ProHance (Page 5 of 5)

14.2 MRI of the Head and Neck

ProHance was evaluated in two blinded read studies in a total of 133 adults who had an indication for head and neck extracranial or extraspinal MRI. These 133 adults (74 men, 59 women) had a mean age of 53 with a range of 19 to 76 years. Of these patients, 85% were Caucasian, 13% Black, 2% Asian, and less than 1% other. The results of the non-contrast and contrast MRI scans were compared. Approximately 75-82% of the scans were enhanced, 45-48% of the scans provided additional diagnostic information, and 8-25% of the diagnoses were changed. The relevance of the findings to disease sensitivity and specificity has not been fully evaluated.

16  HOW SUPPLIED/STORAGE AND HANDLING

How Supplied
ProHance Multipack is supplied as a sterile, nonpyrogenic, and colorless to slightly yellow solution containing 279.3 mg/mL (0.5 mmol/mL) of gadoteridol in rubber stoppered vials. ProHance Multipack is supplied in boxes of five 50 mL pharmacy bulk packages (NDC 0270-1111-70) and boxes of five 100 mL pharmacy bulk packages (NDC-0270-1111-85).

Storage and Handling
Store at 25°C (77° F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from light. DO NOT FREEZE. Should freezing occur in the vial, ProHance Multipack should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 60 minutes, ProHance Multipack should return to a clear, colorless to slightly yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. Should solids persist, discard vial.

17  PATIENT COUNSELING INFORMATION

Medication Guide

  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Nephrogenic Systemic Fibrosis
Instruct patients to inform their physician if they:

  •  have a history of kidney disease
  •  have recently received a GBCA

GBCAs increase the risk for NSF in patients with impaired elimination of the drugs. To counsel patients at risk for NSF:

  •  describe the clinical manifestations of NSF
  •  describe procedures to screen for the detection of renal impairment

Instruct patients to contact their physician if they develop signs or symptoms of NSF following ProHance administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.

General Precautions

  • Pregnancy: Advise a pregnant woman of the potential risk of fetal exposure to ProHance [see Use in Specific Populations (8.1)]
  • Gadolinium retention: Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs [see Warnings and Precautions (5.3)].


Manufactured for:
Bracco Diagnostics Inc.
Monroe Twp., NJ 08831

By BIPSO GmbH78224 Singen (Germany)

November 2021

CL4EF10

This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 12/2020COEB504
MEDICATION GUIDEPROHANCE® (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, distortion of the sense of taste, and headache. 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 08831For more information, go to www.imaging.bracco.com or call 1-800-257-5181.

ProHance 50mL LabelNDC: 0270-1111-70

ProHance 50 mL Label
(click image for full-size original)

ProHance 50mL CartonNDC: 0270-1111-70

ProHance 50 mL Carton
(click image for full-size original)
PROHANCE gadoteridol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0270-1111
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
gadoteridol (gadoteridol) gadoteridol 279.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
calteridol calcium 0.23 mg in 1 mL
tromethamine 1.21 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0270-1111-70 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX contains a VIAL, PHARMACY BULK PACKAGE
1 50 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the BOX (0270-1111-70)
2 NDC:0270-1111-85 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX contains a VIAL, PHARMACY BULK PACKAGE
2 100 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the BOX (0270-1111-85)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021489 10/09/2003
Labeler — Bracco Diagnostics Inc (849234661)
Registrant — Bracco Diagnostics Inc (849234661)
Establishment
Name Address ID/FEI Operations
BRACCO IMAGING SPA 434384007 API MANUFACTURE (0270-1111)
Establishment
Name Address ID/FEI Operations
BIPSO GmbH 342104149 MANUFACTURE (0270-1111), ANALYSIS (0270-1111)
Establishment
Name Address ID/FEI Operations
Labor LS SE & Co. KG 314929072 ANALYSIS (0270-1111)
Establishment
Name Address ID/FEI Operations
BioChem Labor für biologishe und chemische 318354230 ANALYSIS (0270-1111)

Revised: 11/2021 Bracco Diagnostics Inc

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