Names and pronunciation
(pem′broe-liz′ue-mab) Keytruda
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Drug reference
(pem′broe-liz′ue-mab) Keytruda
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Func. class.: Antineoplastics
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Chem. class.: Monoclonal antibodies
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ACTION: A human monoclonal anti- body that binds to the programmed death receptor-1 (PD-1) found on T-cells and blocks the interaction of PD-1 with its ligands, PD-L1 and PD-L2, on the tumor cell
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USES: Unresectable or metastatic malignant melanoma in those who have disease progression after ipilimumab or in BRAF V600 mutation–positive patients who have disease progression after ipilimumab and a BRAF inhibitor, metastatic non–small-cell lung cancer with high PD-L1 expression, lacking EGFR or ALK, recurrent head and neck squamous cell carcinoma, Hodgkin lymphoma, MSI-H or dMMR colorectal cancer
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CONTRAINDICATIONS: Hyper sensitivity, pregnancy, breastfeeding Precautions: Immune-mediated coli- tis, immune-mediated hepatitis, immune-mediated hyperthyroidism/ hypothyroidism; immune-mediated nephritis, acute interstitial nephritis, and renal failure; immune-mediated pneumonitis, adrenocortical insuffi- ciency, arthritis, exfoliative dermatitis, hemolytic anemia, hypophysitis, myas- thenia syndrome, myositis, optic neuri- tis, pancreatitis, partial seizures after inflammatory foci identified in brain parenchyma, rhabdomyolysis, uveitis, incidence of abortion/stillbirths
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SIDE EFFECTS CNS: Seizures, myasthenia, headache, fever, insomnia, chills, dizziness, fatigue ENDO: Hyponatremia, hypothyroidism/ hyperthyroidism, hyperglycemia, hypocal- cemia, immune-mediated hypophysitis EENT: Optic neuritis GI: Nausea, vomiting, abdominal pain, pancreatitis, colitis, diarrhea, hepatitis, constipation GU: Interstitial nephritis, renal failure RESP: Cough, dyspnea, immune-medi- ated pneumonitis INTEG: Rash, pruritus, skin discoloration MS: Myalgia, immune-mediated rhabdomyolysis SYST: Exfoliative dermatitis
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INTERACTIONS None known Drug/Lab Test Increase: LFTs, renal function studies
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DOSAGE AND ROUTES • Adult: IV 200 mg over 30 min q3wk or 400 mg over 30 min q6 wk until disease progression up to 24 mo
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Available forms: Powder for injection 50 mg/vial; solution for injection 25 mg/mL
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Administer: Intermittent IV INFUSION route • Add 2.3 mL of sterile water for injec- tion, 50-mg vial (25 mg/mL); inject ster- ile water along the walls of the vial and not directly on the powder • Gently swirl and allow up to 5 min for bubbles to clear, do not shake, solution will be clear to slightly opalescent, color- less to slightly yellow • Add the required amount of product to a bag of normal saline (0.9% sodium chloride injection) to a final diluted con- centration between 1 and 10 mg/mL; mix by gentle inversion • Discard any unused solution left in the vial • Storage after reconstitution and dilu- tion: Store at room temperature up to 4 hr or refrigerate up to 24 hr (includes reconstitution, dilution, and adminis- tration time). If refrigerated, allow the P diluted solution to warm to room tem- perature before use, give over 30 min • Use a sterile, nonpyrogenic, low–pro- tein binding 0.2- to 5-micron in-line or add-on filter • Do not use with other drugs through the same infusion line • Grade 2 or 3 toxicity: Withhold and give corticosteroids; resume when the adverse event recovers to grade ≤1. Per- manently discontinue if there is no recov- ery within 12 wk, if the corticosteroid dose cannot be reduced to ≤10 mg/day of predniSONE (or equivalent) within 12 wk, or for recurrent severe or grade 3 colitis • Grade 4 toxicity: Permanently discon- tinue, give corticosteroids Hepatitis: • Grade 2 toxicity (AST or ALT >3-5 × upper limit of normal [ULN] or total bilirubin >1.5-3 × ULN): Withhold and give corticosteroids; resume when ad- verse event recovers to grade 1 or less. Permanently discontinue if there is no re- covery within 12 wk or if the corticosteroid dose cannot be reduced to ≤10 mg/day of predniSONE (or equivalent) within 12 wk • Grade 3 or 4 toxicity (AST or ALT >5 × ULN or total bilirubin >3 × ULN): Per- manently discontinue; give corticosteroids • Liver metastases and grade 2 ele- vated transaminase levels at baseline: Permanently discontinue if AST/ALT levels increase by ≥50% over baseline and transaminase level elevations persist for at least 1 wk
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Assess: • For hyperthyroidism/hypothyroidism, renal function studies baseline, periodi- cally during therapy, CCr, BUN; monitor for nephritis • For pneumonitis (new or worsening cough, chest pain, shortness of breath); confirm with radiographic imaging, give corticosteroids ≥ grade 2, withhold in grade 2, resume grade 0-1 • Immune-mediated hepatitis: liver function tests and hepatitis, jaundice, severe nausea/vomiting, easy bleeding or bruising; withhold and give cortico- steroids if grade 2 hepatitis (AST or ALT >3-5 × ULN or total bilirubin >1.5-3 × ULN) • Pregnancy: assess whether pregnancy is planned or suspected or if breastfeed- ing; do not use in pregnancy, breastfeed- ing • Immune-mediated hypophysitis: headache, weakness, fainting, dizziness, blurred vision; use corticosteroids if >grade 2, discontinue >grade 3 • Hyperglycemia: may cause diabetes mellitus 1 or diabetic ketoacidosis
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Evaluate: • Therapeutic response: decreased pro- gression of multiple myeloma
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To notify prescriber immediately of signs of colitis, pneumonitis, hepatitis, hypophysitis • Hyperglycemia: about signs and symp- toms of hyperglycemia, diabetes; how to ensure tight glucose control; to report hyperglycemia immediately • Pregnancy: to use highly effective contraceptive methods during and for 4 mo after treatment; to contact health care provider if pregnancy is sus- pected or confirmed; not to breastfeed HIGH ALERT
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• Adult: IV 200 mg over 30 min q3wk or 400 mg over 30 min q6 wk until disease progression up to 24 mo
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