WHAT IS XIAFLEX (COLLAGENASE)?

Xiaflex is a collagenase derived from the toxin of a bacteria.  Collagenase dissolves collagen which is the main component of a Dupuytren’s cord.

 

IS XIAFLEX (COLLAGENASE) INJECTION SAFE?

The safety of any medication or procedure is based on two factors: 1) The inherent safety of the medication or technique  2) The knowledge and skill of the professional performing the procedure or administering the medication. The FDA has approved use of the collagenase injection for dupuytrens but they have mandated very specific training to help reduce the inherent risks in using the medication.  COLLAGENASE CAN RUPTURE THE TENDONS THAT FLEX YOUR FINGERS.  This is one of the major complications of the medication and is the main reason why the FDA has mandated special training to use the medication.  To download the Medication Guide and the safety information regarding collagenase use for dupuytrens – click here.

Below is the Safety Information listed on the Xiaflex™ website. 

IMPORTANT SAFETY INFORMATION
In the controlled and uncontrolled portions of clinical trials, flexor tendon ruptures occurred after XIAFLEX injection. Injection of XIAFLEX into collagen-containing structures such as tendons or ligaments of the hand may result in damage to those structures and possible permanent injury such as tendon rupture or ligament damage. Therefore, care should be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand.

Other serious local adverse reactions in clinical trials include: pulley rupture, ligament injury, complex regional pain syndrome (CRPS), and sensory abnormality of the hand.

In the controlled portions of the clinical trials, a greater proportion of XIAFLEX-treated patients (15%) compared to placebo-treated patients (1%) had mild allergic reactions (pruritus) after up to 3 injections. The incidence of XIAFLEX-associated pruritus increased after more XIAFLEX injections.

Although there were no severe allergic reactions observed in the XIAFLEX studies (e.g., those associated with respiratory compromise, hypotension, or end-organ dysfunction), severe reactions including anaphylaxis could occur following XIAFLEX injections. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections.

In the XIAFLEX trials, 70% and 38% of XIAFLEX-treated patients developed an ecchymosis/contusion or an injection site hemorrhage, respectively. The efficacy and safety of XIAFLEX in patients receiving anticoagulant medications (other than low-dose aspirin) within 7 days prior to XIAFLEX administration is not known. Therefore, use with caution in patients with coagulation disorders including patients receiving concomitant anticoagulants (except for low-dose aspirin).

The most frequently reported adverse drug reactions (= 25%) in the XIAFLEX clinical trials and at an incidence greater than placebo included edema peripheral (mostly swelling of the injected hand, 73% vs. 5%), contusion (70% vs. 3%), injection site hemorrhage (38% vs. 3%), injection site reaction (35% vs. 6%), and pain in the treated extremity (35% vs. 4%). (To see this page on the Xiaflex website – click here)

 

WILL DR. GRABOW PERFORM XIAFLEX INJECTIONS FOR YOUR DUPUYTRENS CONTRACTURE?

 

 

Other doctors may tell you they don’t recommend a certain procedure or type of injection, but if they don’t know how to do it, how can they give you a complete explanation of your treatment options.  There are many factors that determine what is the best treatment for your contracture.

Since Dr. Grabow offers all forms of treatmet for your Dupuytrens, you will be able to discuss all treatment options and together with Dr. Grabow determine what is the best course of treatment for your condition.

 

WHAT IS BETTER: NEEDLE RELEASE (APONEUROTOMY) OR XIAFLEX INJECTION?

Collagenase injection and Needle Aponeurotomy are the only nonsurgical treatments to help patients suffering from dupuytrens contracture. There are comparison studies of Needle Aponeurotomy and Collagenase injection, but both are effective in releasing the main cord of your contracture.

Unfortunately, many patients see a hand surgeon who is not trained nor skilled in Needle Aponeurotomy so the patient is not given this option. Sadly these patients are not getting the best care for their problem because they do not have the opportunity to talk with a specialist trained in all procedures.
For those specialists like Dr. Grabow, who are able to offer both procedures many factors are used  to determine the right option for you.Needle Aponeurotomy requires far more skill to peform well compared to collagenase injection. It is for this reason that many surgeons will tell you they don’t offer it or don’t recommend it – THEY DON’T KNOW HOW!  They only recommend the injection because it is the “only club in their bag”!

Specialists skilled in Needle Release typically do more Needle Release than Collagenase injection due to the simplicity of the procedure for the patient, ability to do muliply fingers at the same time, ability to address earlier disease, and contractures at all levels of the finger.

Collagenase is often used by those same specialists when the patient has very thick disease or when they have an insurance that will not allow them to do needle release in the office but does allow collagenase injection.  This insurance issue is often a problem in California but is not an issue in Nevada.

Dr. Grabow has a detailed conversation with each patient and together you and he will decide what is the best treatment for you.

 

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