Pembrolizumab

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

  1. bladder cancer
  2. cervical cancer
  3. colorectal cancer
  4. endometrial cancer
  5. esophageal cancer
  6. gastric cancer
  7. head and neck cancer
  8. hepatocellular cancer
  9. Hodgkin lymphoma
  10. malignant melanoma
  11. Merkel cell carcinoma
  12. microsatellite instability-high solid tumors
  13. mismatch repair deficient solid tumors
  14. non-Hodgkin’s lymphoma (NHL)
  15. non-small cell lung cancer (NSCLC)
  16. renal cell cancer
  17. small cell lung cancer (SCLC)
  18. squamous cell skin carcinoma
  19. tumor mutational burden-high solid tumors
  20. urothelial carcinoma

Side Effects

  1. abdominal pain
  2. abdominal pain
  3. acneiform rash
  4. acneiform rash
  5. adrenocortical insufficiency
  6. adrenocortical insufficiency
  7. alopecia
  8. anaphylactoid reactions
  9. anemia
  10. anemia
  11. anorexia
  12. anorexia
  13. antibody formation
  14. arthralgia
  15. arthralgia
  16. ascites
  17. asthenia
  18. asthenia
  19. atopic dermatitis
  20. atopic dermatitis
  21. atrial fibrillation
  22. back pain
  23. back pain
  24. bleeding
  25. bleeding
  26. bone pain
  27. bullous rash
  28. candidiasis
  29. cardiac tamponade
  30. chills
  31. colitis
  32. colitis
  33. confusion
  34. constipation
  35. constipation
  36. contact dermatitis
  37. contact dermatitis
  38. cough
  39. cough
  40. dental pain
  41. diabetes mellitus
  42. diabetic ketoacidosis
  43. diarrhea
  44. diarrhea
  45. dizziness
  46. dizziness
  47. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
  48. dysesthesia
  49. dysphagia
  50. dysphagia
  51. dysphonia
  52. dysphonia
  53. dyspnea
  54. dyspnea
  55. edema
  56. elevated hepatic enzymes
  57. elevated hepatic enzymes
  58. enterocolitis
  59. epistaxis
  60. erythema
  61. erythema
  62. exfoliative dermatitis
  63. fatigue
  64. fatigue
  65. fever
  66. fever
  67. flank pain
  68. flushing
  69. folliculitis
  70. folliculitis
  71. GI bleeding
  72. GI perforation
  73. graft-versus-host disease (GVHD)
  74. Guillain-Barre syndrome
  75. headache
  76. headache
  77. heart failure
  78. hematemesis
  79. hematuria
  80. hematuria
  81. hemolytic anemia
  82. hemoptysis
  83. hepatitis
  84. hepatitis
  85. hepatotoxicity
  86. hepatotoxicity
  87. hyperamylasemia
  88. hyperamylasemia
  89. hyperbilirubinemia
  90. hyperbilirubinemia
  91. hypercalcemia
  92. hypercalcemia
  93. hypercholesterolemia
  94. hypercholesterolemia
  95. hyperglycemia
  96. hyperglycemia
  97. hyperkalemia
  98. hypermagnesemia
  99. hypertension
  100. hypertension
  101. hypertensive crisis
  102. hyperthyroidism
  103. hyperthyroidism
  104. hypertriglyceridemia
  105. hypertriglyceridemia
  106. hypoalbuminemia
  107. hypoalbuminemia
  108. hypocalcemia
  109. hypocalcemia
  110. hypoesthesia
  111. hypoglycemia
  112. hypoglycemia
  113. hypokalemia
  114. hypokalemia
  115. hypomagnesemia
  116. hypomagnesemia
  117. hyponatremia
  118. hyponatremia
  119. hypophosphatemia
  120. hypophosphatemia
  121. hypophysitis
  122. hypophysitis
  123. hypopituitarism
  124. hypotension
  125. hypothyroidism
  126. hypothyroidism
  127. infection
  128. infection
  129. influenza
  130. infusion-related reactions
  131. infusion-related reactions
  132. insomnia
  133. insomnia
  134. interstitial nephritis
  135. interstitial nephritis
  136. intracranial bleeding
  137. intraventricular hemorrhage
  138. lethargy
  139. lethargy
  140. leukoencephalopathy
  141. leukopenia
  142. leukopenia
  143. lymphopenia
  144. lymphopenia
  145. maculopapular rash
  146. maculopapular rash
  147. malaise
  148. malaise
  149. metabolic acidosis
  150. metabolic acidosis
  151. musculoskeletal pain
  152. musculoskeletal pain
  153. myalgia
  154. myalgia
  155. myasthenia
  156. myelitis
  157. myocardial infarction
  158. myocarditis
  159. nausea
  160. nausea
  161. neutropenia
  162. neutropenia
  163. organ transplant rejection
  164. osteomyelitis
  165. palmar-plantar erythrodysesthesia (hand and foot syndrome)
  166. pancreatitis
  167. paresthesias
  168. pelvic pain
  169. pericardial effusion
  170. pericarditis
  171. peripheral edema
  172. peripheral edema
  173. peripheral neuropathy
  174. pharyngitis
  175. pleural effusion
  176. pneumonitis
  177. pneumonitis
  178. prolonged bleeding time
  179. prolonged bleeding time
  180. pruritus
  181. pruritus
  182. pulmonary embolism
  183. rash
  184. rash
  185. renal failure (unspecified)
  186. rhinitis
  187. rhinorrhea
  188. seborrhea
  189. sinus tachycardia
  190. sinus tachycardia
  191. sinusitis
  192. sinusoidal obstruction syndrome (SOS)
  193. skin hypopigmentation
  194. skin ulcer
  195. Stevens-Johnson syndrome
  196. stomatitis
  197. stomatitis
  198. supraventricular tachycardia (SVT)
  199. supraventricular tachycardia (SVT)
  200. syncope
  201. thrombocytopenia
  202. thrombocytopenia
  203. toxic epidermal necrolysis
  204. uveitis
  205. vaginal bleeding
  206. vasculitis
  207. veno-occlusive disease (VOD)
  208. vomiting
  209. vomiting
  210. weakness
  211. weight loss
  212. weight loss
  213. 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. 

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