Pembrolizumab


Generic Medicine Info
Indications and Dosage
Intravenous
Advanced endometrial carcinoma
Adult: In combination with lenvatinib for treatment of patients with a case that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression after prior chemotherapy and are not candidates for surgery or radiation: 200 mg once every 3 weeks over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
PD-L1 expression in metastatic gastric adenocarcinoma, PD-L1 expression in metastatic gastrooesophageal junction adenocarcinoma, PD-L1 expression in recurrent locally advanced gastric adenocarcinoma, PD-L1 expression in recurrent locally advanced gastrooesophageal junction adenocarcinoma
Adult: As monotherapy in patients with disease progression on or after 2 or more prior therapy (e.g. fluoropyrimidine- and platinum-containing chemotherapy, HER2/neu-targeted therapy): 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
PD-L1 expression in metastatic cervical cancer, PD-L1 expression in recurrent cervical cancer
Adult: As monotherapy in patients with disease progression on or following chemotherapy: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
PD-L1 expression in metastatic squamous cell carcinoma of the head and neck, PD-L1 expression in unresectable recurrent squamous cell carcinoma of the head and neck
Adult: As 1st-line treatment: As monotherapy: 200 mg once every 3 weeks or 400 mg once every 6 weeks. In combination with platinum and 5-fluorouracil chemotherapy: 200 mg every 3 weeks. All doses are to be given via infusion over 30 minutes. Continue therapy until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Metastatic melanoma, Unresectable melanoma
Adult: As monotherapy: 200 mg once every 3 weeks or 400 mg once every 6 weeks. Alternatively, 2 mg/kg every 3 weeks. Continue therapy until disease progression or unacceptable toxicity. All doses to be given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Adjuvant treatment of melanoma
Adult: In patients with melanoma with lymph node involvement who have undergone complete resection: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease recurrence or unacceptable toxicity, or for up to 12 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
ALK negative metastatic non-squamous non-small cell lung carcinoma, EGFR negative metastatic non-squamous non-small cell lung carcinoma
Adult: As 1st-line treatment, in combination with pemetrexed and platinum chemotherapy: 200 mg once every 3 weeks, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Alternatively, 400 mg once every 6 weeks. All doses to be given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Metastatic squamous cell carcinoma of the head and neck, Recurrent squamous cell carcinoma of the head and neck
Adult: As monotherapy in patients with disease progression on or following platinum-containing chemotherapy: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Metastatic squamous non-small cell lung carcinoma
Adult: As 1st-line treatment, in combination with carboplatin and paclitaxel or nab-paclitaxel: 200 mg once every 3 weeks, until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Alternatively, 400 mg once every 6 weeks. All doses to be given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Refractory classical Hodgkin lymphoma, Relapsed classical Hodgkin lymphoma
Adult: As monotherapy in patients who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are ineligible for transplant and have failed BV: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: As monotherapy in refractory case or in patients that have relapsed following 2 or more lines of therapy: 2 mg/kg (Max: 200 mg) every 3 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Primary mediastinal large B-cell lymphoma
Adult: As monotherapy in patients with refractory cases or who have relapsed following 2 or more prior lines of therapy: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: As monotherapy in patients with refractory cases or who have relapsed following 2 or more prior lines of therapy: 2 mg/kg (Max: 200 mg) every 3 weeks, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Metastatic microsatellite instability-high solid malignant tumour, Unresectable microsatellite instability-high solid malignant tumour
Adult: As monotherapy in patients who have progressed after prior treatment and when there are no satisfactory alternative options: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: As monotherapy in patients with non-CNS solid tumours who have progressed after prior treatment and when there are no satisfactory alternative options: 2 mg/kg (Max: 200 mg) every 3 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Locally advanced urothelial carcinoma, Metastatic urothelial carcinoma
Adult: As monotherapy: In patients with disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy; in patients with PD-L1 expressing tumours who are not qualified for cisplatin-containing chemotherapy, or who are not qualified for any platinum-containing chemotherapy regardless of PD-L1 status: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continue until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
PD-L1 expression in metastatic non-small cell lung carcinoma
Adult: As monotherapy: As 1st-line treatment in patients with EGFR or ALK negative tumour mutations; in patients with disease progression on or after platinum-containing chemotherapy or with EGFR or ALK positive tumour mutations who have received prior chemotherapy for these aberrations: 200 mg once every 3 weeks or 400 mg once every 6 weeks. Alternatively, in previously treated patients, 2 mg/kg every 3 weeks. Continue therapy until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). All doses to be given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
PD-L1 expression in metastatic squamous cell carcinoma of the oesophagus, PD-L1 expression in recurrent locally advanced squamous cell carcinoma of the oesophagus
Adult: In patients with disease progression following 1 or more prior lines of systemic treatment: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Advanced renal cell carcinoma
Adult: As 1st-line treatment, in combination with axitinib: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Metastatic microsatellite instability-high colorectal cancer, Unresectable microsatellite instability-high colorectal cancer
Adult: As 1st-line treatment; as monotherapy in patients who have progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: In patients who have progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan: 2 mg/kg (Max: 200 mg) every 3 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or up to 24 months. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
PD-L1 expression in locally advanced non-small cell lung carcinoma
Adult: As monotherapy for 1st-line treatment in patients with EGFR or ALK negative mutation who are not qualified for surgical resection or definitive chemoradiation; in patients who have received at least 1 prior chemotherapy or those with EGFR or ALK positive tumour mutations who have received prior chemotherapy for these aberrations: 200 mg once every 3 weeks or 400 mg once every 6 weeks, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Alternatively, in previously treated patients, 2 mg/kg every 3 weeks. All doses to be given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).

