How long does it take for Xiaflex to work?
XIAFLEX works to help gradually break down your plaque over 1 to 4 treatment cycles, with about 6 weeks between each cycle. You will book 3 separate office visits for each treatment cycle Visit 1
How long do you give Xiaflex for Peyronie disease?
Peyronie’s Disease. In these trials, patients were given up to 4 treatment cycles of Xiaflex or placebo (weeks 0, 6, 12, 18), and were followed in a non-treatment follow-up period (weeks 24 -52). In each treatment cycle, two injections of Xiaflex or two injections of placebo were administered 1 to 3 days apart.
How long do I need to wear a bandage after Xiaflex?
Xiaflex is usually given in a treatment cycle of 2 injections given 1 to 3 days apart. Your penis may need to be wrapped in a bandage for a short time after each injection. Follow your doctor's instructions about how long to wear the bandage. One to 3 days after your second injection, your doctor will perform...
How many times can Xiaflex be given in a cycle?
In each cycle, two injections of Xiaflex or two injections of placebo were administered 1 to 3 days apart. A penile modeling procedure was performed at the study site on patients 1 to 3 days after the second injection of the cycle.
How long does it take XIAFLEX to work?
Treatment cycles are typically spaced about 4-6 weeks apart. Some men may see improvements after one or two cycles, while men with severe curvatures may benefit more from three or four cycles.
How long does it take for XIAFLEX to work for Peyronie's disease?
Men who received XIAFLEX and performed gentle penile stretching and straightening activities reported improvement in Bother from the beginning of the study to Week 52 compared to placebo. In clinical studies for Peyronie's disease, XIAFLEX was not associated with shortening of penis length.
How long does XIAFLEX last?
Each treatment cycle is about 6 weeks apart. In between cycles, follow your doctor's instructions on straightening and stretching the penis. Tell your doctor if you have trouble stretching or straightening your penis or if new pain occurs.
What is the success rate of XIAFLEX?
Studies have shown 34% improvement in penile curvature in men who underwent treatment with Xiaflex injection compared to 18% improvement in men treated with saline injection.
Can XIAFLEX be repeated?
Xiaflex® 0.58 mg, 2 injections separated by 1 to 3 days, repeated after 6 weeks for up to 4 treatment cycles. 0.25 mL injections....Condition or diseaseIntervention/treatmentPhasePeyronie's DiseaseDrug: Xiaflex® 0.58 mgPhase 4Dec 6, 2018
Does XIAFLEX dissolve plaque?
The main difference between Xiaflex and other injectable therapy is Xiaflex's ability to dissolve the collagenous fibrous tissue within the plaque (4,5).
What to expect after XIAFLEX injections?
The most common side effects with XIAFLEX for the treatment of Dupuytren's contracture include: swelling of the injection site or the hand. bruising or bleeding at the injection site. pain or tenderness of the injection site or the hand.
How often do you take XIAFLEX?
Xiaflex is usually given in a treatment cycle of 1 to 3 injections given 4 weeks apart.
Why was XIAFLEX discontinued?
The decision to withdraw is not based on safety or efficacy concerns. Despite best efforts to appropriately educate the government and the market on XIAFLEX® over the past several years, the product did not receive government reimbursement approval and demand for the product has remained unsustainably low.
What vitamins help with Peyronie's disease?
While Peyronie's disease is most often found in middle-aged men, it can occur at any age. Drug therapy is helpful for most men who are affected by Peyronie's disease, especially during the acute phase. For instance, oral Vitamin E will make the plaques smaller and help to straighten the bent penis.
How much does an injection of XIAFLEX cost?
Doctors who administer the drug will have to be specially trained and certified. Pain, swelling and bruising can develop in the injection area. Xiaflex costs $3,300 an injection, so a full course of eight injections would cost about $26,000, in addition to a doctor's fee.
Is there a pill to cure Peyronie's disease?
The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie's disease.
Before Receiving This Medicine
You should not use Xiaflex if you are allergic to collagenase clostridium histolyticum. Xiaflex should not be used to treat Peyronie's disease that...
