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UVADEX® (methoxsalen) Sterile Solution is used with the THERAKOS UVAR XTS® or THERAKOS CELLEX® Photopheresis Systems for the treatment of skin problems associated with Cutaneous T-Cell Lymphoma (CTCL) in patients who have not responded to other types of treatment given by their doctor.

Hear from others living with the skin symptoms of CTCL

CTCL is a rare form of non-Hodgkin lymphoma that may cause skin symptoms. Though you may feel alone at times, there are others with CTCL skin symptoms who have been prescribed THERAKOS® Photopheresis. Below are thoughts from some of them. This information reflects their own experiences. Every patient is different, and results may vary. It is recommended that you discuss the therapy and your condition with your doctor.

Lou

  • Diagnosed with CTCL 25 years after skin symptoms first appeared
  • Lou was optimistic about photopheresis after trying several other treatments because he was still struggling with CTCL skin symptoms. Watch the video to see how Lou knew photopheresis was working for him
Photo of Lou

“Have your doctors explain photopheresis to you before you have your treatment. For me, it's not as intimidating as it seemed.”

Please see Important Safety Information and Full Prescribing Information, including the BOXED WARNING, for UVADEX. It is recommended that you discuss the therapy and your conditions with your doctor.

Phyllis

  • Diagnosed with CTCL 6 months after skin symptoms first appeared
  • Phyllis tries to make the most of her scheduled photopheresis treatments by finding ways to have fun after treatment. See what fascinates Phyllis about the photopheresis process in her video below
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"Photopheresis is a fascinating process."

"It's something I can do to help manage my condition."

Please see Important Safety Information and Full Prescribing Information, including the BOXED WARNING, for UVADEX. It is recommended that you discuss the therapy and your conditions with your doctor.

Ed

  • Diagnosed with CTCL 24 years after skin symptoms first appeared
  • Ed has found ways to fit photopheresis into his life and make the most of his time in treatment. Find out why Ed was glad his doctor thought photopheresis was a good option in his video below
Ed photo

“It is absolutely essential for people with CTCL skin symptoms to find a specialist with experience in CTCL so that you can discuss your options together.”

Please see Important Safety Information and Full Prescribing Information, including the BOXED WARNING, for UVADEX. It is recommended that you discuss the therapy and your conditions with your doctor.

Shelia

  • Diagnosed with CTCL 6 years after skin symptoms first appeared
  • After a difficult journey from diagnosis to treatment for her CTCL skin symptoms, Shelia experienced a series of challenges that tested her to the core. But she found support from those around her, and knows the value in giving back to the CTCL community
Photo of Shelia

“When you find yourself at a crossroad, I want you to turn the page—take control of the chapter in your life and own the moment.”

Please see Important Safety Information and Full Prescribing Information, including the BOXED WARNING, for UVADEX. It is recommended that you discuss the therapy and your conditions with your doctor.

Kris

  • Diagnosed with CTCL 11 years after skin symptoms first appeared
  • Kris understands that CTCL can be life changing to patients and their families. Before her diagnosis and treatment for CTCL skin symptoms, Kris was a busy mother of two young boys and didn’t focus on her health. Now, Kris does what she can to be her own best advocate
Photo of Kris

“I encourage you to be your own advocate, create a strong partnership with your healthcare team, and remember you’re not alone in your fight.”

Please see Important Safety Information and Full Prescribing Information, including the BOXED WARNING, for UVADEX. It is recommended that you discuss the therapy and your conditions with your doctor.

Ann

  • Diagnosed with CTCL 40 years after skin symptoms first appeared
  • Before her diagnosis and treatment for CTCL skin symptoms, Ann often felt ostracized doing what she loved: swimming. Now, she no longer hides her “condition,” and works hard to be her own best advocate. Ann has a very strong relationship with her healthcare team, and tremendous support from her family
Photo of Ann

“Keep breathing, keep pacing yourself, keep moving forward. That’s kind of how I’ve approached my life with CTCL skin symptoms. Just keep trying to move forward—and I hope you will, too.”

Please see Important Safety Information and Full Prescribing Information, including the BOXED WARNING, for UVADEX. It is recommended that you discuss the therapy and your conditions with your doctor.

Anita

  • Diagnosed with CTCL 3 years after skin symptoms first appeared
  • Anita first noticed a persistent rash as she was helping her daughter train for a marathon. She knew she needed to become her own best advocate to find a diagnosis and treatment option for her CTCL skin symptoms

 

Photo of Anita

“My journey has taught me that it’s important to search for our inner strength, our personal power, in moments of darkness.”

Please see Important Safety Information and Full Prescribing Information, including the BOXED WARNING, for UVADEX. It is recommended that you discuss the therapy and your conditions with your doctor.

Anita overcame the uncertainty of starting a new treatment by working with her healthcare team

Be inspired by Anita's story—how she struggled for years without the right diagnosis, and how she worked together with her healthcare team to find a treatment that allowed CTCL skin symptoms to be one part of her life, not the focus of it.

Please see Important Safety Information and Full Prescribing Information, including the BOXED WARNING, for UVADEX. It is recommended that you discuss the therapy and your conditions with your doctor.

Want to share your story?

If you are living with or caring for someone living with the skin symptoms of CTCL, Mallinckrodt would like to hear your story. Sharing your experiences with the skin symptoms of CTCL and THERAKOS Photopheresis may help others feel connected. Your story may encourage others to take an active role in their treatment, reach out to their doctors, and find a treatment option.

