Uvadex®

Posted on October 18th, 2010 by

Class: Photoactive agent

Generic Name: Methoxsalen (meth-eh-SAL-en)
Trade Name: Uvadex®

How is this drug used? Methoxsalen is FDA approved to be used with the UVAR Photopheresis System in the treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that does not respond to other standard therapies. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Methoxsalen belongs to a group of agents referred to as psoralens or furocoumarins. Methoxsalen is a photoactive substance and produces its effects when exposed to ultraviolet (UVA) light. Methoxsalen causes damage to the DNA of cells, ultimately causing their death.

How is methoxsalen given (administered)? The process in which methoxsalen is used involves the removal of a patient’s blood, during which time the white blood cells, which comprise the cancer cells in cutaneous T-cell lymphoma, are separated from the rest of the blood. The blood, except for the white blood cells, is returned to the patient. The white blood cells are then treated with methoxsalen. This mixture is exposed to UVA light, which activates methoxsalen to produce its anti-cancer effects. The treated white blood cells are then infused back into the patient.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with methoxsalen.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

In addition, patient’s skin will be monitored, as skin cancers (squamous and basal cell) occur at an increased rate in patients treated with methoxsalen.

What are the most common (effect 30% or more patients) side effects of treatment with methoxsalen?

• Skin sensitivity to sunlight, sunburn
• Cataracts
• Reduced blood pressure
• Infection

What are the possible late side effects of treatment with methoxsalen? Following treatment with methoxsalen, patients are at a slightly increased risk for developing cataracts.

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)

Are there any special precautions patients should be aware of before starting treatment?

• Patients being treated with methoxsalen may be sensitive to sunlight. Patients should wear clothing, hats, sunglasses and sunscreen when exposed to any sunlight.
• Patients treated with methoxsalen should always wear eye protection against sunlight.
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Vision changes
• Light headedness, dizziness
• Signs of infection – fever, chills, sore throat, cough or areas of redness, swelling, tenderness, pus

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

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Tags: Miscellaneous, U

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