| Document Date: 2014-04-01 13:41:25
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City Reference / / Company AstraZeneca / / Facility Laboratory Abnormalities CAPRELSA / / IndustryTerm treatment of symptomatic or progressive medullary thyroid cancer / food / chemical / Monitor for signs and symptoms / / MedicalCondition Chemistries Hypocalcemia / acneiform dermatitis / ventricular tachycardia / lower abdominal pain / TORSADES DE POINTES / hypocalcemia / headache / seizures / congenital long QT syndrome / nail bed infection / nail infection / dermatitis / Includes nail disorder / nausea / Thrombocytopenia / rhinitis / Alopecia / bradyarrhythmias / metastatic disease / hemoptysis / Stevens-Johnson Syndrome / intestinal perforation / fatigue / pulmonary / Dermatitis Acneiform/Acne / Diarrhea / sinusitis / end-stage renal disease / tracheitis / Hypoglycemia / corneal edema / pneumonitis / Correct hypocalcemia / upper respiratory tract infection / diarrhea/colitis / long QT syndrome / paronychia / nail bed inflammation / abdominal pain / progressive medullary thyroid cancer / Hypertension / cancer / disease / severe fatigue / Pruritus Nail abnormalities4 / slowly progressing disease / nasopharyngitis / Hypothyroidism / Includes laryngitis / Hypertension/Hypertensive Crisis/Accelerated Hypertension / Dysgeusia / Carcinogenesis / eczema / reversible posterior leukoencephalopathy syndrome / erythema / Includes rash / corneal opacities / Vomiting / myocardial infarction / medullary thyroid cancer / Heart Failure / pancreatitis / posterior leukoencephalopathy syndrome / hypokalemia / thyroid cancer / corneal opacity / rash / Nutritional Disorders Investigations ECG QT Prolonged7 Eye Disorders Renal Disorders Proteinuria Psychiatric Disorders Depression Endocrine Disorders Hypothyroidism Musculoskeletal Disorders Muscle Spasms / pharyngitis / acute sinusitis / Syndrome / Interstitial Lung Disease / upper respiratory tract infections / dehydration / / MedicalTreatment alternative therapy / contraception / dialysis / / Organization CAPRELSA administration / DOSAGE AND ADMINISTRATION / FDA / / / Position Nervous System Disorders General / / Product granisetron / haloperidol / CAPRELSA tablets / clarithromycin / PATIENT COUNSELING INFORMATION MEDICATION / Digoxin / / RadioStation 5.6 Heart / / Technology MRI / Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / www.caprelsarems.com / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CAPRELSA safely and effectively. See full prescribing information for CAPRELSA. CAPRELSA® (vandetanib) Tablets for