Uvadex

Uvadex

methoxsalen

This medication is used to treat cutaneous T-cell lymphoma (CTCL), a type of cancer that affects the skin and blood and sometimes the lymph nodes and other organs. CTCL is caused by the uncontrolled growth of abnormal white blood cells in the skin. This drug is used in a procedure called photopheresis. Some of your blood is removed from your body through a vein and goes into a special machine that separates the white blood cells. The machine adds methoxsalen to these white blood cells, then shines ultraviolet (UV) light on them. Then the machine returns the treated cells (and the rest of your blood) to your body through the same vein. Your immune system is thought to react to the treated cells and other similar untreated T-cells that are not working properly. This effect helps to restore your immune balance and lessens the skin problems (e.g., rash, plaques, tumors) of CTCL. Methoxsalen is known as a psoralen photosensitizer. It works by making the treated white blood cells more sensitive to UV light.

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About Uvadex

This medication is used to treat cutaneous T-cell lymphoma (CTCL), a type of cancer that affects the skin and blood and sometimes the lymph nodes and other organs. CTCL is caused by the uncontrolled growth of abnormal white blood cells in the skin. This drug is used in a procedure called photopheresis. Some of your blood is removed from your body through a vein and goes into a special machine that separates the white blood cells. The machine adds methoxsalen to these white blood cells, then shines ultraviolet (UV) light on them. Then the machine returns the treated cells (and the rest of your blood) to your body through the same vein. Your immune system is thought to react to the treated cells and other similar untreated T-cells that are not working properly. This effect helps to restore your immune balance and lessens the skin problems (e.g., rash, plaques, tumors) of CTCL. Methoxsalen is known as a psoralen photosensitizer. It works by making the treated white blood cells more sensitive to UV light.

See Uses section.

This medication is injected into your collected white blood cells during photopheresis by a health care professional. This medication is usually used once a day for 2 days in a row or as directed by your doctor. Photopheresis is usually repeated every 4 weeks depending on your response to treatment.

Dosage is based on your medical condition, the amount of white blood cells collected, and response to treatment.

See also Precautions section.

Dizziness, headache, weakness, leg cramps, or bitter/sour taste in the mouth may occur. Skin freckling, dry skin, and skin aging may also occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: depression, swollen ankles/feet, new/unusual skin sores, irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using methoxsalen, tell your doctor or pharmacist if you are allergic to it; or to sunlight; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you: have had an unusual or bad reaction to other psoralen products in the past, have conditions that make you sensitive to light (such as lupus, certain porphyrias, xeroderma pigmentosum, albinism), or have no natural lens in the eye.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: coal tar/UVA treatment, radiation treatment, arsenic treatments, other skin cancer (melanoma, basal cell or squamous cell carcinomas), cataracts, liver problems, kidney problems, heart problems.

For 24 hours after treatment with this medication, your eyes and skin will be more sensitive to the sun, including sunlight through a glass window. Limit your time in the sun. Avoid tanning booths and sunlamps. To protect your skin during this time, use sunscreen and wear protective clothing when outdoors. To protect your eyes, wear dark wrap-around UV-absorbing sunglasses. Get medical help right away if you have vision changes, skin blisters/redness/swelling/peeling, or if you get sunburned. Ask your doctor for details.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) during treatment with this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: anthralin, bacteriostatic soaps, coal tar, certain dyes (methylene blue, toluidine blue, rose bengal, methyl orange), griseofulvin, nalidixic acid, sulfa antibiotics (e.g., sulfamethoxazole, sulfisoxazole), tetracycline antibiotics (e.g., doxycycline, tetracycline), certain "water pills" (thiazide diuretics such as hydrochlorothiazide).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: serious burning/blistering of skin.

Missed Doses:

For the best possible benefit, it is important to receive each scheduled treatment with this medication as directed. If you miss a treatment, contact your doctor to establish a new treatment schedule.

Notes:

Laboratory and/or medical tests (e.g., blood counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

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