How does this medication work? What will it do for me?

Ipilimumab belongs to the group of cancer-fighting medications known as antineoplastics. More specifically, it is a monoclonal antibody. It works by stimulating the body's immune system to attack the cancer cells, reducing the size of the tumours.

This medication is used alone or with other medications to treat melanoma, a specific type of skin cancer, that has spread (metastasized) or cannot be removed by surgery. It is also used to treat renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, and certain types of esophageal cancer that have spread (metastasized).

Ipilimumab has been granted a notice of compliance with conditions (NOC/c) by Health Canada. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

The conditions for which ipilimumab has been granted a NOC/c include certain types of colorectal cancer that has spread after being treated. Part of the condition is that it must be given with nivolumab.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each 1 mL of solution for infusion contains 5 mg of ipilimumab. Nonmedicinal ingredients: tris hydrochloride, sodium chloride, mannitol, diethylene triamine penta acetic acid (DTPA), polysorbate 80, water for injection, and sodium hydroxide or hydrochloric acid to adjust pH.

How should I use this medication?

The recommended dose of ipilimumab for adults is based on weight. Dosing and how often treatments are given varies depending on the type of cancer being treated and whether ipilimumab is being used in combination with other medications.

This medication is given by intravenous (into a vein) infusion. It is usually injected through a site on your skin specially prepared for this purpose.

Very careful handling of this medication is required. Ipilimumab should only be given by health care professionals familiar with the use of chemotherapy medications used to treat cancer. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive ipilimumab, contact your doctor as soon as possible to reschedule your appointment.

This medication will be stored at the hospital or clinic in the refrigerator and protected from light.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to ipilimumab or any ingredients of the medication
  • have a life-threatening autoimmune disease
  • have had an organ transplant

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • fatigue
  • feeling tired or weak
  • hair loss
  • itching
  • loss of appetite
  • nausea
  • skin discolouration
  • skin rash
  • stomach pain
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • behavior changes (irritability, forgetfulness)
  • decreased interest in sexual activity
  • difficulty hearing
  • dizziness
  • eye pain or redness
  • fainting
  • headaches
  • neck stiffness
  • numbness or tingling in the hands or feet
  • ringing in the ears
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
  • symptoms of intestinal inflammation (e.g., diarrhea, blood in stools, stomach pain or tenderness)
  • symptoms of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • symptoms of skin inflammation (e.g., skin rash, mouth blisters, peeling skin)
  • unusual tiredness or sleepiness
  • weakness in the arms, legs, or face
  • vision changes (blurred or double vision)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • signs of an infusion reaction (e.g., flushing, chest pain, difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Autoimmune illnesses: If you have an autoimmune disease, such as lupus or inflammatory bowel disease, using ipilimumab may make the condition worse by stimulating your immune system. This medication is not intended for use by people with autoimmune disorders.

Drowsiness/reduced alertness: Ipilimumab may cause tiredness or fatigue, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.

Immune system reactions: Ipilimumab can cause inflammation to many parts of the body, including the brain, stomach, liver, skin, nerves, hormone glands (e.g. pituitary, adrenal, thyroid), and eyes. This may occur during treatment and up to several months after your last infusion. It is important that you contact your doctor as soon as possible about any concerning side effects.

Immunosuppressant medications: Ipilimumab works by stimulating the immune system. If you have had an organ transplant, ipilimumab may cause your body to reject the organ. This medication is not intended for use by people who are taking immunosuppressants.

Infusion reactions: This medication can cause a hypersensitivity or infusion reaction. Symptoms of this type of reaction generally appear during the infusion of the medication and may include flushing, chest pain, shortness of breath, and a dramatic drop in blood pressure. These reactions can cause death if a health care provider is not informed immediately. If you experience any of these symptoms, or notice them happening to someone, let your nurse or doctor know immediately.

Liver function: Ipilimumab may cause liver damage or reduced liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Medication-related diarrhea: Ipilimumab can cause inflammation to many parts of the body, including the digestive system. This condition, known as enterocolitis, can become life threatening if it is not treated quickly. If you experience diarrhea with mucus or blood in the stool, contact your doctor as soon as possible.

Pregnancy: Ipilimumab may cause harm to a developing baby if it is used during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

People who may become pregnant should use effective birth control during treatment and for 3 months after the last dose.

Breast-feeding: It is not known if this medication passes into breast milk. If you are breast-feeding and are taking ipilimumab, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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