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Keytruda

Keytruda

pembrolizumab

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Pembrolizumab
Indications/Uses
Unresectable or metastatic melanoma. Adjuvant treatment of patients w/ melanoma w/ lymph node involvement who have undergone complete resection. As monotherapy for 1st-line treatment of patients w/ locally advanced or metastatic non-small cell lung carcinoma (NSCLC) whose tumors express PD-L1 w/ ≥1% tumor proportion score (TPS), w/ no EGFR or ALK genomic tumor aberrations. In combination w/ pemetrexed & platinum chemotherapy for 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 1st-line treatment of patients w/ metastatic squamous NSCLC. As monotherapy for advanced NSCLC whose tumors express PD-L1 w/ ≥1% TPS & who have received platinum-containing chemotherapy. Locally advanced or metastatic small cell lung cancer (SCLC) who have received ≥2 prior lines of therapy. 1st-line treatment of metastatic or unresectable recurrent head & neck squamous cell carcinoma (HNSCC) as monotherapy or in combination w/ platinum & 5-fluorouracil (5-FU) chemotherapy. As monotherapy for metastatic or unresectable recurrent HNSCC w/ disease progression on or after platinum-containing chemotherapy. Adult & ped patients w/ relapsed or refractory classical Hodgkin's lymphoma (cHL). Adult & ped patients w/ refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after ≥2 prior lines of therapy. Locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy & whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10], or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Locally advanced or metastatic urothelial carcinoma who have platinum-containing chemotherapy. BCG-unresponsive, high risk, non-muscle invasive bladder cancer (NMIBC) w/ carcinoma in-situ (CIS) w/ or w/o papillary tumors who are ineligible for or have elected not to undergo cystectomy. Hepatocellular carcinoma (HCC) previously treated w/ anti-angiogenic tyrosine kinase inhibitor (TKI). In combination w/ axitinib for 1st-line treatment of patients w/ advanced renal cell carcinoma (RCC). Advanced microsatellite instability-high (MSI-H), including mismatch repair deficient (dMMR), cancer who have received prior therapy. Recurrent locally advanced or metastatic esophageal cancer whose tumors express PD-L1 (CPS ≥10) & who have received 1 prior line of systemic therapy. Recurrent locally advanced or metastatic esophageal cancer who have received ≥2 prior lines of systemic therapy. Recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) w/ disease progression on or after chemotherapy. In combination w/ lenvatinib for advanced endometrial carcinoma that is not MSI-H or dMMR, w/ disease progression following prior systemic therapy & not candidate for curative surgery or radiation. Recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1), w/ disease progression on or after ≥2 prior lines of therapy including fluoropyrimidine- & platinum-containing chemotherapy & if appropriate, HER2/neu-targeted therapy. 1st-line treatment of patients w/ unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC). Adult & ped patients w/ unresectable or metastatic tumor mutational burden high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, that have progressed following prior treatment & who have no satisfactory alternative treatment options.
Dosage/Direction for Use
IV infusion Administer over 30 min. If administered as part of combination w/ IV chemotherapy, administer Keytruda 1st. Adult SCLC, head & neck cancer, cHL, PMBCL, urothelial carcinoma, gastric cancer, MSI-H cancer, esophageal cancer, HCC, RCC, cervical cancer, endometrial carcinoma, colorectal cancer, TMB-H cancer, previously untreated NSCLS or for adjuvant treatment of melanoma 200 mg every 3 wk or 400 mg every 6 wk. Melanoma or previously treated NSCLC 2 mg/kg every 3 wk. Adjuvant treatment of melanoma Administer up to 1 yr or until disease recurrence or unacceptable toxicity. RCC patients In combination w/ axitinib Dose escalation of axitinib above initial 5 mg dose may be considered at intervals of  ≥6 wk. Endometrial carcinoma patients In combination w/ lenvatinib Initial dose of oral lenvatinib is 20 mg once daily until disease progression or unacceptable toxicity. Ped patients cHL, PMBCL, TMB-H cancer 2 mg/kg (up to max of 200 mg) IV infusion over 30 min every 3 wk.
Special Precautions
Withhold therapy & consider administration of corticosteroids based on adverse reaction severity. Permanently discontinue therapy if another episode of severe adverse reaction occurs; Grade 3 or 4 or recurrent moderate (Grade 2) pneumonitis; Grade 4 colitis; Grade 3 or 4 nephritis; AST or ALT >5 x ULN or total bilirubin >3 x ULN; in patients w/ liver metastases who begin treatment w/ moderate Grade 2 elevation of AST or ALT, if AST or ALT increases ≥50% relative to baseline & lasts ≥1 wk; confirmed Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN); Grade 3 or 4 myocarditis, encephalitis & Guillain-Barré syndrome; for severe infusion reactions. Monitor for signs & symptoms of pneumonitis, colitis; for changes in liver function (start of treatment, periodically during treatment) & symptoms of hepatitis; for changes in renal function; for signs & symptoms of adrenal insufficiency & hypophysitis (including hypopituitarism); for hyperglycemia or other signs or symptoms of diabetes; for changes in thyroid function (start of treatment, periodically during treatment) & signs & symptoms of thyroid disorders; for suspected severe skin reactions; liver enzymes before initiation & periodically during treatment. Withhold therapy for Grade 2 pneumonitis, Grade 2 or 3 colitis; for Grade 2 adrenal insufficiency or hypophysitis; in cases of severe hyperglycemia until metabolic control is achieved; for signs or symptoms of SJS or TEN. Administer corticosteroids for ≥Grade 2 events of pneumonitis, colitis, nephritis; for Grade 2 or ≥Grade 3 hepatitis; to treat adrenal insufficiency & other hormone replacement. Withhold or discontinue based on liver enzyme elevations severity; for Grade 3 or 4 adrenal insufficiency or hypophysitis; for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes. Withhold or permanently discontinue & administer corticosteroids based on severity of skin reactions. May increase risk of rejection in solid organ transplant recipients. Risk of acute graft-versus-host-disease in patient w/ history of allogeneic hematopoietic stem cell transplant. Patients w/ multiple myeloma w/ PD-1 or PD-L1 blocking Ab in combination w/ thalidomide analogue + dexamethasone. Women of childbearing potential should use effective contraception during treatment & for at least 4 mth after the last dose. Pregnancy & lactation.
Adverse Reactions
Pneumonitis, colitis, diarrhea & pyrexia. Hypothyroidism, hyperthyroidism, adrenal insufficiency, hepatitis, hypophysitis, nephritis, type 1 DM. Arthralgia, back pain; cough; vitiligo. Abdominal pain; pruritus, rash; hyponatremia; arthralgia. Fatigue, asthenia; neutropenia. Dyspnea. Arthritis, Vogt-Koyanagi-Harada syndrome, hemophagocytic lymphohistiocytosis.
Drug Interactions
Potential interference w/ pharmacodynamic activity & efficacy w/ systemic corticosteroids or immunosuppressants.
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
1's
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