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IMPORTANT SAFETY INFORMATION
FOR THE THERAKOS^TM PHOTOPHERESIS
PROCEDURE INDICATIONS

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

Indications

The THERAKOS^TM UVAR XTS^TM and THERAKOS^TM CELLEX^TM 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^TM Photopheresis is contraindicated in patients possessing a specific history of a light-sensitive disease. THERAKOS^TM Photopheresis is contraindicated in patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 mm³. THERAKOS^TM Photopheresis is contraindicated in patients who have coagulation disorders or who have previously had a splenectomy.

Warnings and Precautions

THERAKOS^TM 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. Both men and women should take adequate contraceptive precautions both during and after completion of photopheresis therapy. Safety in children has not been established.

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.

When prescribing and administering THERAKOS^TM Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy. Please refer to the appropriate product labelling for a complete list of warnings and precautions.

To report an adverse event please contact us at:
INTERNATIONAL FREEPHONE: 00800 84372567 (Available from most countries in Europe and Middle East and Africa)

ecphelp@therakos.com

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS

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. 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. Refer to the Methoxsalen (20 micrograms/mL) labelling or the oral 8-methoxypsoralen dosage formulation package insert for more information on protecting the patient from light and a list of all warnings and precautions.