ipilimumab

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

What is ipilimumab?

Ipilimumab is a cancer medicine that is used alone or in combination with other medicines to treat certain types of cancer such as:

• skin cancer (melanoma);
• non-small cell lung cancer (NSCLC);
• pleural mesothelioma (cancer that affects the lining of the lungs and chest wall);
• squamous cell cancer of the esophagus;
• kidney cancer;
• liver cancer; or
• colorectal cancer that has certain specific DNA mutations.

Ipilimumab 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.

Ipilimumab is given for NSCLC only if your tumor tests positive for "PD-L1" and does not have an abnormal "EGFR" or "ALK" (a specific genetic marker).

Ipilimumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving ipilimumab?

Tell your doctor if you have ever had:

• liver problems;
• an autoimmune disorder (lupus, sarcoidosis, Crohn's disease, ulcerative colitis);
• an organ transplant or stem cell transplant; or
• a nerve-muscle disorder, such as myasthenia gravis, or Guillain-Barre syndrome.

You may need to have a negative pregnancy test before starting this treatment.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ipilimumab on the baby.

How is ipilimumab given?

Ipilimumab is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take 30-90 minutes to complete.

Ipilimumab is usually given once every 3 to 6 weeks. Your other cancer medications may be given more often. Your doctor will determine how long to treat you with all medicines.

You may be given other medications to treat or prevent certain side effects.

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

What happens if I miss a dose?

What happens if I overdose?

Since ipilimumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving ipilimumab?

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

What are the possible side effects of ipilimumab?

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, light-headed, short of breath, itchy, tingly, chilled, or feverish.

• severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;
• fever, swollen glands, body aches;
• new or worsening skin rash, itching, or blistering;
• painful sores in mouth or nose, throat, or genital area;
• chest pain, irregular heartbeats;
• severe muscle weakness, ongoing pain in your muscles or joints;
• numbness or tingling in your hands or feet;
• vision problems, eye pain or redness;
• lung problems --new or worsening cough, chest pain, feeling short of breath;
• kidney problems --little or no urination, swelling in your feet or ankles, blood in your urine;
• liver problems --right-sided upper stomach pain, tiredness, bruising or bleeding, dark urine, yellowing of your skin or eyes;
• signs of a hormonal disorder --frequent or unusual headaches, lack of energy, dizziness, fainting, mood or behavior changes, increased thirst or urination, feeling cold, weight gain, or weight loss; or
• symptoms of brain swelling --confusion, headache, memory problems, hallucinations, neck stiffness, drowsiness, seizure (convulsions).

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

Common side effects may include:

• fever, cough, shortness of breath;
• nausea, vomiting, stomach pain, loss of appetite;
• diarrhea, constipation;
• weight loss;
• hormonal problems;
• rash or itching;
• headache, dizziness, tiredness;
• sleep problems (insomnia); or
• pain in your muscles, joints, or bones.

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 ipilimumab?

Other drugs may affect ipilimumab, 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 ipilimumab.