Intravenous
Metastatic cutaneous squamous cell carcinoma, Recurrent cutaneous squamous cell carcinoma
Adult: In patients with case that is not curable by surgery or radiation: 200 mg once every 3 weeks or 400 mg once every 6 weeks via infusion over 30 minutes, continued until disease progression or unacceptable toxicity, or for up to 24 months (in patients without disease progression). Dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Reconstitution
Inj solution: Dilute required volume in 0.9% NaCl or glucose 5% to prepare a final concentration ranging from 1-10 mg/mL. Gently inverse to mix the diluted solution. Do not shake. Lyophilised powder: Add 2.3 mL sterile water for inj along the vial wall to prepare a 25 mg/mL solution. Swirl the vial slowly and allow 5 minutes for bubbles to dissipate. Do not shake. Withdraw appropriate volume from vial and dilute in 0.9% NaCl or glucose 5% to prepare a final concentration of 1-10 mg/mL. Gently inverse to mix the diluted solution.
Special Precautions
Patient with autoimmune disorder; chronic infection, history of recurring infections, or underlying condition predisposing to development of infection. Patient who received allogeneic haematopoietic stem cell transplant (HSCT) or solid organ transplant. Not indicated for use with thalidomide analogue and dexamethasone for the treatment of multiple myeloma. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Colitis, hepatitis, nephritis, severe endocrinopathies (e.g. adrenal insufficiency, diabetic ketoacidosis, type 1 diabetes mellitus, hypo- or hyperthyroidism, thyroiditis, hypophysitis), solid organ transplant rejection. Rarely, myocarditis, Guillain-Barre syndrome, encephalitis.
Blood and lymphatic system disorders: Anaemia, lymphopenia, neutropenia, thrombocytopenia, haemolytic anaemia, leucopenia.
Cardiac disorders: Arrhythmia, pericarditis.
Eye disorders: Dry eye, uveitis.
Gastrointestinal disorders: Abdominal pain, constipation, diarrhoea, dry mouth, nausea, vomiting, pancreatitis, dysgeusia.
General disorders and administration site conditions: Fatigue, asthenia, lethargy, oedema, chills, pyrexia, influenza-like illness.
Immune system disorders: Sarcoidosis.
Investigations: Increased AST/ALT, alkaline phosphatase, bilirubin, and blood creatinine.
Metabolism and nutrition disorders: Decreased appetite, hypokalaemia, hyponatraemia, hypocalcaemia.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain, arthralgia, arthritis, myositis, pain in extremity, myasthenic syndrome or myasthenia gravis.
Nervous system disorders: Dizziness, headache, neuropathy peripheral, myelitis.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea.
Skin and subcutaneous tissue disorders: Dry skin, erythema, pruritus, rash, vitiligo, eczema, alopecia, dermatitis acneiform.
Vascular disorders: Hypertension.
Potentially Fatal: Pneumonitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, severe infusion-related reactions (e.g. hypersensitivity, anaphylaxis). Graft-versus-host-disease and severe sinusoidal obstructive syndrome/hepatic veno-occlusive disease (particularly in patients who received allogeneic HSCT before or after pembrolizumab therapy).
MonitoringParameters
Obtain pregnancy test before therapy in females of reproductive potential. Confirm PD-L1 expression status and MSI-H or dMMR status as clinically indicated. Monitor glucose, renal function; CBC with differential (in patients with Hodgkin lymphoma or primary mediastinal large B-cell lymphoma); thyroid function and LFT (at baseline then periodically during treatment and as clinically indicated). Assess for signs or symptoms of adrenal insufficiency, colitis, dermatologic toxicity, hypophysitis, thyroid disorders, pneumonitis, infusion reactions.
Drug Interactions
Use of systemic corticosteroids or immunosuppressants before starting therapy may cause interference with the pharmacodynamic activity and efficacy of pembrolizumab. Increased ALT and AST with axitinib.
Action
Description: Pembrolizumab is a humanised immunoglobulin G4 monoclonal antibody which binds to the cell surface receptor programmed death-1 (PD-1), a negative immunoregulatory protein, and prevents it from interacting with ligands PD-L1 and PD-L2. Blockade of the PD-1 pathway results in the reactivation of tumour specific cytotoxic T-lymphocytes and induction of immune response to tumour cells.
Synonym: lambrolizumab.
Pharmacokinetics:
Absorption: Bioavailability: Immediate and complete.
Distribution: Limited extravascular distribution. Volume of distribution: Approx 6 L.
Metabolism: Catabolised through non-specific pathways.
Excretion: Terminal elimination half-life: 22 days.
Storage
Store between 2-8°C. Protect from light. Do not freeze. Follow applicable procedures for receiving, handling, administration, and disposal.
ATC Classification
L01XC18 - pembrolizumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
References
Anon. Pembrolizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/12/2020.

Buckingham R (ed). Pembrolizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/12/2020.

Joint Formulary Committee. Pembrolizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/12/2020.

Keytruda 50 mg Powder for Concentrate for Solution for Infusion (Merck Sharp & Dohme B.V.). European Medicines Agency [online]. Accessed 02/12/2020.

Keytruda Injection (Merck Sharp & Dohme [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 02/12/2020.

Keytruda Injection, Powder, Lyophilized, for Solution; Keytruda Injection, Solution (Merck Sharp & Dohme Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/12/2020.

Keytruda Solution for Injection 100 mg/4 mL (Zuellig/Agencia Lei Va Hong). MIMS Hongkong. http://www.mims.com/hongkong. Accessed 02/12/2020.

Merck Sharp & Dohme (New Zealand). Keytruda Powder for Solution for Infusion and Concentrate for Solution for Infusion data sheet 12 November 2020. Medsafe. http://www.medsafe.govt.nz/. Accessed 02/12/2020.

Disclaimer: This information is independently developed by MIMS based on Pembrolizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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