To learn more and find out if you may be eligible to participate in promotional and educational activities, please call: 1-844-514-6288

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IMPORTANT SAFETY INFORMATION

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UVADEX (methoxsalen) Sterile Solution should only be used by doctors who have special skills in the diagnosis and treatment of CTCL and who have received special training and have experience in the THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis Systems.

DO NOT USE UVADEX IF:

  • You are allergic to methoxsalen, any product similar or related to it, such as psoralen, or any of the other ingredients in UVADEX.
  • You have a history of a light-sensitive condition or disease.

The information below is about the use of UVADEX® (methoxsalen) Sterile Solution with the THERAKOS® UVAR XTS® or THERAKOS CELLEX® Photopheresis Systems for the treatment of skin conditions associated with Cutaneous T-Cell Lymphoma (CTCL).

 

It is recommended that you discuss the therapy and your conditions with your doctor.

 

What is UVADEX (methoxsalen [meth-ox-sah-len]) Sterile Solution?

UVADEX (methoxsalen) Sterile Solution is used with the THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis Systems for the treatment of skin problems associated with CTCL in patients who have not responded to other types of treatment given by their doctor.

IMPORTANT SAFETY INFORMATION

UVADEX (methoxsalen) Sterile Solution should only be used by doctors who have special skills in the diagnosis and treatment of CTCL and who have received special training and have experience in the THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis Systems.

DO NOT USE UVADEX IF:

  • You are allergic to methoxsalen, any product similar or related to it, such as psoralen, or any of the other ingredients in UVADEX.
  • You have a history of a light-sensitive condition or disease.
  • You have had an eye lens removed; use of UVADEX in this condition can increase the risk of retinal damage.

WARNINGS

  • You may be at greater risk of sun sensitivity with UVADEX. Tell your doctor if you are taking other medications that cause sensitivity to sunlight, such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, and certain organic staining dyes, such as methylene blue, toluidine blue, rose bengal, and methyl orange.
  • If you are pregnant or plan to become pregnant, tell your doctor. Methoxsalen can harm your unborn baby. Tell your doctor right away if you become pregnant during your UVADEX treatment. If you are breastfeeding or plan to breastfeed, tell your doctor. It is not known if methoxsalen passes into your breastmilk.
  • After UVADEX is given, exposure to sunlight and/or ultraviolet radiation may result in premature aging of your skin.
  • Let your doctor know if you currently have skin cancer or if you had skin cancer in the past.
  • If you are given too much UVADEX, you may get serious burns from UVA or sunlight (even through window glass).
  • Avoid exposure to sunlight during the 24 hours after treatment.
  • Exposure to UVA light when UVADEX is used can cause cataract formation if proper eye protection is not used.
  • You must wear UVA light-absorbing, wrap-around sunglasses for the 24 hours after treatment with UVADEX when you are exposed to direct or indirect sunlight, whether you are outdoors or exposed through a window.
  • If you are being treated for Graft vs Host Disease (GVHD), consult your physician for information regarding blood clots involving the lung and other parts of the body which have been reported in these patients. The use of UVADEX for the treatment of GVHD is not approved by the FDA.
  • Safety of UVADEX in children has not been shown.

SIDE EFFECTS OF UVADEX

Side effects of UVADEX used with the THERAKOS Photopheresis Systems are mainly related to low blood pressure.


For the THERAKOS UVAR XTS/CELLEX Photopheresis Systems procedure:

 

What is the THERAKOS Photopheresis Systems procedure?

The THERAKOS UVAR XTS/CELLEX Photopheresis Systems procedure is a medical procedure in which blood from a patient is collected into a specialized machine that separates the white blood cells from the other blood components. The other blood components are returned to the patient and white blood cells are then treated with UVADEX, which makes them sensitive to ultraviolet light. The treated white blood cells are exposed to UVA irradiation inside the machine, and then returned to the patient. This medical procedure is used to treat skin problems associated with CTCL in patients who have not been responsive to other forms of treatment given by their doctor.

 

DO NOT UNDERGO THE THERAKOS PHOTOPHERESIS SYSTEMS PROCEDURE IF:

  • You have a condition that makes you unable to tolerate loss of blood volume.
  • You are allergic or hypersensitive to 8-methoxypsoralen, methoxsalen, or psoralen compounds.
  • Your doctor has diagnosed you with a blood-clotting or bleeding problem that can lead to either a blood clot or excessive bleeding.
  • You have had your spleen removed.

WARNINGS FOR THE THERAKOS PHOTOPHERESIS SYSTEMS PROCEDURE

  • Treatments with THERAKOS Photopheresis Systems should always be performed where standard medical emergency equipment is available.
  • THERAKOS Photopheresis Systems procedures should not be performed on the same day as procedures that can cause fluid changes, such as renal dialysis.

SIDE EFFECTS OF THE THERAKOS PHOTOPHERESIS SYSTEMS PROCEDURE

  • Low blood pressure can occur with the THERAKOS Photopheresis Systems procedure.
  • You may get an infection and/or feel pain at the site of injection.
  • Fevers of 100–102°F (37.7–38.9°C) have been seen in some patients within 6 to 8 hours after treatment. Redness of the skin may also occur with the fever.
  • A decrease in red blood cells can occur if the THERAKOS Photopheresis Systems procedure is given too frequently. Low levels of red blood cells may cause you to feel tired.

These are not all of the possible side effects of the THERAKOS Photopheresis Systems procedure.
Tell your doctor about any side effects that bother you, or that do not go away. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling Mallinckrodt at 1-800-778-7898.

 

Please see the Full Prescribing Information, including the BOXED WARNING, for UVADEX.