Xiaflex Dosing Information
Usual Adult Dose of Xiaflex for Dupuytren's Contracture:0.58 mg as a single injection into the target cord, followed by a finger extension procedur...
What Happens If I Overdose?
Since Xiaflex is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What Should I Avoid Before and After Receiving Xiaflex?
After your injection for Dupuytren's contracture, do not flex or extend the fingers of your treated hand until you visit your doctor again. Extendi...
What Other Drugs Can Affect Xiaflex?
Other drugs may interact with collagenase clostridium histolyticum, including prescription and over-the-counter medicines, vitamins, and herbal pro...
How long after Xiaflex can you do penile modeling?
For 6 weeks after each treatment cycle with XIAFLEX#N#®#N#, you'll need to take a few minutes each day to do penile modeling—gentle stretching and straightening activities for your penis. When paired with injections of XIAFLEX#N#®#N#, these activities help to break down your Peyronie's plaque and help reduce the curve in your erection.
What is Xiaflex used for?
Treating Peyronie's disease - XIAFLEX®. A prescription medicine used to treat adult men with Peyronie’s disease who have a “plaque” that can be felt and a curve in their penis greater than 30 degrees when treatment is started. Prescribing Information.
How long does it take for a curved erection to form?
works to help gradually break down your plaque over 1 to 4 treatment cycles, with about 6 weeks between each cycle.
Can you wrap your penis after Xiaflex?
As with any medicine, there are important things to do and not do during treatment with XIAFLEX. ®. . Be sure to follow these instructions throughout your treatment: Your penis may be wrapped with a bandage after each injection Your HCP will tell you when to take the bandage off.
How to straighten a finger?
Bend only the top 2 joints of all fingers, keeping your knuckles straight. Arch your knuckles back 10 times in a row. Repeat the exercise 4 times a day. 1 2 3 4Use the unaffected hand to gently straighten the affected finger 10 times, holding for 5 to 10 seconds. Repeat the exercise 4 times a day.
Can Xiaflex cause a broken tendon?
Tendon rupture or ligament damage. Receiving an injection of XIAFLEX® may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit
Is Xiaflex safe for children?
It is not known if XIAFLEX®is safe and effective in children under the age of 18. IMPORTANT SAFETY INFORMATION FOR XIAFLEX®. Do not receive XIAFLEX®if youhave had an allergic reaction to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX®, or to any other collagenase product.
How long does Xiaflex stay at room temperature?
Before use, remove the vial containing the lyophilized powder of Xiaflex and the vial containing the diluent for reconstitution from the refrigerator and allow the 2 vials to stand at room temperature for at least 15 minutes and no longer than 60 minutes. Visually inspect the vial containing Xiaflex.
Who should administer Xiaflex?
Dosing Overview for Peyronie's Disease#N#Xiaflex should be administered by a healthcare provider experienced in the treatment of male urological diseases, who has completed required training for use of Xiaflex in the treatment of Peyronie’s disease.
What is Xiaflex used for?
Xiaflex is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord. Xiaflex is indicated for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
How much collagenase is in Xiaflex?
Xiaflex is supplied in single-use glass vials containing 0.9 mg of collagenase clostridium histolyticum as a sterile, lyophilized powder for reconstitution. Sterile diluent for reconstitution is provided in the package in a single-use glass vial containing 3 mL of 0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride.
How long after a PIP injection can you perform a finger extension?
At the follow-up visit approximately 24 to 72 hours after the injection (s), if a contracture remains, perform a passive finger extension procedure on each treated joint (as described below) to facilitate cord disruption. If two joints in one finger were treated, perform the finger extension procedure on the affected MP joint before performing the finger extension procedure on the affected PIP joint.
Can Xiaflex cause a ruptured tendon?
