Ipilimumab (Intravenous)

Overview

Although melanoma can be a very aggressive form of skin cancer, it can usually be treated successfully if it is caught early enough. Whilst melanoma can form in other areas of the body, it generally affects the skin and is characterized by new growths on the skin or changes to existing moles. Areas of skin which change color, itch, bleed, burn, tingle or crust should always be assessed in case melanoma is present.

If melanoma is confirmed, surgery can be used to treat the condition in the vast majority of cases. If the cancer hasn't spread, the affected area of skin can usually be removed and no further treatment may be required. However, if the melanoma has spread to other areas or if surgery is not a viable option, alternative treatments may be used.

Delivered intravenously, Ipilimumab targets the CTLA-4 protein receptor. As this receptor typically has a suppressive impact on the immune system, cytotoxic T lymphocyte (CTL) cells are unable to target and/or destroy cancer cells when the CTLA-4 protein receptor is active. By inhibiting the CTLA-4 protein receptor, Ipilimumab allows the cytotoxic T lymphocyte cells to function more effectively. In doing so, these CTL cells are able to destroy the cancer cells which are present.

As some cancer cells produce an antigen which provokes a limited immune response, patients with these types of tumors may respond best to treatment with Ipilimumab. When an immunosuppressive tumor environment exists, CTL cells are not likely to be effective. By administering Ipilimumab and increasing the immune system's response, CTL cells are able to take effect.

Although Ipilimumab is often used to treat patients who are not candidates for surgery or who have metastatic melanoma, it can also be prescribed to patients who have been treated via surgery. Once the melanoma has been surgically removed, Ipilimumab may be prescribed in order to reduce the likelihood of the cancer returning.

Whilst Ipilimumab is not a successful treatment for all patients, it can be particularly beneficial for patients who are unable to have surgery, who have metastatic melanoma and for patients whose tumor antigens are causing the immune system to be suppressed.

Conditions Treated

Type Of Medicine

  • Monoclonal antibody

Side Effects

When patients are treated with Ipilimumab, they may experience some side-effects. The following adverse effects are most common immediately following treatment and, unless severe, they may not require additional treatment:

However, if the patient develops any of the following side-effects while receiving treatment with Ipilimumab, they should obtain immediate medical attention:

  • Tarry, black or bloody stools
  • Nausea
  • Diarrhea
  • Rash on the skin
  • Fever
  • Itching skin
  • Heartburn
  • Severe stomach cramping, pain or burning
  • Indigestion
  • Unusual weakness or tiredness
  • Stomach or abdominal tenderness
  • Vomiting
  • Bloody or watery diarrhea
  • Vomiting of material that looks like coffee grounds, may be severe and continuing
  • Changes in vision
  • Irritation, blistering, itching, reddening or crusting of the skin
  • Cloudy or bloody urine
  • Itching, dry or burning eyes
  • Decreased appetite
  • Numbness, burning, pain or tingling in the arms, feet, hands or legs
  • Darkening of the skin
  • Chest pain
  • Scaly, dry or cracked skin
  • Mental depression
  • Chills
  • Muscle weakness
  • Clay-colored stools
  • Headache, may be severe
  • Cough
  • Fainting
  • Dark urine
  • Blurred vision
  • Decreased amount or frequency of urine
  • Hives
  • Difficulty with swallowing, chewing, breathing or talking
  • Welts
  • Dizziness
  • Loss of appetite
  • Double vision
  • Sore throat
  • Drooping eyelids
  • Severe tiredness
  • Drowsiness
  • Sensation of 'œpins and needles'
  • Excessive tearing or eye discharge
  • Swollen glands
  • Eye pain or increased sensitivity to light
  • Pain, burning, itching, bleeding, swelling or a lump under the skin where the needle was placed
  • Difficult or painful urination
  • Swelling, pain or redness of the eyelid, eye or inner lining of the eyelid
  • White spots, ulcers or sores in the mouth or on the lips
  • Stabbing pain
  • Yellowing of the skin or eyes
  • Unusual weight gain
  • Swelling of the lower legs, feet or face
  • Unusual bruising or bleeding
  • Anxiety
  • Pale or blue skin
  • Bloating
  • Stiff back or neck
  • Chest pain, may move to the neck, shoulder and/or left arm
  • Welts, blisters or sores on the skin
  • Confusion
  • Skin rash or irritation, including a rash which looks like psoriasis
  • Constipation
  • Pains in the side or stomach, possibly radiating to the back
  • Difficulty with moving
  • Swelling, pain or redness in the joints
  • Fast heartbeat
  • Burning or pain in the throat
  • General feeling of illness or discomfort
  • Muscle stiffness or pain
  • Increased thirst
  • Pain in lower back or side
  • Leg, stomach or back pains
  • Bleeding gums
  • Inability to move the legs and arms
  • Throbbing pain
  • Nosebleeds
  • General body swelling

Additionally, patients should obtain medical advice if they experience any side-effects which are not listed above whilst being treated with this medicine.

Dosage

Like many anti-cancer medications, Ipilimumab is usually given in cycles, with one dose of medication given every three weeks, for a total of four doses. If patients are being treated for metastatic melanoma or melanoma which can't be treated with surgery, they are likely to be given 3mg of Ipilimumab per kilogram of bodyweight every three weeks.

However, if patients have previously had surgery for melanoma which also affected their lymph nodes, they may be given 10mg of Ipilimumab per kilogram of bodyweight every three weeks, for a total of four doses, with subsequent doses being given every twelve weeks for up to three years.

