Important Safety Information (EU)

Note: Please refer to the appropriate product labelling for a complete list of warnings and precautions.

 

For methoxsalen used in conjunction with THERAKOS Photopheresis:

 

CAUTION: READ THE THERAKOS UVAR XTS or THERAKOS CELLEX PHOTOPHERESIS SYSTEMS’ OPERATOR'S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION. Do not inject directly into patients.

Methoxsalen 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 with the THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis Systems.

INDICATIONS

 

UVADEX™ 20 MICROGRAMS/ML SOLUTION FOR BLOOD FRACTION MODIFICATION is used in conjunction with either the THERAKOS™ CELLEX™ or the THERAKOS™ UVAR XTS™ Photopheresis System, in the palliative treatment of the skin manifestations (patch plaque, extensive plaque, erythroderma) of advanced stage (T2 – T4) cutaneous T-cell lymphoma (CTCL), only in patients who have not been responsive to other forms of treatment, (e.g. puvatherapy, systemic corticosteroids, caryolysin, interferon alpha).

 

CONTRAINDICATIONS

 

Methoxsalen is contraindicated in patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, psoralen compounds, or any of the excipients. 

 

Methoxsalen is contraindicated in patients with co-existing melanoma, basal cell or squamous cell skin carcinoma.

 

Methoxsalen is contraindicated in sexually active men and women of childbearing potential unless adequate contraception is used during treatment, and during pregnancy and lactation.

Methoxsalen is contraindicated in patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of a lens.

Warnings and Precautions

Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitising agents.

 

Skin burns or premature aging may occur if photosensitizing precautions are not taken.

 

Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. Because the dose with liquid methoxsalen is about 200 times less than with PUVA therapy and the skin is not exposed to high cumulative doses of UVA light, the risk of developing skin cancer following this therapy may be lower.

 

Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.

Safety in children has not been established.

 

Adverse Events

 

Side effects of photopheresis were primarily related to hypotension secondary to changes in extracorporeal volume (>1%). 

 

For the THERAKOS Photopheresis Procedure:

 

Indications

The THERAKOS™ UVAR XTS™ and THERAKOS™ CELLEX™ Photopheresis Systems are indicated for the administration of photopheresis. Please refer to the appropriate product labelling for a complete list of warnings and precautions.

Contraindications

THERAKOS™ Photopheresis is contraindicated in patients possessing a specific history of a light sensitive disease.

 

THERAKOS™ Photopheresis is contraindicated in patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 mm[3].

THERAKOS™ Photopheresis is contraindicated in patients who have coagulation disorders or who have previously had a 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. Safety in children has not been established.

Both men and women should take adequate contraceptive precautions both during and after completion of photopheresis therapy.

 

Adverse Events

 

  • 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 labelling recommendations may result in anaemia. 

  • Venous access carries a small risk of infection and pain.

 

Please refer to the appropriate product labelling for a complete list of warnings and precautions.
 

TO REPORT AN ADVERSE EVENT

International Freephone:

00800 84372567

Available from most countries in Europe and Middle East and Africa
 

Support en français:         
+33 18 288 0867

 

Unterstützung auf Deutsch:    

+49 32 221 093 619
Innerhalb Deutschland:

0800 1811715

 

Supporto in italiano:          

+39 051 042 0666
All’interno dell’Italia:            

800 149 844

 

Support in English

+44 154 860 0009
Within the UK:                    

0808 238 6011

 

Asistencia en español:      

+34 932 20 2094
Dentro de España:              

800 600 798

 

EMAIL: ecphelp@therakos.com
 

 

Healthcare professionals, patients and caregivers play an important role in the reporting process of safety related information. To enable Mallinckrodt to provide the most up-to-date safety information on our products, your support is pivotal in our continued commitment to patient and drug safety.

Mallinckrodt, the 'M' brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.

 

© 2018 Mallinckrodt. Mallinckrodt Pharmaceuticals is a registered business name of Mallinckrodt plc, which is registered in Ireland as a public limited company with registration number 522227 and has its registered office at Damastown, Mulhuddart, Dublin 15, Ireland.