Nivolumab Injection

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving nivolumab injection,

• tell your doctor and pharmacist if you are allergic to nivolumab, any other medications, or any of the ingredients in nivolumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: any medication that weakens your immune system such as antithymocyte globulin (Atgam, Thymoglobulin), azathioprine (Azasan, Imuran), basiliximab (Simulect), belatacept (Nulojix), belimumab (Benlysta), cortisone, cyclosporine (Gengraf, Neoral, Sandimmune), dexamethasone, fludrocortisone, methotrexate (Otrexup, Rasuvo, Trexall), methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol), mycophenolate mofetil (Cellcept), prednisolone (Flopred, Orapred, Pediapred), prednisone (Rayos), sirolimus (Rapamune), and tacrolimus (Astagraf XL, Prograf, Envarsus XR). Many other medications may also weaken your immune system, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever had an organ transplant, Also tell your doctor if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition that causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any type of lung disease or breathing problems; or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving nivolumab injection. You should use effective birth control to prevent pregnancy during your treatment with nivolumab injection and for at least 5 months after your last dose of medication. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving nivolumab injection, call your doctor immediately. Nivolumab injection may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving nivolumab injection.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to nivolumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

OPDIVO®
(op-DEE-voh)
(nivolumab) Injection

Read this Medication Guide before you start receiving OPDIVO and before each infusion. There may be new information. If your healthcare provider prescribes OPDIVO in combination with ipilimumab (YERVOY®), also read the Medication Guide that comes with ipilimumab. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

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

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with ipilimumab.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Symptoms of pneumonitis may include:

• new or worsening cough
• chest pain
• shortness of breath

Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include:

• diarrhea (loose stools) or more bowel movements than usual
• blood in your stools or dark, tarry, sticky stools
• severe stomach-area (abdomen) pain or tenderness

Liver problems (hepatitis). Signs and symptoms of hepatitis may include:

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• drowsiness
• dark urine (tea colored)
• bleeding or bruising more easily than normal
• feeling less hungry than usual

Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:

• headaches that will not go away or unusual headaches
• extreme tiredness
• weight gain or weight loss
• dizziness or fainting
• hair loss
• feeling cold
• constipation
• voice gets deeper
• excessive thirst or lots of urine
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include:

• decrease in the amount of urine
• blood in your urine
• swelling in your ankles
• loss of appetite

Skin Problems. Signs of these problems may include:

• rash
• itching
• skin blistering
• ulcers in mouth or other mucous membranes

Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include:

• headache
• fever
• tiredness or weakness
• confusion
• memory problems
• sleepiness
• seeing or hearing things that are not really there (hallucinations)
• seizures
• stiff neck

Problems in other organs. Signs of these problems may include:

• changes in eyesight
• severe or persistent muscle or joint pains
• severe muscle weakness

Getting medical treatment right away may keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment with OPDIVO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with OPDIVO, if you have severe side effects.

What is OPDIVO?

OPDIVO is a prescription medicine used to treat:

• people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma). You may receive OPDIVO alone or in combination with ipilimumab.
• people with a type of advanced stage lung cancer (called non-small cell lung cancer).
• OPDIVO may be used when your lung cancer:
  • has spread or grown, and
  • you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
    If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
• people with kidney cancer (renal cell carcinoma).
  • OPDIVO may be used when your cancer has spread or grown after treatment with other cancer medications.
• adults with a type of blood cancer called classical Hodgkin lymphoma.
• OPDIVO may be used if:
  • your cancer has come back or spread after a type of stem cell transplant that uses your own stem cells (autologous), and
  • you used the drug brentuximab vedotin (Adcetris®) before or after your stem cell transplant, or
  • you received at least 3 kinds of treatment including a stem cell transplant that uses your own stem cells (autologous).
• people with head and neck cancer (squamous cell carcinoma)
• OPDIVO may be used when your head and neck cancer:
  • has come back or spread, and
  • you have tried chemotherapy that contains platinum and it did not work or is no longer working.
• people with bladder cancer (urothelial carcinoma).
• OPDIVO may be used when your bladder cancer:
  • has spread or grown, and
  • you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
• adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer).
• OPDIVO may be used when your colon or rectal cancer:
  • has spread to other parts of the body (metastatic),
  • has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H)
• people with liver cancer (hepatocellular carcinoma)
  • OPDIVO may be used after you have received treatment with sorafenib (Nexavar®).

It is not known if OPDIVO is safe and effective in children less than 18 years of age for treatment of any cancer other than metastatic, MSI-H or dMMR, colorectal cancer.

What should I tell my healthcare provider before receiving OPDIVO?

Before you receive OPDIVO, tell your healthcare provider if you:

• have immune system problems such as Crohn's disease, ulcerative colitis, or lupus
• have had an organ transplant
• have lung or breathing problems
• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby.
  • Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your healthcare provider about birth control methods that you can use during this time.
  • Tell your healthcare provider right away if you become pregnant during treatment with OPDIVO.
• are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment with OPDIVO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare providers and pharmacist when you get a new medicine.

How will I receive OPDIVO?

• Your healthcare provider will give you OPDIVO into your vein through an intravenous (IV) line over 60 minutes.
• OPDIVO is usually given every 2 weeks.
• When used in combination with ipilimumab, OPDIVO is usually given every 3 weeks, for a total of 4 doses. Ipilimumab will be given on the same day. After that, OPDIVO will be given alone every 2 weeks.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will do blood tests to check you for side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of OPDIVO?

OPDIVO can cause serious side effects, including:

• See “What is the most important information I should know about OPDIVO?”
• Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO:
  • chills or shaking
  • itching or rash
  • flushing
  • difficulty breathing
  • dizziness
  • fever
  • feeling like passing out
• Complications of stem cell transplant that uses donor stem cells (allogeneic) after treatment with OPDIVO. These complications can be severe and can lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

The most common side effects of OPDIVO when used alone include:

• feeling tired
• pain in muscles, bones, and joints
• diarrhea
• weakness
• shortness of breath
• decreased appetite
• upper respiratory tract infection
• rash
• itchy skin
• nausea
• cough
• constipation
• back pain
• fever

The most common side effects of OPDIVO when used in combination with ipilimumab include:

• feeling tired
• diarrhea
• fever
• shortness of breath
• rash
• nausea
• vomiting

These are not all the possible side effects of OPDIVO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of OPDIVO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about OPDIVO, talk with your healthcare provider. You can ask your healthcare provider for information about OPDIVO that is written for health professionals.

What are the ingredients in OPDIVO?

Active ingredient: nivolumab

Inactive ingredients: mannitol, pentetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for Injection. May contain hydrochloric acid and/or sodium hydroxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.