Collagenase Clostridium Histolyticum Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 28, 2024.
Applies to collagenase clostridium histolyticum: injection powder for solution.
Important warnings
This medicine can cause some serious health issues
Injection route (powder for solution)
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.
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.
Serious side effects
Along with its needed effects, collagenase clostridium histolyticum 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 while taking collagenase clostridium histolyticum:
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
Other side effects
Some side effects of collagenase clostridium histolyticum 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
For healthcare professionals
Applies to collagenase clostridium histolyticum: injectable powder for injection.
Musculoskeletal adverse events
- Very common (10% or more): Pain in extremity (35%), arthralgia (11%)
- Common (1% to 10%): Shoulder pain
- Uncommon (0.1% to 1%): Axillary mass, chest wall pain, groin pain, joint crepitation, joint stiffness, limb discomfort, muscle spasms, muscular weakness, musculoskeletal stiffness, neck pain, tendon rupture[Ref]
Local
- Very common (10% or more): Injection site hemorrhage (38%), injection site reaction (erythema, inflammation, irritation, pain, warmth) (35%), injection site swelling and edema (24%), pruritus (15%), blood blister (13%)
- Common (1% to 10%): Ecchymosis, hyperhidrosis, rash, skin laceration
- Uncommon (0.1% to 1%): Eczema, swelling face, pain of skin, skin exfoliation, skin lesion, scab, skin discoloration, skin tightness[Ref]
Cardiovascular
- Very common (10% or more): Peripheral edema (most cases were swelling of the injected hand) (73%)
- Frequency not reported: Vasovagal syncope (after finger extension procedures)[Ref]
Other
- Very common (10% or more): Contusion (any body system) and ecchymosis (70%), tenderness (24%)
- Common (1% to 10%): Axillary pain
- Uncommon (0.1% to 1%): Breast tenderness, hypertrophy breast[Ref]
Dermatologic
- Common (1% to 10%): Lymphadenopathy, lymph node pain
- Uncommon (0.1% to 1%): Thrombocytopenia[Ref]
Gastrointestinal
Genitourinary
Patients with Peyronie's disease:
- Very common (10% or more): Penile hematoma (65.5%), penile swelling (55%), penile pain (45.4%), penile ecchymoses (14.5%), a popping noise or popping sensation in the penis, sometimes described as "snapping" or "cracking", and sometimes accompanied by detumescence, hematoma, and/or pain (13.2%)
- Common (1% to 10%): blood blister (4.5%), penile blister (3.3%), genital pruritus (3.1%), painful erection (2.9%), erectile dysfunction (1.8%), procedural pain (1.6%), injection site vesicles (1.3%), localized edema (1.3%), dyspareunia (1.1%), injection site pruritus (1.1%), nodule (1.1%), suprapubic pain (1.1%)
- Uncommon (0.1% to 1%): Corporal rupture (penile fracture) (0.5%)[Ref]
Hematologic
- Very common (10% or more): Lymphadenopathy (13%)
- Common (1% to 10%): Lymph node pain
- Uncommon (0.1% to 1%): Thrombocytopenia[Ref]
Hypersensitivity
- Uncommon (0.1% to 1%): Hypersensitivity[Ref]
Immunologic
- Uncommon (0.1% to 1%): Injection site cellulitis, lymphangitis[Ref]
Nervous system
- Common (1% to 10%): Burning sensation, dizziness, headache, hypoesthesia, paresthesia
- Uncommon (0.1% to 1%): Disorientation, agitation, insomnia, irritability,
restlessness[Ref]
Ocular
- Uncommon (0.1% to 1%): Eyelid edema[Ref]
Respiratory
See also:
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Pharmaceutical Society of Australia (2006) APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp
3. (2010) "Product Information. Xiaflex (collagenase clostridium histolyticum)." Auxilium Pharmaceuticals Inc
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Further information
Collagenase clostridium histolyticum side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.