Ipilimumab – Uses and Dose

What is ipilimumab?

Ipilimumab is a medicine that is used to treat specific cancers. It will be prescribed to you by your healthcare professional if you have a type of cancer that has been shown to respond well to this medicine.

Ipilimumab was first approved by the FDA in 2011 for late-stage melanoma (a type of skin cancer) and since then has been approved for other cancers.

Ipilimumab will be given to you as an infusion in your arm, every 3 to 12 weeks depending on your treatment plan. Depending on your type of cancer, ipilimumab may be used alone or in combination with other cancer medicines.

Properties and Characteristics of Ipilimumab

Drug class	Antineoplastics, Monoclonal Antibody
Brand Names	Yervoy
Synonyms	Ipilimumab
Molecular Formula	C₆₅₇₂H₁₀₁₂₆N₁₇₃₄O₂₀₈₀S₄₀
Molecular Weight	148000.0 Da
IUPAC Names	Anticuerpo monoclonal humano en contra de la CTLA-4
Structural formula of main component
Pure active ingredient	Ipilimumab
Appearance	Clear to slightly opalescent, colourless to pale yellow liquid
Melting Point	80-90 ºC
Solubility	water solubility 50 mg/ml
Excretion	Data regarding the route of elimination of ipilimumab is not readily available
Available as	Injectable solution, Liquid
Storage	Store the diluted solution for no more than 24 hours under refrigeration (2°C to 8°C, 36°F to 46°F) or at room temperature (20°C to 25°C, 68°F to 77°F)
Prescription	Doctor prescription is required

What is Ipilimumab (Yervoy) used for?

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.

Side effects

What are the most common side effects?

Cough
Constipation
Diarrhea
Fever
Headache, dizziness, tiredness
Hormonal problems
Nausea, vomiting, stomach pain, loss of appetite
Pain in your muscles, joints, or bones
Rash or itching
Shortness of breath
Sleep problems (insomnia)
Weight loss

What are bad (serious) side effects of ipilimumab?

Your doctor may delay or stop treatment if you have certain side effects. You should get emergency medical help if you have signs of an:

allergic reaction with symptoms such as hives, difficult breathing, swelling in your face or throat

Severe skin reaction that has a red or purple skin rash with blistering and peeling, along with fever, sore throat, burning eyes.

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

During treatment with ipilimumab or months after stopping you can have serious and sometimes fatal reactions.
It is important that you call your doctor right away if you have symptom like:
chest pain, irregular heartbeats;

Severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools
Fever, swollen glands, body aches
New or worsening skin rash, itching, or blistering
Severe muscle weakness, ongoing pain in your muscles or joints
Vision problems, eye pain or redness
Numbness or tingling in your hands or feet
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
Lung problems – new or worsening cough, chest pain, feeling short of breath
Symptoms of brain swelling – confusion, headache, memory problems, hallucinations, neck stiffness, drowsiness, seizure (convulsions)
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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Mechanism of action

Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is an inhibitory molecule that competes with the stimulatory CD28 for binding to B7 on antigen presenting cells.3 CTLA-4 and CD28 are both presented on the surface of T-cells. Ipilimumab is a human IgG1 that binds CTLA-4, preventing the inhibition of T-cell mediated immune responses to tumors.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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.

Overdose

Data regarding ipilumumab overdose is not readily available.5 However, the most common adverse reactions to ipilumumab are fatigue, diarrhea, pruritus, rash, and colitis.

What special precautions should I follow?

Before receiving ipilimumab injection,

Tell your doctor and pharmacist if you are allergic to ipilimumab injection, any other medications, or any of the ingredients in ipilimumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
Tell your doctor if you have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) or have ever had an organ transplant. Also, tell your doctor if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn’s disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), lupus (a condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); thyroid problems; or liver disease.
Tell your doctor if you are pregnant or plan to become pregnant. You will need to take a pregnancy test before you receive ipilimumab. You should use effective birth control to prevent pregnancy during your treatment with ipilimumab injection and for 3 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving ipilimumab injection, call your doctor immediately. Ipilimumab injection may harm the fetus.
Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving ipilimumab injection and for 3 months after your final dose.

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