Alert

nivolumab

Pronunciation: nye VOL ue mab

Brand: Opdivo

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

Nivolumab 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, skin sores, confusion, hallucinations, a seizure, or a hormonal disorder (frequent headaches, feeling light-headed, increased thirst or urination, a deeper voice, feeling cold, weight gain or loss).

What is nivolumab?

Nivolumab is a cancer medicine that is used alone or in combination with other medicines to treat:

  • advanced skin cancer (melanoma);
  • non-small cell lung cancer;
  • kidney cancer;
  • classical Hodgkin lymphoma;
  • squamous cell cancer of the head and neck;
  • bladder cancer;
  • liver cancer; or
  • a type of colorectal cancer that laboratory testing proves to have certain specific DNA mutations.

Nivolumab 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, nivolumab is given only if your tumor has a specific genetic marker (an abnormal "EGFR" or "ALK" gene).

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

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

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

Tell your doctor if you have ever had:

  • lung disease or breathing problems;
  • liver disease;
  • an autoimmune disorder (lupus, Crohn's disease, ulcerative colitis); or
  • an organ transplant, or a stem cell transplant from a donor.

You may need to have a negative pregnancy test before starting this treatment.

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.

Do not breastfeed while using this medicine, and for at least 5 months after your last dose.

How is nivolumab given?

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

Nivolumab is given as an infusion into a vein by a healthcare provider. Nivolumab must be given by slow infusion over at least 1 hour.

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

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

Nivolumab 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 nivolumab.

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.

What are the possible side effects of nivolumab?

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, 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, loss of appetite, upper stomach pain, drowsiness, 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, 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 side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;
  • feeling weak, tired, or short of breath;
  • cold symptoms such as runny or stuffy nose, cough, sore throat;
  • fever, body aches;
  • skin rash, itching; or
  • headache, back pain.

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 nivolumab?

Other drugs may affect 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.

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.

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 1996-2019 Cerner Multum, Inc. Version: 12.01. Revision date: 5/17/2019.

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