Bortezomib

Acute diffuse infiltrative pulmonary disease and pericardial disease. Pregnancy and lactation.

Patient with hypotension, cardiac disease, peripheral neuropathy, diabetes, dehydration. Not intended for intrathecal administration. Moderate to severe hepatic impairment (bilirubin >1.5 times the upper limit of normal with any AST concentration). Patient Counselling This drug may cause, dizziness, fatigue, orthostatic/postural hypotension, syncope or blurred vision, if affected, do not drive or operate machinery. Monitoring Parameters Monitor CBC, blood glucose levels. Assess for signs/symptoms of peripheral neuropathy.

Significant: Neutropenia, thrombocytopenia, anaemia, peripheral neuropathy, seizures, hypotension (including orthostatic or postural hypotension), congestive heart failure, tumour lysis syndrome, decreased LVEF, diarrhoea or constipation, nausea, vomiting, herpes zoster virus reactivation, gastrointestinal or intracerebral haemorrhage, serum-sickness-type reaction, polyarthritis with rash, proliferative glomerulonephritis. Rarely, acute hepatic failure, posterior reversible leucoencephalopathy syndrome. Blood and lymphatic system disorders: Leucopenia, lymphopenia, febrile neutropenia. Cardiac disorders: Arrhythmia, cardiac fibrillation, myocardial ischaemia. Ear and labyrinth disorders: Dysacusis. Eye disorders: Abnormal vision, conjunctivitis, eye swelling. Gastrointestinal disorders: Dyspepsia, dysphagia, abdominal pain or distension, flatulence, gastritis, stomatitis, dysgeusia, oropharyngeal pain, oral ulceration. General disorders and administration site conditions: Asthenia, chills, lethargy, pain, pyrexia, fatigue, malaise, inj site reaction. Hepatobiliary disorders: Hepatitis, hyperbilirubinaemia. Immune system disorders: Hypersensitivity. Infections and infestations: Herpes simplex, bacterial or fungal infection. Investigations: Abnormal glucose and hepatic enzyme levels, decreased or increased weight. Metabolism and nutrition disorders: Decreased appetite, dehydration, diabetes mellitus, fluid retention, hypocalcaemia, hypokalaemia, hyponatraemia. Musculoskeletal and connective tissue disorders: Myalgia, musculoskeletal pain, muscle weakness or spasm, pain in extremities. Nervous system disorders: Headache, vertigo, paraesthesia, dysaesthesia, neuralgia, motor neuropathy, loss of consciousness. Psychiatric disorders: Anxiety, sleep or mood disorders. Renal and urinary disorders: Renal impairment, UTI. Respiratory, thoracic and mediastinal disorders: Dyspnoea, epistaxis, cough, hiccups, respiratory tract infection. Skin and subcutaneous tissue disorders: Rash, dry skin, dermatitis, erythema, hair disorder, pruritus. Vascular disorders: Hypertension.
Potentially Fatal: Acute respiratory distress syndrome, interstitial pneumonia, pneumonitis, lung infiltrates, thrombotic microangiopathy, progressive multifocal leucoencephalopathy.

Increased exposure with potent CYP3A4 inhibitors (e.g. ritonavir, ketoconazole). Decreased exposure with potent CYP3A4 inducers (e.g. carbamazepine, rifampicin). May alter the effects of oral hypoglycaemics.

Targeted Cancer Therapy

L01XG01 - bortezomib