View Document Preview and Link Document Date: 2011-08-19 15:23:16 Open Document File Size: 157,86 KB Share Result on Facebook
Company Seattle Genetics Inc. / / Event FDA Phase / / Facility ADC-CD30 complex / / IndustryTerm chemical synthesis / chemical conjugation / medicinal products / treatment of patients with Hodgkin lymphoma / administration site / microtubule network / / MedicalCondition Adverse Reaction General disorders / Tumor Lysis Syndrome Tumor lysis syndrome / urinary tract infection / pneumothorax / nausea / anaphylaxis / thrombocytopenia / WARNINGS AND PRECAUTIONS Peripheral Neuropathy ADCETRIS / Stevens-Johnson syndrome / Peripheral neuropathy / neutropenia / peripheral sensory neuropathy / Dose Modification Peripheral Neuropathy / fatigue / septic shock / Progressive Multifocal Leukoencephalopathy / hypoesthesia / pulmonary embolism / diarrhea / pruritus / Infections / pneumonitis / Back pain / upper respiratory tract infection / Progressive Multifocal Leukoencephalopathy A / abdominal pain / rash / abdominal pain / disease / CD30-expressing hematologic malignancies / rapidly proliferating tumor / dyspnea / Stevens-Johnson Syndrome Stevens-Johnson syndrome / chills / Carcinogenesis / hyperesthesia / Systemic Anaplastic Large Cell Lymphoma ADCETRIS / umbilical hernias / Neutropenia / extremity Muscle spasms / Hodgkin Lymphoma ADCETRIS / Tumor Lysis Syndrome / Hodgkin lymphoma / Gastrointestinal disorders Nausea Diarrhea Abdominal pain Vomiting Constipation / high tumor / pain / vomiting / systemic anaplastic large cell lymphoma / ADCETRIS-induced peripheral neuropathy / supraventricular arrhythmia / pyelonephritis / cough / rash / paresthesia / anemia / severe neutropenia / / MedicalTreatment Premedication / chemotherapy / intravenous infusion / / Organization administration of ADCETRIS / FDA / / / Position Adverse Reaction General / DOSAGE AND ADMINISTRATION General / General / / Product acetaminophen / Sodium Chloride / Dextrose / rifampin / Lactated Ringer's / Sterile Water for Injection / ketoconazole / for / ADCETRIS / / Technology ADC / antibodies / Pharmacokinetics / chemotherapy / Pharmacodynamics / / URL www.fda.gov/medwatch / / SocialTag 
HIGHLIGHTS OF PRESCRIBING INFORMATION • Infusion reactions: If an infusion reaction occurs, the infusion should be interrupted and appropriate medical management