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YERVOY is a brand name for Ipilimumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TBD 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing consideration 03/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment TBD 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 03/2022 4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose 03/2022 7 WARNINGS AND PRECAUTIONS TBD TABLE OF CONTENTS RECENT MAJOR LABEL…
Verbatim from this product's HC label. Tap a section to expand.
5 Missed Dose 03/2022 7 WARNINGS AND PRECAUTIONS TBD TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................. 4 TABLE OF CONTENTS .............................................................................................................
4 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................ 6 1 INDICATIONS......................................................................................................................
1 Pediatrics ............................................................................................................. 2 Geriatrics .............................................................................................................
7 2 CONTRAINDICATIONS ......................................................................................................... 7 3 SERIOUS WARNINGS AND PRECAUTIONS BOX........................................................................
7 4 DOSAGE AND ADMINISTRATION........................................................................................... 1 Dosing Considerations............................................................................................
2 Recommended Dose and Dosage Adjustment............................................................ 4 Administration .................................................................................................... 5 Missed Dose .......................................................................................................
16 5 OVERDOSAGE................................................................................................................... 16
, Clinical Trial Adverse Reactions (Pediatrics), and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions). 2 Geriatrics Geriatrics (≥ 65 years of age): Of the 131 patients treated with YERVOY 3 mg/kg monotherapy in the study MDX-010-20, 30% were 65 years of age or older.
No overall differences in safety or efficacy were reported between elderly patients ( 65 years) and younger patients (<65 years). 2 CONTRAINDICATIONS • YERVOY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • YERVOY is also contraindicated in patients with active, life-threatening autoimmune disease, or with organ transplantation graft where further immune activation is potentially imminently life- threatening (see 7 WARNINGS AND PRECAUTIONS).
When using YERVOY in combination with nivolumab, consult Product Monograph for OPDIVO (nivolumab) for further information on this drug. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions YERVOY as monotherapy or in combination with nivolumab can cause severe and fatal immune - mediated adverse reactions, including enterocolitis, intestinal perforation, hepatitis, dermatitis (including toxic epidermal necrolysis), Stevens-Johnson syndrome, neuropathy, endocrinopathy, pneumonitis, interstitial lung disease, myocarditis, encephalitis, myasthenia gravis, autoimmune hemolytic anemia as well as toxicities in other organ systems.
While most of these reactions occurred during the induction period, onset months after the last dose has been reported (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). Early diagnosis and appropriate management are essential to minimize life-threatening complications.
TBD TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................. 4 TABLE OF CONTENTS .............................................................................................................
4 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................ 6 1 INDICATIONS......................................................................................................................
1 Pediatrics ............................................................................................................. 2 Geriatrics .............................................................................................................
7 2 CONTRAINDICATIONS ......................................................................................................... 7 3 SERIOUS WARNINGS AND PRECAUTIONS BOX........................................................................
7 4 DOSAGE AND ADMINISTRATION........................................................................................... 1 Dosing Considerations............................................................................................
2 Recommended Dose and Dosage Adjustment............................................................ 4 Administration .................................................................................................... 5 Missed Dose .......................................................................................................
16 5 OVERDOSAGE................................................................................................................... 16 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING............................................. 16 7 WARNINGS AND PRECAUTIONS..........................................................................................
• YERVOY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• YERVOY is also contraindicated in patients with active, life-threatening autoimmune disease, or with organ transplantation graft where further immune activation is potentially imminently life- threatening (see 7 WARNINGS AND PRECAUTIONS).
When using YERVOY in combination with nivolumab, consult Product Monograph for OPDIVO (nivolumab) for further information on this drug.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients should be monitored for signs and symptoms suggestive of immune- mediated adverse reactions [see 4 DOSAGE AND ADMINISTRATION and 7 WARNINGS AND PRECAUTIONS]. YERVOY as monotherapy or in combination with nivolumab must be permanently discontinued for any severe immune-mediated adverse reaction that recurs and for any life-threatening immune- Product Monograph Master Template Template Date: September 2020 YERVOY® (ipilimumab for injection) Page 8 of 74 mediated adverse reaction (see 7 WARNINGS AND PRECAUTIONS and 4 DOSAGE AND ADMINISTRATION).
Healthcare professionals should consult the OPDIVO (nivolumab) Product Monograph prior to initiation of YERVOY in combination with nivolumab. , electrolytes, liver function test, adrenocorticotropic hormone (ACTH) level, and thyroid function tests) should be evaluated at baseline and before each dose.
Patient Selection Metastatic NSCLC:
Select patients with metastatic NSCLC for treatment with YERVOY in combination with nivolumab based on PD-L1 expression. A test authorized by Health Canada which is equivalent to that used in clinical trials should be required.
