Ipilimumab

What is Ipilimumab?

Ipilimumab (Yervoy) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody used to treat:

• Colorectal cancer
• Hepatocellular carcinoma
• Malignant pleural mesothelioma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Esophageal Cancer

Ipilimumab 5TRU

What are the uses of this medicine?

Ipilimumab (Yervoy) is a prescription medicine used:

• to treat a kind of skin cancer called melanoma.
• Yervoy may be used alone in adults and children 12 years of age and older or in combination with nivolumab in adults when melanoma has spread or cannot be removed by surgery.
• Yervoy may be used alone 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 instability-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.

in people with liver cancer (hepatocellular carcinoma).

• Yervoy may be used in combination with nivolumab if you have previously received treatment with sorafenib.

in adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Yervoy may be used in combination with nivolumab as your first treatment for NSCLC:

• when your lung cancer has spread to other parts of your body (metastatic), and
• your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.

Yervoy may be used in combination with nivolumab and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine, as the first treatment of your NSCLC when your lung cancer:

• has spread or grown, or comes back, and
• your tumor does not have an abnormal EGFR or ALK gene.

• in adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma.
• Yervoy may be used in combination with nivolumab as your first treatment for malignant pleural mesothelioma that cannot be removed by surgery.

in people with cancer of the tube that connects your throat to your stomach (esophageal cancer).

• Yervoy may be used in combination with nivolumab when your esophageal cancer:
• is a type called squamous cell carcinoma, and
• cannot be removed with surgery

How does this medicine work?

• Ipilimumab (ip” i lim’ ue mab) is a human recombinant monoclonal immunoglobulin G1 antibody to the cytotoxic T lymphocyte antigen-4 (CTLA-4) which is used in cancer immunotherapy.
• The CTLA-4 antigen is an important check-point molecule that modulates and down regulates T cell responses.
• Inhibition of CTLA on the surface of activated T cells prevents its binding to the costimulatory factor B7, which allows for a continued activation and proliferation of T cells.
• The subsequent enhancement of cytotoxic reactivity may play a beneficial role in cancer immunotherapy and can break immunological tolerance.
• In several large multicenter studies, ipilimumab therapy resulted in a prolongation of survival in patients with advanced, metastatic or unresectable malignant melanoma, and a proportion of patients had a long term remission.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take.

Is this medicine FDA approved?

• Ifosfamide was approved for use in the United States in 1988 and its major indication is for germ cell testicular cancer, but it is also used in combination with other agents in the treatment of breast, lung, bladder, cervical, and ovarian cancer, Hodgkin's and non-Hodgkin’s lymphoma, and soft tissue and osteogenic sarcomas.
• Ifosfamide is given intravenously and is available in liquid formulations (1 and 3 gram vials), generically and under the trade name Ifex.

How should this medicine be used?

Recommended dosage: Unresectable or Metastatic Melanoma:

• Yervoy 3 mg/kg every 3 weeks for a maximum of 4 doses.
• Yervoy 3 mg/kg immediately following nivolumab 1 mg/kg on the same day, every 3 weeks for 4 doses.
• After completing 4 doses of the combination, administer nivolumab as a single agent as recommended.

Adjuvant Treatment of Melanoma:

• Yervoy 10 mg/kg every 3 weeks for 4 doses, followed by 10 mg/kg every 12 weeks for up to 3 years.

Advanced Renal Cell Carcinoma:

• Yervoy 1 mg/kg immediately following nivolumab 3 mg/kg on the same day, every 3 weeks for 4 doses.
• After completing 4 doses of the combination, administer nivolumab as a single agent as recommended.

Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer:

• Yervoy 1 mg/kg intravenously over 30 minutes immediately following nivolumab 3 mg/kg intravenously over 30 minutes on the same day, every 3 weeks for 4 doses.
• After completing 4 doses of the combination, administer nivolumab as a single agent as recommended.

