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PROHANCE- gadoteridol injection, solution


  1. Patient Information
  2. Instruct Patients To Inform Their Physician If They:
  3. Revised: 10/2019document Id:

Patient Information 

  • 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 the 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
Instruct patients to inform their physician if they;

  • are pregnant or breast feeding
  • have a history of renal disease or heart disease, seizure, asthma or allergic respiratory diseases

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[
    • 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
      • 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

        • 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.

          ProHance 50mL Label
          NDC: 0270-1111-70

          ProHance 50 mL Label

          ProHance 50mL Carton
          NDC: 0270-1111-70

          ProHance 50 mL Carton
          PROHANCE
          gadoteridol injection, solution
          Product Information
          Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0270-1111
          Route of AdministrationINTRAVENOUS
          Active Ingredient/Active Moiety
          Ingredient NameBasis of StrengthStrength
          gadoteridol(UNII: 0199MV609F) (gadoteridol - UNII:0199MV609F)gadoteridol279.3 mg in 1 mL
          Inactive Ingredients
          Ingredient NameStrength
          calteridol calcium(UNII: RPH56VWA1A)0.23 mg in 1 mL
          tromethamine(UNII: 023C2WHX2V)1.21 mg in 1 mL
          Packaging
          #Item CodePackage DescriptionMarketing Start DateMarketing End Date
          1NDC:0270-1111-705 in 1 BOX10/09/2003
          150 mL in 1 VIAL, PHARMACY BULK PACKAGE; Type 0: Not a Combination Product
          Marketing Information
          Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
          NDANDA02148910/09/2003
          Labeler -Bracco Diagnostics Inc (849234661)
          Registrant -Bracco Diagnostics Inc (849234661)
          Establishment
          NameAddressID/FEIBusiness Operations
          BRACCO IMAGING SPA434384007API MANUFACTURE(0270-1111)
          Establishment
          NameAddressID/FEIBusiness Operations
          BIPSO GmbH342104149MANUFACTURE(0270-1111) , ANALYSIS(0270-1111)
          Establishment
          NameAddressID/FEIBusiness Operations
          Lacor LS SE & Co. KG314929072ANALYSIS(0270-1111)

Revised: 10/2019document Id: 

b590f069-6586-ebf9-a148-ecb5f143af4bSet id: e8b76200-c0aa-491b-aad7-e22d2f68496fVersion: 12Effective Time: 20191005Bracco Diagnostics Inc



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