MONITORING and MANAGING ADVERSE
REACTIONS

Management of adverse reactions includes identification and education of all those involved in the patient’s care. Patients receiving KEYTRUDA and their caregivers should be educated to recognize and report any signs and symptoms that may occur during treatment.1


Select an Adverse Reaction
to View Monitoring and Management Details

Pneumonitis

MONITORING for Pneumonitis

Monitor Patients

Monitor patients for signs and symptoms of pneumonitis.

  • If pneumonitis is suspected, evaluate with radiographic imaging.
  • Incidence (all grades): 3.4% of 2,799 patients receiving KEYTRUDA in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010.
  • Discontinuation rate: 1.3%.
  • Median time to onset: 3.3 months (range: 2 days to 19.3 months)
  • Median duration: 1.5 months (range: 1 day to 17.2+ months).
Ask Patients to
Immediately Report
  • Shortness of breath
  • Chest pain
  • New or worsening cough

MANAGING Pneumonitis

Evaluate

If pneumonitis is suspected, evaluate with radiographic imaging.

  • Grade 2: Symptomatic; medical intervention indicated; limiting instrumental ADL2,a
  • Grade 3: Severe symptoms; limiting self-care ADLb; oxygen indicated2
  • Grade 4: Life-threatening respiratory compromise; urgent intervention indicated (eg, tracheotomy or intubation)2

Ensure adequate evaluation to confirm etiology or exclude other causes.

Manage
  • Grade 2: Withhold KEYTRUDA; administer corticosteroids (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper).
    • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.c
    • Resume KEYTRUDA when the immune-mediated adverse reaction remains at Grade 1 or less following corticosteroid taper.
    • Permanently discontinue KEYTRUDA for recurrent Grade 2 pneumonitis.
  • Grade 3 or 4: Permanently discontinue KEYTRUDA; administer corticosteroids.
  • Also permanently discontinue KEYTRUDA for any of the following:
    • Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks
    • Persistent Grade 2 or 3 adverse reactions that do not recover to Grade 0–1 within 12 weeks after last dose of KEYTRUDA

aInstrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.2

bSelf-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not being bedridden.2

cBased on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered.

ADL = activities of daily living.

Colitis

MONITORING for Colitis

Monitor Patients

Monitor patients for signs and symptoms of colitis.

  • Incidence (all grades): 1.7% of 2,799 patients receiving KEYTRUDA in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010
  • Discontinuation rate: 0.5%
  • Median time to onset: 3.5 months (range: 10 days to 16.2 months)
  • Median duration: 1.3 months (range: 1 day to 8.7+ months)
Ask Patients to
Immediately Report
  • Diarrhea or more bowel movements than usual
  • Stools that are black, tarry, sticky, or have blood or mucus
  • Severe stomach-area (abdomen) pain or tenderness

MANAGING Colitis

Evaluate
  • Grade 2: Abdominal pain; mucus or blood in stool2
  • Grade 3: Severe abdominal pain; peritoneal signs2
  • Grade 4: Life-threatening consequences; urgent intervention indicated2

Ensure adequate evaluation to confirm etiology or exclude other causes.

Manage
  • Grade 2 or 3: Withhold KEYTRUDA; administer corticosteroids (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper).
    • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.a
    • Resume KEYTRUDA when the immune-mediated adverse reaction remains at Grade 1 or less following corticosteroid taper.
  • Grade 4: Permanently discontinue KEYTRUDA; administer corticosteroids.
  • Also permanently discontinue KEYTRUDA for any of the following:
    • Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks
    • Persistent Grade 2 or 3 adverse reactions that do not recover to Grade 0–1 within 12 weeks after last dose of KEYTRUDA
    • Any severe or Grade 3 treatment-related adverse reaction that recurs

aBased on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered.

Hepatitis

MONITORING for Hepatitis

Monitor Patients

Monitor patients for changes in liver function.

