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This site is intended for U.S. Healthcare Professionals only.

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ADJUVANT THERAPY
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Bristol-Myers Squibb remains committed to helping you and your patient throughout treatment with YERVOY® (ipilimumab).

Bristol-Myers Squibb remains committed to helping you and your patient throughout treatment with YERVOY® (ipilimumab).

Call 1-855-YERVOY-1 (1-855-937-8691)
Call 1-855-YERVOY-1
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FOR LIVE SUPPORT AND ASSISTANCE
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Additional Bristol-Myers Squibb Resources

Medical Inquiries
and Reporting

Visit BMSmedinfo.com or
Call 1-800-721-5072

Report side effects to the FDA
at 1-800-332-1088

 

Helpful Materials for Your Practice

Below please find quick YERVOY reference materials to keep at your office.

Formulary Tool Kit

The Formulary Tool Kit is provided to help pharmacists, P&T (Pharmacy and Therapeutics) committee members, and formulary decision-makers learn more about YERVOY.

Ordering Guide for YERVOY

Your guide to starting adjuvant treatment for fully resected Stage III melanoma (lymph node >1 mm) with YERVOY, including dosing and administration, and dose modifications.

 
 

Patient Management Resources for Healthcare Professionals

Immune-mediated Adverse Reactions Management Guide

More detailed guidance on the signs, symptoms, and recommended management of immune-mediated adverse reactions.

 

Patient Monitoring Checklist

A tool to help nurses identify signs and symptoms of immune-mediated adverse reactions.

 

Patient Wallet Card

A quick patient reference for recognizing and reporting symptoms of immune-mediated adverse reactions.

 
 
 

Connect With Other Helpful Professional Resources

The following websites offer additional tools and cancer information for healthcare professionals:

National Comprehensive Cancer Network (NCCN) >

National Cancer Institute (NCI) >

The above list of organizations/links is provided for information purposes only.
Bristol-Myers Squibb neither is affiliated with nor endorses these organizations.

 

How to order YERVOY

Dosing for YERVOY is weight based; therefore, the dose of YERVOY will vary by patient. For example, a patient weighing 60 kg (132 lb) would require a total dose of 600 mg of YERVOY, or three 200-mg vials, whereas a person weighing 85 kg (187 lb) would require a total dose of 850 mg of YERVOY, or one 50-mg vial and four 200-mg vials.

Determining your order for YERVOY 
Determining your order for YERVOY 
 

How it’s supplied

YERVOY is supplied as 50-mg or 200-mg single-use vials, each containing 10 mL or 40 mL, respectively,
of a 5-mg/mL sterile solution.

How to store YERVOY 
Determining your order for YERVOY 

For oncology/office-based settings:

For hospital/infusion centers:

Use these contacts as the ordering distributor in any hospital setting or location including infusion centers.

  • ASD Healthcare
    1-800-746-6273
    Monday-Thursday, 7:30 AM-6:30 PM CT
    Friday, 7 AM-6 PM CT
    (24-hour emergency on call)
    Fax Orders: 1-800-547-9413
    https://www.asdhealthcare.com
  • Cardinal Health Specialty Pharmaceutical Distribution
    1-866-677-4844
    Monday-Friday, 7 AM-6 PM CT
    (24-hour emergency on call)
    Fax Orders: 1-888-345-4916
    https://orderexpress.cardinalhealth.com
  • McKesson Plasma & Biologics
    1-877-625-2566
    Monday-Friday 8:00 AM-6:30 PM CT
    Fax Orders: 1-888-752-7626
    https://connect.mckesson.com
 

 

Request to be visited by a YERVOY Specialist

You can request to be visited by a YERVOY Specialist.

Call 1-855-4-YERVOY (1-855-493-7869) to start the process. The initial phone call and any emails that may follow are to schedule a live appointment only. Your YERVOY Specialist will discuss product information and answer your questions in person during the scheduled visit.

NOTE: This is not for reporting adverse events. To report an adverse event or product quality complaint, please call 1-800-721-5072.

