Trioxsalen (Oral)

Trioxsalen is part of a group of medicines known as psoralens. It is used together with ultraviolet light (found in sunlight and some special lamps) in a treatment called psoralen plus ultraviolet light A (PUVA) to treat vitiligo, a condition where skin color is lost. Trioxsalen may also be used for other conditions as decided by your doctor.

Trioxsalen was available only with your doctor's prescription.

Trioxsalen was discontinued by the manufacturer in December 2002.

Your doctor should check your progress at regular visits to make sure this medicine is working and that it does not cause unwanted effects. Eye examinations should be included.

This medicine makes your skin and lips more sensitive to sunlight. Therefore, being in the sun, even through window glass or on a cloudy day, could lead to a serious burn. If you need to go outside during the day:

• Before each treatment, cover your skin for at least 24 hours by wearing protective clothing, such as long-sleeved shirts, full-length pants, a wide-brimmed hat, and gloves. Also, protect your lips with a sun block lipstick that has a sun protection factor of at least 15. Check with your doctor before using sun block products on other parts of your body before a treatment, as sun block products should not be used on the areas of your skin that will be treated.
• After each treatment, cover your skin for at least 8 hours by wearing protective clothing. Additionally, use a sun block product with a sun protection factor of at least 15 on your lips and on those areas of your body that cannot be covered.

If you have any questions about this, ask your health care professional.

Your skin may remain sensitive to sunlight for some time after treatment with this medicine. Use extra caution for at least 48 hours after each treatment if you plan to be in the sun. Do not sunbathe during this time.

For 24 hours after you take each dose of trioxsalen, your eyes should be protected during daylight hours with special wraparound sunglasses that completely block or absorb ultraviolet light (ordinary sunglasses are not enough). This is to prevent cataracts. Your doctor will advise you on what kind of sunglasses to use. These glasses should be worn even in indirect light, such as light coming through windows or on a cloudy day.

Eating certain foods while you are taking trioxsalen may increase your skin's sensitivity to sunlight. To help prevent this, avoid eating limes, figs, parsley, parsnips, mustard, carrots, and celery while being treated with this medicine.

This medicine may cause your skin to become dry or itchy. However, check with your doctor before applying anything to your skin to treat this problem.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. For this medicine, keep the following in mind:

Trioxsalen is a very powerful medicine that makes your skin more sensitive to sunlight. If not used correctly, it can lead to serious sunburns and may increase the risk of skin cancer and cataracts. Additionally, like too much sunlight, PUVA can cause early aging of the skin. Therefore, trioxsalen should only be used as directed and should not be used just for tanning. Make sure you discuss its use with your doctor before starting this medicine.

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of trioxsalen in children to its use in other age groups. However, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way as they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of trioxsalen in the elderly to its use in other age groups.

Breast Feeding

There are no adequate studies in women to determine the risks to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there could be an interaction. In such cases, your doctor may adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been highlighted based on their potential importance and are not necessarily exhaustive.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to sunlight (family history of) or
• Lupus erythematosus or
• Porphyria or
• Other conditions that increase sensitivity to light—This medicine will worsen the condition.

• Eye problems, such as cataracts or loss of the lens of the eyes—Using this medicine may worsen your cataracts or other eye issues; having no lens in your eye may increase the side effects of this medicine.

• Severe heart or blood vessel disease—The heat from the light treatment may worsen the condition.

• Infection or
• Stomach problems—Using this medicine may worsen these conditions.

• History of melanoma or other skin cancer or
• Recent treatment with x-rays or cancer medicines or plans to have x-rays soon—This may increase your risk of skin cancer.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blistering and peeling of skin
• reddened, sore skin
• swelling, especially of feet or lower legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Itching of skin
• nausea

Less common

• Dizziness
• headache
• mental depression
• nervousness
• trouble in sleeping

There is an increased risk of developing skin cancer after using trioxsalen. You should regularly check your body and show your doctor any skin sores that do not heal, new skin growths, and skin growths that have changed in how they look or feel.

Premature aging of the skin may occur as a result of prolonged trioxsalen therapy. This effect is permanent and is similar to what happens when a person sunbathes for long periods of time.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Chemical Class: Psoralen

This medicine may take several weeks or months to help your condition. Do not increase the amount of trioxsalen you are taking or spend extra time in the sunlight or under an ultraviolet lamp. This will not make the medicine act any more quickly and may result in a serious burn.

If this medicine upsets your stomach, it may be taken with meals or milk.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For vitiligo: Adults and children 12 years of age and over—20 to 40 milligrams (mg) taken two to four hours before ultraviolet light A (UVA) exposure. This treatment (trioxsalen and UVA) is given two or three times a week with the treatments spaced at least forty-eight hours apart. Children up to 12 years of age—Dose must be determined by your doctor. For increasing tolerance to sunlight or increasing color of the skin: Adults and children 12 years of age and over—20 to 40 mg taken two hours before ultraviolet light A (UVA) exposure. This treatment (trioxsalen and UVA) is given two or three times a week with the treatments spaced at least forty-eight hours apart. Children up to 12 years of age—Dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.