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Company Seattle Genetics Inc. / / Country United States / / Event FDA Phase / / IndustryTerm imaging / medicinal products / treatment of patients with Hodgkin lymphoma / treatment of patients with / MedicalCondition Opportunistic Infections Serious infections / urinary tract infection / pneumothorax / nausea / Muscle spasms / thrombocytopenia / Anaphylaxis / Serious infections / toxic epidermal necrolysis / WARNINGS AND PRECAUTIONS Peripheral Neuropathy ADCETRIS / Peripheral neuropathy / Stevens-Johnson syndrome / neutropenia / peripheral sensory neuropathy / Dose Modification Peripheral Neuropathy / fatigue / pulmonary / injury / septic shock / PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY / Lymphadenopathy / hypoesthesia / pulmonary toxicity / pulmonary embolism / diarrhea / Infusion Reactions Hematologic Toxicities Serious Infections / pruritus / Infections / pneumonitis / INDICATIONS AND USAGE Hodgkin Lymphoma ADCETRIS / respiratory tract infection / sepsis / upper respiratory tract infection / arrhythmia / Tumor / abdominal pain / pneumonia / bacteremia / opportunistic infections / disease / rapidly proliferating tumor / dyspnea / chills / Carcinogenesis / hyperesthesia / Systemic Anaplastic Large Cell Lymphoma ADCETRIS / neutropenia / Peripheral Neuropathy Anaphylaxis / fever / Tumor lysis syndrome / Hodgkin lymphoma / high tumor / viral infections / pain / vomiting / nervous system abnormalities / systemic anaplastic large cell lymphoma / virus infection / anaplastic large cell lymphoma / ADCETRIS-induced peripheral neuropathy / pyelonephritis / infection / cough / inflammation / rash / paresthesia / pulmonary symptoms / anemia / severe neutropenia / disorders / / MedicalTreatment Premedication / chemotherapy / intravenous infusion / immunosuppression / / Organization Preparation and Administration Administration / FDA / Administration Administration / / / Position General / / Product acetaminophen / DOSAGE FORMS AND STRENGTHS For injection / Sodium Chloride / Dextrose / Lactated Ringer's / Sterile Water for Injection / dacarbazine / for / ADCETRIS / / Technology Pharmacokinetics / chemotherapy / Pharmacodynamics / / URL www.fda.gov/medwatch / / SocialTag 
Draft Labeling Text - Redline, 2014Oct23