  • Incidence (all grades): 0.7% of 2,799 patients receiving KEYTRUDA in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010
  • Discontinuation rate: 0.2%
  • Median time to onset: 1.3 months (range: 8 days to 21.4 months).
  • Median duration: 1.8 months (range: 8 days to 20.9+ months)
Ask Patients to
Immediately Report
  • Yellowing of skin or the whites of eyes
  • Nausea or vomiting
  • Pain on the right side of the abdomen
  • Dark urine
  • Feeling less hungry than usual
  • Bleeding or bruising more easily than normal

MANAGING Hepatitis

Evaluate
  • Grade 2: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increased >3.0–5.0 x upper limit of normal (ULN); blood bilirubin increased >1.5–3.0 x ULN2
  • Grade 3: ALT and/or AST increased >5.0–20.0 x ULN; blood bilirubin increased >3.0–10.0 x ULN2
  • Grade 4: ALT and/or AST increased >20.0 x ULN; blood bilirubin increased >10.0 x ULN2

Ensure adequate evaluation to confirm etiology or exclude other causes.

Manage
  • Grade 2 hepatitis: Withhold and administer corticosteroids (initial dose 0.5 to 1 mg/kg/day prednisone or equivalent followed by a taper).
    • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.a
    • Resume KEYTRUDA when the immune-mediated adverse reaction remains at Grade 1 or less following corticosteroid taper.
  • Grade 3 or greater hepatitis: Permanently discontinue and administer corticosteroids (1 to 2 mg/kg/day prednisone or equivalent followed by a taper).
  • Permanently discontinue KEYTRUDA for any of the following:
    • Patients with liver metastasis who begin treatment with Grade 2 AST or ALT, if AST or ALT increases by ≥50% relative to baseline and lasts for ≥1 week
    • Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks
    • Persistent Grade 2 adverse reactions that do not recover to Grade 0–1 within 12 weeks after last dose of KEYTRUDA

aBased on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered.

Hypophysitis

MONITORING for Hypophysitis

Monitor Patients

Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency).

  • Incidence (all grades): 0.6% of 2,799 patients receiving KEYTRUDA in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010
  • Discontinuation rate: 0.1%
  • Median time to onset: 3.7 months (range: 1 day to 11.9 months)
  • Median duration: 4.7 months (range: 8+ days to 12.7+ months)
Ask Patients to
Immediately Report
  • Rapid heartbeat
  • Weight loss or weight gain
  • Increased sweating
  • Feeling more hungry or thirsty
  • Urinating more often than usual
  • Hair loss
  • Feeling cold
  • Constipation
  • Deepening voice
  • Muscle aches
  • Dizziness or fainting
  • Headaches that will not go away or unusual headache

MANAGING Hypophysitis

Evaluate
  • Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting instrumental ADL2,a
  • Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self care ADL2,b
  • Grade 4: Life-threatening consequences; urgent intervention indicated2
Manage
  • Grade 2: Withhold KEYTRUDA; administer corticosteroids and hormone replacement therapy as clinically indicated.
    • Resume when the immune-mediated adverse reaction remains at Grade 1 or less following corticosteroid taper and continue to taper over at least 1 month.c
  • Grade 3 or 4: Withhold or discontinue KEYTRUDA; administer corticosteroids and other hormone replacement therapy as clinically indicated.
    • Resume when the immune-mediated adverse reaction remains at Grade 1 or less following corticosteroid taper and continue to taper over at least 1 month.c
  • Also permanently discontinue KEYTRUDA for any of the following:
    • Any severe or Grade 3 treatment-related adverse reaction that recurs
    • Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks

aInstrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.2

bSelf-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not being bedridden.2

cBased on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered.

ADL = activities of daily living.

Hypothyroidism

MONITORING for Hypothyroidism

Monitor Patients

Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders.

  • Incidence (all grades): 8.5% of 2,799 patients receiving KEYTRUDA in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010.
  • Discontinuation rate: <0.1% (1 patient).
  • Median time to onset: 3.5 months (range 1 day to 18.9 months).
  • Median duration: Not reached (range: 2 days to 27.7 months).
  • The incidence of new or worsening hypothyroidism was higher in patients with HNSCC: 15% of the 192 patients receiving. Of these 28 patients, 15 had no prior history of hypothyroidism.

Thyroiditis occurred in 16 (0.6%) of 2,799 patients receiving KEYTRUDA, including Grade 2 (0.3%) thyroiditis. The median time to onset was 1.2 months (range: 0.5 to 3.5 months).

