1 What is Xiaflex?

Brand: Xiaflex

Generic: Collagenase Clostridium Histolyticum

Xiaflex injection is an enzyme used for the treatment of fixed flexion contracture called Dupuytren's contracture with a palpable cord.

Peyronie's disease with the drug is to be given only by or under the supervision of your healthcare professional.

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2 What to Know Before Using

Before using Xiaflex, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in the pediatric population on the correlation of age to the effects of collagenase clostridium histolyticum injection have not been performed while safety and efficacy have not been established.

Studies in the elderly have not reported any geriatric-specific problems that would limit the utility of collagenase clostridium histolyticum injection.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other prescription or non-prescription drugs. Intake of specific food or using alcohol or tobacco with colistimethate is associated with an increased risk of certain side effects.

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare provider for any other medical problems such as blood clotting disorders, or Peyronie's plaque in the penile urethra.

3 Proper Usage

Proper usage of Xiaflex requires strict adherence to your doctor’s orders. A trained healthcare professional will give you this drug in a hospital.

This drug is administered intravenously through a needle placed into the cord that is causing your finger to bend or into the plaque that is causing your penis to curve.

Follow the instructions on the label or as advised by your healthcare professional. Your affected hand will be wrapped with a bandage after receiving the injection if you are taking this drug for Dupuytren’s contracture.

Avoid making any unnecessary movement on the treated finger. Your healthcare professional may give you 2 injections if you have more than one contracture in the same hand.

It is very imperative that you return to your healthcare professional 1 to 3 days after receiving the injection. This will allow your healthcare professional to see the injected hand, and to do a possible finger extension procedure to disrupt the cord.

To prevent swelling, elevate the fingers of the injected hand until bedtime. To prevent more injury, refrain from moving or massaging the cord, bending, or extending the fingers of the injected hand, or doing a heavy activity using your hand.

Your healthcare professional may advise you to split your affected hand at bedtime for up to 4 months. Do finger bending and extending exercises as instructed by your healthcare professional.

For people with Peyronie's disease: This drug is available only through a restricted program called XiaflexВ® REMS Program.

Healthcare professionals who are enrolled in the restricted program can write a prescription for this drug. Your penis may be wrapped with a bandage after receiving the injection.

Your healthcare professional will tell you when to take the bandage off. This drug is given as part of a treatment cycle.

In a treatment cycle, you will receive an injection followed by a second injection 1 to 3 days later. It is very important that you return to your healthcare professional 1 to 3 days after your second injection.

This will allow your healthcare professional to do a manual procedure to stretch and help straighten your penis. Do not have sexual intercourse or have any sexual activity for at least 2 weeks after the second injection of a treatment cycle and after pain and swelling have gone away.

4 Precautions to Take

Before using Xiaflex, there are some precautions you must take. Regular visits and laboratory tests should be made to your healthcare provider to track your progress and to monitor the effectiveness of this drug as well as check for unwanted effects.

Using this drug for Dupuytren’s contracture may cause injury to the blood vessels, tendons, or ligaments of the hand.

If you have pain or numbness in your hand or arm, tears in the skin of your treated finger or hand, trouble bending the finger after the swelling goes down, or bleeding at the injection site, consults with your healthcare professional immediately.

Inform your healthcare professional immediately if you have symptoms of an infection such as fever, chills, or increasing redness or swelling of your hand.

This drug may cause penile fracture or other serious injuries to the penis for people with Peyronie's disease. It may damage the tubes in your penis (corpora) during erection after receiving this drug.

A popping sound or sensation in an erect penis, sudden loss of the ability to maintain an erection, bruising, swelling, or pain in your penis, trouble urinating or blood in your urine may be signs of damaged tubules in the penis.

Contact emergency medical services immediately if this happens. You may take over-the-counter pain drugs if you have mild to moderate pain in your penis.

Contact medical services immediately if you experience symptoms of anaphylaxis such as itching, rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after you receive this drug.

This drug may cause bleeding or bruising at the injection site. Tell your healthcare professional if you have blood clotting problems before receiving this drug.

5 Potential Side Effects

Make sure you meet with your doctor in using Xiaflex to avoid unwanted potential side effects. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Inform you healthcare provider immediately if you experience any unusual symptoms such as:

  • Dupuytren's contracture
  • bruising or bleeding at the injection site swelling of the hands tearing of the skin
  • Peyronie's disease
  • itching
  • pain
  • redness
  • swelling or bruise of the penis
  • popping sound or sensation in an erect penis
  • Peyronie's disease
  • decreased interest in sexual intercourse
  • inability to have or keep an erection
  • the loss in sexual ability, desire, drive, or performance
  • painful sexual intercourse
  • Dupuytren's contracture
  • bone pain at lower back or side pain, or painful, swollen joints

Some side effects may occur that usually do not need medical attention. As your body adjusts to the drug, these side effects may eventually disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.