• imAEs are specific AEs caused by immunotherapy
  • Intervention and management is critical for the management as imAEs can develop at any point during a patient’s course of therapy
  • imAEs can occur even after the end of therapy
  • Please select the AEs below that have been identified with the patient to understand the best methods for management and safety
  • Please note that this is not an exhaustive list of imAEs however are select AEs that are manageable.
Click here to select proper imAEs accounted for: (Check all that apply)










For all imAEs remember the key steps of Look, Listen, and Recognize

Adrenal Insufficiency
  • Does the patient appear lethargic, weak, or depressed?
  • Is the patient in pain?
  • Is the patient faint or dizzy when standing?
  • Has the patient experienced a change in mood?
  • Is the patient craving salty foods?
If answers to questions and reviewed signs and symptoms click the confirmation button below
CONFIRMED
Bullous Dermatoses and SCARs (eg. SJS, TEN)
  • Does the patient appear unwell?
  • Are there any skin changes such as dry skin or changes in skin pigment/color?
  • Is the skin integrity intact?
  • Have symptoms worsened?
  • Is there a history of dermatitis, pre-existing skin issues?
If answers to questions and reviewed signs and symptoms click the confirmation button below
CONFIRMED
Diarrhea and Colitis
  • Has the patient lost weight?
  • Is the patient experiencing abdominal pain or cramping?
  • Is the patient experiencing bloating or increased gas?
  • Are serum chemistry/hematology values normal?
If answers to questions and reviewed signs and symptoms click the confirmation button below
CONFIRMED
Maculopapular Rash
  • Is there any obvious rash? Oral involvement?
  • Does the rash involve the genito-vaginal region or the scalp?
  • Does the patient have pruritus with or without rash?
  • Have symptoms worsened?
  • Is there a history of dermatitis, pre-existing skin issues?
If answers to questions and reviewed signs and symptoms click the confirmation button below
CONFIRMED
Pneumonitis
  • Is the patient have tachypnea (abnormally rapid and shallow breathing)?
  • Does the patient appear to be in respiratory distress?
  • Does the patient notice a new cough or a change in an existing cough?
  • Is pulse oximetry low? IS it lower than baseline or compared with last visit?
  • History of prior respiratory compromise (ex. asthma, COPD, congestive heart failure)?
If answers to questions and reviewed signs and symptoms click the confirmation button below
CONFIRMED
Pruritus
  • Does the patient have pruritus with or without rash?
  • Is the patient scratching during the visit?
  • Are there any skin changes such as dryness or altered pigmentation?
  • Are symptoms interfering with ADLs or with Sleep?
  • Is there a history of dermatitis, pre-existing skin issues?
If answers to questions and reviewed signs and symptoms click the confirmation button below
CONFIRMED
Renal Toxicity
  • Has there been a change in urination (eg, urine output, color, frequency)?
  • Are there symptoms consistent with an alternative cause including UTI/pyelonephritis or worsening CHF?
  • Are there laboratory abnormalities (eg, elevated creatinine, electrolyte abnormalities)?
  • Are there urinalysis abnormalities (casts)?
If answers to questions and reviewed signs and symptoms click the confirmation button below
CONFIRMED
Thyroid Dysfunction
  • Have there been changes in weight since last visit?
  • Is the patient hyperactive or lethargic? Is the patient experiencing hot or cold intolderance?
  • Are there changes in energy, mood, or behavior?
  • Signs of thyroid storm (fever, tachycardia, sweating, dehydration, cardiac decompensation, delirium/psychosis, liver failure, abdominal pain, nausea/vomiting, diarrhea)?
If answers to questions and reviewed signs and symptoms click the confirmation button below
CONFIRMED

Steps:
  1. Please view the Grading table below (CTCAE 5.0) for each imAE tab confirmed and CLICK on the corresponding grade for proper management techniques. Guideline recommendations on dose modifications, interruptions, or discontinuations should be determined in accordance with the applicable product label and the clinical judgement of the treating HCP.
  2. When you have found the proper grade, click SAVE underneath the Grade level management. You must save exactly 1 grade on each tab.
  3. When finished saving all associated management on each imAE Tab, click FINISH at the bottom of the page to print out the report notes.
  4. If you would like to add/remove/or change imAEs, click GO BACK

Potential symptoms to watch: Nausea or vomiting; fatigue; muscle/joint pain; salt cravings; decreased libido; mood swings; weight loss; dizziness; fever