MSI-H/dMMR metastatic colorectal cancer:
Patients should be selected for treatment based on MSI-H or dMMR tumor status as determined by an experienced laboratory using validated testing methods. When using YERVOY in combination with nivolumab consult Product Monograph for OPDIVO (nivolumab) for further information.
2 Recommended Dose and Dosage Adjustment Recommended Dose - YERVOY as monotherapy Melanoma: The recommended induction regimen of YERVOY is 3 mg/kg administered intravenously over a 30-minute period every 3 weeks to a maximum of four doses, and within 16 weeks of the first dose.
Patients should receive the entire induction regimen (four doses) as tolerated, regardless of the appearance of new lesions or growth of existing lesions. Assessments of tumor response to YERVOY should be conducted only after completion of induction therapy.
Liver function tests (LFTs), thyroid function tests, and electrolytes should be evaluated at baseline and before each dose of YERVOY. In addition, any signs or symptoms of immune-mediated adverse reactions, including diarrhea and colitis, should be assessed during treatment (see 7 WARNINGS AND PRECAUTIONS).
Recommended Dose - YERVOY in combination with nivolumab Melanoma:
The recommended dose of YERVOY is 3 mg/kg administered as an intravenous infusion over 30 minutes in combination with nivolumab 1 mg/kg administered intravenously over 30 minutes, on the same day, Product Monograph Master Template Template Date: September 2020 YERVOY® (ipilimumab for injection) Page 9 of 74 every 3 weeks for the first 4 doses or until unacceptable toxicity, whichever occurs earlier.
After the completion of the 4 doses of YERVOY and nivolumab, administer nivolumab as a single agent, either: • 3 mg/kg every 2 weeks or • 240 mg every 2 weeks or • 480 mg every 4 weeks as an intravenous infusion over 30 minutes (Table 1).
Continue treatment as long as clinical benefit is observed or until treatment is no longer tolerated by the patient.
Table 1:
Recommended doses and infusion times for intravenous administration of ipilimumab in combination with nivolumab Combination phase, every 3 weeks for 4 dosing cycles Monotherapy phase Nivolumab 1 mg/kg over 30 minutes 3 mg/kg every 2 weeks over 30 minutes1 or 240 mg every 2 weeks over 30 minutes1 or 480 mg every 4 weeks over 30 minutes2 Ipilimumab 3 mg/kg over 30 minutes - 1.
3 weeks after the last dose of the combination of nivolumab and ipilimumab 2. 6 weeks after the last dose of the combination of nivolumab and ipilimumab Renal Cell Carcinoma and colorectal cancer: The recommended dose of YERVOY is 1 mg/kg administered as an intravenous infusion over 30 minutes, in combination with 3 mg/kg nivolumab administered intravenously over 30 minutes, on the same day, every 3 weeks for the first 4 doses.
After completion of the combination phase, administer nivolumab as a single agent, either: • 3 mg/kg every 2 […]
1 Special Populations.............................................................................................. 1 Pregnant Women.............................................................................................. 2 Breast-feeding..................................................................................................
3 Pediatrics ........................................................................................................ 4 Geriatrics.........................................................................................................
29 8 ADVERSE REACTIONS ........................................................................................................ 1 Adverse Reaction Overview ..................................................................................
2 Clinical Trial Adverse Reactions ......................................................................... 1 Clinical Trial Adverse Reactions - Pediatrics ................................................... 3 Less Common Clinical Trial Adverse Reactions .........................................................
5 Post-Market Adverse Reactions ............................................................................. 38 9 DRUG INTERACTIONS ........................................................................................................
4 Drug-Drug Interactions......................................................................................... 5 Drug-Food Interactions ........................................................................................ 6 Drug-Herb Interactions.........................................................................................
7 Drug-Laboratory Test Interactions.......................................................................... 39 10 Clinical Pharmacology......................................................................................................
1 Mechanism of Action ......................................................................................... 2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ..............................................................................................
40 11 STORAGE, STABILITY AND DISPOSAL ................................................................................. 43 12 SPECIAL HANDLING INSTRUCTIONS ...................................................................................
43 PART II: SCIENTIFIC INFORMATION........................................................................................ 44 13 PHARMACEUTICAL INFORMATION....................................................................................
44 14 CLINICAL TRIALS ............................................................................................................. 1 Clinical Trials by Indication ..................................................................................
44 15 MICROBIOLOGY.............................................................................................................. 48 16 NON-CLINICAL TOXICOLOGY.............................................................................................
48 17 SUPPORTING PRODUCT MONOGRAPHS...................................................................... 65 PATIENT MEDICATION INFORMATION ................................................................................... 66 Product Monograph Master Template Template Date: September 2020 YERVOY® (ipilimumab for injection) Page 6 of 74 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS YERVOY (ipilimumab for injection) is indicated for: Unresectable or Metastatic Melanoma: • YERVOY as a single agent is indicated for the treatment of unresectable […]