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Description of product
What is Opdivo and how is it used?
Opdivo is a prescription medicine used to treat:
It is not known if Opdivo is safe and effective when used:
- people with a type of skin cancer called melanoma:
- Opdivo may be used alone or in combination with ipilimumab to treat melanoma that has spread or cannot be removed by surgery (advanced melanoma), or
- Opdivo may be used alone to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
- people with a type of advanced stage lung cancer called non-small cell lung cancer (NSCLC).
- Opdivo may be used in combination with ipilimumab as your first treatment for NSCLC:
- when your lung cancer has spread to other parts of your body (metastatic), and
- your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.
- Opdivo may be used in combination with ipilimumab and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine, as the first treatment of your NSCLC when your lung cancer:
- has spread or grown, or comes back, and
- your tumor does not have an abnormal EGFR or ALK gene.
- Opdivo may be used when your lung cancer:
If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
- has spread or grown, and
- you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
- Opdivo may be used in combination with ipilimumab as your first treatment for NSCLC:
- people with a type of lung cancer called small cell lung cancer.
- Opdivo may be used when your lung cancer:
- has spread or grown, and
- you have tried at least two different types of chemotherapy, including one that contains platinum, and it did not work or is no longer working.
- Opdivo may be used when your lung cancer:
- people with kidney cancer (renal cell carcinoma).
- Opdivo may be used alone when your cancer has spread or grown after treatment with other cancer medicines.
- Opdivo may be used in combination with ipilimumab in certain people when their cancer has spread.
- adults with a type of blood cancer called classical Hodgkin lymphoma.
- Opdivo may be used if:
- your cancer has come back or spread after a type of stem cell transplant that uses your own stem cells (autologous), and
- you used the drug brentuximab vedotin before or after your stem cell transplant, or
- you received at least 3 kinds of treatment including a stem cell transplant that uses your own stem cells (autologous).
- Opdivo may be used if:
- people with head and neck cancer (squamous cell carcinoma).
- Opdivo may be used when your head and neck cancer:
- has come back or spread, and
- you have tried chemotherapy that contains platinum and it did not work or is no longer working.
- Opdivo may be used when your head and neck cancer:
- people with bladder cancer (urothelial carcinoma).
- Opdivo may be used when your bladder cancer:
- has spread or grown, and
- you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
- Opdivo may be used when your bladder cancer:
- adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer).
- Opdivo may be used alone or in combination with ipilimumab when your colon or rectal cancer:
- has spread to other parts of the body (metastatic),
- is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and
- you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
- Opdivo may be used alone or in combination with ipilimumab when your colon or rectal cancer:
- people with liver cancer (hepatocellular carcinoma).
- Opdivo may be used alone or in combination with ipilimumab if you have previously received treatment with sorafenib.
- in children younger than 12 years of age with MSI-H or dMMR metastatic colorectal cancer, or
- in children younger than 18 years of age for the treatment of any other cancers.
What are the possible side effects of Opdivo?
Opdivo can cause serious side effects, including:
- See “What is the most important information I should know about Opdivo?”
- Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of Opdivo:
- chills or shaking
- itching or rash
- flushing
- difficulty breathing
- dizziness
- fever
- feeling like passing out
- Complications of stem cell transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. 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
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
These are not all the possible side effects of Opdivo.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
DESCRIPTION
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody. Nivolumab is an IgG4 kappa immunoglobulin that has a calculated molecular mass of 146 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line.
OPDIVO is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colorless to pale-yellow liquid that may contain light (few) particles.
OPDIVO (nivolumab) injection for intravenous use is supplied in single-dose vials. Each mL of OPDIVO solution contains nivolumab 10 mg, mannitol (30 mg), pentetic acid (0.008 mg), polysorbate 80 (0.2 mg), sodium chloride (2.92 mg), sodium citrate dihydrate (5.88 mg), and Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide to adjust pH to 6.
INDICATIONS
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 [see DOSAGE AND ADMINISTRATION], 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.
This indication is approved under accelerated approval based on overall response rate [see Clinical Studies]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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 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.
This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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 [see Clinical Studies]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Hepatocellular Carcinoma
OPDIVO, as a single agent or 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 [see Clinical Studies]. 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.