therakos-us.upthere.studio Open in urlscan Pro
3.9.164.133  Public Scan

Form analysis
0 forms found in the DOM

Text Content

This site is for US healthcare professionals only. Visit the patient website.
Follow us:



Sign in


English



 * English

 * German

 * Italian

 * Spanish

Therakos Photopheresis

 * Overview
 * THERAKOS CELLEX Photopheresis System
 * Clinical Profile
 * Prescribing ECP
 * Supporting Access to Treatment

Customer Support

 * Overview
 * Therakos® Total Care
 * Therakos Institute
 * Professional Resources
 * Contact a THERAKOS Business Manager

MyTherakos
Contact Us


 * Therakos Photopheresis
   * THERAKOS CELLEX Photopheresis System
   * Clinical Profile
   * Prescribing ECP
   * Supporting Access to Treatment
 * Customer Support
   * Therakos® Total Care
   * Therakos Institute
   * Professional Resources
   * Contact a THERAKOS Business Manager
 * MyTherakos
 * Contact Us


Languages:
English German Italian Spanish

UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal
administration with the THERAKOS® CELLEX® Photopheresis System in the palliative
treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is
unresponsive to other forms of treatment.





WHEN SYSTEMIC IS NEXT, THERAKOS® PHOTOPHERESIS IS A LOGICAL WAY FORWARD

What is THERAKOS Photopheresis?



IDENTIFYING POTENTIAL PHOTOPHERESIS PATIENTS

FIND OUT WHICH PATIENTS WITH CTCL SKIN SYMPTOMS MAY BE APPROPRIATE FOR THERAKOS®
PHOTOPHERESIS

Learn about CTCL & Skin symptoms



THERAKOS INSTITUTE

HELPING BUILD A COMMUNITY OF EXPERT OPERATORS

Therakos Institute



CONTACT A THERAKOS® BUSINESS MANAGER

THERAKOS BUSINESS MANAGERS (TBMS) ARE AVAILABLE FOR PHONE CALLS, VIRTUAL
MEETINGS, OR IN-PERSON VISITS

Contact a THERAKOS® Business Manager



EXPERIENCE THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM

THERAKOS® CELLEX® Photopheresis System

Previous Next

THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM

Discover more

PRESCRIBING ECP

Discover more

THERAKOS INSTITUTE

Discover more

CUSTOMER SUPPORT

Discover more

CUSTOMER SUPPORT SERVICES

Discover more

PATIENT RESOURCES

Discover more



INDICATIONS AND USAGE

UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal
administration with the THERAKOS® CELLEX® Photopheresis System in the palliative
treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is
unresponsive to other forms of treatment.

IMPORTANT SAFETY INFORMATION

CAUTION: READ THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM’S OPERATOR’S MANUAL
PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have
special competence in the diagnosis and treatment of cutaneous T-cell lymphoma
and who have special training and experience in the THERAKOS CELLEX
Photopheresis System. Please consult the CELLEX Operator's Manual before using
this product.

For the THERAKOS® CELLEX® Photopheresis Procedure:

The THERAKOS CELLEX Photopheresis System is indicated for use in the
ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug
8-methoxypsoralen (8-MOP®), of extracorporeally circulating leukocyte-enriched
blood, in the palliative treatment of the skin manifestations of cutaneous
T-cell lymphoma (CTCL), in persons who have not been responsive to other forms
of treatment.

CONTRAINDICATIONS

UVADEX is contraindicated in:

 * Patients exhibiting idiosyncratic or hypersensitivity reactions to
   methoxsalen, other psoralen compounds, or any of the excipients
 * Patients possessing a specific history of a light-sensitive disease state,
   including lupus erythematosus, porphyria cutanea tarda, erythropoietic
   protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism
 * Patients with aphakia because of significantly increased risk of retinal
   damage
 * Patients that have contraindications to the photopheresis procedure

WARNINGS AND PRECAUTIONS

 * Patients who are receiving concomitant therapy (either topically or
   systemically) with known photosensitizing agents 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 may be at greater risk
   for photosensitivity reactions with UVADEX
 * Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA
   therapy) is carcinogenic. Methoxsalen also causes DNA damage, interstrand
   cross-links and errors in DNA repair
 * Methoxsalen may cause fetal harm when given to a pregnant woman. Women of
   childbearing potential should be advised to avoid becoming pregnant.  If
   UVADEX is used during pregnancy, or if the patient becomes pregnant while
   receiving UVADEX, the patient should be apprised of the potential hazard to
   the fetus 
 * Severe photosensitivity can occur in patients treated with UVADEX. Advise
   patients to wear UVA absorbing, wrap-around sunglasses and cover exposed skin
   or use a sunblock (SPF 15 or higher), and avoid all exposure to sunlight for
   twenty-four (24) hours following photopheresis treatment
 * After methoxsalen administration, exposure to sunlight and/or ultraviolet
   radiation may result in "premature aging" of the skin
 * Since oral psoralens may increase the risk of skin cancers, monitor closely
   those patients who exhibit multiple basal cell carcinomas or who have a
   history of basal cell carcinomas
 * Serious burns from either UVA or sunlight (even through window glass) can
   result if the recommended dosage of methoxsalen is exceeded or precautions
   are not followed
 * Exposure to large doses of UVA light causes cataracts in animals. Oral
   methoxsalen exacerbates this toxicity
 * Safety in children has not been established
 * Thromboembolic events, such as pulmonary embolism and deep vein thrombosis,
   have been reported with UVADEX administration through photopheresis systems
   for treatment of patients with graft-versus-host disease, a disease for which
   UVADEX is not approved

