Is THERAKOS™ Photopheresis safe?

The THERAKOS™ CELLEX™ Photopheresis System and the THERAKOS™ UVAR XTS™ Photopheresis System are the only integrated, automated systems that are CE marked specifically to perform photopheresis. Both the THERAKOS™ CELLEX™ and THERAKOS™ UVAR XTS™ Photopheresis Systems have been rigorously tested and have been demonstrated to provide safe and effective photopheresis treatments:

• THERAKOS™ Photopheresis is a completely sterile process. A single-use, sterile fluid path kit is discarded after each treatment
• All phases of the treatment take place within the integrated system
  • Blood collection and separation
  • Treatment of isolated white blood cells with medication and UVA light
  • Return of treated cells to the body
• Blood is not removed from the THERAKOS™ Photopheresis closed system, ensuring that your blood never gets contaminated with someone else's blood, thus minimizing your risk for infection
• Since the isolated white blood cells are treated with medication while they are in the THERAKOS™ Photopheresis system, your exposure to the medication is low

How often will I receive THERAKOS™ Photopheresis?

For cutaneous T-cell lymphoma (CTCL), treatment is usually started on 2 consecutive days once a month for about 6 months. For patients who fail to show a response after several treatments, the treatments may be administered closer together – that is, 2 consecutive days every 2 weeks. For chronic graft-versus-host disease (cGVHD), photopheresis is often administered on 2 consecutive days every 2 weeks. Treatment for solid organ transplant (SOT) rejection may be more frequent. If you do have a positive response to therapy, the frequency of treatment may be decreased gradually or, in some cases, stopped entirely. The attending doctor will determine the best schedule based on individual needs.

Do I have to spend the night in the hospital?

People usually receive photopheresis as an outpatient procedure, but your clinical condition or other needs may warrant a overnight hospital admission. If you need to receive treatment on two consecutive days and live a long way from the centre you may have to stay in hospital overnight. To receive photopheresis you will be admitted to the hospital and receive the treatment in a special chair or hospital bed. While undergoing the procedure, patients are able to read or relax. Once the treatment is completed, patients are usually able to go home. However, each patient is different, and as mentioned, in some cases you may require an overnight stay in the hospital. Talk with your doctor about your options – he or she will recommend the best plan for you based on your particular health needs.

How long does the procedure take?

Typically, the procedure takes from one and a half to 3 hours, although treatment time varies from patient to patient.

Is the procedure painful?

Most patients report little or no discomfort. You may feel minor discomfort when the IV needle is inserted. If you are concerned about this possibility, you can ask your nurse or doctor about receiving a local anaesthetic. You may experience sensations during the procedure that are not painful, such as a slight pulsing from the instrument's pump, a slight chill, or a cool feeling where blood reenters the body. In very rare cases, some patients have a bitter or sour taste in their mouth for a brief period (30 minutes or less).

A small number of patients feel a little weak or dizzy during or immediately after the procedure. This is typically associated with a slight drop in blood pressure that can usually be corrected by your healthcare provider. Eating a small, nonfat meal before your treatment may prevent this. If you experience any dizziness or weakness, tell your photopheresis provider.

Is THERAKOS™ Photopheresis associated with any side effects?

The medication used in the photopheresis treatment will make you more sensitive to sunlight for about 24 hours after the treatment. For this reason, you must take some simple but very important precautions to protect your eyes and skin. (Without taking these precautions, you put yourself at risk of cataracts or serious sunburn.) For 24 hours, you should:

• Avoid sunlight as much as possible—even indirect sunlight coming through a window
• Wear sunscreen (no lower than SPF 15) when exposed to sunlight (outdoors or indoors)
• Wear UVA-protective, full-coverage sunglasses when exposed to sunlight

Other possible side effects are usually minor and go away within a day. These could include fatigue, temporary increase in itchiness, or a slight fever or redness appearing 6 to 8 hours after treatment. There is a small risk of developing an infection around the needle puncture site. Talk to your doctor about any concerns you may have about potential risks or side effects.

