Xiaflex
Xiaflex Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Xiaflex (collagenase Clostridium histolyticum) is a nonsurgical enzyme treatment, derived from Clostridium histolyticum bacteria for adults with Dupuytren's contracture when a cord can be felt. Xiaflex is available in a generic form as collagenase Clostridium histolyticum. Xiaflex is injected directly into the Dupuytren's cord. Potential side effects of Xiaflex can include tendon or ligament damage, nerve injury, and allergic reactions.
Xiaflex is available in single-use, glass vials containing 0.9 mg of collagenase derived from Clostridium histolyticum. Xiaflex should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of Dupuytren's contracture; the drug is injected into the contracture cord. The amounts vary depending on which joint is affected. Serious side effects include tendon rupture and allergic reactions. The effects of Xiaflex in pregnant women have not been studied. As such, Xiaflex should only be used during pregnancy only if clearly needed. It is not known whether collagenase derived from Clostridium histolyticum is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xiaflex is administered to a nursing woman. The safety and effectiveness of Xiaflex in the pediatric population has not been done.
Our Xiaflex Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Xiaflex in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregiver at once if you have a serious side effect such as:
- feeling like you might pass out (even while lying down);
- bruising or bleeding in the treated hand;
- severe pain, itching, redness, warmth, swelling, or other irritation in the treated hand;
- numbness or tingling in the treated hand;
- fever, chills, body aches, flu symptoms, swollen glands;
- swollen glands in your elbow or underarm; or
- sudden pain, snapping or popping sound, bruising, loss of movement, or swelling in the joints of your hand.
Less serious side effects may include:
- mild pain or tenderness in the treated hand;
- cracked skin; or
- underarm pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Xiaflex (Collagenase Clostridium Histolyticum) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Xiaflex FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following serious adverse reactions are discussed in greater detail elsewhere in the labeling:
- Tendon ruptures or other serious injury to the injected extremity [see WARNINGS AND PRECAUTIONS]
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 N=249 |
Placebo N=125 |
| All Adverse Reactions | 98% | 51% |
| Edema Peripherala | 73% | 5% |
| Contusionb | 70% | 3% |
| Injection Site Hemorrhage | 38% | 3% |
| Injection Site Reactionc | 35% | 6% |
| Pain in Extremity | 35% | 4% |
| Tenderness | 24% | 0% |
| Injection Site Swellingd | 24% | 6% |
| Prurituse | 15% | 1% |
| Lymphadenopathyf | 13% | 0% |
| Skin Laceration | 9% | 0% |
| Lymph Node Pain | 8% | 0% |
| Erythema | 6% | 0% |
| Axillary Pain | 6% | 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 |
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Some patients developed vasovagal syncope after finger extension procedures.
Immunogenicity
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 entire FDA prescribing information for Xiaflex (Collagenase Clostridium Histolyticum) »
Additional Xiaflex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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