Pronunciation:

kol-AJ-e-nase klos-TRID-ee-um his-toe-LIT-ik-um

Brand Names:

• Xiaflex

Dosage Forms:

• Powder for Solution

Warnings:

Warning: Corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie's diseaseCorporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) collagenase clostridium histolyticum-treated patients in clinical studies. In other collagenase clostridium histolyticum-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or penile "popping" sound or sensation was reported, in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) collagenase clostridium histolyticum-treated patients.Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention.Because of the risks of corporal rupture or other serious penile injury, collagenase clostridium histolyticum is available for the treatment of Peyronie's disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the collagenase clostridium histolyticum REMS program .

Classifications:

Therapeutic—

Tissue Permeability Modifier

Pharmacologic—

Collagenase

Uses of This Medicine:

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.

Before Using This Medicine:

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:

Allergies—

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.

Children—

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.

Older adults—

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

Other medicines—

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.

Other interactions—

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.

Other medical problems—

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.

Proper Use of This Medicine:

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 4 weeks after the second injection of a treatment cycle and after pain and swelling has gone away.
• Avoid situations that may cause straining your stomach muscles (eg, straining during bowel movements).

Precautions While Using This Medicine:

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 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.
• Tell your doctor right away if you have sudden lower back pain moving to your legs, feet, arms, or chest, or difficulty in walking after receiving this medicine.
• You may take over-the-counter (OTC) pain medicines if you have mild to moderate pain in your penis.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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 receiving 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.

Fainting or near fainting may occur after you receive this medicine. Check with your doctor right away if you feel dizzy or faint. You may lie down until your symptoms go away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common—Dupuytren's contracture

Bruising or bleeding at the injection site

swelling of the hands

tearing of the skin

More common—Peyronie's disease

Itching, pain, redness, swelling, or bruise of the penis

popping sound or sensation in an erect penis

Less common—Peyronie's disease

Decreased interest in sexual intercourse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

painful sexual intercourse

Incidence not known—Dupuytren's contracture

Bone pain

dizziness

fainting

lower back or side pain

painful, swollen joints

Incidence not known—Peyronie's disease

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or tightness

difficult or labored breathing

dizziness

fainting

lower back pain, possibly radiating to the legs, feet, arms, or chest

muscle spasms

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common—Dupuytren's contracture

Blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, lumps, numbness, rash, scarring, stinging, tingling, or ulceration at the injection site

bruise

flushing, redness of the skin or unusually warm skin at the injection site

itching, pain, swelling, or tenderness at the injection site

swollen, painful, or tender lymph glands in the neck or armpit

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.