NN&I - May 2010
Brief Summary (See Package Insert For Full Prescribing Information) Therapeutic Class: Hematinic CLINICAL INDICATIONS AND USAGE Venofer ® (iron sucrose injection,USP) is indicated in the treatment of iron deficiency anemia in the fol\lowing patients: CONTRAINDICATIONS The use of Venofer ® ® WARNINGS PRECAUTIONS and ADVERSE REACTIONS. PRECAUTIONS General: Because body iron excretion is limited and excess tissue iron can be hazardous,caution should be exercised to withhold iron adm inistration in ® require periodic monitoring of hematologic and hematinic parameters DOSAGE ANDADMINISTRATION and OVERDOSAGE. Hypersensitivity Reactions: ® ® ADVERSE REACTIONS. Hypotension: administration of Venofer ® ® according DOSAGE AND ADMINISTRATION. Carcinogenesis,Mutagenesis,and Impairment of Fertility: ® Venofer ® Venofer ® Pregnancy Category B: maximum human ® esponse,this drug Nursing Mothers: Venofer ® ® Pediatric Use: ® ® ® ® Geriatric Use: ey respond d other reported clinical ADVERSE REACTIONS Adverse Events observed in all treated populations ® ® ® Table 2.Most Common Treatment-Emergent Adverse Events Reported in 2% of Patients By Clinical Indication (Multidose Safety Population) HDD-CKD PDD-CKD Adverse Events Venofer ® Venofer ® EPO Only (Preferred Term) (N=231) (N=75) (N=46) %%% Subjects with any adverse event Eye Disorders Gastrointestinal Disorders General Disorders and Administration Site Conditions Infections and Infestations Injury,Poisoning and Procedural Complications Investigations (Table 2 continued) HDD-CKD PDD-CKD Adverse Events Venofer ® Venofer ® EPO Only (Preferred Term) (N=231) (N=75) (N=46) %%% Metabolism and Nutrition Disorders Musculoskeletal and Connective Tissue Disorders Nervous System Disorders Respiratory,Thoracic and Mediastinal Disorders Skin and Subcutaneous Tissue Disorders Vascular Disorders Table 3.Most Common Treatment-Emergent Adverse Events Reported in 2% of Patients by Dose Group (Multidose Safety Population) HDD-CKD PDD-CKD Adverse Events 100 mg 300 mg for 2 doses followed by (Preferred Term) (N=231) 400 mg for 1 dose (N=75) %% Subjects with any adverse event Eye Disorders Gastrointestinal Disorders General Disorders and Administration Site Conditions Infections and Infestations Injury,Poisoning and Procedural Complications Investigations Metabolism and Nutrition Disorders Musculoskeletal and Connective Tissue Disorders Nervous System Disorders Respiratory,Thoracic and Mediastinal Disorders Skin and Subcutaneous Tissue Disorders Vascular Disorders FVEN0071 RBE-Sprd Ad DR 2/11/10 6:53 PM Page 2 Ads_NNI0510.indd 44 4/14/10 9:12:26 AM
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