Nivolumab Intravenous

Nivolumab injection is used alone or together with other medicines (eg, ipilimumab) to treat melanoma (skin cancer) that has spread throughout the body (metastatic) or that cannot be removed by surgery. It is also used to treat non-small cell lung cancer that has spread throughout the body and after other cancer medicines have been tried. Nivolumab injection is also used to treat kidney cancer in patients who have received other medicines. It is also used to treat classical Hodgkin lymphoma (white blood cell cancer) that has come back or spread after autologous hematopoietic stem cell transplantation (HSCT) and used brentuximab vedotin after stem cell transplant, or after you received at least 3 kinds of treatment including autologous HSCT. nivolumab is also used to treat squamous cell cancer of the head and neck that has come back or spread throughout the body after receiving medicines containing platinum. It is also used to treat patients with urothelial cancer (bladder cancer) that has spread or grown and have tried cancer medicines containing platinum but did not work well.

Nivolumab is a monoclonal antibody that affects the immune system and helps control the growth of cancer cells.

nivolumab is to be given only by or under the supervision of your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nivolumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nivolumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nivolumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nivolumab injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of nivolumab. Make sure you tell your doctor if you have any other medical problems, especially:

• Crohn disease or
• Immune system problems or
• Kidney disease or
• Liver disease or
• Lung or breathing problems or
• Stomach or bowel problems or
• Systemic lupus erythematosus (lupus, SLE) or
• Thyroid problems or
• Ulcerative colitis—Use with caution. May make these conditions worse.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Back pain
• blistering, peeling, or loosening of the skin
• chest tightness
• chills
• constipation
• cough
• depressed mood
• diarrhea
• dry skin and hair
• feeling cold
• fever
• flushing
• hair loss
• headache
• hoarseness or husky voice
• itching
• joint or muscle pain
• loss of appetite
• muscle cramps and stiffness
• nausea and vomiting
• red, irritated eyes
• slowed heartbeat
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• trouble breathing
• unusual tiredness or weakness
• weight gain

• Chest pain
• dark urine
• general feeling of discomfort or illness
• light-colored stools
• nervousness
• pain
• sensitivity to heat
• stomach cramps
• sweating
• tenderness
• thickening of bronchial secretions
• trouble sleeping
• upper right abdominal or stomach pain
• watery or bloody diarrhea
• weight loss
• yellow eyes and skin

• Bloating
• bloody or cloudy urine
• blurred vision or other change in vision
• darkening of the skin
• dizziness
• drowsiness
• eye pain
• fainting
• fast heartbeat
• fruity breath odor
• increased hunger, thirst, and urination
• indigestion
• mental depression
• pains in the stomach, side, or abdomen, possibly radiating to the back
• redness of the eye
• sensitivity of the eye to light
• skin rash
• swelling of the face, feet, or lower legs
• tearing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Diarrhea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: signs of infection (such as fever, runny/stuffy nose, new/worsening cough), diarrhea with blood/mucus, mouth/throat sores, severe stomach/abdominal pain, symptoms of liver disease (such as persistent nausea/vomiting, loss of appetite, yellowing eyes/skin, dark urine), signs of kidney problems (such as change in the amount of urine, pink/bloody urine), easy bruising/bleeding, swelling hands/ankles/feet, unusual weakness, joint stiffness/pain, muscle weakness/tenderness/pain/spasms/cramps, numbness/tingling of arms/legs, loss of coordination, eye redness/pain, sensitivity to light, vision changes, persistent/unusual headache, seizures.

Nivolumab may cause hormone gland problems (such as thyroid, pituitary, adrenal, pancreas). Your body could make too much or too little hormone. Tell your doctor right away if you have any symptoms such as: cold or heat intolerance, unexplained weight loss/gain, increased thirst/urination, mood or behavior changes (such as decreased sex drive, irritability, forgetfulness), slow/fast/pounding/irregular heartbeat, unusual tiredness, constipation.

Get medical help right away if you have any very serious side effects, including: chest pain, shortness of breath.

Nivolumab can commonly cause itching or a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop any rash or itching.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using nivolumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: organ transplant.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while receiving this medication and for 5 months after treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.