YERVOY Resources LibraryResource Library

Helpful Materials for Your Practice

Below please find quick YERVOY reference materials to keep at your office.

Formulary Tool Kit

The Formulary Tool Kit is provided to help pharmacists, P&T (Pharmacy and Therapeutics) committee members, and formulary decision-makers learn more about YERVOY.

Ordering Guide for YERVOY

Your guide to starting adjuvant treatment for fully resected Stage III melanoma (lymph node >1 mm) with YERVOY, including dosing and administration, and dose modifications.

 
 

Patient Management Resources for Healthcare Professionals

 

Patient Monitoring Checklist

A tool to help nurses identify signs and symptoms of immune-mediated adverse reactions.

 

Patient Wallet Card

A quick patient reference for recognizing and reporting symptoms of immune-mediated adverse reactions.

 

Connect With Other Helpful Professional Resources

The following websites offer additional tools and cancer information for healthcare professionals:

National Comprehensive Cancer
Network (NCCN) >

National Cancer Institute (NCI) >

The above list of organizations/links is provided for information purposes only.
Bristol-Myers Squibb neither is affiliated with nor endorses these organizations.

 

Ordering YERVOYOrdering YERVOY

How to order YERVOY

Dosing for YERVOY is weight based; therefore, the dose of YERVOY will vary by patient. For example, a patient weighing 60 kg (132 lb) would require a total dose of 600 mg of YERVOY, or three 200-mg vials, whereas a person weighing 85 kg (187 lb) would require a total dose of 850 mg of YERVOY, or one 50-mg vial and four 200-mg vials.

Determining your order for YERVOY 
 

How it’s supplied

YERVOY is supplied as 50-mg or 200-mg single-use vials, each containing 10 mL or 40 mL, respectively, of a 5-mg/mL sterile solution

How to store YERVOY

For oncology/office-based settings:

For hospital/infusion centers:

Use these contacts as the ordering distributor in any hospital setting or location including infusion centers.

  • ASD Healthcare
    1-800-746-6273
    Monday-Thursday, 7:30 AM-6:30 PM CT
    Friday, 7 AM-6 PM CT
    (24-hour emergency on call)
    Fax Orders: 1-800-547-9413
    https://www.asdhealthcare.com
  • Cardinal Health Specialty Pharmaceutical Distribution
    1-866-677-4844
    Monday-Friday, 7 AM-6 PM CT
    (24-hour emergency on call)
    Fax Orders: 1-888-345-4916
    https://orderexpress.cardinalhealth.com
  • McKesson Plasma & Biologics
    1-877-625-2566
    Monday-Friday 8:00 AM-6:30 PM CT
    Fax Orders: 1-888-752-7626
    https://connect.mckesson.com

 

Meeting a YERVOY Specialist   Meeting a YERVOY
Specialist

Request to be visited by a YERVOY Specialist

You can request to be visited by a YERVOY Specialist.

Call 1-855-4-YERVOY (1-855-493-7869) to start the process. The initial phone call and any emails that may follow are to schedule a live appointment only. Your YERVOY Specialist will discuss product information and answer your questions in person during the scheduled visit.

NOTE: This is not for reporting adverse events. To report an adverse event or product quality complaint, please call 1-800-721-5072.

 

Additional Bristol-Myers Squibb Resources

Medical Inquiries and Reporting
Visit BMSmedinfo.com or
Call 1-800-721-5072

Report side effects to the FDA
at 1-800-332-1088

Back to Top

Expand

Important Safety Information

Important Safety Information
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY (ipilimumab) can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Click here for Important Safety Information, including the Boxed WARNING regarding Immune-mediated adverse reactions
Recommended Dose Modifications

Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. Discontinue in patients with severe or life-threatening infusion reactions.

Endocrine: Withhold YERVOY for symptomatic endocrinopathy. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for symptomatic reactions lasting 6 weeks or longer or an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day.

Ophthalmologic: Permanently discontinue YERVOY for Grade 2-4 reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic treatment.

