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Opdivo

Generic Name: nivolumab (nye VOL ue mab)
Brand Names: Opdivo

Medically reviewed by Sophia Entringer, PharmD. Last updated on Oct 5, 2020.

What is Opdivo?

Opdivo (nivolumab) is a cancer medicine that is used alone or in combination with other medicines that works with your immune system to interfere with the growth and spread of cancer cells in the body.

Opdivo may be used to treat:

Opdivo is often given when the cancer has spread to other parts of the body, or cannot be surgically removed, or has come back after prior treatment.

For some types of cancer, Opdivo is given only if your tumor has a specific genetic marker (an abnormal "EGFR" or "ALK" gene).

Important Information

Opdivo can cause side effects in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed.

Call your doctor at once if you have: chest pain, cough, shortness of breath, vision changes, severe muscle pain or weakness, diarrhea and severe stomach pain, blood in your stools, little or no urinating, swelling, bruising or bleeding, dark urine, yellowing of the skin or eyes, confusion, hallucinations, a seizure, skin blistering, sores in your mouth, nose, rectum, or genitals, or a hormonal disorder (frequent headaches, feeling light-headed, increased thirst or urination, a deeper voice, feeling cold, weight gain or loss).

Before taking this medicine

You should not use Opdivo if you are allergic to nivolumab.

To make sure Opdivo is safe for you, tell your doctor if you have ever had:

Do not use Opdivo if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 5 months after your last dose.

You should not breast-feed while using this medicine.

How is Opdivo given?

Opdivo is given as an infusion into a vein by a healthcare provider. This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

Opdivo is usually given once every 2 to 4 weeks. Your doctor will determine how long to treat you with this medicine.

Your doctor will perform tests to make sure this medicine is the best treatment for your type of cancer.

You may be given medication to treat or prevent certain side effects of nivolumab.

Opdivo can cause side effects in many parts of your body by changing how your immune system works. Some side effects may be treated with other medicine, and your cancer treatments may be delayed or stopped.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Opdivo.

Opdivo dosing information

Usual Adult Dose for Melanoma -- Metastatic:

AS A SINGLE AGENT:
UNRESECTABLE OR METASTATIC MELANOMA:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity
ADJUVANT TREATMENT OF MELANOMA:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity for up to one year
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity for up to one year

IN COMBINATION:
UNRESECTABLE OR METASTATIC MELANOMA:
1 mg/kg IV over 30 minutes every 3 weeks with ipilimumab 3 mg/kg IV over 90 minutes on the same day for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier
THEN:
240 mg IV over 30 minutes every 2 weeks; after completing 4 doses of combination therapy, administer as single agent until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks; after completing 4 doses of combination therapy, administer as single agent until disease progression or unacceptable toxicity

Uses:
-As a single agent or in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma
-For the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection

Usual Adult Dose for Non-Small Cell Lung Cancer:

AS A SINGLE AGENT:
METASTATIC NON-SMALL CELL LUNG CANCER:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity
SMALL CELL LUNG CANCER:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity

IN COMBINATION:
METASTATIC OR RECURRENT NON-SMALL CELL LUNG CANCER EXPRESSING PD-L1:
3 mg/kg IV over 30 minutes every 2 weeks with ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression
METASTATIC OR RECURRENT NON-SMALL CELL LUNG CANCER:
360 mg IV over 30 minutes every 3 weeks with ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks and histology-based platinum doublet chemotherapy every 3 weeks for the first 2 cycles, then 360 mg IV over 30 minutes every 3 weeks with ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

Uses:
-This drug, in combination with ipilimumab, is for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1% or greater) with no EGFR or ALK genomic tumor aberrations
-This drug, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, 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
-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 this drug

Usual Adult Dose for Renal Cell Carcinoma:

AS A SINGLE AGENT:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

IN COMBINATION:
3 mg/kg IV over 30 minutes every 3 weeks with ipilimumab 1 mg/kg IV over 30 minutes on the same day for 4 doses
THEN AFTER COMPLETING 4 DOSES OF COMBINATION THERAPY, ADMINISTER AS SINGLE AGENT:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