Although this is a standard dosing regime for treatment with Ipilimumab, physicians will determine the appropriate dose based on the patient's unique clinical presentation.

Ipilimumab is administered intravenously and must be given fairly slowly. Usually, each dose of Ipilimumab will take at least ninety minutes to administer. However, patients will not have to calculate or administer their own medication as Ipilimumab will be given by an experienced healthcare practitioner.

As Ipilimumab must be given in accordance with a specific schedule, patients should contact their physician in advance if they think they will be unable to attend their next treatment session.

Potential Drug Interactions

As some drugs can interact with each other, patients should tell their physician if they are taking any other medicines before they are given Ipilimumab. This includes prescription medicines, over-the-counter medicines, vitamins and/or supplements.

In addition to this, patients should obtain medical advice before using any new medicines, supplements or vitamins once they have started treatment with Ipilimumab.

Warnings

If patients have other health conditions, they must notify their physician before their treatment commences. There are certain conditions which can affect the use of Ipilimumab and these may include:

As studies have not been carried on the effects of Ipilimumab on pediatric patients, this medicine is not normally used to treat children or infants.

When patients are being treated with Ipilimumab, they may develop colitis. Patients should obtain medical help straight away if they experience the following symptoms:

  • Stomach tenderness or pain
  • Fever
  • Bloody or watery diarrhea

Ipilimumab may increase the patient's risk of developing a liver problem. Patients should seek immediate medical advice if they develop the following symptoms:

  • Dark urine
  • Nausea
  • Loss of appetite
  • Yellowing of the skin or eyes
  • Pale stools
  • Unusual weakness or tiredness
  • Tenderness or pain in the upper stomach

Patients may experience serious skin reactions whilst they are being treated with Ipilimumab. If patients exhibit the following symptoms, they should obtain medical help:

  • Red skin lesions
  • Loosening, peeling or blistering of the skin
  • Ulcers or sores on the skin
  • Severe acne or rash
  • Chills or fever

Whilst receiving treatment with Ipilimumab, patients could develop a nerve problem which, in some cases, could lead to paralysis. Patients should seek immediate medical attention if they experience the following symptoms:

  • Painful or tingling sensations in the hands, arms, feet or legs
  • Numbness
  • Unusual weakness in the legs or arms

Ipilimumab may increase the patient's risk of experiencing serious thyroid, pituitary or adrenal glands problems. Patients should obtain medical help if they exhibit the following symptoms:

  • Unusual or continuing headaches
  • Lightheadedness
  • Fainting
  • Dizziness
  • Changes in behavior or mood (e.g. becoming forgetful)
  • Increase in weight
  • Unusual sluggishness

Some patients may experience vision problems during their treatment with Ipilimumab. If so, they should notify their doctor. These changes may include difficulty reading and/or blurred vision. Patients may be referred to an ophthalmologist for a comprehensive eye examination.

If Ipilimumab is administered when a patient is pregnant, it may cause harm to the unborn fetus. Patients should use effective birth control during treatment with Ipilimumab and for at least three months afterwards.

If patients become pregnant whilst being treated with Ipilimumab, they should notify their doctor immediately.

It is not known whether Ipilimumab can be transmitted via human breastmilk and, if so, what level of risk it would pose to the infant. Due to this, patients are normally advised to stop breastfeeding during treatment with Ipilimumab and for at least three months afterwards.

Before patients are treated with Ipilimumab, they should tell their physician if they are allergic to any substances or if they have ever exhibited an allergic reaction before. This includes allergies to medicines, foods, preservatives, animals and dyes. In rare cases, patients may exhibit an allergic reaction whilst they are being treated with Ipilimumab and, if so, they will require urgent medical treatment. An allergic reaction may be characterized by the following symptoms:

  • Wheezing
  • Itching
  • Hives
  • Difficulty breathing
  • Hoarseness
  • Difficulty swallowing
  • Shortness of breath
  • Rash on the skin
  • Swelling of the face, lips, throat, mouth, tongue and/or hands

Storage

When storing Ipilimumab, the medication should be kept in accordance with the manufacturer's instructions. Usually unopened vials of Ipilimumab can be kept between temperatures of 2?-8?C (36?-46?F) but should be protected from the light.

Once Ipilimumab has been diluted, it can be kept in a refrigerator or at room temperature for a period of twenty-four hours. After this, diluted Ipilimumab which is unused should be disposed of.

As Ipilimumab is administered intravenously, patients should only be given this medicine in a clinical setting, such as a treatment center or a hospital. As a result, patients should not have to keep or store this medicine at home under any circumstances.

Summary

Providing melanoma is diagnosed quickly enough, surgical treatments can be extremely successful in removing the cancer completely. However, if the cancer has impacted on the patient's lymph nodes, Ipilimumab may be used following the initial surgery as this can help to prevent the cancer from coming back.

Alternatively, if patients have been unable to have surgery or if they have been diagnosed with metastatic melanoma, Ipilimumab may be used as an alternative form of treatment. By enabling cytotoxic T lymphocyte cells to function more effectively, Ipilimumab enables the body to target and destroy cancer cells with greater success. As a result, the melanoma may be prevented from spreading and the existing cancer cells may be removed from the patient's body.

Whilst patients do tend to experience some side-effects during treatment, the benefits of undergoing treatment with Ipilimumab often outweigh the possible risk of side-effects occurring. If treatment is successful, Ipilimumab can ensure that patients are able to recover from melanoma and can also reduce the chance of the cancer returning in the future.