All Other Organ Systems: Withhold YERVOY for Grade 2 adverse reactions. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for Grade 2 reactions lasting 6 weeks or longer, an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day, and Grade 3 or 4 adverse reactions.

Immune-mediated Enterocolitis

Immune-mediated enterocolitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms. Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent). Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients. Consider adding anti-TNF or other immunosuppressant agents for management of immune-mediated enterocolitis unresponsive to systemic corticosteroids within 3-5 days or recurring after symptom improvement. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-5 immune-mediated enterocolitis occurred in 76 patients (16%) and Grade 2 enterocolitis occurred in 68 patients (14%). Seven (1.5%) developed intestinal perforation and 3 patients (0.6%) died as a result of complications.

Immune-mediated Hepatitis

Immune-mediated hepatitis, including fatal cases, can occur with YERVOY. Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution. Withhold YERVOY in patients with Grade 2 hepatotoxicity. Permanently discontinue YERVOY in patients with Grade 3-4 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune-mediated hepatitis occurred in 51 patients (11%) and moderate Grade 2 immune-mediated hepatitis occurred in 22 patients (5%). Liver biopsy performed in 6 patients with Grade 3-4 hepatitis showed evidence of toxic or autoimmune hepatitis.

Immune-mediated Dermatitis

Immune-mediated dermatitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated. Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically; administer topical or systemic corticosteroids if there is no improvement within 1 week. Withhold YERVOY in patients with moderate to severe signs and symptoms. Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune-mediated dermatitis occurred in 19 patients (4%). There were 99 patients (21%) with moderate Grade 2 dermatitis.

Immune-mediated Neuropathies

Immune-mediated neuropathies, including fatal cases, can occur with YERVOY. Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities). Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities), such as Guillain-Barre-like syndromes. Institute medical intervention as appropriate for management for severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-5 immune-mediated neuropathy occurred in 8 patients (2%); the sole fatality was due to complications of Guillain-Barré syndrome. Moderate Grade 2 immune-mediated neuropathy occurred in 1 patient (0.2%).

Immune-mediated Endocrinopathies

Immune-mediated endocrinopathies, including life-threatening cases, can occur with YERVOY. Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism. Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated. Monitor clinical chemistries, adrenocorticotropic hormone (ACTH) level, and thyroid function tests at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland. Withhold YERVOY in symptomatic patients and consider referral to an endocrinologist. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune-mediated endocrinopathies occurred in 39 patients (8%) and Grade 2 immune-mediated endocrinopathies occurred in 93 patients (20%). Of the 39 patients with Grade 3-4 immune-mediated endocrinopathies, 35 patients had hypopituitarism (associated with 1 or more secondary endocrinopathies, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 3 patients had hyperthyroidism, and 1 had primary hypothyroidism. The median time to onset of Grade 3-4 immune-mediated endocrinopathy was 2.2 months (range: 2 days-8 months). Twenty-seven (69.2%) of the 39 patients were hospitalized for immune-mediated endocrinopathies. Of the 93 patients with Grade 2 immune-mediated endocrinopathy, 74 had primary hypopituitarism (associated with 1 or more secondary endocrinopathy, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 9 had primary hypothyroidism, 3 had hyperthyroidism, 3 had thyroiditis with hypo- or hyperthyroidism, 2 had hypogonadism, 1 had both hyperthyroidism and hypopituitarism, and 1 subject developed Graves’ ophthalmopathy. The median time to onset of Grade 2 immune-mediated endocrinopathy was 2.1 months (range: 9 days-19.3 months).

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations

Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions. 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 for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease 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 YERVOY and may require treatment with systemic steroids to reduce the risk of permanent vision loss. In Trial 2, the following clinically significant immune-mediated adverse reactions were seen in <1% of YERVOY-treated patients unless specified: cytopenias, eosinophilia (2.1%), pancreatitis (1.3%), meningitis, pneumonitis, sarcoidosis, pericarditis, uveitis and fatal myocarditis. Across 21 dose-ranging trials administering YERVOY at doses of 0.1 to 20 mg/kg (n=2478), the following likely immune-mediated adverse reactions were also reported with <1% incidence unless specified: angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, iritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, arthritis, autoimmune thyroiditis, neurosensory hypoacusis, autoimmune central neuropathy (encephalitis), myositis, polymyositis, ocular myositis, cytopenias (2.5%), and nephritis.

