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 (gadofosveset trisodium injection) with MRA, a total of 1,676 (1379 patients and 297 healthy subjects) were exposed to various doses ABLAVAR (gadofosveset trisodium injection) . The mean age of the 1379 patients who received ABLAVAR (gadofosveset trisodium injection) 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 (gadofosveset trisodium injection) at a dose of 0.03 mmol/kg.
Table 2 : Common Adverse Reactions in 802 Subjects Receiving
ABLAVAR (gadofosveset trisodium injection) 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 (gadofosveset trisodium injection) 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 (gadofosveset trisodium injection) 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 (gadofosveset trisodium injection) (0.05 mmol/kg) did not alter the anticoagulant activity of warfarin as measured by the International Normalized Ratio (INR).
Last reviewed on RxList: 2/9/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Ablavar Information
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