Risks associated with the procedure include a drop in blood pressure, fever, or worsening of skin redness, which usually resolves in 1 day.

What causes cutaneous T-cell lymphoma?

Currently, we do not know what causes cutaneous T-cell lymphoma (CTCL).³ Research does not suggest that it’s inherited, so you can’t pass the disease on to your children. Nor is CTCL an infectious disease, so you can’t spread it to anyone else.² No environmental factors, such as chemicals or toxins, have been linked to CTCL.

Is there a cure for cutaneous T-cell lymphoma?

There is currently no cure for CTCL. Therapies applied to the skin, as well as those taken orally or by injection, can reduce symptoms and put some patients with the disease into remission. Research has shown that patients who are diagnosed with CTCL-MF at an early stage of the disease can have a normal life expectancy.¹⁴

Who is affected by cutaneous T-cell lymphoma?

Cutaneous T-cell lymphoma most commonly affects older people. The average age at the time of diagnosis is 55 years. Children are rarely affected. For unknown reasons, CTCL occurs roughly twice as often in men as in women. Each year, approximately 1500 people in the United States and 1200 people in Europe are diagnosed with CTCL.^3,24 However, because of the difficulties that may arise in diagnosing CTCL, these statistics may not be accurate.

How does the lymphocyte become abnormal?

Most lymphomas begin in a lymphocyte in a lymph node. Damage to the cell's genetic material (DNA) causes the cell to change. This is called a mutation. The abnormal cell divides and grows in an uncontrolled way, resulting in a tumour.³

What is graft-versus-host disease?

Graft-versus-host disease (GVHD) can occur after bone marrow transplantation (BMT) or stem cell transplantation (SCT), which are interventions used to treat cancers like leukaemia and lymphoma that affect blood cells and immune system cells. Graft-versus-host disease occurs when immune cells from the transplant donor attack body cells of the transplant recipient.

There are two types of GVHD. These are acute GVHD (aGVHD) and chronic GVHD (cGVHD). Acute GVHD tends to occur within 100 days of transplant and cGVHD tends to occur 100 days or more after transplant. However, this isn’t always the case, and your doctor will use other factors such as clinical signs and symptoms, and medical tests like tissue biopsy, to diagnose which type of GVHD you have.

What are the symptoms of graft-versus-host disease?

Acute GVHD usually begins with a rash, often on the palms of the hands or soles of the feet. Acute GVHD can also affect the liver and the gut. Chronic GVHD affects multiple organs including the skin (causing a dry, itchy rash, symptoms of sclerodermatous skin?), liver and gut. Chronic GVHD can also affect other areas such as the mouth, eyes, hair, nails and lungs. Both forms of GVHD can range from mild to severe.

Is there a cure for graft-versus-host disease?

Both forms of GVHD can be treated with corticosteroids and immunosuppressive drugs, as well as adjunctive therapies such as photopheresis. Outcomes for both forms of GVHD can result in a complete or partial response to treatment, but in some patients the disease does not respond to treatment. For many people GVHD gradually improves over a period of months, but for some it can last longer and may continue for several years. Chronic GVHD can develop from aGVHD and some symptoms of GVHD may persist even after the disease has been resolved.

What is solid organ transplant rejection?

After the transplantation of a solid organ (such as the heart, liver, lung or kidney) from one person to another, the immune system of the recipient will identify the transplanted organ as a foreign body and attempt to reject the transplant. This complication is managed with the use of immunosuppressive drugs and steroids but, if this is unsuccessful, the result may be solid organ transplant (SOT) rejection.

What are the symptoms of solid organ transplant rejection?

Symptoms of SOT rejection vary depending on the kind of organ transplant that has been carried out. General symptoms can include pain at the site of transplant, general malaise, flu-like symptoms, fever, weight changes, and changes in heart rate. Organ rejection can be acute or chronic, and sometimes acute rejection can lead to chronic rejection. Rejection doesn't mean that the organ will necessarily be lost; it may simply mean that the immunosuppressive medicine needs to be adjusted. Rejection also becomes less likely over time.