Safety Profile

XARACOLL Safety information and studies

Adverse reactions with incidence ≥2% and greater than placebo in Phase III studies

XARACOLL
(N=411) n (%)		 Placebo*
(N=208) n (%)
Subjects Reporting Treatment Emergent Adverse Events 256 (62.3) 143 (68.8)
Injury, Poisoning, and Procedural Complications
Incision site swelling 60 (14.6) 30 (14.4)
Post procedural discharge 20 (4.9) 10 (4.8)
Seroma 12 (2.9) 5 (2.4)
Nervous System Disorders
Dysgeusia 31 (7.5) 13 (6.3)
Headache 17 (4.1) 1 (0.5)
Tremor 15 (3.6) 6 (2.9)
Gastrointestinal Disorders
Hypoaesthesia oral 9 (2.2) 4 (1.9)
Reproductive System and Breast Disorders
Scrotal swelling 12 (2.9) 2 (1.0)
General Disorders and Administration Site Conditions
Pyrexia 10 (2.4) 1 (0.5)
Eye Disorders
Vision blurred 15 (3.6) 6 (2.9)
*Placebo consisted of three collagen implants.
  • In Phase III clinical studies, eight patients reported serious adverse events (SAEs), none of which was considered treatment related3
  • Five patients (1.2%) receiving XARACOLL reported 15 SAEs in 5 system organ classes1
    • Cardiac
    • Gastrointestinal
    • Infections/infestations
    • Metabolism/nutrition
    • Renal/urinary disorders
  • Three patients (1.4%) receiving placebo reported 3 SAEs in 3 system organ classes1
    • Cardiac (1 fatal)
    • Gastrointestinal
    • Musculoskeletal/connective tissue disorders
 Xaracoll matrix pile

Pharmacokinetics

PK Study Design: A multicenter, randomized, single-blind, active comparator-controlled study. 52 patients were randomized prior to open inguinal hernioplasty in a 2:1 ratio to receive either 3 x 100 mg XARACOLL bupivacaine HCl collagen implants (total bupivacaine HCl dose 300 mg) or Marcaine® 0.25% (bupivacaine HCl) 175-mg infiltration.2

The most common treatment-related adverse events reported, experienced by patients across treatments, were tremors (8.8% vs 6.3%), dysgeusia (5.9% vs 6.3%), and somnolence (5.9% vs 6.3%), for patients receiving XARACOLL vs placebo, respectively.2

Nominal Time After Treatment (H)

Delivers bupivacaine immediately and over time

In a 52-patient pharmacokinetics (PK) study, local placement of XARACOLL resulted in detectable plasma levels of bupivacaine at the first measured time point (0.5 hours) and throughout the 96-hour observation period.2 Systemic plasma levels of bupivacaine following application of XARACOLL do not correlate with local efficacy.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
  • Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after placement of XARACOLL
  • Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. See full Prescribing Information for more detail on managing these risks