Clinical Signs: Abnormal lab values for ACTH; cortisol; hypoglycemia; anemia; hyponatremia; hyper pigmentation; hypotension

Managing the IO regimen:
  • Consider holding until stabilized on replacement hormone or hold.
imAE management:
  • Hormone replacement therapy.
  • Titrate dose up or down as symptoms dictate.
  • Consider inpatient care.
SAVE
Managing the IO regimen:
  • Consider holding until stabilized on replacement hormone or hold.
imAE management:
  • Increase hormone dose to manage acute symptoms.
  • Maintenance therapy as in Grade 1.
SAVE
Managing the IO regimen:
  • Hold until stabilized on replacement hormone.
imAE management:
  • Saline and IV stress-dose corticosteroids.
  • Maintenance therapy as in Grade 1.
SAVE
Managing the IO regimen:
  • Hold until stabilized on replacement hormone.
imAE management:
  • Saline and IV stress-dose corticosteroids.
  • Maintenance therapy as in Grade 1.
SAVE

Potential symptoms to watch: Skin inflammation and fluid filled blisters; SCARs are characterized by separation of epidermis from dermis

Physical examination: Presence of baseline skin toxicities in patients with history of treatments associated with skin reactions, consider clinical monitoring with the use of serial clinical photography

Managing the IO regimen:
  • Hold IO therapy.
imAE management:
  • Local wound care.
  • Treatment with high-potency topical corticosteroids to affected areas.
SAVE
Managing the IO regimen:
  • Hold IO therapy until symptoms < Grade 1.
imAE management:
  • Local wound care.
  • Treatment with topical corticosteroid.
  • Prednisone/methylprednisolone 0.5-1 mg/kg/day.
SAVE
Managing the IO regimen:
  • Hold or permanently discontinue IO therapy.
imAE management:
  • Hospitalize.
  • Prednisone/methylprednisolone 1-2 mg/kg/day, if no improvement after 3 days, consider nonsteroidal immunosuppressants.
  • Topical emollient.
  • Oral Antihistamine.
  • Treatment with high-strength topical steroids to affected areas.
SAVE
Managing the IO regimen:
  • Permanently discontinue IO therapy.
imAE management:
  • Hospitalize.
  • Prednisone/methylprednisolone 1-2 mg/kg/day.
  • IVIG or cyclosporine may also be considered in severe or corticosteroid unresponsive cases.
SAVE

Clinical Signs: Monitor pretreatment bowel movements, establish baseline fecal lactoferrin and calprotectin

Grade Severity1234
Diarrhea
  • Increase of 4 stools per day over baseline.
  • Mild increase in ostomy output compared to baseline.
  • Increase of 4-6 stools per day over baseline.
  • Mild increase in ostomy output compared with baseline.
  • Limiting instrumental ADL.
  • Increase of ≥7 stools per day over baseline.
  • Moderate increase in ostomy output compared with baseline.
  • Limiting self-care ADL.
  • Life threatening consequences (eg, hemodynamic collapse, ischemia, bleeding, perforation, toxic megacolon).
Colitis
  • No symptoms; clinical or diagnostic observation only.
  • Abdominal pain; blood or mucus in stool.
  • Severe abdominal pain; peritoneal signs.
  • Life threatening consequences (eg, hemodynamic collapse, ischemia, bleeding, perforation, toxic megacolon).
Managing the IO regimen:
  • IO therapy can be continued or consider holding.
imAE management:
  • Close monitoring.
  • Ensure adequate hydration.
  • Initiate dietary consultation so recommendations can be made based on history and anatomy.
  • Antidiarrheal medication is optional but not highly recommended if infectious workup is negative.
  • If symptoms persist or progress, start routine stool and blood tests.
SAVE
Managing the IO regimen:
  • Hold IO therapy until symptoms resolve.
  • Consider permanently discontinuing CTLA-4 agent.
imAE management:
  • If diarrhea symptoms only consider observing for 2-3 days, then start corticosteroids.
  • If diarrhea and colitis symptoms, start corticosteroids.
  • Prednisone 1-2 mg/kg/day (or methylprednisolone equivalent).
  • If no improvement after 2-3 days, increase dose to prednisone 2 mg/kg/day or consider adding nonsteroidal immunosuppressant (ex, infliximab).
SAVE
Managing the IO regimen:
  • Discontinue IO therapy.
  • Consider restarting PD-1/PD-L1 agents if symptoms resolve.
imAE management:
  • Consider hospitalization.
  • Initiate high-dose IV corticosteroids (prednisone 1-2 mg/kg/day or methylprednisolone equivalent).
  • If no improvement after 2-3 days, consider adding nonsteroidal immunosuppressant.
SAVE
Managing the IO regimen:
  • Permanently discontinue IO therapy.
imAE management:
  • Consider hospitalization.
  • Initiate high-dose IV corticosteroids (methylprednisolone 1-2 mg/kg/day or equivalent).
  • If no improvement after 2-3 days, consider adding nonsteroidal immunosuppressant.
SAVE

