDIVO.

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f570b9c4-6846-4de2-abfa-4d0a4ae4e394/spl-doc?hl=Opdivo

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