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, confusion, skin blistering, sores in your mouth or nose or on your genitals, frequent headaches, dizziness, increased thirst or urination, numbness or tingling, feeling cold, or weight gain or loss.

What is nivolumab?

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

  • advanced skin cancer (melanoma);
  • advanced non-small cell lung cancer;
  • pleural mesothelioma (cancer that affects the lining of the lungs and chest wall);
  • kidney cancer;
  • classical Hodgkin lymphoma;
  • squamous cell cancer of the esophagus or head and neck;
  • bladder cancer; or
  • liver cancer.

Nivolumab is also used to treat adults and children 12 years and older with 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 advanced lung cancer, nivolumab is given only if your tumor is positive for a protein called PD-L1, and your tumor does not have 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?

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.

Nivolumab may harm an 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. Tell your doctor if you become pregnant.

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. This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

Nivolumab is usually given once every 2 to 4 weeks. Your other cancer medicines may be given on different schedules. Your doctor will determine how long to treat you with all medicines.

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 a chemotherapy appointment.

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 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;
  • eye pain, vision changes, sensitivity to light;
  • severe muscle pain or weakness;
  • confusion, memory problems, neck stiffness, drowsiness, balance problems;
  • numbness or tingling in your arms or legs;
  • kidney problems --little or no urination, swelling in your feet or ankles, blood in your urine;
  • liver problems --severe nausea or vomiting, right-sided upper stomach pain, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
  • lung problems --new or worsening cough, chest pain, feeling short of breath;
  • signs of a hormonal disorder --frequent or unusual headaches, fast heartbeats, dizziness, fainting, tiredness, mood or behavior changes, hunger, increased thirst or urination, constipation, hair loss, hoarse or deepened voice, sweating, feeling cold, weight gain, or weight loss; or
  • (if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling near your transplanted organ;

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;
  • hormonal problems;
  • cold symptoms such as runny or stuffy nose, cough, sore throat;
  • fever, body aches;
  • headache, dizziness;
  • itching, rash; 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 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.

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