Ask Patients to
Immediately Report

Ask patients to immediately report hormone gland problems, such as:

  • Rapid heartbeat
  • Weight loss or weight gain
  • Increased sweating
  • Feeling more hungry or thirsty
  • Urinating more often than usual
  • Hair loss
  • Feeling cold
  • Constipation
  • Deepening voice
  • Muscle aches
  • Dizziness or fainting
  • Headaches that will not go away or unusual headache

MANAGING Hypothyroidism

Evaluate
  • Grade 2: Symptomatic; thyroid suppression therapy indicated; limiting instrumental ADL2,a
  • Grade 3: Severe symptoms; limiting self-care ADL2,b; hospitalization indicated
  • Grade 4: Life-threatening consequences; urgent intervention indicated2

Ensure adequate evaluation to confirm etiology or exclude other causes.

Manage
  • Grade 2: Administer hormone replacement therapy.
  • Permanently discontinue KEYTRUDA for any of the following:
    • Any severe or Grade 3 treatment-related adverse reaction that recurs

aInstrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.2

bSelf-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not being bedridden.2

HNSCC = head and neck squamous cell carcinoma; ADL = activities of daily living.

Hyperthyroidism

MONITORING for Hyperthyroidism

Monitor Patients

Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders.

  • Incidence (all grades): 3.4% of 2,799 patients receiving KEYTRUDA in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010
  • Discontinuation rate: <0.1%
  • Median time to onset: 1.4 months (range: 1 day to 21.9 months)
  • Median duration: 2.1 months (range: 3 days to 15.0+ months)

Thyroiditis occurred in 16 (0.6%) of 2,799 patients receiving KEYTRUDA, including Grade 2 (0.3%) thyroiditis. The median time to onset was 1.2 months (range: 0.5 to 3.5 months).

Ask Patients to
Immediately Report

Ask patients to immediately report hormone gland problems, such as:

  • Rapid heartbeat
  • Weight loss or weight gain
  • Increased sweating
  • Feeling more hungry or thirsty
  • Urinating more often than usual
  • Hair loss
  • Feeling cold
  • Constipation
  • Deepening voice
  • Muscle aches
  • Dizziness or fainting
  • Headaches that will not go away or unusual headache

MANAGING Hyperthyroidism

Evaluate
  • Grade 2: Symptomatic; thyroid suppression therapy indicated; limiting instrumental ADL2,a
  • Grade 3: Severe symptoms; limiting self-care ADL2,b; hospitalization indicated
  • Grade 4: Life-threatening consequences; urgent intervention indicated2

Ensure adequate evaluation to confirm etiology or exclude other causes.

Manage
  • Grade 2: Manage with thionamides and beta-blockers as appropriate.
  • Grade 3 or 4: Withhold or discontinue KEYTRUDA; manage with thionamides and beta-blockers as appropriate.
  • Also permanently discontinue KEYTRUDA for any of the following:
    • Any severe or Grade 3 treatment-related adverse reaction that recurs

aInstrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.2

bSelf-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not being bedridden.2

ADL = activities of daily living.

Type 1 diabetes

MONITORING for Type 1 diabetes

Monitor Patients

Monitor patients for hyperglycemia or other signs and symptoms of type 1 diabetes mellitus (including diabetic ketoacidosis).

  • Incidence (all grades): 0.2% of 2,799 patients receiving KEYTRUDA in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010
Ask Patients to
Immediately Report
  • Rapid heartbeat
  • Weight loss or weight gain
  • Increased sweating
  • Feeling more hungry or thirsty
  • Urinating more often than usual
  • Hair loss
  • Feeling cold
  • Constipation
  • Deepening voice
  • Muscle aches
  • Dizziness or fainting
  • Headaches that will not go away or unusual headache

MANAGING Type 1 diabetes

Evaluate
  • Grade 2: Change in daily management from baseline for a diabetic; oral antiglycemic agent initiated; workup for diabetes2
  • Grade 3: Insulin therapy initiated; hospitalization indicated2
  • Grade 4: Life-threatening consequences; urgent intervention indicated2

Ensure adequate evaluation to confirm etiology or exclude other causes.

Manage
  • Type 1 diabetes: Administer insulin.
  • Severe hyperglycemia: Withhold KEYTRUDA; administer anti-hyperglycemics.
  • Permanently discontinue KEYTRUDA for any of the following:
    • Any severe or Grade 3 treatment-related adverse reaction that recurs
Nephritis and renal dysfunction

MONITORING for Nephritis and renal dysfunction

Monitor Patients

Monitor patients for changes in renal function.

