DRUG CLASS AND MECHANISM: Xiaflex is an injectable formulation of purified collagenase derived from the bacterium, clostridium histolyticum. It is used for treating Dupuytren's contracture. A Dupuytren's contraction is caused by an abnormal accumulation of collagen (scar) in the tissue beneath the skin of the palm of the hand. The collagen binds the tissue to the skin of the palm, limiting the movement of the skin over the underlying tissues and preventing extension of the fingers. Collagenase is an enzyme that breaks down collagen. Xiaflex breaks down excessive collagen by disrupting its chemical structure. Reducing the accumulation of collagen improves movement of the affected fingers. The FDA approved Xiaflex in February 2010.
GENERIC AVAILABLE: No
PREPARATIONS: Powder for Injection: Single use vial, 0.9 mg
STORAGE: Vials should be refrigerate at 2-8 C (36-46 F) prior to mixing with diluents but should not be frozen After diluting, it should be kept at room temperature for one hour at 20-25 C (68-77 F) or refrigerated for up to 4 hours at 2-8 C (36-46 F).
PRESCRIBED FOR: Xiaflex is used for the treatment of adult patients with Dupuytren's contracture with a palpable cord of collagen.
DOSING: The recommended dose is 0.58 mg per injection into a palpable cord. Re-injection may occur 4 weeks after the initial injection if the contracture remains. Injections may be repeated up to 3 times per cord at 4 week intervals.
DRUG INTERACTIONS: In clinical trials many patients treated with Xiaflex developed bruising or bleeding at the injection site. Therefore, Xiaflex should be used with caution in patients with an abnormal tendency to bleed or who are taking drugs that cause bleeding. Except for low dose aspirin, Xiaflex has not been tested in patients receiving drugs that reduce the ability of blood to clot.
PREGNANCY: Use in pregnant women has not been adequately evaluated. It should be used only if it is clearly needed.
NURSING MOTHERS: Xiaflex has not been studied in women who are breastfeeding.
SIDE EFFECTS: The most common adverse reactions of Xiaflex are fluid retention (swelling of the injected hand), contusion (bruising), injection site bleeding, injection site swelling, pain in the treated hand, and tenderness. Tendon rupture or other serious injury to the injected hand may occur. Allergic reactions and development of antibodies to Xiaflex also may occur.
Reference: FDA Prescribing Information