What is YERVOY™?
YERVOY™ is a fully human anti-CTLA-4 monoclonal antibody (IgG1K) produced in mammalian cell cultureby recombinant DNA technology. Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a negative regulator of T-cellactivation. YERVOY™ is a T-cell potentiator that specifically blocks the inhibitory signal of CTLA-4, resultingin the induction of T-cell activation, proliferation, and infiltration, potentially leading to tumour cell death.The mechanism of action of YERVOY™ is indirect, through a T-cell mediated immune response.(1) See Novel Mechanism of Action
What is YERVOY™ indicated for?
YERVOY™ is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
What is the recommended dose of YERVOY™?
The recommended induction regimen of YERVOY™ is 3 mg/kg administered intravenously (IV) over a 90-minuteperiod every 3 weeks for a total of 4 doses. Patients should receive the entire induction regimen (4 doses) as tolerated, regardless of the appearance of new lesions or growth of existing lesions. (1)
Assessments of tumour response to YERVOY™ should be conducted only after completion of induction therapy (1), 12 weeks after treatment initiation. (2) See Dosing and Administration and Specific patterns of response.
What are the potential adverse reactions of YERVOY™ treatment?
YERVOY™ is associated with inflammatory adverse reactions resulting from increased or excessiveimmune activity (immune-related Adverse Reactions, irARs), likely to be related to its mechanismof action. Immune-related Adverse Reactions, which can be severe or life-threatening, may involvethe gastrointestinal, liver, skin, nervous, endocrine, or other organ systems. While most irARs occurred during the induction period, onset months after the last dose of YERVOY™ has also been reported. (1) Unless an alternate aetiology has been identified, diarrhoea, increased stool frequency, bloody stool, Liver Function Tests (LFT) elevations, rash and endocrinopathy must be considered inflammatory and YERVOY™ related. (1)
Early diagnosis and appropriate management are essential to minimise life-threatening complications. Systemic high-dose corticosteroid with or without additional immunosuppressive therapy may be required for the management of severe immune-related Adverse Reactions. (1)
The YERVOY™-specific Managment Guide for irARs intends to aid early diagnosis and appropriate management of life-threatening complications. See Immune-related Adverse Reactions Management Guide.
Please refer to the YERVOY™ Summary of Product Characteristics for a comprehensive description of these risks and others.
What should you discuss with you patients about YERVOY™?
Your role in educating patients and caregivers about their new therapy and its possible effects and adverse reactions is very important. You will need to inform patients of the differences between chemotherapy and immunotherapy (YERVOY™) and teach patients to recognize the adverse reactions of immunotherapy and to report them immediately to you.
The earlier adverse reactions are reported, the sooner they can be treated. You will be an extremely important contact for patients throughout their treatment, and will need to provide not only clinical care.
A Patient Information Brochure (in Swedish) and an Patient Alert Card (in Swedish) are available for patients. Also see the Healthcare Professionals FAQ brochure (in Swedish).
What should be done prior to using YERVOY™?
Liver function tests and thyroid function tests should be evaluated at baseline and before each dose of YERVOY™. In addition, any signs or symptoms of immune-related adverse reactions, including diarrhoea and colitis, must be assessed during treatment with YERVOY™. (1)
YERVOY (ipilimumab) 5 mg/ml koncentrat till infusionsvätska, lösning. Antineoplastiska medel, monoklonala antikroppar, ATC kod: L01XC11.
Indikation: YERVOY är indicerat för behandling av avancerat (icke-resektabelt eller metastaserande) melanom hos vuxna.
Varningar och försiktighet: Behandling ska initieras och övervakas av specialistläkare med erfarenhet av cancerbehandling. YERVOY är associerat med inflammatoriska biverkningar till följd av förhöjd eller alltför hög immunaktivitet (immunrelaterade biverkningar). Tidig diagnos av dessa och lämplig behandling är nödvändig för att minimera livshotande komplikationer.
Förpackningar: 1 injektionsflaska om 10 ml eller 40 ml
Övrig information: Rx, EF. För fullständig information, se http://www.fass.se/.
Texten är baserad på produktresumé: 21 april 2016
Bristol Myers Squibb AB, Tel. 08-704 71 00, www.bms.se
1. YERVOY™ Summary of Product Characteristics
2. Eggermont AM et al. Eur J Cancer 2011;47:2150–7.
3. Hodi FS et al. N Engl J Med 2010;363:711–23.
4. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) Assessment Report For YERVOY™ (ipilimumab) 24 October 2013.
4. Eggermont AM et al. Eur J Cancer 2011;47:2150–7.
5. Margolin KA et al. Poster presented at the European Cancer Congress (ECCO-ESMO-ESTRO), 27 Sep–1 Oct 2013, Amsterdam, Netherlands.
6. Patt D et al. Poster presented at the European Cancer Congress (ECCO-ESMO-ESTRO), 27 Sep–1 Oct 2013, Amsterdam, Netherlands.