ipilimumab 50 mg/10 mL (5 mg/mL) intravenous solution

Generic name:
Ipilimumab - injection

Pronunciation
(IP-i-LIM-ue-mab)

Brand name(s)
Yervoy

Ipilimumab is used to treat various cancers. Ipilimumab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. However, it can have serious side effects in other parts of your body (see also Side Effects section).

Read the Medication Guide and Patient Wallet Card provided by your pharmacist before you start using ipilimumab and before each treatment with this medication. If you have any questions, ask your doctor or pharmacist. Carry the Patient Wallet Card with you at all times. Show the card to all of your health care providers to let them know that you are being treated with ipilimumab.

This medication is given by injection into a vein as directed by your doctor, usually by slow injection over 30 or 90 minutes. The injection is given by a health care professional. The dosage and treatment schedule are based on your medical condition, weight, and response to treatment.

To decrease the risk of side effects, your doctor may prescribe other medications to take along with this medication. Carefully follow your doctor's directions for all your medications.

Infusion reactions may happen during the infusion of this drug. Tell your doctor right away if you have symptoms of infusion reaction such as shortness of breath, feeling faint, dizziness, or fever.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also How To Use section.

Tiredness, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

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

This medication can cause serious (sometimes fatal) side effects in many parts of the body. These effects can occur during treatment with ipilimumab, but can also occur months after the last dose of this medication. Get medical help right away if you have any very serious side effects, including:

• headache that doesn't go away
• signs of intestinal problems (such as diarrhea, mucus or blood in your stool, stomach pain)
• signs of liver disease (such as yellowing of skin/eyes, dark urine)
• unusual bleeding/bruising
• unusual weakness
• mouth sores
• numbness/tingling in hands/feet
• signs of thyroid problems (such as feeling cold all the time, heat intolerance, weight gain/loss, fast/pounding/irregular heartbeat)
• mental /mood changes
• change in sex drive
• signs of kidney problems (such as change in the amount of urine)
• increased thirst/urination
• dizziness
• fainting
• eye pain/redness
• vision changes (such as blurred vision, double vision, decreased vision, blindness)
• signs of lung problems (such as chest pain, shortness of breath, new/worsening cough)
• seizure
• muscle pain
• hearing loss
• night sweats

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:

• fever
• swollen lymph nodes
• 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 ipilimumab, 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
• stem cell transplant with donor cells
• immune system disorders (such as Guillain-Barre syndrome, lupus, sarcoidosis, Crohn's disease, ulcerative colitis)

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

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ipilimumab. Ipilimumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 3 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 3 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug include:

• vemurafenib

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as liver/thyroid/kidney function, ACTH blood levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.