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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; stage IIB or IIC melanoma who have undergone complete resection in adult & ped ≥12 yr; adjuvant treatment of patients w/ melanoma w/ lymph node involvement who have undergone complete resection. Non-small cell lung cancer (NSCLC): 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 1st-line treatment of patients w/ locally advanced/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; 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 treatment. Small cell lung cancer (SCLC): Treatment of patients w/ locally advanced/metastatic SCLC who have received ≥2 prior lines of therapy. Head & neck cancer: 1st-line treatment of patients w/ metastatic or unresectable recurrent head & neck squamous cell carcinoma (HNSCC) as monotherapy or in combination w/ platinum & 5-fluorouracil (5-FU) chemotherapy; treatment of patients w/ metastatic or unresectable recurrent HNSCC w/ disease progression on or after platinum-containing chemotherapy. Classical Hodgkin lymphoma: Treatment of adult & ped w/ refractory classical Hodgkin lymphoma (cHL). Urothelial carcinoma: Treatment of patients w/ locally advanced/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/metastatic urothelial carcinoma who have received platinum-containing chemotherapy; treatment of patients w/ Bacillus Calmette-Guerin (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. Gastric cancer: 1st-line treatment of patients w/ locally advanced unresectable or metastatic HER2 +ve gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination w/ trastuzumab, fluoropyrimidine- & platinum containing chemotherapy; recurrent locally advanced/metastatic gastric or GEJ 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, HER2/neu-targeted therapy. Esophageal cancer: 1st-line treatment of patients w/ locally advanced unresectable or metastatic carcinoma of the esophagus or GEJ in combination w/ platinum & fluoropyrimidine based chemotherapy; treatment of patients w/ recurrent locally advanced/metastatic esophageal cancer whose tumors express PD-L1 [combined +ve score (CPS) ≥10] as determined by a validated test, & who have received 1 prior line of systemic therapy; treatment of patients w/ recurrent locally advanced/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) including mismatch repair deficient (dMMR), cancer who have received prior therapy. Colorectal cancer: 1st-line treatment of patients w/ unresectable or metastatic MSH-I or dMMR colorectal cancer (CRC). Hepatocellular carcinoma: Treatment of patients w/ hepatocellular carcinoma (HCC) who have been previously treated w/ anti-angiogenic tyrosine kinase inhibitor (TKI). Cervical cancer: Treatment of patients w/ persistent, recurrent or metastatic cervical cancer in combination w/ chemotherapy w/ or w/o bevacizumab; 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. Renal cell carcinoma: 1st-line treatment of patients w/ advanced renal cell carcinoma (RCC) in combination w/ axitinib; 1st-line treatment of patients w/ advanced RCC in combination w/ lenvatinib; adjuvant treatment of patients w/ RCC at intermediate-high or risk of recurrence following nephrectomy & resection of metastatic lesions. Endometrial carcinoma: Treatment of patients w/ advanced endometrial carcinoma who have disease progression following prior systemic therapy & not candidates for curative surgery or radiation in combination w/ lenvatinib. Tumor mutational burden-high cancer: Treatment of adult & ped w/ unresectable or metastatic tumor mutational burden-high (TMBH) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by a validated test, that have progressed following prior treatment & who have no satisfactory alternative treatment options. Triple -ve breast cancer: Treatment of patients w/ high-risk early-stage triple -ve breast cancer (TNBC) in combination w/ chemotherapy as neoadjuvant treatment, & then continued as monotherapy as adjuvant treatment after surgery; treatment of patients w/ locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CP ≥10) as determined by a validated test in combination w/ chemotherapy.
