Evicel

EVICEL® Fibrin Sealant (Human) is 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.

Dosage Forms And Strengths

EVICEL® is supplied as a kit consisting of two separate packages:

• A package containing one vial each of BAC2 (55-85 mg/ml fibrinogen) and Thrombin (800-1200 IU/ml human thrombin) frozen solutions.
• A modular spray application device which includes a 6 cm flexible yellow tip. Optional accessory tips are distributed seperately.

The different EVICEL® dosage strengths include the following sizes (Table 3):

Table 3: EVICEL® package sizes

Storage And Handling

EVICEL® is supplied as a kit consisting of two separate packages:

• A package containing one vial each of BAC2 (55-85 mg/ml fibrinogen) and Thrombin (800-1200 IU/ml human thrombin) frozen solutions.
• A spray application device.

The different EVICEL® dosage strengths include the following sizes (Table 9):

Table 10: EVICEL® package sizes

The vials must be stored in an upright position.

Store frozen vials at -18 °C or colder (frozen) for up to 2 years.

Unopened vials can be stored at 2°C to 8°C (refrigerated) for up to 30 days.

The two EVICEL® components, BAC2 and Thrombin, have been shown to be stable for up to 24 hours at room temperature.

Do not use after the expiration date stated on the box, or after 30 days if stored at 2°C to 8°C after thawing.

Do not re-freeze EVICEL® once it has been thawed.

Do not refrigerate EVICEL® once it has reached room temperature. Discard unused product after 24 hours at room temperature.

Discard if the packaging of EVICEL® is damaged.

Vials are for single use only. Discard unused contents.

Manufactured by: Omrix Biopharmaceuticals Ltd. MDA Blood Bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000, ISRAEL. Revised: 2013

Included as part of the "PRECAUTIONS" Section

No Information Provided

Clinical Trials 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 practice.

The following adverse reactions which occurred during clinical studies were evaluated as having a possible causal relationship to treatment with EVICEL®. The frequency of all of the reactions listed below was common (defined as > 1/100, < 1/10).

Table 4: Adverse Reactions Clinical Trials Experience

Among 135 patients undergoing retroperitoneal and intra-abdominal surgery (67 patients treated with EVICEL® and 68 controls), one abdominal abscess in the EVICEL® group and one abdominal and one pelvic abscess in the control group) were considered by the Sponsor to be possibly related to study treatment.

In a controlled study involving 147 patients undergoing vascular grafting procedures (75 treated with EVICEL® and 72 controls), nine patients experienced 12 adverse events that were assessed by the Sponsor as being possibly related to treatment. These included graft or staphylococcal infection, hematoma, incision site hemorrhage, peripheral edema, and decreased hemoglobin.

In a controlled study involving 121 patients undergoing liver surgery (58 treated with fibrin sealant and 63 controls), no adverse reactions causally related to the study treatment were observed.

Post-Marketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Post-marketing fatalities due to air embolism have been reported in association with the use of EVICEL® when applied using a spray device. These cases have occurred where EVICEL® was sprayed at a higher than indicated pressure 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 post-marketing experience with EVICEL® and are categorized by MedDRA System Organ Class and Perferred Terms in order of decreasing frequency:

Table 5: Adverse Reactions Post-Marketing Experience

Read the entire FDA prescribing information for Evicel (Fibrin Sealant (Human) )