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The following adverse reactions are discussed in greater detail in other sections of the label:
- Nephrogenic systemic fibrosis [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Clinical Studies Experience
In all clinical trials evaluating ABLAVAR with MRA, a total of 1,676 (1379 patients and 297 healthy subjects) were exposed to various doses ABLAVAR. The mean age of the 1379 patients who received ABLAVAR was 63 years (range 18 to 91 years); 66% (903) were men and 34% (476) were women. In this population, there were 80% (1100) Caucasian, 8% (107) Black, 12% (159) Hispanic, 1% (7) Asian, and < 1% (6) patients of other racial or ethnic groups. Table 2 shows the most common adverse reactions ( ≥ 1%) experienced by subjects receiving ABLAVAR at a dose of 0.03 mmol/kg.
Table 2 : Common Adverse Reactions in 802 Subjects
Receiving ABLAVAR at 0.03 mmol/kg
|Preferred Term||n (%)|
|Injection site bruising||19 (2)|
|Burning sensation||17 (2)|
|Venipuncture site bruise||17 (2)|
|Dizziness (excluding vertigo)||8 (1)|
|Feeling cold||7 (1)|
Because post-marketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The profile of adverse reactions identified during the post-marketing experience outside the United States was similar to that observed during the clinical studies experience.
Read the Ablavar (gadofosveset trisodium injection) Side Effects Center for a complete guide to possible side effects
Following injection, ABLAVAR binds to blood albumin and has the potential to alter the binding of other drugs that also bind to albumin. No drug interaction reactions were observed in clinical trials. Consider the possibility of ABLAVAR interaction with concomitantly administered medications that bind to albumin. An interaction may enhance or decrease the activity of the concomitant medication [see CLINICAL PHARMACOLOGY].
In a clinical trial of 10 patients receiving a stable dose of warfarin, a single dose of ABLAVAR (0.05 mmol/kg) did not alter the anticoagulant activity of warfarin as measured by the International Normalized Ratio (INR).
Read the Ablavar Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 8/23/2013
Additional Ablavar Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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