Dosage/Direction for Use
IV infusion over 30 min. Recommended dose: Adult 200 mg every 3 wk or 400 mg every 6 wk. NSCLC, urothelial carcinoma, gastric cancer, esophageal cancer, microsatellite instability-high cancer, cervical cancer 200 mg every 3 wk or 400 mg every 6 wk until disease progression or unacceptable toxicity. Administer 1st when part of a combination w/ IV chemotherapy. RCC patients in combination w/ axitinib Dose escalation of axitinib above initial dose 5 mg may be considered at intervals of >6 wk. Endometrial carcinoma in combination w/ lenvatinib Initially, lenvatinib 20 mg once daily until disease progression or unacceptable toxicity. Adjuvant treatment of melanoma or RCC Should be administered for up to 1 yr or until disease recurrence or unacceptable toxicity. Neoadjuvant & adjuvant treatment of high-risk early-stage TNBC: In combination w/ chemotherapy: 8 doses of 200 mg every 3 wk or 4 doses of 400 mg every 6 wk or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment w/ Keytruda; as monotherapy: 9 doses of 200 mg every 3 wk or 5 doses of 400 mg every 6 wk or until disease recurrence or unacceptable toxicity. Melanoma, cHL & TMB-H cancer in ped patients 2 mg/kg (up to max of 200 mg) as IV infusion over 30 min every 3 wk.
Special Precautions
Monitor for signs & symptoms of pneumonitis; colitis; changes in liver functions & symptoms of hepatitis; changes in renal function; adrenal insufficiencies & hypophysitis (including hypopituitarism). Type 1 DM including diabetic ketoacidosis; Hypo & hyperthyroidism & thyroiditis; history of allogenic hematopoietic stem cell (HSCT). Monitor patients for suspected severe skin reactions (SJS & TEN). Other immune-mediated adverse reactions eg, uveitis, myositis, Guillain-Barré syndrome, pancreatitis, encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis (including exacerbation), myelitis & vasculitis. Increased risk of rejection in solid organ transplant recipients. Monitor liver enzymes before initiation of & periodically throughout treatment. Not recommended outside of clinical trials in combination w/ thalidomide analogue & dexamethasone. Permanently discontinue in severe infusion reactions including hypersensitivity & anaphylaxis. Not recommended during pregnancy. Consider use of effective contraception in women of childbearing potential during treatment. Discontinue breastfeeding. Childn <12 yr.
Adverse Reactions
Immune mediated: Hypothyroidism, hyperthyroidism, pneumonitis, colitis, adrenal insufficiency, hepatitis, hypophysitis, nephritis, type 1 DM. Endocrinopathies. Others: Melanoma: Arthralgia & cough. NSCLC (combination therapy): Alopecia & arthralgia; monotherapy: dyspnea & cough. Other cancers: Head & neck cancer: Fatigue, mucosal inflammation & stomatitis; gastric cancer: vomiting, anemia, decreased platelet count & lymphopenia; cervical cancer: anemia, neutropenia, thrombocytopenia, asthenia; esophageal cancer: vomiting, stomatitis, decreased neutrophil count & blood cell count; renal cell carcinoma in combination w/ axitinib: diarrhea, HTN, fatigue, hypothyroidism, decreased appetite, palmar-plantar erythrodysaesthesia syndrome, nausea, ALT increased, AST increased, dysphonia, cough & constipation; in combination w/ lenvatinib: diarrhea, nausea, vomiting, constipation, abdominal pain, HTN, hypothyroidism, decreased appetite, dysphonia, decreased wt, proteinuria, rash, arthralgia, headache; endometrial carcinoma: HTN, hypothyroidism, diarrhea, nausea, vomiting, abdominal pain, decreased appetite/wt, increased ALT, fatigue, asthenia, arthralgia, proteinuria, UTI, headache, dysphonia, palmar-plantar erythrodysaesthesia syndrome; triple -ve breast cancer: diarrhea, rash, pyrexia & decreased appetite.
Drug Interactions
Potential interference in pharmacodynamic activity & efficacy w/ systemic corticosteroids or immunosuppressants.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FF02 - pembrolizumab ; Belongs to the class of PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. 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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