Hepatocellular Carcinoma:

• Yervoy 3 mg/kg intravenously over 30 minutes immediately following nivolumab 1 mg/kg intravenously over 30 minutes on the same day, every 3 weeks for 4 doses.
• After completing 4 doses of the combination, administer nivolumab as a single agent as recommended.

Metastatic non-small cell lung cancer:

• Yervoy 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks.
• Yervoy 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks and 2 cycles of platinum-doublet chemotherapy.

Malignant pleural mesothelioma:

• Yervoy 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks.

Esophageal squamous cell carcinoma:

• Yervoy 1 mg/kg every 6 weeks with nivolumab 3 mg/kg every 2 weeks or 360 mg every 3 weeks.

Administration:

• Your healthcare provider will give you Yervoy into your vein through an intravenous (IV) line.
• Yervoy is usually given over 30 minutes.
• If you are receiving Yervoy as treatment for melanoma that has been removed by surgery to help prevent it from coming back, Yervoy will be given over 90 minutes.
• In combination with nivolumab, Yervoy is usually given every 3 weeks for 4 doses. After that, nivolumab alone is usually given every 2 or 4 weeks.
• For NSCLC that has spread to other parts of your body, Yervoy is given every 6 weeks and nivolumab is given every 3 weeks for up to 2 years. Your healthcare provider will determine if you will also need to receive chemotherapy every 3 weeks for 2 cycles.
• For malignant pleural mesothelioma that cannot be removed by surgery, Yervoy is given every 6 weeks and nivolumab is given every 3 weeks for up to 2 years.
• When Yervoy is used in combination with nivolumab for esophageal squamous cell carcinoma (ESCC), Yervoy is given every 6 weeks and nivolumab is given every 2 or 3 weeks for up to 2 years.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 50 mg/10 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• Yervoy

What side effects can this medication cause?

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
• diarrhea
• rash
• itching
• nausea
• pain in muscles, bones, and joints
• fever
• cough
• decreased appetite
• vomiting
• stomach-area (abdominal) pain
• shortness of breath
• upper respiratory tract infection
• headache
• low thyroid hormone levels (hypothyroidism)
• constipation
• decreased weight
• dizziness

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

• feeling tired
• pain in muscles, bones, and joints
• nausea
• diarrhea
• rash
• decreased appetite
• constipation
• itching

Yervoy can cause serious side effects, including:

• Intestinal problems
• Liver problems
• Skin problems
• Hormone gland problems
• Lung problems
• Kidney problems
• Eye problems
• Severe infusion-related reactions
• graft-versus-host disease (GVHD)

What special precautions should I follow?

• Yervoy is a fully human monoclonal antibody that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, thereby removing inhibition of the immune response with the potential for induction of immune-mediated adverse reactions. In general, withhold Yervoy for severe (grade 3) and permanently discontinue for life-threatening (grade 4) immune-mediated adverse reactions.
• Severe infusion-related reactions can occur with Yervoy. Discontinue for severe and life-threatening infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions.
• Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with Yervoy. Follow patients closely for evidence of GVHD and intervene promptly. Consider the benefit versus risks of treatment with Yervoy after allogeneic HSCT.
• Based on its mechanism of action and findings from animal studies, Yervoy can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Yervoy and for 3 months after the last dose.
• Ipilimumab has major side effects, many of which can be serious and life threatening including acute liver injury.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings from animal studies, Yervoy can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: ipilimumab

• Inactive ingredients: diethylene triamine pentaacetic acid (DTPA), mannitol, polysorbate 80 (vegetable origin), sodium chloride, tris hydrochloride, and Water for Injection

Who manufactures and distributes this medicine?

Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ USA

What should I know about storage and disposal of this medication?

• Store Yervoy under refrigeration at 2°C to 8°C (36°F to 46°F).
• Protect Yervoy from light by storing in the original carton until time of use.
• Do not freeze or shake.

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• Dailymed label info on Ipilimumab
• FDA Ipilimumab