Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥3%) were thrombosis, fever, pain, anastomotic stenosis, rupture or anastomotic failure, and infection.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Humacyte Global, Inc.
at 1-833-591-0081 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to adverse reaction rates in clinical trials of other products, and they may not reflect the rates observed in real-world clinical practice.
The safety data described in this section reflect exposure to SYMVESS in one single arm, open-label study in patients requiring vascular replacement or reconstruction for life or limb threatening vascular trauma, Study 1 (CLN-PRO-V005;
NCT03005418).
A total of 54 adults received extremity implantation of SYMVESS as a vascular conduit.
The patient population ranged in age from 18 to 72 years (mean age 33 years).
Each patient received a SYMVESS implant ranging in length from 1 to 35 cm (mean length 10.1 cm).
The most frequently occurring adverse reactions are shown in Table 1 .
5 WARNINGS AND PRECAUTIONS Graft Rupture.
( 5.1 ) Anastomotic Failure.
( 5.2 ) Thrombosis.
( 5.3 ) Transmission of Infectious Diseases ( 5.4 ) 5.1 Graft Rupture Vascular graft rupture has occurred in patients treated with SYMVESS [see Clinical Trials Experience (6.1) ] .
Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia.
Like all medications, Symvess can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: