Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of collagenase clostridium histolyticum injection in the elderly.
Drug Interactions
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
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
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
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.
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