Hyaluronidase and nivolumab

Hyaluronidase and nivolumab is used in adults either alone or with other medicines to prevent or treat certain types of cancers affecting the skin, esophagus, stomach, lung, liver, colon, rectum, bladder, urinary tract, kidney, or head and neck.

Hyaluronidase and nivolumab is often given when the cancer has spread to other parts of the body (metastatic), has returned after previous treatment, cannot be surgically removed, or when other cancer treatments did not work or have stopped working.

Your doctor will ensure you have the correct type of tumor to be treated with hyaluronidase and nivolumab.

Hyaluronidase and nivolumab may also be used for purposes not listed in this medication guide.

Hyaluronidase and nivolumab helps your immune system attack tumor cells, but it can also target healthy organs and tissues in your body, leading to serious or life-threatening side effects. Some side effects may require treatment with other medicines, and your cancer treatments could be postponed.

Call your doctor immediately if you experience: a cough, shortness of breath, chest pain, changes in vision, muscle pain or weakness, stomach pain, diarrhea, blood in your stools, urinating less, dark urine, yellowing of your skin or eyes, frequent headaches, dizziness, confusion, increased thirst or urination, skin issues, numbness or tingling, feeling cold, or weight gain or loss.

Tell your doctor if you have or have ever had:

• an autoimmune disorder (lupus, Crohn's disease, ulcerative colitis);
• to receive or plan to receive a stem cell transplant that uses donor stem cells;
• to receive an organ or tissue transplant, including corneal transplant;
• radiation to your chest; or
• a nervous system disorder such as myasthenia gravis or Guillain-Barré syndrome.

May harm an unborn baby. You may need a pregnancy test to confirm you are not pregnant. Use effective birth control while using hyaluronidase and nivolumab and for at least 5 months after your last dose. Tell your doctor if you become pregnant.

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

Get emergency medical help if you have signs of an allergic reaction (hives, trouble 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).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Hyaluronidase and nivolumab may cause serious side effects. Call your doctor right away if you have:

• severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;
• confusion, drowsiness, memory problems, neck stiffness, muscle pain, weakness, muscle cramps, balance problems, irregular heartbeat;
• eye pain, numbness or tingling in your arms or legs;
• (if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling;
• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed, cold hands and feet;
• skin problems--rash, peeling, blistering, swollen glands, fever or flu-like symptoms, painful sores in your mouth, nose, throat, or genital area;
• liver problems--loss of appetite, nausea, vomiting, itching, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lung or kidney problems--new or worsening cough, chest pain, swelling, urinating less, feeling tired or short of breath, blood in your urine; or
• signs of a hormonal disorder--frequent or unusual headaches, vision problems, fast heartbeats, dizziness, fainting, mood or behavior changes, hunger, increased thirst or urination, constipation, hair loss, hoarse or deepened voice, sweating, feeling cold, weight gain or loss.

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of hyaluronidase and nivolumab may include:

• muscle, joint, back, or bone pain;
• feeling weak, tired, or short of breath;
• numbness, tingling, or burning pain in your hands or feet;
• diarrhea, stomach pain, nausea, vomiting, constipation, loss of appetite, altered sense of taste;
• skin rash, itchy skin, mouth sores;
• redness, rash, or blisters on the palms of your hands or the soles of your feet;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• increased blood pressure;
• fever, cough, headache;
• low levels of thyroid hormone;
• pain and burning when you urinate; or
• liver problems.

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.

Hyaluronidase and nivolumab is injected under the skin in the stomach or thigh area. You will receive this medicine in a medical setting.

Hyaluronidase and nivolumab is usually given once every 2 to 4 weeks. Your doctor will determine the right treatment schedule for you.

You may be given other medications if you have certain conditions. Follow your doctor's instructions.

You will need frequent blood tests before and during treatment with hyaluronidase and nivolumab. Your treatment may be delayed or permanently discontinued based on the results.

Hyaluronidase and nivolumab can cause side effects in different parts of your body. You may also be given medication to treat certain side effects.

Call your doctor for instructions if you miss an appointment for your Hyaluronidase and nivolumab injection.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor about all other cancer treatments you are receiving.

Tell your doctor about all your other medicines, especially:

• lenalidomide, pomalidomide, or thalidomide; or
• dexamethasone.

This list is not complete. Other drugs may affect hyaluronidase and nivolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.