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Xiaflex

Generic name: collagenase clostridium histolyticum [KOL-a-JEN-ase-klos-TRID-ee-um-HIS-toe-LIT-ik-um]
 Drug class: miscellaneous uncategorized agents

What is Xiaflex?

Xiaflex is an amalgamation of proteins that originates from a particular bacteria.

Xiaflex can be used to treat Dupuytren's contracture in adults. This condition leads to an abnormal thickening of tissues in the hand's palm. This condition could become more severe as time passes and may result in the appearance of a "cord" in your palm and an irreparable bend to your finger.

Xiaflex can also be utilised to treat a similar condition known as Peyronie's disease, which affects adult males. The condition results in scar tissue, or "plaque," developing under the penis's skin, which causes an irregular penis's curvature when erecting.

Xiaflex is available to treat Peyronie's disease only through an accredited pharmacy that is part of an exclusive programme called Xiaflex REMS. You must be enrolled in the programme and know the potential risks associated with taking this medication.

Warnings

Before you take Xiaflex, inform your physician if you have bleeding or a blood clotting disorder like haemophilia.

Xiaflex could cause damage to a tendon, nerve, or ligament on the hand where the medication is. After the swelling of the injection has diminished, contact your physician if you experience numbness, discomfort, tingling, difficulty bending your fingers towards your wrist, or if you are experiencing newly developed or worsened problems with movement in the hand you've treated.

Xiaflex can also cause damage to the erectile tissues in the male penis, which could require surgery to fix. Consult your doctor now if you experience swelling and bruises on your penis, pain whenever you urinate, bloody urine in your urine, sudden problems with erection, or a "popping" sound or sensation inside your penis after an intimate session.

Before you take this drug

It is not recommended to take Xiaflex when you have an allergy to collagenase clostridium. This medication should not serve to cure Peyronie's condition that affects the urinary tract (the tube that carries urine from the bladder).

Stop taking Xiaflex and contact your doctor immediately if you've ever had:

  • A blood clotting or bleeding disorder such as haemophilia.
  • You may have received Xiaflex to treat another ailment, for example.
  • Any other medical issues.

It is unknown whether collagenase from Clostridium histolyticum could harm a newborn baby. Consult your physician if you are expecting or planning to become pregnant.Consult a physician for advice on whether it is safe to breastfeed while taking Xiaflex.Similar or related drugs collagenase, Clostridium histolyticumHow is Xiaflex offered?

It is injected directly into the "cord" of the affected hand, or in the "plaque" of the penis. A medical professional will provide the injection. Follow the instructions of your doctor attentively.

Dupuytren's contracture:

  • Don't bend or straighten the fingers of your treated hand until your doctor has instructed you to.
  • Maintain the hand that was treated in a position that is elevated until bedtime.
  • It is possible that you will need to wear an arm splint for a short period of time in order to ensure your fingers are straight. You might also have to exercise your fingers daily.
  • A few days to three days after the injection into your hand, your doctor will inspect the hand to determine whether it is healthier.

for Peyronie's Disease:

  • The penis of your patient may have to be wrapped in the form of a bandage for a limited period following every injection. Follow the directions of your doctor on how long you keep the bandage on.
  • A few days to three days after the third Xiaflex injection, the physician will begin a stretching treatment to aid in straightening the curve of your penis.
  • You might also have to carry out easy exercises for stretching and straightening your penis at home. Be sure to follow the instructions on how to do these exercises.
  • There should be no sexual activity during the time between your first and second Xiaflex injections, for a minimum of 4 weeks following your second injection, or after any swelling or pain in your penis has gone away.

