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ONCO-1230760-0029


Online enrolment and ordering for the Patient Programme
is under development.
To register a patient or request resupply please contact dpoc.nz@merck.com

KEYTRUDA (pembrolizumab) 50mg powder for infusion

Before prescribing KEYTRUDA, read the data sheet for information on dosage, contraindications, precautions, interactions and adverse effects available at www.medsafe.govt.nz or on request from Merck Sharp & Dohme (New Zealand) Limited. Prescription Only Medicine Indication: As monotherapy for the treatment of unresectable or metastatic melanoma in adults. In combination with platinum-pemetrexed for first-line treatment of metastatic non-squamous NSCLC. As monotherapy for first-line treatment of patients with metastatic NSCLC whose tumours express PD-L1 ≥50% tumour proportion score (TPS) on a validated test, with no EGFR or ALK genomic tumour aberrations. As monotherapy for the treatment of patients with advanced NSCLC with a PD-L1 TPS level ≥1% and who have received platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving KEYTRUDA. As monotherapy for refractory/ relapsed classical Hodgkin Lymphoma (cHL). As monotherapy for patients with locally advanced/ metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, or who have received platinum-containing chemotherapy. See full data sheet. Contraindications: None. Precautions: Immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, nephritis, hypophysitis, type 1 diabetes mellitus, hyperthyroidism, hypothyroidism, thyroiditis, uveitis, myositis, Guillain-Barre syndrome, pancreatitis, encephalitis, sarcoidosis, myasthenic syndrome, severe skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis), and severe infusion reactions including hypersensitivity and anaphylaxis. Increased mortality when in combination with dexamethasone and a thalidomide analogue in multiple myeloma (not indicated). Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. For management of immune-mediated adverse events, see full data sheet. Limited information in patients with active infection and patients with on-going adverse reaction to ipilimumab – use caution. Acute graft-versus-host-disease in patients with history of allogeneic HSCT. Post-marketing: solid organ transplant rejection and myocarditis. See full data sheet for further information. Interactions: None expected. Avoid corticosteroids or immunosuppressants prior to treatment. Side effects: Clinical trials (treatment-related only): nasopharyngitis, anaemia, hypothyroidism, decreased appetite, dizziness, headache, cough, dyspnea, abdominal pain, constipation, diarrhea, nausea, vomiting, erythema, pruritus, rash, vitiligo, arthralgia, back pain, myalgia, pain in extremity, asthenia, chills, fatigue, oedema peripheral, pyrexia, colitis, hepatitis, hyperthyroidism, hypophysitis, nephritis, pneumonitis, type 1 diabetes mellitus, adrenal insufficiency, autoimmune hepatitis, alopecia, upper respiratory tract infection. Dosage and administration: The recommended dose of KEYTRUDA is 200 mg for previously untreated NSCLC, cHL, and urothelial carcinoma, and 2 mg/kg or 200 mg for melanoma or previously treated NSCLC (administered as an intravenous infusion over 30 minutes every 3 weeks). KEYTRUDA should be administered first when given in combination with pemetrexed and carboplatin. Treat with KEYTRUDA until disease progression or unacceptable toxicity. Atypical responses (i.e. an initial transient increase in tumour size or small new lesions followed by shrinkage) have been observed. Clinically stable patients (i.e. asymptomatic and not requiring urgent intervention) with initial evidence of progression can remain on treatment until confirmed. See full data sheet for further information, including details on PD-L1 testing. KEYTRUDA is a funded medicine for melanoma patients– restrictions apply. KEYTRUDA is a private purchase medicine for NSCLC, cHL and urothelial carcinoma patients. Based on data sheet prepared 10 April 2018.

Copyright © 2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. All rights reserved. Copyright © 2018 Merck Sharp & Dohme (New Zealand) Limited. Level 3, 123 Carlton Gore Road, Newmarket, Auckland. All rights reserved.
ONCO-1230760-0024 DA1827MW First Issued October 2015 Updated: May 2018
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