Ipilimumab (Yervoy): Chemotherapy Drug, Dosage, Side Effects

What is ipilimumab (Yervoy), and how is it used?

Yervoy is a prescription medicine used:

• to treat a kind of skin cancer called melanoma. Yervoy may be used:
  • in adults and children 12 years of age and older when melanoma has spread or cannot be removed by surgery
  • to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery
• in people with kidney cancer (renal cell carcinoma). Yervoy may be used in combination with nivolumab in certain people when their cancer has spread.
• in adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer). Yervoy in combination with nivolumab may be used when your colon or rectal cancer:
  • has spread to other parts of the body (metastatic).
  • is microsatellite stability-high (MSI-H) or mismatch repair deficient (dMMR), and
  • You have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.

It is not known if Yervoy is safe and effective in children younger than 12 years of age.

What are the side effects of ipilimumab (Yervoy)?

Yervoy can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with Yervoy or after you have completed treatment. Some of these problems may happen more often when Yervoy is used in combination with nivolumab. Call your healthcare provider right away if you develop any of these signs or symptoms or they get worse. Do not try to treat symptoms yourself.

Intestinal problems (colitis) that can cause tears or holes (perforation) in the intestines

Signs and symptoms of colitis may include:

• diarrhea (loose stools) or more bowel movements than usual
• mucus or blood in your stools
• dark, tarry, sticky stools
• stomach pain (abdominal pain) or tenderness
• you may or may not have fever

Liver problems (hepatitis) that can lead to liver failure

Signs and symptoms of hepatitis may include:

• yellowing of your skin or the whites of your eyes
• dark urine (tea colored)
• nausea or vomiting
• pain on the right side of your stomach
• bleeding or bruise more easily than normal
• decreased energy

Skin problems that can lead to severe skin reaction

Signs and symptoms of severe skin reactions may include:

• skin rash with or without itching
• sores in your mouth
• your skin blisters or peels

Nerve problems that can lead to paralysis

Symptoms of nerve problems may include:

• unusual weakness of legs, arms, or face
• numbness or tingling in hands or feet

Hormone gland problems (especially the pituitary, adrenal, and thyroid glands)

Signs and symptoms that your glands are not working properly may include:

• persistent or unusual headaches
• unusual sluggishness
• feeling cold all the time
• weight gain
• changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness
• dizziness or fainting Lung problems (pneumonitis).

Symptoms of pneumonitis may include:

• new or worsening cough
• chest pain
• shortness of breath Kidney problems, including nephritis and kidney failure.

Signs of kidney problems may include:

• decrease in the amount of urine
• blood in your urine
• swelling in your ankles
• loss of appetite Inflammation of the brain (encephalitis).

Signs and symptoms of encephalitis may include:

• headache
• fever
• tiredness or weakness
• confusion
• memory problems
• sleepiness
• seeing or hearing things that are not really there (hallucinations)
• seizures
• stiff neck

Eye problems

Symptoms may include:

• blurry vision, double vision, or other vision problems
• eye pain or redness

Severe infusion reactions

Tell your doctor or nurse right away if you get these symptoms during an infusion of Yervoy:

• chills or shaking
• itching or rash
• flushing
• difficulty breathing
• dizziness
• fever
• feeling like passing out

Common side effects

The most common side effects of Yervoy when used alone include:

• feeling tired
• diarrhea
• nausea
• itching
• rash
• vomiting
• headache
• weight loss
• fever
• decreased appetite
• difficulty falling or staying asleep

The most common side effects of Yervoy when used in combination with nivolumab include:

• feeling tired
• rash
• diarrhea
• nausea
• fever
• pain in muscles, bones, and joints
• itching
• abdominal pain
• vomiting
• cough
• decreased appetite
• shortness of breath

These are not all of the possible side effects of Yervoy. Call your doctor for medical advice about side effects.

What is the dosage of ipilimumab (Yervoy)?

Yervoy alone is given to you into your vein through an intravenous (IV) line over 90 minutes.

• When Yervoy is used in combination with nivolumab, nivolumab is given to you into your vein through an IV line over 30 minutes. Then Yervoy is also given through an IV over 30 minutes on the same day.
• Yervoy in combination with nivolumab is usually given every 3 weeks for 4 doses. After that, nivolumab alone is usually given every 2 or 4 weeks.
• Your healthcare provider will decide how many treatments you will need.
• Your healthcare provider will do blood tests before starting and during treatment with Yervoy.
• It is important for you to keep all appointments with your healthcare provider. Call your healthcare provider if you miss an appointment. There may be special instructions for you.

Unresectable or metastatic melanoma:

Yervoy 3 mg/kg administered intravenously over 90 minutes every 3 weeks for a total of 4 doses.

Adjuvant melanoma:

Yervoy 10 mg/kg administered intravenously over 90 minutes every 3 weeks for 4 doses, followed by 10 mg/kg every 12 weeks for up to 3 years or until documented disease recurrence or unacceptable toxicity.

Advanced renal cell carcinoma:

Nivolumab 3 mg/kg administered intravenously over 30 minutes followed by Yervoy 1 mg/kg administered intravenously over 30 minutes on the same day, every 3 weeks for 4 doses, then nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks, administered intravenously over 30 minutes.

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What drugs interact with ipilimumab (Yervoy)?

No formal pharmacokinetic drug interaction studies have been conducted with Yervoy.

Is ipilimumab (Yervoy) safe to use while pregnant or breastfeeding?

Can cause fetal harm. Females who are able to become pregnant should use effective birth control during treatment with Yervoy and for 3 months after the last dose of Yervoy.

Do not breastfeed during treatment with Yervoy and for 3 months after the last dose of Yervoy.