Details on dosage

Usual Adult Dose of Xiaflex for Dupuytren's Contracture:

0.58 mg is injected into a palpable cord to cause an enlargement of the metacarpophalangeal (MP) joint or an interphalangeal proximal (PIP) joint.
Comments:
This drug must be administered by a medical professional who is skilled in injecting procedures for the hand as well as for the treatment of patients suffering from Dupuytren's contracture.
Up to two joints on the same hand could be treated in a single treatment visit. Two palpable cords that affect two joints could be injected. Alternatively, one cord with a palpable effect on two joints of the same finger can be injected at two locations during a treatment. If a patient is suffering from other palpable cords that have contractures of the MP or PIP joints, those cords can be injected at subsequent appointments, which are approximately 4 weeks apart.
Between 24 and 72 hours after an injection, an extension of the fingers is recommended in the event of a persistent contracture. Refer to the product's manufacturer's information or the local protocol to get information about the finger extension procedure.
Injections and procedures for finger extension are able to be administered up to three times per cord at about 4-week intervals.
Up to two cords in the same hand can be injected during a treatment visit. If the patient has additional cords that have contractures, these cords should be injected during a subsequent treatment appointment.
The vital signs must be observed, and appropriate equipment must be in place to handle any serious local or systemic reactions, including the possibility of anaphylaxis that may develop following injection.

Usual Adult Dose of Xiaflex for Peyronie's Disease:

0.58 mg is injected into the plaque of interest once every two days, one to three days apart.
Comments:
This medication should only be given by a medical professional skilled in the treatment of male urological disorders who has completed the required education for the treatment of peyronie's disease.
A treatment cycle comprises two injection procedures as well as penile modelling.
For each plaque that causes the curvature deformity, four treatment cycles can be given. Each treatment cycle can be repeated at approximately six-week intervals. If the curvature defect has less than 15° following the first, second, or third treatment cycles, or a further treatment isn't required, the subsequent treatment cycles should not be given.
The safety of more than one treatment option for the disease Peyronie's is not yet known.

What happens if I miss a dose?

Consult your physician for the appropriate treatment in the event that you don't make an appointment to receive your Xiaflex injection.

What happens if I overdose?

In a medical environment, an overdose could be taken care of quickly.

What should be avoided Xiaflex?

Avoid all strenuous activities with the hand that has been treated until your physician tells you to return to your regular routine.

Beware of situations that could stress your stomach muscles, like constipation.

Xiaflex adverse reactions

Get immediate medical attention. If you exhibit symptoms that you are experiencing an allergic reaction to Xiaflex, such as asthmatic breathing difficulties and swelling of your lips, face, or tongue,

Collagenase Clostridium histolyticum could harm a tendon, nerve, or ligament on the hand where the medicine is injected. Call your doctor immediately if you experience:

  • Fever, chills, heightened redness, or swelling;
  • Numbness or tingling on the affected finger;
  • Difficulty in bending the finger after swelling has decreased.

Xiaflex can also cause damage to the erectile tissues of the penis of a man, which could require surgery to fix. See your physician right away If you are experiencing:

  • The swelling and bruising of your penis;
  • Urinary pain and blood are found in your urine.
  • Sudden erection problems; or
  • A "popping" sound or sensation inside your penis when you are having a sexual erection.

Contact your doctor at the earliest opportunity if you are suffering from:

  • unexpected back pain in the back, chest pain, or difficulty walking following an injection.
  • the feeling that you are about to get the feeling that you could (even when lying down).

Common Xiaflex side effects can be:

  • Bleeding, swelling, bruising, and tenderness at the site of injection;
  • Swelling glands in your elbow or underarm
  • Irritation, redness, or warmth on the skin;
  • Cracked skin;
  • Underarm pain;
  • Discomfort or tingling on your hand that you have treated;
  • The penis may be bruised, the scrotum may have problems with erection, or
  • Discoloration of your skin, blisters, or bruises at the site of injection.

There isn't an exhaustive description of the various negative consequences. Other side effects could be present. Consult your physician to seek medical advice on adverse effects. It is possible to report any adverse reaction to FDA by calling 1-800-FDA-1088.

Interaction with other drugs

Tell your physician about other medications you're taking such as:

  • Is a blood thinner: warfarin, coumadin, and Jantoven.

This list is not exhaustive. Other medications can interfere with collagenase clostridium, such as prescription and over-the-counter medications, vitamins, and herbal remedies. There are many possible interactions between drugs. are listed here.

 

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