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Ipilimumab

Brand Name and Other Names: Ipilimumab is used to treat malignant melanoma, renal cell carcinoma, and metastatic colorectal cancer.

Generic Name: Ipilimumab

Drug Class: Antineoplastics, Monoclonal Antibody

What Is Ipilimumab Used For and How Does it Work?

Ipilimumab is used to treat malignant melanoma, renal cell carcinoma, and metastatic colorectal cancer.

Ipilimumab is available under the following different brand names: Yervoy.

What Are the Dosages of Ipilimumab?

Dosages of Ipilimumab:

Injectable Solution, Single-Dose, Adult and Pediatric

  • 5 mg/mL (10mL, 40mL)

Dosage Considerations – Should be Given as Follows:

Malignant Melanoma

Unresectable or metastatic melanoma

  • Indicated for the treatment of unresectable or metastatic melanoma in adults and children aged 12 years or older
  • 3 mg/kg intravenously (IV) every 3 weeks for a maximum of 4 doses
  • Infuse IV over 90 minutes
  • In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose

Adjuvant treatment

  • Indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes greater than 1 mm who have undergone complete resection, including total lymphadenectomy
  • 10 mg/kg IV every 3 weeks for 4 doses followed by 10 mg/kg q12Week for up to 3 years
  • Infuse IV over 90 minutes
  • In the event of toxicity, doses are omitted, not delayed

Children under 12 years: Safety and efficacy not established

Renal Cell Carcinoma

  • Indicated in combination with nivolumab for patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma
  • 1 mg/kg IV infused over 30 min immediately following nivolumab on the same day; repeat every 3 weeks for up to 4 doses or until intolerable toxicity or disease progression

Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer

  • Indicated in combination with nivolumab is indicated for adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) which progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan
  • Adults and children 12 years and older: 1 mg/kg IV infused over 30 minutes immediately following nivolumab on the same day; repeat every 3 weeks for up to 4 doses or until intolerable toxicity or disease progression

Dosage Modifications

Renal impairment: No dose adjustment is required

Hepatic impairment

  • Mild (TB greater than 1 to 1.5 x ULN or AST greater than ULN): No dose adjustment is required
  • Moderate-to-severe (TB greater than 1.5 x ULN and any AST): Not studied; caution advised

Withhold dosing

  • When administered with nivolumab, if ipilimumab is withheld, nivolumab should also be withheld
  • Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions
  • Symptomatic endocrine adverse effects and all another grade 2 adverse effects
  • Resume dosing in patients with complete or partial resolution of adverse reactions (grade 0 to 1) and who are receiving less than 7.5 mg prednisone or equivalent per day

Permanently discontinue

  • Severe or life-threatening infusion reactions
  • Endocrine
    • Symptomatic reactions lasting 6 weeks or more
    • Inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day
  • Ophthalmologic
    • Grade 2 through 4 reactions that do not improve to grade 1 within 2 weeks while receiving topical therapy
    • Grade 2 through 4 reactions requiring systemic treatment
  • All other
    • Grade 2 reactions lasting 6 weeks or more
    • Inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day
    • Grade 3 or 4 reactions

What Are Side Effects Associated with Using Ipilimumab?

Common side effects of ipilimumab include:

Rare side effects of ipilimumab include:

Postmarketing side effects of ipilimumab reported include:

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What Other Drugs Interact with Ipilimumab?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Mild interaction of blessed thistle include:

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

What Are Warnings and Precautions for Ipilimumab?

Warnings

  • This medication contains ipilimumab. Do not take Yervoy if you are allergic to ipilimumab or any ingredients contained in this drug.

Black Box Warnings

Immune-mediated adverse reactions

  • Severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation may involve any organ system
  • The most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy
  • Other immune-mediated adverse reactions include ocular manifestations include autoimmune central neuropathy (encephalitis), neurosensory hyperacusis, myositis, polymyositis, ocular myositis, and sarcoidosis
  • These reactions typically manifest during treatment but may occur weeks to months after discontinuation
  • If severe immune-mediated reactions occur, permanently discontinue and initiate systemic high-dose corticosteroid therapy
  • Assess signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries, including liver function

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

  • No known contraindications

Effects of Drug Abuse

  • No information is available

Short-Term Effects

  • See "What Are Side Effects Associated with Using Ipilimumab?"

Long-Term Effects

  • See "What Are Side Effects Associated with Using Ipilimumab?"

Cautions

  • May cause immune-mediated adverse reactions including enterocolitis, hepatitis, dermatitis, neuropathies, endocrinopathies, ocular, and other significant or severe immune-mediated manifestations; may require initiation of systemic corticosteroids at a dose of 1 to 2 mg/kg/day of prednisone or equivalent
  • Fatal or serious graft-versus-host disease (GVHD) can occur in patients who receive a CTLA-4 receptor blocking antibody either before or after allogeneic hematopoietic stem cell transplantation (HSCT); follow patients closely for evidence of GVHD and intervene promptly; consider benefit versus risks of treatment with a CTLA-4 receptor blocking antibody after allogeneic HSCT
  • Withhold dose for moderate immune-mediated adverse reactions until return to baseline, improvement to mild severity, or complete resolution, and the patient is receiving less than 7.5 mg/day prednisone or equivalent
  • Cytomegalovirus (CMV) infection/reactivation reported in patients with corticosteroid-refractory immune-mediated colitis; in cases of corticosteroid-refractory colitis, consider repeating an infectious workup to exclude alternative etiologies; consider adding anti-TNF or other immunosuppressant agents for the management of immune-mediated enterocolitis unresponsive to systemic corticosteroids within 3 to 5 days or recurring after symptom improvement, if other causes are excluded
  • Administer systemic high-dose corticosteroids for severe, persistent, or recurring immune-mediated reactions
  • Evaluate liver function tests before each dose; permanently discontinue Grade 3-4 hepatotoxicity
  • Monitor thyroid function tests and clinical chemistries before each dose
  • Evaluate at each visit for signs and symptoms of endocrinopathy and institute hormone replacement therapy as needed
  • Binding antibodies against ipilimumab may develop
  • Based on its mechanism of action and data from animal studies, can cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ipilimumab
  • Severe infusion reactions may occur when ipilimumab is used in combination with nivolumab; discontinue severe or life-threatening reactions; interrupt or slow infusion rate with mild or moderate reactions

Ocular toxicity

  • Monitor patients for signs or symptoms of ocular toxicity, which may include blurred vision and reduced visual acuity
  • Immune-mediated ocular toxicity may be associated with retinal detachment or permanent vision loss
  • Administer corticosteroid eye drops to patients who develop uveitis, iritis, or episcleritis
  • Permanently discontinue therapy for an immune-mediated ocular disease that is unresponsive to local immunosuppressive therapy
  • If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt Koyanagi-Harada-like syndrome, which has been observed in patients receiving drugs and may require treatment with systemic steroids to reduce the risk of permanent vision loss

Pregnancy and Lactation

  • Based on data from animal studies and its mechanism of action, ipilimumab can cause fetal harm when administered to a pregnant woman. Females of reproductive potential are advised to use effective contraception during treatment with ipilimumab and for 3 months after the last dose.
  • A Pregnancy Safety Surveillance Study has been established to collect information about pregnancies in women who have received ipilimumab therapy. Healthcare providers are encouraged to enroll patients or have their patients enroll directly by calling 1-844-593-7869.
  • It is unknown whether ipilimumab is distributed in human breast milk. Women are advised to discontinue nursing during treatment with ipilimumab and for 3 months after the final dose. There are no data to assess the effects on milk production.