ADVERSE REACTIONS

 * Side effects of photopheresis (UVADEX used with the THERAKOS Photopheresis
   Systems) were primarily related to hypotension secondary to changes in
   extracorporeal volume (>1%)

For the THERAKOS® CELLEX® Photopheresis Procedure:

INDICATIONS

The THERAKOS CELLEX Photopheresis System is indicated for use in the
ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug
8-methoxypsoralen (8-MOP), of extracorporeally circulating leukocyte-enriched
blood, in the palliative treatment of the skin manifestations of cutaneous
T-cell lymphoma (CTCL), in persons who have not been responsive to other forms
of treatment.

 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

The THERAKOS CELLEX Photopheresis System is not designated, sold, or intended
for use except as indicated.

Certain underlying medical conditions contraindicate THERAKOS Photopheresis,
including patients:

 * who cannot tolerate extracorporeal volume loss during the
   leukocyte-enrichment phase
 * exhibiting idiosyncratic or hypersensitivity reactions to
   8-methoxypsoralen/psoralen compounds
 * with coagulation disorders
 * who have had previous splenectomy

WARNINGS AND PRECAUTIONS

 * THERAKOS Photopheresis treatments should always be performed in locations
   where standard medical emergency equipment is available. Volume replacement
   fluids and/or volume expanders should be readily available throughout the
   procedure
 * Patients who may not be able to tolerate the fluid changes associated with
   extracorporeal photopheresis should be monitored carefully
 * Procedures, such as renal dialysis, which might cause significant fluid
   changes (and expose the patient to additional anticoagulation) should not be
   performed on the same day as extracorporeal photopheresis
 * Individual patients may require a heparin dosage that varies from the
   recommended dose to prevent post-treatment bleeding or clotting during a
   treatment

ADVERSE REACTIONS

 * Hypotension may occur during any treatment involving extracorporeal
   circulation. Closely monitor the patient during the entire treatment for
   hypotension
 * Transient pyretic reactions, 37.7-38.9°C (100-102°F), have been observed in
   some patients within six to eight hours of reinfusion of the photoactivated
   leukocyte-enriched blood. A temporary increase in erythroderma may accompany
   the pyretic reaction
 * Treatment frequency exceeding labeling recommendations may result in anemia
 * Venous access carries a small risk of infection and pain

Please see accompanying Full Prescribing Information, including the BOXED
WARNING for UVADEX, and see the THERAKOS Photopheresis System Operator’s Manual.

 

IMPORTANT SAFETY INFORMATION



CAUTION: READ THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM’S OPERATOR’S MANUAL
PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have
special competence in the diagnosis and treatment of cutaneous T-cell lymphoma
and who have special training and experience in the THERAKOS CELLEX
Photopheresis System. Please consult the CELLEX Operator's Manual before using
this product.

Important Safety Information

Click Here

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are
trademarks of a Mallinckrodt company. Other brands are trademarks of a
Mallinckrodt company or their respective owners. 

The product information provided in this site is intended only for residents of
the United States.

 

This website may identify third-party organizations and provide links to
third-party websites or other third-party information (third-party content). The
third-party content is meant for informational purposes only, is not endorsed by
or under the control of Mallinckrodt Pharmaceuticals, and is not meant to
replace a physician’s medical advice. Mallinckrodt Pharmaceuticals has no
responsibility or liability for and makes no representations or warranties
whatsoever about any third-party content. All trademarks, service marks and
logos appearing on this site are the property of their respective owners. Any
rights not expressly granted herein are reserved.

 

By viewing this site you agree to our Terms of Use.

 

© 2024 Mallinckrodt. US-2400492 05/24.

Medical Affairs Contact us

Contact a THERAKOS Business Manager Terms of Use

Privacy Policy




WELCOME TO THERAKOS.COM

I am a US Healthcare Professional
I am a US Patient or Caregiver

This website is intended for US healthcare professionals only and is not
intended for the general public.

X


THANK YOU FOR VISITING THERAKOS.COM

You are about to leave a Mallinckrodt site. Mallinckrodt does not control or
endorse the content on the site you are about to view.
YES, CONTINUE
NO, CANCEL

English

Italian

Spanish

German
×
This website uses cookies
This website uses cookies to improve user experience. By using our website you
consent to all cookies in accordance with our Cookie Policy. Read more
Accept all