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GADAVIST- gadobutrol injection

  1. Patient Information
  2. Instruct Patients To Inform Their Physician If They:
  3. Gbcas Increase The Risk Of Nsf Among Patients With Impaired Elimination Of Drugs. To Counsel Patients At Risk Of Nsf:
  4. Inform Patients That They May Experience:

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 and/or liver disease, or
Have recently received a GBCA

Gbcas Increase The Risk Of Nsf Among Patients With Impaired Elimination Of Drugs. To Counsel Patients At Risk Of Nsf: 

Describe the clinical manifestation 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 Gadavist 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.

Common Adverse Reactions

Inform Patients That They May Experience: 

Reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site
Side effects of headache, nausea, abnormal taste and feeling hot

General Precautions

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 macrocyclicGBCAs [

Gadavist is a prescription medicine called a gadolinium-based contrast agent (GBCA). Gadavist, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.
An MRI exam with a GBCA, including Gadavist, helps your doctor to

Gadavist 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: gadobutrol

Inactive ingredients: calcobutrol sodium, trometamol, hydrochloric acid (for pH adjustment) and water for injection

Manufactured for Bayer HealthCare Pharmaceuticals Inc.

Manufactured in Germany

2011, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

For more information, go to www.gadavist.com or call 1-888-842-2937.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. 4/2018

The following is a representative example of Gadavist labeling. See the "How Supplied" section for a complete listing of all components.

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