ORDERING INFORMATION | REIMBURSEMENT | NEWS AND EVENTS | CONTACT US | BRACCO.COM     SEARCH
BRACCO DIAGNOSTICS INC.
Sign In

PROHance SAFETY INFORMATION

An added sense of security for your patients

With 14.5 million doses administered worldwide, ProHance has demonstrated consistently low overall rates of
adverse events.1

These events were mild to moderate in severity, and are comparable to other gadolinium-containing MRI contrast
agents as demonstrated in clinical trials.2-7 The most commonly noted adverse experiences were nausea and taste
perversion, with an incidence of 1.4%8.

90% of the dose is excreted within 24 hours post-injection8.

No contraindications for all patients including patients with renal impairment8. Screen patients for acute kidney injury
and other conditions that may reduce renal function, and take this information into account when making treatment decisions.

ProHance does not interfere with serum calcium determinations by
colorimetric methods9-10

This pooled data is derived from the safety data reported in the approved labeling for each respective product. In the
absence of adequate and well-controlled head-to-head investigations, no clinical conclusions or comparisons may be
made among products. Prohance does not interfere with serum calcium determinations by colorimetric methods9-10

Pseudohypocalcemia has been shown to occur following administration of Omniscan and OptiMARK11-13

  • In one comparative clinical study, false hypocalcemia was noted in 15.7% of 1,049 examinations performed
    with Omniscan9
  • In 25 examinations (2.4%), the decreases in serum calcium readings resulted in measurements of “critical”
    hypocalcemia, resulting in inappropriate and potentially dangerous therapy in 18 patients9

Adapted from Prince M, et al. Radiology, 2003; 227:644. Used with permission.



 FDA NSF Safety Update

REFERENCES: 1. Postmarketing Surveillance and Utilization Report 2010. On file, Bracco Diagnostics Inc. 2. Kirchin MA, Runge VM. Contrast agents for magnetic resonance imaging: safety update. Top Magn Reson Imaging. 2003;14:426-435. 3. Goldstein HA, Kashanian FK, Blumetti RF, Holyoak WL, Hugo FP, Blumenfield DM. Safety assessment of gadopentetate dimeglumine in U.S. clinical trials. Radiology. 1990;174:17-23. 4. Runge VM, Parker JR. Worldwide clinical safety assessment of gadoteridol injection: an update. Eur Radiol. 1997; 7(suppl 5S):243-245. 5. Sze G, Brant-Zawadzki M, Haughton VM, et al. Multicenter study of gadodiamide injection as a contrast agent in MR imaging of the brain and spine. Radiology. 1991;181:693-699. 6. Kirchin MA, Pirovano G, Venetianer C, Spinazzi A. Safety assessment of gadobenate dimeglumine (MultiHance): Extended clinical experience from phase 1 studies to post-marketing surveillance. J Magn Reson Imaging. 2001;14:281-294.7. Goldstein HA, Kashanian FK, Blumetti R, et al. Safety assessment of Gd-DPTA in U.S. Clinical Trials. Radiology. 1990; 174:17-23. 8. ProHance (gadoteridol) injection 279.3 mg/mL full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; July 2011. 9. Prince MR, Erel HE, Lent RW, et al. Gadodiamide administration causes spurious hypocalcemia. Radiology. 2003;22:639-646. 10. Emerson J, Kost G. Spurious hypocalcemia after Omniscan-or OptiMARK-enhanced magnetic resonance imaging. Arch Pathol Lab Med. 2004;128:1151-1156. 11. Normann PT, Froysa A, Svaland M. Interference of gadodiamide injection (OMNISCAN) on the colorimetric determination of serum calcium. Scand J Clin Lab Invest. 1995;55:421-426. 12. Lin J, Idee JM, Port M, et al. Interference of magnetic resonance imaging contrast agents with the serum calcium measurement technique using colorimetric reagents. J Pharm Biomed Anal. 1999;21:931-943. 13. Proctor KA, Rao LV, Roberts WL.Gadolinium magnetic resonance contrast agentsproduce analytic interference in multiple serum assays. Am J Clin Pathol. 2004;121:282-292.

 

 
.

PROHANCE INDICATIONS AND USAGE
Central Nervous System
ProHance (Gadoteridol) Injection is indicated for use in MRI in adults and children over 2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.

Extracranial/Extraspinal Tissues
ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.

IMPORTANT SAFETY 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.

  • 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 Warnings ]

As with all paramagnetic agents, caution should be exercised in patients with deoxygenated sickle erythrocytes and renal insufficiency with or without hepatic impairment. The possibility of a reaction, including serious, life threatening, or fatal, anaphylactic or cardiovascular reactions, or other idiosyncratic reactions, should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic disorders.

Please consult full Prescribing Information for ProHance including boxed WARNING contained within this website.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

All trademarks and registered trademarks are the property of their respective owners.

MultiHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany) and by Patheon Italia SpA, Ferentino, Italy.
ProHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany).