Note: This document contains side effect information about collagenase clostridium histolyticum. Some dosage forms listed on this page may not apply to the brand name Xiaflex.

Summary

Common side effects of Xiaflex include: bleeding at injection site, pruritus, bruise, and ecchymoses. Continue reading for a comprehensive list of adverse effects.

Applies to collagenase clostridium histolyticum: injection powder for solution.

Serious side effects of Xiaflex

Along with its needed effects, collagenase clostridium histolyticum (the active ingredient contained in Xiaflex) 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 of Xiaflex

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

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

Common (1% to 10%): Nausea

Uncommon (0.1% to 1%): Diarrhea, vomiting, abdominal pain upper^[Ref]

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

Uncommon (0.1% to 1%): Dyspnea, hyperventilation^[Ref]