Potential symptoms to watch: Inflammatory rashes such as these often appear across the limbs and trunk after the first few treatment cycles

Clinical Signs: Presence of baseline skin toxicities in patients with history of treatments associated with skin reactions, consider clinical monitoring with the use of serial clinical photography

Grade Severity1234
Maculopapular Rash
  • Macules/papules covering < 10% BSA with or without symptoms (eg. pruritis, burning, tightness).
  • Macules/papules covering 10-30% BSA with or without symptoms (eg. pruritis, burning, tightness).
  • Limiting instrumental ADL.
  • Rash covering >30% BSA with or without mild symptoms.
  • Macules/papules covering >30% BSA with moderate or severe symptoms.
  • Limiting self-care ADL.
  • All severe rashes unmanageable with prior interventions and intolerable.
Managing the IO regimen:
  • Continue IO therapy.
imAE management:
  • Topical emollient.
  • Oral Antihistamine.
  • Treatment with moderate-potency topical corticosteroids to affected areas; Class Ia topical corticosteroid for body; Class V/VIb corticosteroid for face.
SAVE
Managing the IO regimen:
  • Continue IO therapy.
imAE management:
  • Topical emollient.
  • Oral Antihistamine.
  • Treatment with high-potency topical steroids to affected areas AND/OR.
  • Prednisone 0.5-1 mg/kg/day.
SAVE
Managing the IO regimen:
  • Hold IO therapy.
imAE management:
  • Consider hospitalization.
  • Treatment with high-potency topical steroids to affected areas.
  • Prednisone 0.5-1 mg/kg/day (increase up to 2 mg/kg/day, if no improvement.
  • Topical emollient.
  • Oral Antihistamine.
SAVE
Managing the IO regimen:
  • Immediate hold IO therapy; consider resuming once symptoms resolve.
imAE management:
  • Hospitalize.
  • Intitiate IV corticosteroids (methylprednisolone 1-2 mg/kg/day or equivalent).
SAVE

Clinical Signs: Oxygen saturation (resting and with ambulation), PFT for high-risk patients, consider chest CT

Managing the IO regimen:
  • Consider holding IO therapy.
  • If imaging abnormalities resolve, consider resuming.
imAE management:
  • Monitor at least biweekly.
  • If worsens, treat as higher grade.
SAVE
Managing the IO regimen:
  • Withhold IO therapy.
  • If imaging abnormalities resolve and no requirement for steroid, consider resuming.
imAE management:
  • Consider empiric antibiotics if infection not fully excluded.
  • Start oral or IV corticosteroid (prenisone/methylprednisolone 1-2 mg/kg/day).
  • If no improvement after 2-3 days of corticosteroid, treat as Grade 3.
SAVE
Managing the IO regimen:
  • Permanently discontinue IO therapy.
imAE management:
  • Hospitalize.
  • Initiate IV corticosteroids (methylprednisolone 1-2 mg/kg/day).
  • If no improvement after 2 days, consider nonsteroidal immunosuppressants.
SAVE
Managing the IO regimen:
  • Permanently discontinue IO therapy.
imAE management:
  • Hospitalize.
  • Initiate IV corticosteroids (methylprednisolone 1-2 mg/kg/day).
  • If no improvement after 2 days, consider nonsteroidal immunosuppressants.
SAVE

Potential symptoms to watch: Occurs either alone or associated with maculopapular rash

Clinical Signs: Presence of baseline skin toxicities in patients with history of treatments associated with skin reactions, consider clinical monitoring with the use of serial clinical photography

