Medical Editor: John P. Cunha, DO, FACOEP
What Is Evicel?
Evicel (fibrin sealant, human) is a fibrin sealant indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
What Are Side Effects of Evicel?
Common side effects of Evicel include:
- slow heart rate,
- low blood potassium,
- low blood pressure (hypotension),
- graft infection,
- vascular graft occlusion,
- swelling of extremities, and
Dosage for Evicel?
Evicel is administered by a healthcare professional onto the tissue in short bursts (a dose of 0.1-0.2 26 ml) to produce a thin, even layer.
What Drugs, Substances, or Supplements Interact with Evicel?
Evicel is not known to interact with other drugs. Tell your doctor all medications and supplements you use.
Evicel During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Evicel; it is unknown how it would affect a fetus. Consult your doctor before breastfeeding.
Our Evicel (fibrin sealant, human) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The most common adverse reactions (0.5% of subjects) reported in clinical trials are peripheral edema, abdominal abscess, infection, hematoma, incision site hemorrhage, vascular graft occlusion, postoperative wound complication and decreased hemoglobin.
The most common additional adverse reactions reported in postmarketing experience are, pyrexia, seroma, cardiac arrest, tachycardia, pulmonary embolism, dyspnea, and urticaria (6.2).
Clinical Trials Experience
Clinical trials are conducted under widely varying conditions; therefore 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 practice.
In a controlled study involving 147 subjects undergoing vascular grafting procedures (75 treated with EVICEL® and 72 controls), nine subjects experienced 12 adverse reactions including graft or staphylococcal infection, hematoma, incision site hemorrhage, peripheral edema and decreased hemoglobin.
Retroperitoneal Or Intra-Abdominal Surgery
Among 135 subjects undergoing retroperitoneal and intra-abdominal surgery (67 subjects treated with EVICEL® and 68 controls), one subject experienced an abdominal abscess in the EVICEL® group. In the control group, one subject experienced an abdominal abscess and one subject experienced a pelvic abscess.
In a controlled study involving 121 subjects undergoing liver surgery (58 treated with EVICEL® and 63 controls), no adverse reactions were observed.
Table 4 provides the adverse reactions of EVICEL® from three clinical trials. A total of 200 subjects were exposed to EVICEL® from these studies.
Table 4: Frequency of Adverse Reactions from Clinical Trials
|System organ class||Adverse Reactions||EVICEL|
|GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS||Total||1|
|INFECTIONS AND INFESTATIONS||Total||4|
|INJURY, POISONING AND PROCEDURAL COMPLICATIONS||Total||6|
|INCISION SITE HEMORRHAGE||1|
|INCISION SITE HEMATOMA||1|
|POST PROCEDURAL HEMATOMA||1|
|POSTOPERATIVE WOUND COMPLICATION||1|
|VASCULAR GRAFT OCCLUSION||1|
|POSTOPERATIVE WOUND INFECTION||1|
The following adverse reactions are reported voluntarily from a population of uncertain size, therefore, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Postmarketing fatalities attributable to air or gas embolism have been reported with the use of EVICEL® when applied using a spray device. These cases have occurred where EVICEL® was sprayed at a pressure higher than indicated for the device in use and when the spray tip was placed closer than the specified distance from the target site.
The following adverse reactions have been reported in postmarketing experience with EVICEL® in order of decreasing frequency (Table 5):
Table 5: Adverse Reactions Postmarketing Experience
|MedDRA System Organ Class||Adverse Reactions|
|GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS||PYREXIA|
|INJURY, POISONING AND PROCEDURAL COMPLICATIONS||SEROMA|
|CARDIAC DISORDERS||CARDIAC ARREST|
|RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS||PULMONARY EMBOLISM|
|SKIN AND SUBCUTANEOUS TISSUE DISORDERS||URTICARIA|
Read the entire FDA prescribing information for Evicel (Fibrin Sealant (Human) )
© Evicel Patient Information is supplied by Cerner Multum, Inc. and Evicel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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