| Document Date: 2015-05-07 15:45:45
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Company Hydrocephalus / Pacira Pharmaceuticals Inc. / Sigma-Tau Pharmaceuticals Inc. / Sigma-Tau (weeks 1 and 3) (2.4) Pharmaceuticals Inc. / / Event Product Issues / Business Partnership / Product Recall / FDA Phase / / IndustryTerm severe chemical arachnoiditis / chemical arachnoiditis / chemical name / drug products / nonliposome drug products / / MedicalCondition CSF pleocytosis / anemia NOS / lymphomatous meningitis / bowel dysfunction Headache / Hydrocephalus / Psychiatric Disorders Insomnia Agitation Depression Anxiety Infections / dysarthria / lymphoma / headache / seizures / meningism / severe chemical arachnoiditis / untreated / chemical arachnoiditis / Cauda Equina Syndrome / Solid Tumors / diarrhea NOS / nausea / thrombocytopenia / muscle weakness / hemiplegia / visual disturbances / myelopathy and other neurologic toxicity / peripheral neuropathy / Tremor / DepoCyt Headache / Syncope / numbness / extensive lymphoma / phocomelia / fatigue / deafness / cerebrospinal fluid flow Symptoms Diplopia / encephalopathy / Incl Cysts / hypoesthesia / both neoplastic meningitis / constipation / Chemical Arachnoiditis Chemical arachnoiditis / Lymphatic Disorders Anemia NOS Thrombocytopenia / neurologic deficits / neck pain / Connective Tissue Disorders Back pain / back pain / blindness / apparent disease / arachnoiditis / Leukemia / insomnia / dizziness NOS / significant neurologic deficit / General Disorders / Lymphoma DepoCyt / cancer / Gastrointestinal Disorders Nausea / disease / arthralgia / active meningeal infection / High-grade lymphoma / complete boxed warning Chemical arachnoiditis / severe and life-threatening arachnoiditis / dysphagia / sensory changes / Carcinogenesis / controlled lymphoma study / chemical arachnoiditis / facial numbness / neutropenia / permanent neurologic deficit / fever / lethargy / urinary tract infection NOS / Myelopathy / pain / vomiting / CHEMICAL ARACHNOIDITIS ADVERSE REACTIONS Chemical arachnoiditis / cleft palate / headache NOS / focal seizures / meningeal irritation / neoplastic meningitis / irritation / cranial nerve palsies / severe and lifethreatening arachnoiditis / lymphomatous meningitis receiving DepoCyt / metastases / paresthesias / paresthesia / syndrome / inflammatory / status epilepticus / dehydration / / MedicalTreatment chemotherapy / / Organization DepoCyt administration / Intrathecal administration / U.S. Securities and Exchange Commission / Concomitant administration / Neurotoxicity Intrathecal administration / DOSAGE AND ADMINISTRATION / FDA / Sensory Exam / / / Position physician for immediate toxic reactions / General / / Product TRIAD / dexamethasone / sodium chloride / cytarabine / Sigma / DepoCyt / / Technology MRI / Pharmacokinetics / chemotherapy / / URL www.fda.gov/medwatch / www.depocyt.com / / |
Indication DepoCyt® (cytarabine liposome injection) is indicated for the intrathecal treatment of lymphomatous meningitis. Important Safety Information WARNING: CHEMICAL ARACHNOIDITIS ADVERSE REACTIONS Chemical arachnoi