Pembrolizumab Brand Name– Keytruda
What is Pembrolizumab
Pembrolizumab is a programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by preventing the interaction between PD-1 and the PD-L1 and PD-L2 ligands.
It is indicated for the treatment of certain types of endometrial cancer, esophageal cancer, melanoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), gastric cancer, Hodgkin lymphoma, head and neck cancer, hepatocellular cancer, urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors (including colorectal cancer), cervical cancer, primary mediastinal large B-cell lymphoma (PMBCL), Merkel cell carcinoma, cutaneous squamous cell carcinoma (cSCC), renal cell carcinoma, and tumor mutational burden-high (TMB-H) solid tumors.
Patients with cervical cancer, esophageal cancer, gastric cancer, head and neck cancer, NSCLC, and urothelial cancer receiving pembrolizumab monotherapy should have PD-L1 expression confirmed by an FDA-approved test.
Pembrolizumab is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy; additionally, safety and effectiveness have not been established in pediatric patients with MSI-H.
The FDA-approved indication for pembrolizumab is restricted in patients with cisplatin-ineligible advanced urothelial cancer to patients with high tumor expression of PD-L1. In an ongoing multicenter, randomized trial in previously untreated patients with metastatic urothelial carcinoma who are eligible for platinum-containing chemotherapy (KEYNOTE-361), patients with low levels of PD-L1 expression (Combined Positive Score (CPS), less than 10%) had decreased survival with pembrolizumab monotherapy compared to those who received platinum-based chemotherapy; the monotherapy arm of this trial was closed to accrual for patients with low PD-L1 expression upon the recommendation of the independent Data Monitoring Committee.
Immune-mediated adverse reactions including colitis, pneumonitis, hepatitis, hypophysitis, nephritis, hypothyroidism/hyperthyroidism, and encephalitis have been reported with pembrolizumab use; treatment with high-dose corticosteroids may be necessary for patients who develop immune-mediated toxicity
Indications
- bladder cancer
- cervical cancer
- colorectal cancer
- endometrial cancer
- esophageal cancer
- gastric cancer
- head and neck cancer
- hepatocellular cancer
- Hodgkin lymphoma
- malignant melanoma
- Merkel cell carcinoma
- microsatellite instability-high solid tumors
- mismatch repair deficient solid tumors
- non-Hodgkin’s lymphoma (NHL)
- non-small cell lung cancer (NSCLC)
- renal cell cancer
- small cell lung cancer (SCLC)
- squamous cell skin carcinoma
- tumor mutational burden-high solid tumors
- urothelial carcinoma
Side Effects
- abdominal pain
- abdominal pain
- acneiform rash
- acneiform rash
- adrenocortical insufficiency
- adrenocortical insufficiency
- alopecia
- anaphylactoid reactions
- anemia
- anemia
- anorexia
- anorexia
- antibody formation
- arthralgia
- arthralgia
- ascites
- asthenia
- asthenia
- atopic dermatitis
- atopic dermatitis
- atrial fibrillation
- back pain
- back pain
- bleeding
- bleeding
- bone pain
- bullous rash
- candidiasis
- cardiac tamponade
- chills
- colitis
- colitis
- confusion
- constipation
- constipation
- contact dermatitis
- contact dermatitis
- cough
- cough
- dental pain
- diabetes mellitus
- diabetic ketoacidosis
- diarrhea
- diarrhea
- dizziness
- dizziness
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- dysesthesia
- dysphagia
- dysphagia
- dysphonia
- dysphonia
- dyspnea
- dyspnea
- edema
- elevated hepatic enzymes
- elevated hepatic enzymes
- enterocolitis
- epistaxis
- erythema
- erythema
- exfoliative dermatitis
- fatigue
- fatigue
- fever
- fever
- flank pain
- flushing
- folliculitis
- folliculitis
- GI bleeding
- GI perforation
- graft-versus-host disease (GVHD)
- Guillain-Barre syndrome
- headache
- headache
- heart failure
- hematemesis
- hematuria
- hematuria
- hemolytic anemia
- hemoptysis
- hepatitis
- hepatitis
- hepatotoxicity
- hepatotoxicity