  • Incidence (all grades): 0.3% of 2,799 patients receiving KEYTRUDA in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010
  • Discontinuation rate: 0.1%
  • Median time to onset: 5.1 months (range: 12 days to 12.8 months)
  • Median duration: 3.3 months (range: 12 days to 8.9+ months)
Ask Patients to
Immediately Report
  • Change in amount or color of urine

MANAGING Nephritis and renal dysfunction

Evaluate
  • Grade 2: Creatinine increased >1.5–3.0 x baseline; >1.5–3.0 x ULN2
  • Grade 3: Creatinine increased >3.0 x baseline; >3.0–6.0 x ULN2
  • Grade 4: Creatinine increased >6.0 x ULN2

Ensure adequate evaluation to confirm etiology or exclude other causes.

Manage
  • Grade 2: Withhold KEYTRUDA; administer corticosteroids (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper).
    • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.a
    • Resume KEYTRUDA when the immune-mediated adverse reaction remains at Grade 1 or less following corticosteroid taper.
  • Grade 3 or 4: Permanently discontinue KEYTRUDA; administer corticosteroids.
  • Also permanently discontinue KEYTRUDA for any of the following:
    • Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks
    • Persistent Grade 2 adverse reactions that do not recover to Grade 0–1 within 12 weeks after last dose of KEYTRUDA

aBased on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered.

ULN = upper limit of normal.

Skin reactions

MONITORING for Skin reactions

Monitor Patients
  • Immune-mediated rashes, including exfoliative dermatitis and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and exclude other causes.
Ask Patients to
Immediately Report
  • Rash
  • Itching
  • Skin blistering, peeling, or sores
  • Ulcers in mouth or in lining of nose, throat, or genital area

MANAGING Skin reactions

Evaluate

Rash maculopapular2:

  • Grade 1: Macules/papules covering <10% BSA with or without symptoms (eg, pruritus, burning, tightness)
  • Grade 2: Macules/papules covering 10%–30% BSA with or without symptoms (eg, pruritus, burning, tightness); instrumental limiting ADLa; rash covering >30% BSA with or without mild symptoms
  • Grade 3: Macules/papules covering >30% BSA with moderate or severe symptoms; limiting self-care ADLb

Bullous dermatitis2:

  • Grade 1: Asymptomatic; blisters covering <10% BSA
  • Grade 2: Blisters covering 10%–30% BSA; painful blisters; limiting instrumental ADL
  • Grade 3: Blisters covering >30% BSA; limiting self-care ADL
  • Grade 4: Blisters covering >30% BSA; associated with fluid or electrolyte abnormalities; ICU care or burn unit indicated
Manage
  • Grade 3: Withhold and administer corticosteroids followed by a taper.
    • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.c
    • Resume when the immune-mediated adverse reaction remains at Grade 1 or less following corticosteroid taper.
  • Grade 4: Permanently discontinue and administer corticosteroids followed by a taper.
    • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.c
  • Also permanently discontinue KEYTRUDA for any of the following:
    • Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks
    • Persistent Grade 2 or 3 adverse reactions that do not recover to Grade 0–1 within 12 weeks after last dose of KEYTRUDA
    • Any severe or Grade 3 treatment-related adverse reaction that recurs

aInstrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.2

bSelf-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not being bedridden.2

cBased on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered.

BSA = body surface area; ADL = activities of daily living; ICU = intensive care unit.

Stevens-Johnson syndrome/​toxic epidermal necrolysis

MANAGING SJS/TEN

Evaluate

SJS2:

  • Grade 3: Skin sloughing covering <10% BSA with associated signs (eg, erythema, purpura, epidermal detachment, and mucous membrane detachment)
  • Grade 4: Skin sloughing covering 10%–30% BSA with associated signs (eg, erythema, purpura, epidermal detachment, and mucous membrane detachment)

TEN2:

  • Grade 4: Skin sloughing covering ≥30% BSA with associated symptoms (eg, erythema, purpura, or epidermal detachment)
Ask Patients to
Immediately Report
  • Rash
  • Itching
  • Blisters, peeling, or skin sores
  • Painful sores or ulcers in the mouth or in the nose, throat, or genital area
Manage

SJS or TEN:

  • Signs and symptoms of SJS or TEN (suspected SJS or TEN): Withhold and refer the patient for specialized care for assessment and treatment.
  • Confirmed SJS or TEN: Permanently discontinue.

