ABOUT KEYTRUDA

KEYTRUDA and the
immune system

KEYTRUDA supports the immune system to help find and fight cancer cells

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Frequently asked questions

Access to KEYTRUDA

KEYTRUDA is funded for patients as monotherapy for the treatment of unresectable or metastatic melanoma in adults.1 See Home Page

All other indications for KEYTRUDA are currently unfunded but are available to patients through private treatment centres.1 See How to access KEYTRUDA.

MSD New Zealand run patient programmes to help patients access KEYTRUDA treatment. For further details about these programmes email dpoc.nz@merck.com or see How to access KEYTRUDA for downloadable information to give your patients.

New Zealand has a number of private cancer care centres across the country. A list of these clinics is available here.

MSD New Zealand run a patient access programme to help patients access PD-L1 testing. For further details about this programme email dpoc.nz@merck.com

Dosing and Administration

The recommended dose of KEYTRUDA for melanoma is 2 mg/kg administered intravenously over 30 minutes every 3 weeks.1

The recommended dose of KEYTRUDA for NSCLC, cHL and mUC is a 200mg flat dose administered intravenously over 30 minutes every 3 weeks.1

For more information see Treatment Overview.

Age (range 18 – 94 years), gender, mild or moderate renal impairment, mild hepatic impairment, and tumour burden did not significantly impact clearance of KEYTRUDA and thus no dose adjustment is necessary. Refer to KEYTRUDA Data Sheet (www.medsafe.govt.nz) for guidance on when KEYTRUDA should be withheld or discontinued.1

The recommended dosage frequency for KEYTRUDA is once every 3 weeks. Outside of this regime is a clinical decision.1

The recommendation is for the infusion rate to stay below 5.7 mL/min through a peripheral line or indwelling catheter.1

Across clinical studies with KEYTRUDA in approximately 5000 patients, severe infusion-related reactions have been reported in less than 0.1% of patients. Pre-medications are generally not required when first initiating KEYTRUDA.

Severe infusion reactions, including hypersensitivity and anaphylaxis, have been reported in 6 (0.2%) of 2,799 patients receiving KEYTRUDA in KEYNOTE-001, KEYNOTE-002, KEYNOTE-006, and KEYNOTE-010.1

Attach the infusion line to the pump and prime the line, either with normal saline (at least 25mL) or with infusion solution in accordance with the protocol of your centre, before starting the infusion.

KEYTRUDA is not a chemotherapy and therefore chemotherapy handling precautions are not required. Guidance on aseptic reconstitution can be found in the KEYTRUDA Data Sheet.

Adverse Events

Immune-mediated adverse reactions occurred in patients receiving KEYTRUDA. In clinical trials, most immune-mediated adverse reactions occurred during treatment, were reversible and managed with interruptions of KEYTRUDA, administration of corticosteroids and/or supportive care. Immune-related adverse reactions have also occurred after the last dose of KEYTRUDA. Immune-adverse reactions affecting more than one body system can occur simultaneously.1

For more information see Treatment Overview.

See Treatment Overview or download the guide on Managing Immune-mediated adverse events.

For the latest ESMO guidelines download a copy from Educational Resources.

Reference: 1. KEYTRUDA Data Sheet











ONCO-1230760-0048


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 pemetrexed and platinum chemotherapy for first-line treatment of metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations. 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. Severe and fatal cases of immune-mediated adverse reactions have occurred. 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 (potentially fatal) 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, neutropenia, 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 platinum chemotherapy. 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 08 June 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: August 2018
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