Managing the IO regimen:
  • Continue IO therapy.
imAE management:
  • Topical emollient.
  • Oral Antihistamine.
  • Treatment with moderate-potency topical corticosteroids to affected areas; Class Ia topical corticosteroid for body; Class V/VIb corticosteroid for face.
SAVE
Managing the IO regimen:
  • Continue IO therapy with intensified antipruritic therapy.
imAE management:
  • Oral Antihistamine.
  • Treatment with high-potency topical corticosteroids to affected areas; Class Ia topical corticosteroid for body; Class V/VIb corticosteroid for face.
  • Oral prednisone (or methylprednisolone equivalent) 0.5-1 mg/kg/day.
SAVE
Managing the IO regimen:
  • Hold IO therapy.
imAE management:
  • Oral antihistamine.
  • Oral prednisone (or methylprednisolone equivalent) 0.5-1 mg/kg/day.
  • Consider GABA agonists.
  • Consider a selective NK1 receptor antagonist or anti-IgE therapy.
  • Urgent dermatology consultation.
SAVE

Potential symptoms to watch: Identifying immune-mediated renal toxicity is mainly one of exclusion

Clinical Signs: Kidney function (baseline creatinine established before start of treatment), monitor creatinine and urine protein more frequently if levels appear to be rising

Grade Severity1234
Renal Toxicity
  • Creatinine Increased
    • >ULN-1.5x ULN.
  • Acute Kidney Injury
    • Creatinine increase of >0.3 mg/DL; creatinine 1.5-2x above baseline.
  • Creatinine Increased
    • 1.5-3x baseline; >1.5-3x ULN.
  • Acute Kidney Injury
    • Creatinine 2-3x above baseline.
  • Creatinine Increased
    • 3x baseline; >3-6x ULN.
  • Acute Kidney Injury
    • Creatinine 3x above baseline or >4mg/DL.
  • Creatinine Increased
    • 6x ULN.
  • Acute Kidney Injury
    • Life-threatening consequences.
Managing the IO regimen:
  • Consider holding IO therapy.
imAE management:
  • Monitor closely; follow creatinine and urine protein every 3-7 days.
  • Initiate workup to evaluate potential alternate etiologies.
SAVE
Managing the IO regimen:
  • Hold IO therapy temporarily.
imAE management:
  • Follow creatinine and urine protein every 3-7 days.
  • Start prednisone 0.5-1 mg/kg/day, if other etiologies are ruled out.
  • If no improvement after 1 week, prednisone/methylprednisolone 1-2 mg/kg/day (treat as Grade 3).
SAVE
Managing the IO regimen:
  • Permanently Discontinue IO therapy.
imAE management:
  • Consider hospitalization.
  • Initiate prednisone (or methylprednisolone) 1-2 mg/kg/day.
  • If Grade >2 after 1 week of corticosteroids, consider adding azathioprine, cyclophosphamide (monthly), cyclosporine, infliximab, or mycophenolate.
SAVE
Managing the IO regimen:
  • Permanently Discontinue IO therapy.
imAE management:
  • Hospitalize.
  • Dialysis indicated.
  • Initiate prednisone (or methylprednisolone) 1-2 mg/kg/day.
  • If Grade >2 after 1 week of corticosteroids, consider adding azathioprine, cyclophosphamide (monthly), cyclosporine, infliximab, or mycophenolate.
SAVE

Potential symptoms to watch: Radioactive iodine uptake scan can be used to assess cause. Low uptake may indicate thyroiditis, while high uptake may indicate goiter, adenoma, or Graves’ disease

Clinical Signs: Thyroid function test (TSH and free T4) should be repeated prior to the start of each dose and monitored during therapy as indicated

Managing the IO regimen: Hyper/hypothyroidism
  • Continue IO therapy.
imAE management: Hyper/hypothyroidism
  • Close monitoring of TSH and free T4.
SAVE
Managing the IO regimen: Hyper/hypothyroidism
  • Consider withholding IO therapy until symptoms resolve.
imAE management: Hyperthyroidism
  • Beta-blocker for symptom relief.
  • Hydration and supportive care.

Hypothyroidism
  • Thyroid hormone supplementation as indicated; monitor TSH every 6-8 weeks until normal.
SAVE
Managing the IO regimen: Hyper/hypothyroidism
  • Hold until stabilized on replacement hormone.
imAE management: Hyperthyroidism
  • Beta-blocker for symptom relief.
  • For severe symptoms or concern for thyroid storm, hospitalize and initiate high-dose prednisone or equivalent 1-2 mg/kg/day.

Hypothyroidism
  • Thyroid hormone supplementation as indicated; monitor TSH every 6-8 weeks until normal.
  • May admit for IV therapy if signs of myxedema.
SAVE


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