The most serious reactions to Gadavist (gadobutrol) are nephrogenic systemic fibrosis and hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect Gadavist (gadobutrol) exposure in 4549 subjects (4411 adults and 138 children aged 2-17) who received a dose that ranged from < 0.09 to 0.51 mmol/kg body weight; the majority (n=2434) received the recommended dose of 0.1 (±0.01) mmol/kg body weight. Overall, 58.5% of the subjects were men and the ethnic distribution was 64.8% Caucasian, 27.3% Asian, 3% Hispanic, 1.3% Black, and 3.6% patients of other ethnic groups. The average age was 54.2 years (range from 2 to 93 years).
Overall, 4% of subjects reported one or more adverse reactions during a follow-up period that ranged from 24 hours to 7 days after Gadavist (gadobutrol) administration.
Adverse reactions associated with the use of Gadavist (gadobutrol) are usually mild to moderate in severity and transient in nature. Table 1 lists adverse reactions that occurred in ≥ 0.1% subjects who received Gadavist (gadobutrol) .
Table 1: Adverse Reactions
|Reaction|| Rate (%)
|Injection site reactions||0.6|
|Rash (includes generalized, macular, papular, pruritic)||0.3|
|Pruritus (includes generalized)||0.2|
Adverse reactions that occurred with a frequency of < 0.1% in subjects who received Gadavist (gadobutrol) include: hypersensitivity/anaphylactoid reactions (hypotension, urticaria, flushing, pallor), loss of consciousness, convulsion, parosmia, tachycardia, palpitation, dry mouth, malaise and feeling cold.
The following additional adverse reactions have been reported during postmarketing use of Gadavist (gadobutrol) . Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Cardiac arrest
- Nephrogenic Systemic Fibrosis (NSF)
- Hypersensitiviry/anaphylactoid reactions (anaphylactoid shock, circulatory collapse, blood pressure increased, chest pain, respiratory arrest, bronchospasm, cyanosis, oropharyngeal swelling, laryngeal edema, face edema, angioedema, conjunctivitis, eyelid edema, hyperhidrosis, cough, sneezing, and burning sensation) [see WARNINGS AND PRECAUTIONS]
Read the Gadavist (gadobutrol) Side Effects Center for a complete guide to possible side effects »
There are no known drug interactions. Gadavist (gadobutrol) does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Do not mix Gadavist (gadobutrol) with other drugs.
Last reviewed on RxList: 5/5/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Gadavist Information
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