What is Xiaflex?

Corporal rupture (penile fracture) and severe penile hematoma have been reported with use. Promptly evaluate signs or symptoms that reflect serious penile injury, as surgical intervention may be required. Collagenase clostridium histolyticum is only available through a restricted program called the Xiaflex REMS program .

Collagenase clostridium histolyticum injection is used to treat Dupuytren's contracture with a palpable cord. It is also used to treat Peyronie's disease with a palpable plaque and curvature deformity in men.

This medicine is to be given only by or under the supervision of your doctor.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given 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.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are receiving this medicine for Dupuytren's contracture:

• Your affected hand will be wrapped with a bandage after receiving the injection. Avoid moving and using your treated finger.
• Your doctor may give you 2 injections if you have more than one contracture in the same hand.
• It is very important that you return to your doctor 1 to 3 days after receiving the injection. This will allow your doctor to see the injected hand, and to do a possible finger extension procedure to disrupt the cord.
• It is very important that you elevate the fingers of the injected hand until bedtime to prevent swelling. Do not try to move or massage the cord, bend, or extend the fingers of the injected hand, or do heavy activity using your hand to prevent more injury.
• Your doctor may put a splint on your hand after giving this medicine. Wear the splint at bedtime for up to 4 months. Do finger bending and extending exercises as instructed by your doctor.

If you are receiving this medicine for Peyronie's disease:

• This medicine is available only through a restricted program called Xiaflex® REMS Program. Doctors who are enrolled in the restricted program can write a prescription for this medicine.
• Your penis may be wrapped with a bandage after receiving the injection. Your doctor will tell you when to take the bandage off.
• This medicine 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 doctor 1 to 3 days after your second injection. This will allow your doctor to do a manual procedure to stretch and help straighten your penis.
• Do not have sexual intercourse or have any sexual activity between the first and second injections of a treatment cycle, and for at least 2 weeks after the second injection of a treatment cycle and after pain and swelling has gone away.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of collagenase clostridium histolyticum injection in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of collagenase clostridium histolyticum injection in the elderly.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clotting disorders—Use with caution. May make these conditions worse.

• Peyronie's plaque in the penile urethra—Should not be used in patients with this condition.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you are receiving this medicine for Dupuytren's contracture:

• Using this medicine may cause injury to the blood vessels, tendons, or ligaments of the hand. Tell your doctor right away 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.
• This medicine may cause infection. Tell your doctor right away if you have a fever, chills, or increasing redness or swelling of your hand.

If you are receiving this medicine for Peyronie's disease:

• This medicine may cause penile fracture (corporal fracture) or other serious injury to the penis. It may damage the tubes in your penis (corpora) during erection after receiving this medicine. Call your doctor right away if you have the following symptoms: 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.
• You may take over-the-counter (OTC) pain medicines if you have mild to moderate pain in your penis.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have itching, rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after you receive this medicine.

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