SJS = Stevens-Johnson syndrome; TEN = toxic epidermal necrolysis; BSA = body surface area.

Other immune-mediated
adverse reactions

MONITORING for Other immune-mediated adverse reactions

Monitor Patients
  • These immune-mediated reactions may occur in any organ system.
  • For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes.
  • Monitor patients for signs and symptoms of solid organ transplant rejection. Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients.
Ask Patients to
Immediately Report
  • Changes in eyesight
  • Severe or persistent muscle or joint pains
  • Severe muscle weakness
  • Low red blood cells (anemia)
  • Shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis)
  • Signs and symptoms of organ transplant rejection

MANAGING Other immune-mediated adverse reactions

Evaluate
  • For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids.
Manage
  • Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper).
  • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.a
  • Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immuno­suppressants can be considered.
  • Resume KEYTRUDA when the immune-mediated adverse reaction remains at Grade 1 or less following corticosteroid taper.

Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

aBased on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered.

Infusion-related reactions

MONITORING for Infusion-related reactions

Monitor Patients

Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever.

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis.

  • Incidence (all grades): 6 (0.2%) of 2,799 patients receiving KEYTRUDA in KEYNOTE-001, KEYNOTE-002, and KEYNOTE-006
Ask Patients to
Immediately Report
  • Chills or shaking
  • Shortness of breath or wheezing
  • Itching or rash
  • Flushing
  • Dizziness
  • Fever
  • Feeling like passing out

MANAGING Infusion-related reactions

Evaluate

Infusion-related reactions:

  • Grade 1: Mild transient reaction; infusion interruption not indicated; intervention not indicated2
  • Grade 2: Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDs, narcotics, IV fluids); prophylactic medications indicated for ≤24 hrs2
  • Grade 3: Prolonged (eg, not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae2
  • Grade 4: Life-threatening consequences; urgent intervention indicated2

Anaphylaxis:

  • Grade 3: Symptomatic bronchospasm, with or without urticaria; parenteral intervention indicated; allergy-related edema/angioedema; hypotension2
  • Grade 4: Life-threatening consequences; urgent intervention indicated2

NSAIDs = nonsteroidal anti-inflammatory drugs.

Manage
  • Grade 3 or 4: Stop infusion and permanently discontinue KEYTRUDA.

NSAIDs = nonsteroidal anti-inflammatory drugs.

Allogeneic HSCT

MONITORING for Allogeneic HSCT

Monitor Patients

Monitor patients for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3–4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions.

  • Incidence: Of 23 patients with cHL who proceeded to allogeneic HSCT after treatment with KEYTRUDA on any trial, 6 patients (26%) developed GVHD, one of which was fatal, and 2 patients (9%) developed severe hepatic VOD after reduced-intensity conditioning, one of which was fatal. Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor-blocking antibody before transplantation.
  • These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.
  • In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after treatment with KEYTRUDA. Consider the benefit of treatment with KEYTRUDA versus the risk of possible GVHD in patients with a history of allogeneic HSCT.

MANAGING Allogeneic HSCT

Evaluate
  • Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3–4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions.

Ensure adequate evaluation to confirm etiology or exclude other causes.

Manage
  • Intervene promptly.

GVHD = graft-versus-host disease; VOD = veno-occlusive disease; cHL = classical Hodgkin lymphoma; HSCT = hematopoietic stem cell transplantation; PD-1 = programmed death receptor-1.

Hematological toxicity in
patients with cHL

MANAGING Hematological toxicity in patients with cHL or PMBCL

Manage
  • Grade 4: Withhold KEYTRUDA.

cHL = classical Hodgkin lymphoma.


