Keytruda

Keytruda

pembrolizumab

Manufacturer:

Merck Sharp & Dohme

Distributor:

Merck Sharp & Dohme
Concise Prescribing Info
Contents
Pembrolizumab
Indications/Uses
Melanoma: Treatment of patients w/ unresectable or metastatic melanoma; adjuvant treatment of patients w/ melanoma w/ lymph node involvement who have undergone complete resection. Non-small cell lung cancer (NSCLC): As monotherapy for the 1st-line treatment of patients w/ locally advanced or metastatic NSCLC whose tumors express PD-L1 w/ a ≥1% tumor proportion score (TPS) as determined by a validated test, w/ no EGFR or ALK genomic tumor aberrations; in combination w/ pemetrexed & platinum chemotherapy for the 1st-line treatment of patients w/ metastatic non-squamous NSCLC, w/ no EGFR or ALK genomic tumor aberrations; in combination w/ carboplatin & either paclitaxel or nab-paclitaxel for the 1st-line treatment of patients w/ metastatic squamous NSCLC; as monotherapy for the treatment of patients w/ advanced NSCLC whose tumors express PD-L1 w/ a ≥1% TPS as determined by a validated test & who have received platinum-containing chemotherapy. Patient w/ EGFR or ALK genomic tumor aberrations should have received prior therapy for these aberrations prior to receiving Keytruda. Small cell lung cancer (SCLC): Treatment of patients w/ locally advanced or metastatic SCLC who have received ≥2 prior lines of therapy. Head & neck cancer: 1st-line treatment of patients w/ recurrent or metastatic head & neck squamous cell carcinoma (HNSCC) as a single agent or in combination w/ platinum & 5-fluorouracil (5-FU) chemotherapy. Classical Hodgkin lymphoma: Treatment of patients w/ refractory classical Hodgkin Lymphoma (cHL), or who have relapsed after ≥3 prior lines of therapy. Urothelial carcinoma: Treatment of patients w/ locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy & whose tumors express PD-L1 [combined +ve score (CPS) ≥10] as determined by a validated test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status; treatment of patients w/ locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy. Gastric cancer: Treatment of patients w/ recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [CPS ≥1] as determined by a validated test, w/ disease progression on or after ≥2 prior lines of therapy including fluoropyrimidine- & platinum-containing chemotherapy & if appropriate, HERS2/neu-targeted therapy. Esophageal cancer: Treatment of patients w/ recurrent locally advanced or metastatic esophageal cancer whose tumors express PD-L1 [combined +ve score (CPS) ≥10] as determined by a validated test, & who have receive 1 prior line of systemic therapy; treatment of patients w/ recurrent locally advanced or metastatic esophageal cancer who have received ≥2 prior lines of systemic therapy. Microsatellite instability-high cancer: Treatment of patients w/ advanced microsatellite instability-high (MSI-H) cancer including mismatch repair deficient (dMMR), cancer who have received prior therapy. Cervical cancer: Treatment of patients w/ recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by a validated test, w/ disease progression on or after chemotherapy. Hepatocellular carcinoma: Treatment of patients w/ hepatocellular carcinoma (HCC) who have been previously treated w/ an anti-angiogenic tyrosine kinase inhibitor (TKI). Renal cell carcinoma: 1st-line treatment of patients w/ advanced renal cell carcinoma (RCC) in combination w/ axitinib.
Dosage/Direction for Use
NSCLC that has been previously untreated, HNSCC, classical Hodgkin lymphoma, urothelial carcinoma, gastric cancer, esophageal cancer, MSI-H cancer, cervical cancer, HCC or for the adjuvant treatment of melanoma 200 mg over 30 min IV infusion every 3 wk until disease progression or unacceptable toxicity. NSCLC or HRCC in combination therapy 200 mg over 30 min IV infusion every 3 wk until disease progression or unacceptable toxicity. When used in combination, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of 6 wk or longer. Unresectable or metastatic melanoma or previously treated NSCLC 2 mg/kg IV infusion over 30 min every 3 wk until disease progression or unacceptable toxicity. Adjuvant treatment of melanoma Administer up to 1 yr or until disease recurrence or unacceptable toxicity.
Special Precautions
Monitor patients for signs & symptoms of immune-mediated adverse reactions: Withhold use for moderate grade 2 pneumonitis, grade 2 or 3 colitis, grade 2 nephritis, grade 2 hypophysitis (including hypopituitarism & secondary adrenal insufficiency), AST or ALT >3 to 5x ULN or total bilirubin >1.5 to 3x ULN. Permanently discontinue use if grade 3 or 4 pneumonitis or recurrent grade 2 pneumonitis, grade 4 or recurrent grade 3 colitis, severe liver enzyme elevations, grade 3 or 4 nephritis, grade 3 or 4 hypophysitis, grade 3 or 4 hyperthyroidism, AST or ALT >5x ULN or total bilirubin >3x ULN, severe skin reactions (eg, SJS, TEN), grade 3 myocarditis, encephalitis, or Guillain-Barre syndrome, & severe infusion-related reactions (eg, hypersensitivity, anaphylaxis) occur. Risk of possible organ rejection or possible GVHD in patients w/ a history of allogeneic HSCT. Embryofetal toxicity; use highly effective contraception during treatment & for at least 4 mth after last dose. Treatment of patients w/ multiple myeloma w/ PD-1 or PD-L1 blocking antibody in combination w/ a thalidomide analogue plus dexamethasone is not recommended. Concomitant use w/ axitinib for RCC. Pregnancy & lactation.
Adverse Reactions
Monotherapy: Immune-mediated adverse reactions eg, hypothyroidism, hyperthyroidism, pneumonitis, colitis, hepatitis, hypophysitis, nephritis, type 1 DM; diarrhea, pyrexia, arthralgia, back pain, cough, vitiligo, abdominal pain, pruritus, rash, hyponatremia. Combination therapy w/ pemetrexed & carboplatin: Fatigue, nausea, constipation, vomiting, diarrhea, rash, pruritus, alopecia, dyspnea, headache, upper resp tract infections. Uveitis, myositis, Guillain-Barre syndrome, pancreatitis, encephalitis, sarcoidosis & myasthenic syndrome/myasthenia gravis (including exacerbation). Eye disorders: Vogt-Koyanagi-harada syndrome.
Drug Interactions
Elevated liver enzymes w/ axitinib for RCC.
ATC Classification
L01XC18 - pembrolizumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Keytruda soln for inj 100 mg/4 mL
Packing/Price
10 mL x 1's
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