Nivolumab and hyaluronidase-nvhy Injection

WHY is this medicine prescribed?

Nivolumab and hyaluronidase-nvhy injection is used alone or with other drugs to treat certain types of cancer, including the following:

• melanoma (a type of skin cancer)
• lung cancer (non-small cell lung cancer; NSCLC)
• renal cell cancer (RCC; a type of cancer that begins in the kidneys)
• Hodgkin's lymphoma (Hodgkin's disease)
• head and neck cancer
• urinary tract cancer (urothelial cancer; cancer of the lining of the bladder and other parts of the urinary tract)
• cancer of the colon (large intestine) or rectum
• hepatocellular cancer (HCC; a type of liver cancer)
• esophageal cancer (cancer of the tube that connects your throat to your stomach)
• gastric cancer (cancer of the stomach)
• gastroesophageal junction cancer (cancer located in the area where the stomach meets the esophagus)

Nivolumab is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells. Hyaluronidase is an endoglycosidase. It helps to keep nivolumab in the body longer so that the medication will have a greater effect.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Nivolumab and hyaluronidase-nvhy comes as a solution (liquid) to be injected subcutaneously (just under the skin) by a doctor or nurse. It is injected into the stomach or thigh over 3 to 5 minutes once every 2-4 weeks. The time between your injections and the length of your treatment will depend on your condition and how well your body responds to treatment.

Your doctor may temporarily or permanently stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with nivolumab and hyaluronidase-nvhy injection.

You will be given the Medication Guide when you begin treatment with nivolumab and hyaluronidase-nvhy and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visithttps://www.fda.gov/Drugs/DrugSafety/ucm085729.htmto obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before receiving nivolumab and hyaluronidase-nvhy injection,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) or have ever had an organ transplant, including corneal transplant, or received radiation therapy to your chest. 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 condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); any type of lung disease or breathing problems; or thyroid, kidney or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You may need to take a pregnancy test before you receive nivolumab and hyaluronidase-nvhy injection. You should not become pregnant while you are receiving nivolumab and hyaluronidase-nvhy injection. Use effective birth control to prevent pregnancy during your treatment with nivolumab and hyaluronidase-nvhy injection and for at least 5 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving nivolumab and hyaluronidase-nvhy injection, call your doctor immediately. Nivolumab and hyaluronidase-nvhy injection may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving nivolumab and hyaluronidase-nvhy injection and for 5 months after your final dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive nivolumab and hyaluronidase-nvhy injection, call your doctor as soon as possible..

What SIDE EFFECTS can this medicine cause?

Nivolumab and hyaluronidase-nvhy injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• joint, back, or bone pain
• muscle pain or weakness
• nausea
• vomiting
• mouth sores
• change in sense of taste
• pain, irritation, swelling, redness or itching in the place where the injection was given

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• new or worsening cough, shortness of breath, chest pain
• diarrhea; stomach area pain or tenderness; stools that are black, tarry, sticky, or contain blood
• yellowing of skin or eyes, dark-colored urine, bleeding or bruising more easily than normal, loss of appetite, decreased energy, or pain on right side of stomach area
• tiredness or weakness; feeling cold; deepening of voice or hoarseness; rapid or irregular heartbeat; increased sweating; changes in weight (gain or loss); changes in mood or behavior (decreased sex drive, irritability, or forgetfulness); headaches, including those that are unusual or will not go away; constipation; increased urination; or hair loss
• confusion, sleepiness, memory problems, stiff neck, balance problems, or tingling or numbness of the arms or legs
• decreased urination; blood in urine; swelling of face, arms, legs, feet or ankles; or decreased appetite
• changes in vision, including sensitivity to light, double vision, blurry vision, or eye pain
• blisters or peeling skin; rash; itching;painful sores or ulcers in mouth, nose, throat, or genital area;fever or flu-like symptoms; orswollen glands

Nivolumab and hyaluronidase-nvhy may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.