The effects of overdose of Xiaflex are unknown. It is possible that multiple simultaneous or excessive doses of Xiaflex may cause more severe local effects than the recommended doses including serious adverse reactions in the injected area (e.g., tendon ruptures or corporal ruptures dependent on the injection site). Supportive care and symptomatic treatment are recommended in these circumstances.
Is Xiaflex excreted in milk?
It is not known whether collagenase clostridium histolyticum is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xiaflex is administered to a nursing woman.
Indications and Usage For Xiaflex
Xiaflex Dosage and Administration
- Dosage and Administration for Dupuytren’s Contracture
Dosing Overview for Dupuytren’s Contracture Xiaflex should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of patients with Dupuytren’s contracture. Xiaflex, supplied as a lyophilized powder, must be reconstituted with th… - Dosage and Administration for Peyronie’s Disease
Dosing Overview for Peyronie's Disease Xiaflex should be administered by a healthcare provider experienced in the treatment of male urological diseases, who has completed required training for use of Xiaflex in the treatment of Peyronie’s disease. Xiaflex, supplied as lyophilized powder, mu…
Dosage Forms and Strengths
- Xiaflex is supplied in single-use glass vials containing 0.9 mg of collagenase clostridium histolyticum as a sterile, lyophilized powder for reconstitution. Sterile diluent for reconstitution is provided in the package in a single-use glass vial containing 3 mL of 0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride.
Contraindications
- Xiaflex is contraindicated in: 1. the treatment of Peyronie’s plaques that involve the penile urethra due to potential risk to this structure. 2. patients with a history of hypersensitivity to Xiaflex or to collagenase used in any other therapeutic application or application method [see Warnings and Precautions (5.4)].
Warnings and Precautions
- Tendon Rupture or Other Serious Injury to the Injected Finger/Hand in the Treatment of Dupuytre…
In the controlled and uncontrolled portions of clinical trials in Dupuytren’s contracture, flexor tendon ruptures occurred after Xiaflex injection [see Adverse Reactions (6.1)]. Injection of Xiaflex into collagen-containing structures such as tendons or ligaments of the hand may result in dam… - Corporal Rupture (Penile Fracture) or Other Serious Injury to the Penis in the Treatment of Peyro…
Corporal rupture was reported as an adverse reaction after Xiaflex injections in 5 of 1044 (0.5%) Xiaflex-treated patients in the controlled and uncontrolled clinical trials in Peyronie’s disease. In other Xiaflex-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hemato…
Adverse Reactions
- The following serious adverse reactions in patients with Dupuytren’s contracture are discussed in greater detail elsewhere in the labeling: 1. Tendon ruptures or other serious injury to the injected extremity [see Warnings and Precautions (5.1)] The following serious adverse reactions in patients with Peyronie’s disease are discussed in greater detail elsewhere in the labeling: 1. Corp…
Drug Interactions
- Anticoagulant drugs: Xiaflex should be used with caution in patients receiving concomitant anticoagulants (except for low-dose aspirin) [see Warnings and Precautions (5.5)].
Use in Specific Populations
- Pregnancy
Pregnancy Category B There are no adequate and well-controlled studies of Xiaflex in pregnant women. Because animal reproduction studies are not always predictive of human response, Xiaflex should be used during pregnancy only if clearly needed. Risk Summary Based on animal … - Nursing Mothers
It is not known whether collagenase clostridium histolyticum is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xiaflex is administered to a nursing woman.
Overdosage
- The effects of overdose of Xiaflex are unknown. It is possible that multiple simultaneous or excessive doses of Xiaflex may cause more severe local effects than the recommended doses including serious adverse reactions in the injected area (e.g., tendon ruptures or corporal ruptures dependent on the injection site). Supportive care and symptomatic treatment are recommended …
Xiaflex Description
- Xiaflex contains purified collagenase clostridium histolyticum, consisting of two microbial collagenases in a defined mass ratio, Collagenase AUX-I and Collagenase AUX-II, which are isolated and purified from the fermentation of Clostridium histolyticumbacteria. Collagenase AUX-I is a single polypeptide chain consisting of approximately 1000 amino acids of known sequenc…