ALL INDICATIONS

  • ADVANCED MELANOMA:KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
  • FIRST-LINE MONOTHERAPY:KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC)NSCLC whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
  • SECOND-LINE OR GREATER MONOTHERAPY:KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
  • FIRST-LINE COMBINATION THERAPY:KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC)NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
  • RECURRENT OR METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA ON OR AFTER PLATINUM-CONTAINING CHEMOTHERAPY:KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
  • REFRACTORY OR RELAPSED cHL:KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
  • REFRACTORY OR RELAPSED PMBCL:KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
  • FIRST-LINE MONOTHERAPY—CISPLATIN INELIGIBLE:KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • SECOND-LINE MONOTHERAPY—POST–PLATINUM FAILURE:KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  • ADVANCED MSI-H/dMMR CANCERS:KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
    • solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
    • colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
    This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
  • ADVANCED GASTRIC OR GEJ CANCER:KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
  • ADVANCED CERVICAL CANCER:KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
PD-L1 = programmed death ligand 1;
EGFR = epidermal growth factor receptor;
ALK = anaplastic lymphoma kinase;
HER2/neu = human epidermal growth factor receptor 2.
mNSCLC = metastatic NSCLC; 
PD-L1 = programmed death ligand 1;
EGFR = epidermal growth factor receptor;
ALK = anaplastic lymphoma kinase.
PD-L1 = programmed death ligand 1;
HER2/neu = human epidermal growth factor receptor 2.
SELECTED SAFETY INFORMATION for KEYTRUDA® (pembrolizumab)
  • KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 94 (3.4%) of 2799 patients receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%) pneumonitis, and occurred more frequently in patients with a history of prior thoracic radiation (6.9%) compared to those without (2.9%). Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.
  • KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 48 (1.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%) colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.
  • KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 19 (0.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%) hepatitis. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.
  • KEYTRUDA can cause hypophysitis. Hypophysitis occurred in 17 (0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%) hypophysitis. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3 or 4 hypophysitis.
  • KEYTRUDA can cause thyroid disorders, including hyperthyroidism, hypothyroidism, and thyroiditis. Hyperthyroidism occurred in 96 (3.4%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.8%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 237 (8.5%) of 2799 patients receiving KEYTRUDA, including Grade 2 (6.2%) and 3 (0.1%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in patients with HNSCC, occurring in 28 (15%) of 192 patients with HNSCC, including Grade 3 (0.5%) hypothyroidism. Thyroiditis occurred in 16 (0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.3%) thyroiditis. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism.
  • KEYTRUDA can cause type 1 diabetes mellitus, including diabetic ketoacidosis, which have been reported in 6 (0.2%) of 2799 patients. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.
  • KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 9 (0.3%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.
  • Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.
  • Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA. While immune-mediated adverse reactions usually occur during treatment with PD-1/PD-L1 blocking antibodies, they may occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.
  • The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma (cHL), and postmarketing use.
  • Solid organ transplant rejection has been reported in postmarketing use of KEYTRUDA. Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment with KEYTRUDA vs the risk of possible organ rejection in these patients.
  • KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 6 (0.2%) of 2799 patients. Monitor patients for signs and symptoms of infusion-related reactions, including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.
  • Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 developed graft-versus-host disease (GVHD) (one fatal case) and 2 developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (one fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor–blocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.
  • In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.
  • In clinical trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled clinical trials.
  • Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.
  • In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). Adverse reactions leading to interruption of KEYTRUDA occurred in 21% of patients; the most common (≥1%) was diarrhea (2.5%). The most common adverse reactions with KEYTRUDA vs ipilimumab were fatigue (28% vs 28%), diarrhea (26% with KEYTRUDA), rash (24% vs 23%), and nausea (21% with KEYTRUDA). Corresponding incidence rates are listed for ipilimumab only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.
  • In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC. The most common adverse event resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.8%). Adverse reactions leading to interruption of KEYTRUDA occurred in 23% of patients; the most common (≥1%) were diarrhea (1%), fatigue (1.3%), pneumonia (1%), liver enzyme elevation (1.2%), decreased appetite (1.3%), and pneumonitis (1%). The most common adverse reactions (occurring in at least 20% of patients and at a higher incidence than with docetaxel) were decreased appetite (25% vs 23%), dyspnea (23% vs 20%), and nausea (20% vs 18%).