Uses:
-As a single agent for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy
-In combination with ipilimumab the treatment of patients with intermediate or poor risk, previously untreated advanced RCC

Usual Adult Dose for Hodgkin's Disease:

AS A SINGLE AGENT:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

Use: For 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

Usual Adult Dose for Head and Neck Cancer:

AS A SINGLE AGENT:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

Use: For recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy

Usual Adult Dose for Urothelial Carcinoma:

AS A SINGLE AGENT:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

Use: For locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Usual Adult Dose for Colorectal Cancer:

AS A SINGLE AGENT:
40 KG OR GREATER:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

IN COMBINATION:
40 KG OR GREATER:
3 mg/kg IV over 30 minutes every 3 weeks with ipilimumab 1 mg/kg IV over 30 minutes on the same day for a total of 4 doses
AFTER COMPLETING 4 DOSES OF COMBINATION THERAPY, ADMINISTER AS SINGLE AGENT:
40 KG OR GREATER:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

Use: As a single agent or in combination with ipilimumab for 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

Usual Adult Dose for Hepatocellular Carcinoma:

AS A SINGLE AGENT:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

IN COMBINATION:
1 mg/kg IV over 30 minutes every 3 weeks with ipilimumab 3 mg/kg IV over 30 minutes on the same day for 4 doses
THEN AFTER COMPLETING 4 DOSES OF COMBINATION THERAPY, ADMINISTER AS SINGLE AGENT:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

Use: As a single agent or in combination with ipilimumab for hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

Usual Adult Dose for Small Cell Lung Cancer:

AS A SINGLE AGENT:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity

Use: For the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least 1 other line of therapy

Usual Pediatric Dose for Colorectal Cancer:

AS A SINGLE AGENT:
12 years and older:
LESS THAN 40 KG:
3 mg/kg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
12 years and older:
40 KG OR GREATER:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

IN COMBINATION:
12 years and older:
3 mg/kg IV over 30 minutes every 2 weeks with ipilimumab 1 mg/kg IV over 30 minutes on the same day for a total of 4 doses
AFTER COMPLETING 4 DOSES OF COMBINATION THERAPY, ADMINISTER AS SINGLE AGENT:
LESS THAN 40 KG:
3 mg/kg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
40 KG OR GREATER:
240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
OR
480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

Use: As a single agent or in combination with ipilimumab for 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 in pediatric patients 12 years and older

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Opdivo injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Opdivo?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Opdivo side effects

Get emergency medical help if you have signs of an allergic reaction to Opdivo: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, short of breath, itchy, tingly, chilled, or feverish.

Call your doctor at once if you have:

  • severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;

  • new or worsening skin rash, itching, or blistering;

  • sores or ulcers in your mouth, nose, rectum, or genitals;

  • changes in your vision;

  • severe muscle weakness, ongoing pain in your muscles or joints;

  • (if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling near your transplanted organ;

  • lung problems - new or worsening cough, chest pain, feeling short of breath;

  • symptoms of brain swelling - confusion, headache, memory problems, hallucinations, neck stiffness, drowsiness, seizure (convulsions);

  • kidney problems - little or no urinating; blood in your urine; swelling in your feet or ankles;

  • liver problems - severe nausea or vomiting, right-sided upper stomach pain, lack of energy, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes); or

  • signs of a hormonal disorder - frequent or unusual headaches, dizziness, fainting, mood or behavior changes, increased thirst or urination, constipation, hair loss, sweating, hoarse or deepened voice, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Opdivo side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;

  • feeling weak, tired, or short of breath;

  • hormonal problems;

  • cold symptoms such as runny or stuffy nose, cough, sore throat;

  • fever, body aches;

  • headache, dizziness;

  • skin rash, itching; or

  • weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Opdivo?

Other drugs may interact with nivolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Opdivo only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.