- hyperamylasemia
- hyperamylasemia
- hyperbilirubinemia
- hyperbilirubinemia
- hypercalcemia
- hypercalcemia
- hypercholesterolemia
- hypercholesterolemia
- hyperglycemia
- hyperglycemia
- hyperkalemia
- hypermagnesemia
- hypertension
- hypertension
- hypertensive crisis
- hyperthyroidism
- hyperthyroidism
- hypertriglyceridemia
- hypertriglyceridemia
- hypoalbuminemia
- hypoalbuminemia
- hypocalcemia
- hypocalcemia
- hypoesthesia
- hypoglycemia
- hypoglycemia
- hypokalemia
- hypokalemia
- hypomagnesemia
- hypomagnesemia
- hyponatremia
- hyponatremia
- hypophosphatemia
- hypophosphatemia
- hypophysitis
- hypophysitis
- hypopituitarism
- hypotension
- hypothyroidism
- hypothyroidism
- infection
- infection
- influenza
- infusion-related reactions
- infusion-related reactions
- insomnia
- insomnia
- interstitial nephritis
- interstitial nephritis
- intracranial bleeding
- intraventricular hemorrhage
- lethargy
- lethargy
- leukoencephalopathy
- leukopenia
- leukopenia
- lymphopenia
- lymphopenia
- maculopapular rash
- maculopapular rash
- malaise
- malaise
- metabolic acidosis
- metabolic acidosis
- musculoskeletal pain
- musculoskeletal pain
- myalgia
- myalgia
- myasthenia
- myelitis
- myocardial infarction
- myocarditis
- nausea
- nausea
- neutropenia
- neutropenia
- organ transplant rejection
- osteomyelitis
- palmar-plantar erythrodysesthesia (hand and foot syndrome)
- pancreatitis
- paresthesias
- pelvic pain
- pericardial effusion
- pericarditis
- peripheral edema
- peripheral edema
- peripheral neuropathy
- pharyngitis
- pleural effusion
- pneumonitis
- pneumonitis
- prolonged bleeding time
- prolonged bleeding time
- pruritus
- pruritus
- pulmonary embolism
- rash
- rash
- renal failure (unspecified)
- rhinitis
- rhinorrhea
- seborrhea
- sinus tachycardia
- sinus tachycardia
- sinusitis
- sinusoidal obstruction syndrome (SOS)
- skin hypopigmentation
- skin ulcer
- Stevens-Johnson syndrome
- stomatitis
- stomatitis
- supraventricular tachycardia (SVT)
- supraventricular tachycardia (SVT)
- syncope
- thrombocytopenia
- thrombocytopenia
- toxic epidermal necrolysis
- uveitis
- vaginal bleeding
- vasculitis
- veno-occlusive disease (VOD)
- vomiting
- vomiting
- weakness
- weight loss
- weight loss
- wheezing
Monitoring Parameters
- blood glucose
- CBC with differential
- LFTs
- pregnancy testing
- serum bilirubin
- serum creatinine/BUN
- thyroid function tests (TFTs)
Contraindications
- adrenal insufficiency
- allogeneic stem cell transplant
- anemia
- asthma
- breast-feeding
- children
- chronic obstructive pulmonary disease (COPD)
- colitis
- contraception requirements
- diabetes mellitus
- diabetic ketoacidosis
- Guillain-Barre syndrome
- hemolytic anemia
- hepatic disease
- hepatitis
- hepatotoxicity
- hyperglycemia
- hyperthyroidism
- hypophysitis
- hypopituitarism
- hypothyroidism
- immune-mediated reactions
- infusion-related reactions
- multiple myeloma
- myasthenia gravis
- myocarditis
- neutropenia
- organ transplant
- pancreatitis
- pneumonitis
- pregnancy
- pregnancy testing
- radiation therapy
- renal failure
- renal impairment
- reproductive risk
- sarcoidosis
- serious rash
- sinusoidal obstruction syndrome (SOS)
- thrombocytopenia
- treatment outside of a clinical trial
- type 1 diabetes mellitus
- uveitis
- vasculitis
- veno-occlusive disease (VOD)
Interactions
- Palifermin
- Penicillamine
- Tuberculin Purified Protein Derivative, PPD
Palifermin: (Moderate) Palifermin should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of antineoplastic agents.
Penicillamine: (Major) Do not use penicillamine with antineoplastic agents due to the increased risk of developing severe hematologic and renal toxicity.
Tuberculin Purified Protein Derivative, PPD: (Moderate) Immunosuppressives may decrease the immunological response to tuberculin purified protein derivative, PPD. This suppressed reactivity can persist for up to 6 weeks after treatment discontinuation. Consider deferring the skin test until completion of the immunosuppressive therapy.