Embryo-fetal Toxicity

Based on its mechanism of action, YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with a YERVOY-containing regimen and for 3 months after the last dose of YERVOY.

Lactation

It is not known whether YERVOY is secreted in human milk. Advise women to discontinue breastfeeding during treatment with YERVOY and for 3 months following the final dose.

Common Adverse Reactions

The most common adverse reactions (≥5%) in patients who received YERVOY at 10 mg/kg were rash (50%), diarrhea (49%), fatigue (46%), pruritus (45%), headache (33%), weight loss (32%), nausea (25%), pyrexia (18%), colitis (16%), decreased appetite (14%), vomiting (13%), and insomnia (10%).

Indication

YERVOY® (ipilimumab) is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.

Please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY, and Medication Guide..

References:

  1. YERVOY [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2018.
  2. Eggermont AMM, Chiarion-Sileni V, Grob JJ, et al. Adjuvant ipilimumab versus placebo after complete resection or high-risk stage Ill melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015;16(5):522-530.
  3. Eggermont AMM, Chiarion-Sileni V, Grob JJ, et al. Prolonged survival in stage III melanoma with ipilimumab adjuvant therapy. N Engl J Med. 2016;375(19):1845-1855.
  4. Romano E, Scordo M, Dusza SW, Coit DG, Chapman PB. Site and timing of first relapse in stage Ill melanoma patients: implications for follow-up guidelines. J Clin Oncol. 2010;28(18):3042-3047.
  5. Fracchia AA, Evans JF, Eisenberg, BL. Stage Ill carcinoma of the breast. Ann Surg. 1980;192(6):705-710.
  6. Harlan LC, Lynch CF, Sallard-Barbash R, Zeruto C. Trends in the treatment and survival for local and regional cutaneous melanoma in a US population-based study. Melanoma Res. 2011;21(6):547-554.
  7. Nasabzadeh TJ, Tsai H-T, Tefera E, et al. Trends and variations in the use of adjuvant immunotherapy for stage Ill melanoma in the U.S. population. Poster presented at American Society of Clinical Oncology Annual Meeting; May 31-June 4; Chicago, IL. Abstract 9077.
  8. Edwards BK, Brown ML, Wingo PA, et al. Annual report to the nation on the status of cancer, 1975-2002, featuring population-based trends in cancer treatment. J Natl Cancer Inst. 2005;97(19):1407-1427.
  9. Lawson DH. Choices in adjuvant therapy of melanoma. Cancer Control. 2005;12(4):236-241.
  10. Data on file. YERV 042. Princeton, NJ: Bristol-Myers Squibb Company; 2017.
  11. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma (V.1.2018). © 2017 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed January 4, 2018. To view the most recent and complete version of NCCN Guidelines, go online to NCCN.org.
  12. O'Day S, Hodi FS, McDermott D, et al. A phase Ill, randomized, double-blind, multicenter study comparing monotherapy with ipilimumab or gp100 peptide vaccine and the combination in patients with previously treated, unresectable stage Ill or IV melanoma. Study MOX010-20. Plenary session presentation at American Society of Clinical Oncology Annual Meeting; June 4-8, 2010; Chicago, IL Abstract 4.
  13. Mellman I, Coukos G, Dranoff G. Cancer lmmunotherapy comes of age. Nature. 2011;480(7378):480-489.
  14. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711-723.
  15. Fong L, Small EJ. Anti-cytotoxic T-lymphocyte antigen-4 antibody: The first in an emerging class of immunomodulatory antibodies for cancer treatment J Clin Oncol. 2008:26(8):5275-5283.

 

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