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Keytruda健痊得

Keytruda

pembrolizumab

Manufacturer:

MSD

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Pembrolizumab
Indications/Uses
Unresectable or metastatic melanoma. As monotherapy for adjuvant treatment of patients w/ Stage III melanoma w/ involvement of lymph node(s) following complete resection. In combination w/ pemetrexed & platinum chemotherapy for the 1st-line treatment of patients w/ metastatic nonsquamous non-small cell lung cancer (NSCLC), w/o EGFR or ALK genomic tumor aberrations. In combination w/ carboplatin & either paclitaxel or paclitaxel protein-bound, for the 1st-line treatment of patients w/ metastatic squamous NSCLC. As a single agent for the 1st-line treatment of patients w/ NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%)] as determined by a validated test, w/o EGFR or ALK genomic tumor aberrations & is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation; or metastatic. As a single agent for the treatment of patients w/ metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by a validated test, w/ disease progression on or after platinum-containing chemotherapy. Patients w/ EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving Keytruda. Locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy & where tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by a validated test, or in patients who are ineligible for any platinum-containing chemotherapy regardless of PD-L1 status. Locally advanced or metastatic urothelial carcinoma w/ disease progression during or following platinum-containing chemotherapy or w/in 12 mth of neoadjuvant or adjuvant treatment w/ platinum-containing chemotherapy. Monotherapy for the treatment of adult patients w/ relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) & brentuximab vedotin (BV), or who are transplant-ineligible & have failed BV. Unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR): Solid tumors that have progressed following prior treatment & have no satisfactory alternative treatment options; or colorectal cancer that has progressed following treatment w/ a fluoropyrimidine, oxaliplatin, & irinotecan. In combination w/ axitinib, for the 1st-line treatment of patients w/ advanced renal cell carcinoma.
Dosage/Direction for Use
Adult Monotherapy for unresectable or metastatic melanoma 200 mg by IV infusion over 30 min every 3 wk until disease progression or unacceptable toxicity. Monotherapy for adjuvant treatment of melanoma 200 mg by IV infusion over 30 min every 3 wk until disease recurrence, unacceptable toxicity, or up to 12 mth. Monotherapy for NSCLC, cHL, locally advanced or metastatic urothelial carcinoma, MSI-H or dMMR cancer 200 mg by IV infusion over 30 min every 3 wk until disease progression, unacceptable toxicity, or up to 24 mth. Combination therapy for NSCLC 200 mg by IV infusion over 30 min every 3 wk until disease progression, unacceptable toxicity, or up to 24 mth. Administer Keytruda prior to chemotherapy when given on the same day. Combination therapy for RCC 200 mg by IV infusion over 30 min every 3 wk until disease progression, unacceptable toxicity, or up to 24 mth. Administer Keytruda in combination w/ axitinib 5 mg PO bd.
Special Precautions
Immune-mediated pneumonitis: Withhold treatment for Grade 2 pneumonitis, & permanently discontinue for Grade 3, Grade 4, or recurrent Grade 2 pneumonitis. Immune-mediated colitis: Withhold treatment for Grade 2 or 3 colitis, & permanently discontinue for Grade 4 colitis. Immune-mediated hepatitis (w/o hepatocellular carcinoma): Administer corticosteroids for Grade 2 or greater hepatitis. Withhold if AST or ALT >3 to 5x upper limit of normal (ULN) or total bilirubin >1.5 & up to 3x ULN. Permanently discontinue in patients w/o liver metastases if AST or ALT >5x ULN or total bilirubin >3x ULN. Permanently discontinue in patients w/ liver metastasis & Grade 2 AST or ALT at baseline, w/ an increase in AST or ALT of ≥50% relative to baseline that persists for at least 1 wk. In patients w/ RCC: Withhold both Keytruda & axitinib if ALT or AST ≥3x ULN but <10x ULN w/o concurrent total bilirubin ≥2x ULN, until recovery to Grades 0-1. Consider corticosteroid therapy; or rechallenge w/ a single drug or sequential rechallenge w/ both drugs after recovery. Permanently discontinue both Keytruda & axitinib & consider corticosteroid therapy if ALT or AST ≥10x ULN or >3x ULN w/ concurrent total bilirubin ≥2x ULN. Immune-mediated endocrinopathies: Withhold treatment for Grade 2 hypophysitis. Withhold or discontinue for Grade 3 or 4 hypophysitis or hyperthyroidism. Administer insulin for type 1 DM, & withhold Keytruda & administer anti-hyperglycemics in patients w/ severe hyperglycemia. Immune-mediated nephritis & renal dysfunction: Administer corticosteroids for Grade 2 or greater nephritis. Withhold Keytruda for Grade 2, & permanently discontinue for Grade 3 or 4 nephritis. Immune-mediated skin adverse reactions: Withhold for Grade 3 severe skin reactions or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). Permanently discontinue for Grade 4 severe skin reactions or confirmed SJS or TEN. Hematologic toxicity in patient w/ cHL: Withhold treatment for Grade 4 hematologic toxicity until resolution to Grades 0 or 1. Other immune-mediated adverse reactions: Withhold for any other Grade 2 or 3 treatment-related adverse reaction, based on the severity & type of reaction. Permanently discontinue for Grade 3 (based on severity & type of reaction) or Grade 4 immune-mediated AR; recurrent Grade 2 pneumonitis; recurrent Grade 3 or 4 immune-mediated AR; persistent Grade 2 or 3 AR lasting ≥12 wk after last dose of Keytruda (excluding endocrinopathies controlled w/ hormone replacement therapy). Infusion-related reactions: Permanently discontinue for Grade 3 or 4 infusion-related reactions. Permanently discontinue if unable to taper corticosteroid dose to <10 mg prednisone or equivalent per day w/in 12 wk after last dose of Keytruda. For the situation of withholding Keytruda, it can be resumed in patients whose AR recover to Grade 1 or less following corticosteroid taper. Closely monitor patients for early evidence of transplant-related complications eg, hyperacute graft versus host disease (GvHD), severe (Grade 3-4) acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, & other immune-mediated AR, & intervene promptly. Risk of GvHD in patients w/ history of allogeneic hematopoietic stem cell transplantation (HSCT). Increased mortality in patients w/ multiple myeloma when Keytruda is combined w/ thalidomide analogue & dexamethasone. Risk of fetal harm. Females of reproductive potential should use effective contraception during treatment & for 4 mth after the last dose. Pregnancy & lactation. Childn.
Adverse Reactions
As a single agent: Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, abdominal pain. In combination w/ chemotherapy: Fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis. In combination w/ axitinib: Diarrhea, fatigue/asthenia, HTN, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, constipation.
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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