Avelumab

Intravenous
Locally advanced urothelial carcinoma, Metastatic urothelial carcinoma

Intravenous
Advanced renal cell carcinoma

Intravenous
Metastatic Merkel cell carcinoma

IV infusion: Withdraw the required volume from the vial then transfer to an infusion bag containing 250 mL of NaCl 0.9% or NaCl 0.45% solution. Mix by gentle inversion. Do not shake.

Patient with myasthenia gravis. Patients who received allogeneic haematopoietic cell transplant before or after treatment with an anti-programmed-death ligand-1 (PD-L1) or programmed cell death-1 (PD-1) monoclonal antibody. Pregnancy. Discontinue breastfeeding during therapy and for at least 1 month after the last dose.

Significant: Immune-mediated reactions including endocrinopathies (e.g. adrenal insufficiency, diabetes mellitus including diabetic ketoacidosis, hypophysitis, thyroid disorders), dermatologic toxicity (e.g. exfoliative dermatitis including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, toxic epidermal necrolysis), colitis, uveitis, iritis, other ocular inflammatory toxicities, nephritis with kidney dysfunction.
Blood and lymphatic system disorders: Anaemia, lymphopenia, thrombocytopenia.
Gastrointestinal disorders: Nausea, diarrhoea, vomiting, constipation, abdominal pain, dry mouth.
General disorders and administration site conditions: Fatigue, pyrexia, peripheral oedema, asthenia, chills, influenza-like illness.
Investigations: Decreased weight; increased blood creatinine, alkaline phosphatase, lipase, GGT or amylase.
Metabolism and nutrition disorders: Decreased appetite, hyponatraemia.
Musculoskeletal and connective tissue disorders: Back pain, arthralgia, myalgia.
Nervous system disorders: Headache, dizziness, peripheral neuropathy.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea.
Skin and subcutaneous tissue disorders: Rash, pruritus, dry skin, maculopapular rash.
Vascular disorders: Hypertension.
Potentially Fatal: Immune-mediated reactions including cardiovascular events (e.g. myocarditis, pericarditis, vasculitis), hepatitis, pancreatitis, pneumonitis, meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome, myasthenia gravis (including exacerbation), cystitis, sarcoidosis, Guillain-Barre syndrome, myositis or polymyositis; infusion-related reactions.

Women of childbearing potential must use proven birth control methods during therapy and for at least 1 month after the last dose. This drug may cause fatigue, if affected, do not drive or operate machinery.

Monitor LFTs (e.g. AST, ALT, total bilirubin), kidney function (e.g. creatinine) and thyroid function tests (at baseline, periodically thereafter during treatment and as clinically indicated); blood glucose (for hyperglycaemia). Assess for signs and symptoms of infusion-related reactions and immune-mediated adverse effects.

Description:
Mechanism of Action: Avelumab is an IgG₁ lambda immunoglobulin and a human anti-programmed-death ligand-1 monoclonal antibody antineoplastic agent. It binds to programmed death ligand 1 (PD-L1) to selectively inhibit the interaction between the programmed cell death-1 (PD-1), a negative immunoregulatory protein, and B7.1 receptors. This eliminates the suppressive effects of PD-L1 on cytotoxic CD8⁺ T-cells, leading to the restoration of anti-tumour T-cell responses. Additionally, it has been shown to promote natural killer cell-mediated tumour cell lysis through antibody-dependent cell-mediated cytotoxicity.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: Within 1 hour.
Distribution: Crosses the placenta.
Metabolism: Metabolised via proteolytic degradation.
Excretion: Elimination half-life: 6.1 days.

Intact vial: Store between 2-8°C. Do not freeze. Protect from light. Diluted solution: Store at room temperature for up to 4 hours or between 2-8°C for up to 24 hours. Do not freeze.

Cancer Immunotherapy

L01FF04 - avelumab ; Belongs to the class of PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

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