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

What is Opdivo?

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

Opdivo is used to treat a certain type of melanoma (skin cancer) that cannot be treated with surgery, or that has spread to other parts of the body.

Opdivo is also used to treat a certain type of non-small cell lung cancer. Nivolumab may increase the chance of a longer survival time in people with this type of lung cancer.

Opdivo is used for melanoma or lung cancer only if your tumor has a specific genetic marker that your doctor will test for.

This medicine is also used to treat advanced kidney cancer that has not responded to other cancer medicines, or Hodgkin lymphoma that has relapsed or progressed after stem cell transplant and treatment with brentixumab vedotin (Adcetris).

Opdivo is given alone or in combination with other cancer medicines. It is sometimes given after other medicines have been tried without success.

Important information

Opdivo was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis for some types of cancer. In clinical studies, Opdivo produced complete or partial responses, or longer survival time without progression of the cancer. However, further studies are needed.

Opdivo can cause side effects that may cause symptoms 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. You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Opdivo.

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:

  • lung disease;

  • liver disease;

  • kidney disease;

  • a thyroid disorder;

  • an autoimmune disorder such as lupus, Crohn's disease, or ulcerative colitis; or

  • if you have received an organ transplant.

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.

It is not known whether nivolumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is Opdivo given?

Opdivo is injected into a vein through an IV. A healthcare provider will give you this injection.

Before you start treatment, your doctor will perform tests to make sure nivolumab is the best treatment for your type of cancer.

Opdivo is usually given once every 2 to 3 weeks. Your doctor will determine how long to treat you with this medicine.

Opdivo must be given slowly. The IV infusion can take at least 1 hour to complete.

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

Opdivo can cause certain side effects by changing the way your immune system works. These side effects can cause symptoms 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 or stopped altogether.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Opdivo. Do not miss any follow-up visits to your doctor.

Opdivo dosing information

Usual Adult Dose for Melanoma - Metastatic:

Dose: 3 mg/kg IV infusion over 60 minutes every 2 weeks
Duration of therapy: Continue therapy until disease progresses or unacceptable toxicity occurs.

-This drug has been approved under accelerated approval based on tumor response rate and durability of response. Continued approval will be contingent upon verification and description of clinical benefit in confirmatory trials.

Use: For the treatment of unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor

Usual Adult Dose of Opdivo for Lung Cancer:

Usual Adult Dose:
Dose: 3 mg/kg IV infusion over 60 minutes every 2 weeks
Duration of therapy: Continue therapy until disease progresses or unacceptable toxicity occurs.

Use: Metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy

See also: Dosage Information (in more detail)

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 of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, 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;

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

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

  • lung problems - new or worsening cough, sudden chest pain or discomfort, wheezing, 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 - nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • signs of a hormonal disorder - frequent or unusual headaches, vision problems, feeling light-headed or very tired, rapid heartbeats, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, 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, loss of appetite, diarrhea, constipation;

  • feeling tired or short of breath;

  • fever, body aches;

  • cough, runny or stuffy nose;

  • skin rash, itching; or

  • headache.

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.

See also: Side effects (in more detail)

What other drugs will affect Opdivo?

Other drugs may interact with nivolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Opdivo.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 2.01. Revision Date: 2016-06-27, 3:22:27 PM.