  • In KEYNOTE-021(G1), when KEYTRUDA was administered in combination with carboplatin and pemetrexed (carbo/pem) in advanced nonsquamous NSCLC, KEYTRUDA was discontinued in 10% of 59 patients. The most common adverse reaction resulting in discontinuation of KEYTRUDA (≥2%) was acute kidney injury (3.4%). Adverse reactions leading to interruption of KEYTRUDA occurred in 39% of patients; the most common (≥2%) were fatigue (8%), neutrophil count decreased (8%), anemia (5%), dyspnea (3.4%), and pneumonitis (3.4%). The most common adverse reactions (≥20%) with KEYTRUDA compared to carbo/pem alone were fatigue (71% vs 50%), nausea (68% vs 56%), constipation (51% vs 37%), rash (42% vs 21%), vomiting (39% vs 27%), dyspnea (39% vs 21%), diarrhea (37% vs 23%), decreased appetite (31% vs 23%), headache (31% vs 16%), cough (24% vs 18%), dizziness (24% vs 16%), insomnia (24% vs 15%), pruritus (24% vs 4.8%), peripheral edema (22% vs 18%), dysgeusia (20% vs 11%), alopecia (20% vs 3.2%), upper respiratory tract infection (20% vs 3.2%), and arthralgia (15% vs 24%). This study was not designed to demonstrate a statistically significant difference in adverse reaction rates for KEYTRUDA as compared to carbo/pem alone for any specified adverse reaction.
  • In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (reported in at least 20% of patients) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC, with the exception of increased incidences of facial edema (10% all Grades; 2.1% Grades 3 or 4) and new or worsening hypothyroidism.
  • In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL, and treatment was interrupted due to adverse reactions in 26% of patients. Fifteen percent (15%) of patients had an adverse reaction requiring systemic corticosteroid therapy. Serious adverse reactions occurred in 16% of patients. The most frequent serious adverse reactions (≥1%) included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; one from GVHD after subsequent allogeneic HSCT and one from septic shock. The most common adverse reactions (occurring in ≥20% of patients) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).
  • In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL, and treatment was interrupted due to adverse reactions in 15%. Twenty-five percent (25%) of patients had an adverse reaction requiring systemic corticosteroid therapy. Serious adverse reactions occurred in 26% of patients and included: arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (occurring in ≥20% of patients) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).
  • In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reactions (in ≥20% of patients) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%). Eighteen patients (5%) died from causes other than disease progression. Five patients (1.4%) who were treated with KEYTRUDA experienced sepsis which led to death, and 3 patients (0.8%) experienced pneumonia which led to death. Adverse reactions leading to interruption of KEYTRUDA occurred in 22% of patients; the most common (≥1%) were liver enzyme increase, diarrhea, urinary tract infection, acute kidney injury, fatigue, joint pain, and pneumonia. Serious adverse reactions occurred in 42% of patients, the most frequent (≥2%) of which were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis.
  • In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Adverse reactions leading to interruption of KEYTRUDA occurred in 20% of patients; the most common (≥1%) were urinary tract infection (1.5%), diarrhea (1.5%), and colitis (1.1%). The most common adverse reactions (≥20%) in patients who received KEYTRUDA vs those who received chemotherapy were fatigue (38% vs 56%), musculoskeletal pain (32% vs 27%), pruritus (23% vs 6%), decreased appetite (21% vs 21%), nausea (21% vs 29%), and rash (20% vs 13%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients, the most frequent (≥2%) of which were urinary tract infection, pneumonia, anemia, and pneumonitis.
  • In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients (in Cohort E) with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA. The most frequent serious adverse reactions reported included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (occurring in ≥20% of patients) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).
  • It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.
  • There is limited experience in pediatric patients. In a study, 40 pediatric patients (16 children aged 2 years to younger than 12 years and 24 adolescents aged 12 years to 18 years) with advanced melanoma, lymphoma, or PD-L1–positive advanced, relapsed, or refractory solid tumors were administered KEYTRUDA 2 mg/kg every 3 weeks. Patients received KEYTRUDA for a median of 3 doses (range 1–17 doses), with 34 patients (85%) receiving 2 doses or more. The safety profile in these pediatric patients was similar to that seen in adults treated with KEYTRUDA. Toxicities that occurred at a higher rate (≥15% difference) in these patients when compared to adults under 65 years of age were fatigue (45%), vomiting (38%), abdominal pain (28%), hypertransaminasemia (28%), and hyponatremia (18%).
HNSCC = head and neck squamous cell carcinoma; PD-1 = programmed death receptor-1; PD-L1 = programmed death ligand 1; NSCLC = non–small cell lung cancer. Before prescribing KEYTRUDA, please read the accompanying Prescribing Information. The Medication Guide also is available.

References:
  1. Teply BA, Lipson EJ. Identification and management of toxicities from immune checkpoint–blocking drugs. Oncology (Williston Park). 2014;28(suppl 3):30–38.
  2. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE); v5.0. Bethesda, MD: National Cancer Institute 2017. NIH publication 09-5410. Updated version CTCAE v5.0 published November 27, 2017.


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