- Patient Information:
Details with Side Effects
The following serious adverse reactions are discussed in greater detail elsewhere in the labeling:
The most frequently reported adverse drug reactions ( ≥ 25%) in the XIAFLEX clinical trials included edema peripheral (mostly swelling of the injected hand), contusion, injection site hemorrhage, injection site reaction, and pain in the treated extremity.
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Out of 1082 patients who received 0.58 mg of XIAFLEX in the controlled and uncontrolled portions of the XIAFLEX studies (2630 XIAFLEX injections), 3 (0.3%) patients had a flexor tendon rupture of the treated finger within 7 days of the injection.
The data described below are based on two pooled randomized, double-blind, placebo-controlled trials through Day 90 in patients with Dupuytren's contracture (Studies 1 and 2). In these trials, patients were treated with up to 3 injections of 0.58 mg of XIAFLEX or placebo with approximately 4-week intervals between injections and the patients had finger extension procedures the day after injection, if needed, to facilitate disruption of the cord [see Clinical Studies]. These trials were comprised of 374 patients of whom 249 and 125 received 0.58 mg of XIAFLEX and placebo, respectively. The mean age was 63 years, 80% were male and 20% were female, and 100% were white.
In the placebo-controlled portions of Studies 1 and 2 through Day 90, 98% and 51% of XIAFLEX-treated and placebo-treated patients had an adverse reaction after up to 3 injections, respectively. Over 95% of XIAFLEX-treated patients had an adverse reaction of the injected extremity after up to 3 injections. Approximately 81% of these local reactions resolved without intervention within 4 weeks of XIAFLEX injections. The adverse reaction profile was similar for each injection, regardless of the number of injections administered. However, the incidence of pruritus increased with more injections [see WARNINGS AND PRECAUTIONS].
Table 2 shows the incidence of adverse reactions that were reported in greater than or equal to 5% of XIAFLEX-treated patients and at a frequency greater than placebo-treated patients after up to 3 injections in the pooled placebo-controlled trials through Day 90 (Studies 1 and 2).
Table 2. Adverse Reactions Occurring in ≥ 5% of XIAFLEX-Treated
Patients and at a Greater Incidence than Placebo in the Placebo-Controlled Trials
Through Dav 90 After UD to 3 Injections
|Adverse Reaction|| XIAFLEX
|All Adverse Reactions||98%||51%|
|Injection Site Hemorrhage||38%||3%|
|Injection Site Reactionc||35%||6%|
|Pain in Extremity||35%||4%|
|Injection Site Swellingd||24%||6%|
|Lymph Node Pain||8%||0%|
| a Most of these events were swelling of the injected hand.
b Includes the terms: contusion (any body system) and ecchymosis
c Includes the terms: injection site reaction, injection site erythema, injection site inflammation, injection site irritation, injection site pain, and injection site warmth
d Includes the terms: injection site swelling and injection site edema
e Includes the terms: pruritus and injection site pruritus
f Includes the terms: lymphadenopathy and axillary mass
Some patients developed vasovagal syncope after finger extension procedures.
During clinical studies, patients with Dupuytren's contracture were tested at multiple time points for antibodies to the protein components of XIAFLEX (AUX-I and AUX-II). At 30 days post the first injection of XIAFLEX 0.58 mg, 92% of patients had antibodies detected against AUX-I and 86% of patients had antibodies detected against AUX-II. After the fourth injection of XIAFLEX, every XIAFLEX-treated patient developed high titers of antibodies to both AUX-I and AUX-II. Neutralizing antibodies to AUX-I or AUX-II, were detected in 10% and 21%, respectively, of patients treated with XIAFLEX. However, there was no apparent correlation of antibody frequency, antibody titers, or neutralizing status to clinical response or adverse reactions.
Since the protein components in XIAFLEX (AUX-I and AUX-II) have some sequence homology with human matrix metalloproteinases (MMPs), anti-product antibodies could theoretically interfere with human MMPs.
Immunogenicity assay results are highly dependent on the sensitivity and specificity of the assay used in detection and may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to collagenase clostridium histolyticum with the incidence of antibodies to other products may be misleading.
Read the Xiaflex (collagenase clostridium histolyticum) Side Effects Center for a complete guide to possible side effects
Read the Xiaflex Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/13/2012
This monograph has been modified to include the generic and brand name in many instances.
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