Drug Information

Vasovist Side Effects

Please note - some side effects for Vasovist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Vasovist Side Effects - for the Professional

Vasovist

The most common (>2%) adverse reactions are pruritis, headache, nausea, vasodilatation, and paresthesia (6.1, 6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Bayer Pharmaceuticals Corporation at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

See 17 for PATIENT COUNSELING INFORMATION
Revised: 01/2009

FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Dosing Guidelines 2.2 Imaging Guidelines 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Nephrogenic Systemic Fibrosis 5.2 Hypersensitivity Reactions 5.3 Acute Renal Failure 5.4 QTc Prolongation and Risk for Arrhythmias 6 ADVERSE REACTIONS 6.1 Clinical Studies Experience 6.2 Post-marketing Experience 7 DRUG INTERACTIONS 7.1 Warfarin 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION: CONTENTS*

* Sections or subsections omitted from the full prescribing information are not listed

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Guidelines

2.2 Imaging Guidelines

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Nephrogenic Systemic Fibrosis

5.2 Hypersensitivity Reactions

5.3 Acute Renal Failure

5.4 QTc Prolongation and Risk for Arrhythmias

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Post-marketing Experience

7 DRUG INTERACTIONS

7.1 Warfarin

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

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More resources:

Drugs.com Vasovist

FDA Vasovist

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