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nivolumab

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

What is nivolumab?

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

Nivolumab 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.

Nivolumab 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.

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

Nivolumab 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).

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

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

Nivolumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about nivolumab?

Nivolumab 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 nivolumab.

What should I discuss with my healthcare provider before receiving nivolumab?

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

To make sure nivolumab 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 nivolumab 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 nivolumab given?

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

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

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

Nivolumab 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 nivolumab.

Nivolumab 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 nivolumab. Do not miss any follow-up visits to your doctor.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your nivolumab 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 nivolumab?

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

Nivolumab side effects

Get emergency medical help if you have signs of an allergic reaction: 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 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)

Nivolumab dosing information

Usual Adult Dose for Melanoma - Metastatic:

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

In combination with ipilimumab:
1 mg/kg IV over 60 minutes, followed by ipilimumab on the same day, every 3 weeks for 4 doses. The recommended subsequent dose of this drug, as a single agent, is 3 mg/kg IV over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

Comments:
-Manufacturer prescribing information should be consulted for ipilimumab dosing.
-When this drug is administered in combination with ipilimumab, if this drug is withheld, ipilimumab should also be withheld.
-When this drug is administered in combination with ipilimumab, infuse this drug first followed by ipilimumab on the same day. Use separate infusion bags and filters for each infusion.
-Refer to the manufacturer product information for recommended dose modifications for colitis, pneumonitis, hepatitis, hypophysitis, adrenal insufficiency, nephritis and renal dysfunction, rash, encephalitis, or other conditions.

Uses: Unresectable or metastatic melanoma:
-As a single agent in patients with disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
-In combination with ipilimumab in patients with BRAF V600 wild-type melanoma

Usual Adult Dose for Lung Cancer:

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

Comments:
-Refer to the manufacturer product information for recommended dose modifications for colitis, pneumonitis, hepatitis, hypophysitis, adrenal insufficiency, nephritis and renal dysfunction, rash, encephalitis, or other conditions.

Use: Metastatic squamous non-small cell lung cancer (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:

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

Comments:
-Refer to the manufacturer product information for recommended dose modifications for colitis, pneumonitis, hepatitis, hypophysitis, adrenal insufficiency, type 1 diabetes mellitus, nephritis and renal dysfunction, rash, encephalitis, or other conditions.

Use: For the treatment of advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy

What other drugs will affect nivolumab?

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 nivolumab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication 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 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2016-06-27, 3:22:27 PM.

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