Pembrolizumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Metastatic melanoma; Unresectable melanoma 2 mg/kg or 200 mg once every 3 weeks until disease progression or unacceptable toxicity. Locally advanced non-small cell lung carcinoma; Metastatic non-small cell lung carcinoma In patients who have been treated with chemotherapy: 2 mg/kg once every 3 weeks until disease progression or unacceptable toxicity. Recurrent squamous cell carcinoma of the head and neck; Metastatic squamous cell carcinoma of the head and neck; Relapsed classical Hodgkin lymphoma; Refractory classical Hodgkin lymphoma; Locally advanced urothelial carcinoma; Gastro-oesophageal junction adenocarcinoma; Recurrent locally advanced gastric cancer; Metastatic gastric cancer; Metastatic urothelial carcinoma; Unresectable microsatellite instability-high cancer; Metastatic microsatellite instability-high cancer; First-line treatment for Metastatic non-small cell lung carcinoma 200 mg once every 3 weeks until disease progression or unacceptable toxicity, or for up to 24 months (or 35 cycles) in patients without disease progression. All doses may be modified, interrupted, or discontinued (based on severity) if immune- or infusion-related reactions occur.
Dosage Details
Intravenous
Metastatic melanoma, Unresectable melanoma
Adult: 2 mg/kg or 200 mg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur (refer to detailed product guideline).

Intravenous
Locally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma
Adult: In patients who have been treated with chemotherapy: 2 mg/kg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur (refer to detailed product guideline).

Intravenous
Metastatic non-small cell lung carcinoma
Adult: As first-line treatment: 200 mg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (or 35 cycles) in patients without disease progression. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur (refer to detailed product guideline).

Intravenous
Gastro-oesophageal junction adenocarcinoma, Locally advanced urothelial carcinoma, Metastatic gastric cancer, Metastatic microsatellite instability-high cancer, Metastatic squamous cell carcinoma of the head and neck, Metastatic urothelial carcinoma, Recurrent locally advanced gastric cancer, Recurrent squamous cell carcinoma of the head and neck, Refractory classical Hodgkin lymphoma, Relapsed classical Hodgkin lymphoma, Unresectable microsatellite instability-high cancer
Adult: 200 mg once every 3 weeks via infusion over 30 minutes, until disease progression or unacceptable toxicity, or for up to 24 months (or 35 cycles) in patients without disease progression. Dose modification, interruption, or discontinuation (based on severity) may be required if immune- or infusion-related reactions occur (refer to detailed product guideline).
Reconstitution
Injection solution: Dilute in NaCl 0.9% or glucose 5% to prepare a final concentration ranging from 1-10 mg/mL. Lyophilised powder: Add 2.3 mL sterile water for injection along the vial wall to prepare a 25 mg/mL solution. Swirl the vial slowly and allow 5 minutes for bubbles to dissipate. Withdraw appropriate volume from vial and dilute in NaCl 0.9% or glucose 5% to prepare a final concentration of 1-10 mg/mL.
Special Precautions
Patient with autoimmune disorders. Patients who received allogeneic haematopoietic stem cell transplant (HSCT) or solid organ transplant. Not indicated for multiple myeloma. Pregnancy and lactation.
Adverse Reactions
Significant: Colitis, hepatitis, nephritis, severe endocrinopathies (e.g. diabetic ketoacidosis, diabetes mellitus, hypo- or hyperthyroidism, hypophysitis, severe infusion-related reactions (e.g. hypersensitivity, anaphylaxis); hepatic veno-occlusive disease in patients with classical Hodgkin lymphoma undergoing allogeneic HSCT.
Blood and lymphatic system disorders: Anaemia.
Gastrointestinal disorders: Abdominal pain, constipation, diarrhoea, dry mouth, nausea, vomiting.
General disorders and administration site conditions: Fatigue, asthenia, oedema, chills, pyrexia, influenza-like illness.
Investigations: Increased AST/ALT, alkaline phosphatase, and blood creatinine.
Metabolism and nutrition disorders: Decreased appetite.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain, arthralgia, arthritis, myositis, pain in extremity.
Nervous system disorders: Dizziness, dysgeusia, headache.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea.
Skin and subcutaneous tissue disorders: Dry skin, erythema, pruritus, rash, vitiligo.
Potentially Fatal: Pneumonitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Graft-versus-host-disease and severe sinusoidal obstructive syndrome (in patients with history of HSCT).
Patient Counseling Information
This drug may cause fatigue, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor PD-L1 expression status, LFT, glucose; CBC with differential, renal and thyroid function; signs/symptoms of 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.
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 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 7.5 L.
Metabolism: Catabolised through non-specific pathways.
Excretion: Terminal elimination half-life: Approx 25 days.
Storage
Store between 2-8°C. Protect from light. Do not freeze.
This is a cytotoxic drug. 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.
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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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