Do not administer as an IV push or bolus. Progressive multifocal leukoencephalopathy; closely monitor for new or worsening neurological, cognitive, or behavioural signs or symptoms suggestive of PML. Permanently discontinue if diagnosis of PML is confirmed. Discontinue if acute pancreatitis occurs. Pulmonary toxicity, including pneumonitis, ILD & acute resp distress syndrome. Serious infections eg, pneumonia, staph bacteraemia, sepsis/septic shock (including fatal outcomes) & herpes zoster, cytomegalovirus reactivation & opportunistic infections eg,
Pneumocystis jirovecii pneumonia & oral candidiasis. Monitor for the emergence of possible serious & opportunistic infections. Immediate & delayed infusion-related reactions, anaphylactic reactions. Immediate & permanently discontinuation if anaphylactic reaction occurs. Tumour lysis syndrome. Sensory & motor peripheral neuropathy; delay & dose reduction or discontinue in patients w/ new or worsening peripheral neuropathy. Grade 3 or 4 anaemia, thrombocytopenia & prolonged (≥1 wk) grade 3 or 4 neutropenia. Febrile neutropenia; closely monitor for fever. Severe cutaneous adverse reactions including SJS, TEN & DRESS. GI complications including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation & haemorrhage. Hepatotoxicity; increased risk w/ pre-existing liver disease, comorbidities, & concomitant medications. Test liver function before initiating treatment & routinely during therapy. Hyperglycemia. Infusion site extravasation. Closely monitor the infusion site for possible infiltration. Monitor CBC prior to admin of each dose. Other CD30+ CTCL patients. Na content in excipients. May have moderate influence on the ability to drive & use machines. Renal & hepatic impairment. Men should have sperm samples frozen & stored before treatment. Women of childbearing potential should use 2 methods of effective contraception during & until 6 mth after treatment; men should not father a child during & for up to 6 mth following the last dose. Pregnancy & lactation. Childn <18 yr.