Pemro

Metastatic melanoma, Unresectable melanoma, Locally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma, 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.

IV Preparation Reconstitute vial by adding 2.3 mL of Sterile Water for Injection (resulting concentration 25 mg/mL) Slowly swirl vial; allow up to 5 minutes for bubbles to clear Do NOT shake vial Visually inspect reconstituted solution for particulate matter and discoloration prior to administration Reconstituted solution should appeared clear to slightly opalescent, colorless to slightly yellow solution; discard if extraneous particulate matter other than translucent to white proteinaceous particles is observed IV infusion preparation Withdraw required volume from vial(s) and transfer into IV bag containing 0.9% NaCl or D5W; mix diluted solution by gentle inversion Final concentration of diluted solution: 1-10 mg/mL Discard any unused portion left in vial IV Administration Infuse over 30 minutes through an IV line containing a sterile, nonpyrogenic, low-protein binding 0.2-5 micron in-line or add-on filter NSCLC (combination therapy): Administer prior to chemotherapy Do not co administer other drugs through the same infusion line

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. 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. 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. 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.

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.

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. Lactation Unknown if distributed in human breast milk No studies conducted to assess impact of pembrolizumab on milk production or its presence in breast milk Instruct women to discontinue nursing during treatment and for 4 months after final dose

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).

Use of systemic corticosteroids or immunosuppressants before starting therapy may cause interference with the pharmacodynamic activity and efficacy of pembrolizumab.