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 Yervoy (Ipilimumab). If you are concerned about side effects, discuss the risks and benefits of Yervoy (Ipilimumab) with your doctor.

The following side effects have been reported by at least 1% of people taking Yervoy (Ipilimumab). 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:

• paralysis
• 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 Yervoy (Ipilimumab).

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

Do not take Yervoy (Ipilimumab) if you:

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

There may be an interaction between Yervoy (Ipilimumab) and any of the following:

• medications that suppress the immune system (e.g., cancer medications, corticosteroids, mycophenolate, Tacrolimus, Cyclosporine)
• Vemurafenib

If you are taking any of these 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.

Medications other than those listed above may interact with Yervoy (Ipilimumab). 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.

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 Yervoy (Ipilimumab).

Autoimmune illnesses: If you have an autoimmune disease, such as Lupus or inflammatory bowel disease, using Yervoy (Ipilimumab) may make the condition worse by stimulating your immune system. Yervoy (Ipilimumab) is not intended for use by people with autoimmune disorders.

Drowsiness/reduced alertness: Yervoy (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 Yervoy (Ipilimumab) affects you.

Immune system reactions: Yervoy (Ipilimumab) can cause inflammation to many parts of the body, including the 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: Yervoy (Ipilimumab) works by stimulating the immune system. If you have had an organ transplant, Yervoy (Ipilimumab) may cause your body to reject the organ. Yervoy (Ipilimumab) is not intended for use by people who are taking immunosuppressants.

Infusion reactions: Yervoy (Ipilimumab) 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: Yervoy (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: Yervoy (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: Yervoy (Ipilimumab) may cause harm to a developing baby if the mother uses Yervoy (Ipilimumab) during pregnancy. Yervoy (Ipilimumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Yervoy (Ipilimumab), contact your doctor immediately.

Women 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 Yervoy (Ipilimumab) passes into breast milk. If you are breast-feeding and are taking Yervoy (Ipilimumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Yervoy (Ipilimumab) have not been established for children.