Included as part of the "PRECAUTIONS" Section
Apply EVICEL® as a thin layer. Excessive clot thickness may negatively interfere with the
product’s efficacy and the wound healing process.
To reduce the risk of potentially life threatening air embolism, spray EVICEL® using
pressurized CO2 gas only. For specific spray instructions on the recommended pressure and
distance from tissue per type of surgical procedure and length of application tip, see Section
DOSAGE AND ADMINISTRATION.
Use EVICEL® spray application only if it is possible to accurately judge the distance from the spray tip to the tissue surface, especially during laparoscopy.
Monitor changes in blood pressure, pulse, oxygen saturation and end tidal CO2 when spraying EVICEL® due to the possibility of occurrence of gas embolism.
When using accessory tips with this product, follow the the instructions for use of the tips with attention to the spray pressure and distance ranges for each tip.
Prior to applying EVICEL®, dry surface areas of the wound by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Infection Risk From Human Plasma 150
Because EVICEL® is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, the bacteria, parasites, variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the classic CJD agent.”The risk of transmitting an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician to have been possibly transmitted by this product should be reported by the physician or other healthcare provider to ETHICON Customer Support Center at (877) 384-4266. The physician should discuss the risks and benefits of this product with the patient.
Local Tolerance And Acute-Repeat Toxicology Studies
EVICEL® has been classified as non-irritant in the Primary Cutaneous Irritation Test and
slightly irritant in the Ocular Irritation test.
No toxicological effects due to the solvent detergent reagents (TnBP and Triton X-100) used
in the virus inactivation procedure are expected based on acute and repeat toxicity studies
and since the residual levels are less than 5μg/ml.
Neurotoxicity studies performed with EVICEL® confirmed that subdural administration in
the rabbit was not associated with any evidence of neurotoxicity.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of
EVICEL® due to the human origin of both thrombin and fibrinogen contents.
Neither BAC2 nor Thrombin solution induces mutagenic effects in the Ames test. Studies
performed in bacteria to determine mutagenicity were negative for Thrombin alone, BAC
(containing fibrinogen, citrate, glycine, tranexamic acid, and arginine hydrochloride), TnBP
alone, and Triton X-100 alone at all concentrations tested. All concentrations of the
combination of TnBP and Triton X-100 also tested negative in assays performed to
determine mammalian cell mutagenicity, chromosomal aberrations and micronuclei
The effect of EVICEL® on fertility has not been evaluated.
Reproductive studies performed in rats with the combination of TnBP and Triton X-100 at
doses up to approximately 600-fold (TnBP, 900 μg/kg/day) and 3000-fold (Triton X-100,
4500 μg/kg/day) the human dose resulted in increased post-implantation loss and an
increased number of late resorptions. No embryo-fetal adverse effects were observed at
doses up to 200-fold (TnBP, 300 μg/kg/day) and 1000-fold (Triton X-100, 1500 μg/kg/day)
the human dose. Other studies performed with the combination of TnBP at doses
approximately 300-fold (TnBP, 450 μg/kg/day) and 1500-fold (Triton X-100, 2250
μg/kg/day) the human dose had increased resorption rates, decreased fetal body weights, and
an increased number of runts. No embryo-fetal adverse effects were observed at doses up to
100-fold (TnBP, 150 μg/kg/day) and 500-fold (Triton X-100, 750 μg/kg/day) the human
Use In Specific Populations
Pregnancy Category C
Animal reproduction studies have not been conducted with EVICEL®. It is not known
whether EVICEL® can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. EVICEL® should be given to a pregnant woman only if clearly
Labor And Delivery
The safety of EVICEL® for use during labor and delivery has not been established.
The safety of EVICEL® for use during breast-feeding has not been established. Use only if
Limited data are available to support the safety and effectiveness of EVICEL® in children.
No data are currently available for ages 0 to 6 months.
Of 135 patients undergoing retroperitoneal and intra-abdominal surgery who were included
in the adequate and well controlled study of EVICEL®, 4 patients treated with EVICEL®
were age 16 years or younger. Of these, 2 were children age 2 to 11 years and 2 were
adolescents of 12 to 16 years.
Pediatric patients for vascular surgery are rare and were therefore not included in the clinical
trials involving vascular surgery.
Of the 155 patients undergoing liver surgery who were treated in adequate and wellcontrolled
studies, eight were pediatric patients. Of these, five were less than 2 years old and
three were between 2 and 12 years old.
Use of EVICEL® in pediatric patients above age 6 months is supported by these data and by
extrapolation of efficacy in adults. Data can not be extrapolated to ages 0 to 6 months.
Clinical trials included 101 patients of 65 years of age or older (30 undergoing
retroperitoneal or intra-abdominal surgery, 24 undergoing liver surgery and 47 undergoing
No differences in safety or effectiveness were observed between the elderly and younger