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MEDICATION GUIDE PROHANCE® (Prō-ˈhan(T)S) (Gadoteridol)

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MEDICATION GUIDE PROHANCE® (Prō-ˈhan(T)S) (Gadoteridol) MEDICATION GUIDE PROHANCE® (prō-ˈhan(t)s) (Gadoteridol) Injection for intravenous use What is PROHANCE? • PROHANCE is a prescription medicine called a gadolinium-based contrast agent (GBCA). PROHANCE, like other GBCAs, is used with a magnetic resonance imaging (MRI) scanner. • An MRI exam with a GBCA, including PROHANCE, helps your doctor to see problems better than an MRI exam without a GBCA. • Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam. What is the most important information I should know about PROHANCE? • PROHANCE contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). • It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys. • Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. • There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance. • People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body. • Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive PROHANCE. Do not receive PROHANCE if you have had a severe allergic reaction to PROHANCE. Before receiving PROHANCE, tell your healthcare provider about all your medical conditions, including if you: • have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures. • are pregnant or plan to become pregnant. It is not known if PROHANCE can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as PROHANCE is received during pregnancy • have kidney problems, diabetes, or high blood pressure • have had an allergic reaction to dyes (contrast agents) including GBCAs What are the possible side effects of PROHANCE? • See “What is the most important information I should know about PROHANCE?” • Allergic reactions. PROHANCE can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction. The most common side effects of PROHANCE include: nausea, taste perversion, headache, feeling hot, or burning at the injection site. These are not all the possible side effects of PROHANCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of PROHANCE. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about PROHANCE that is written for health professionals. What are the ingredients in PROHANCE? Active ingredient: gadoteridol Inactive ingredients: calteridol calcium, tromethamine Manufactured by: BIPSO GmbH-78224 Singen (Germany) Manufactured for: Bracco Diagnostics Inc., Monroe Township, NJ 08831 US Patent No. 5,474,756; 5,846,519; and 6,143,274. For more information, go to www.imaging.bracco.com or call 1-800-257-5181. This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 04/2018 COEB503 Reference ID: 4254645 HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------DOSAGE AND ADMINISTRATION--------------------------- These highlights do not include all the information needed to use • Dispense multiple single doses into separate sterile syringes for PROHANCE MULTIPACK safely and effectively. See full prescribing intravenous administration (2) information for PROHANCE MULTIPACK. • Recommended dose in adults and pediatric patients >2 years of age is 0.2 mL/kg administered as rapid intravenous infusion or bolus (2) PROHANCE MULTIPACK (gadoteridol) injection, for intravenous use, • Follow injection with a saline flush of at least 5 mL normal saline (2) PHARMACY BULK PACKAGE -- NOT FOR DIRECT INFUSION Initial US Approval: 2003 -------------------------DOSAGE FORMS AND STRENGTHS------------------------- Injection: Each mL of ProHance contains 279.3 mg of gadoteridol (3) WARNING: NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning --------------------------------CONTRAINDICATIONS--------------------------------- Allergic or hypersensitivity reactions to ProHance (4) Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. --------------------------WARNINGS AND PRECAUTIONS--------------------------- Avoid use of GBCAs in these patients unless the diagnostic • Nephrogenic Systemic Fibrosis has occurred in patients with information is essential and not available with non-contrasted impaired elimination of GBCAs. Higher than recommended dosing MRI or other modalities. NSF may result in fatal or debilitating or repeated dosing appears to increase risk (5.1) systemic fibrosis affecting the skin, muscle and internal organs. • Severe and fatal hypersensitivity reactions including anaphylaxis can • The risk for NSF appears highest among patients with: occur. Monitor patients closely for need of emergency • chronic, severe kidney disease (GFR <30 cardiorespiratory support (5.2) 2 mL/min/1.73m ), or • Gadolinium is retained for months or years in brain, bone, and • acute kidney injury other organs. (5.3) ---------------------------------ADVERSE REACTIONS---------------------------------- • Screen patients for acute kidney injury and other conditions The most commonly reported adverse reactions are nausea and taste that may reduce renal function. For patients at risk for perversion with an incidence of 1.4% (6.1) chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing (5.1). To report SUSPECTED ADVERSE REACTIONS, Contact Bracco Diagnostics Inc. at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ------------------------------RECENT MAJOR CHANGES------------------------------- See 17 for PATIENT COUNSELING INFORMATION and Medication Guide Warnings and Precautions, Gadolinium Retention (5.3) 04/2018 Revised: 04/2018 ------------------------------INDICATIONS AND USAGE------------------------------- ProHance Multipack is a gadolinium-based paramagnetic MRI contrast agent indicated for intravenous use to visualize: • lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients over 2 years of age (1.1) • lesions in the head and neck in adults (1.2) 7. DRUG INTERACTIONS FULL PRESCRIBING INFORMATION: CONTENTS* 8. USE IN SPECIFIC POPULATIONS WARNING: NEPHROGENIC SYSTEMIC FIBROSIS 8.1 Pregnancy 1 INDICATIONS AND USAGE 8.3 Nursing Mothers 1.1 MRI of the Central Nervous System (CNS) 8.4 Pediatric Use 1.2 MRI of Extracranial/Extraspinal Tissues 8.5 Geriatric Use 2 DOSAGE AND ADMINISTRATION 10 OVERDOSAGE 2.1 Dosing and Imaging Instructions 11 DESCRIPTION 2.2 Administration 12 CLINICAL PHARMACOLOGY 2.3 Directions for Proper Use of Pharmacy Bulk Package 12.1 Mechanism of Action 3 DOSAGE FORMS AND STRENGTHS 12.2 Pharmacodynamics 4 CONTRAINDICATIONS 12.3 Pharmacokinetics 5 WARNINGS AND PRECAUTIONS 13 NONCLINICAL TOXICOLOGY 5.1 Nephrogenic Systemic Fibrosis (NSF) 13.1 Carcinogenesis, Mutagenesis, 5.2 Hypersensitivity Reactions Impairment of Fertility 5.3 Gadolinium Retention 14 CLINICAL STUDIES 5.4 Acute Kidney Injury (AKI) 16 HOW SUPPLIED/STORAGE AND HANDLING 6 ADVERSE REACTIONS 17 PATIENT COUNSELING INFORMATION 6.1 Clinical Trials Experience 6.2 Post-marketing Experience *Sections or subsections omitted from the full prescribing Information are not listed Reference ID: 4254645 FULL PRESCRIBING INFORMATION WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non- contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs [see Warnings and Precautions (5.1)]. • The risk for NSF appears highest among patients with: • chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or • acute kidney injury • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. • For patients at highest risk for NSF, do not exceed the recommended ProHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration [see
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