Oxsoralen (Topical)

Methoxsalen is part of a group of medicines known as psoralens. It is used together with ultraviolet light (which can come from sunlight or special lamps) in a treatment called psoralen plus ultraviolet light A (PUVA) to treat vitiligo, a condition where skin color is lost. Methoxsalen may also be used for other conditions as directed by your doctor.

Methoxsalen is available only with a prescription and must be given by or under the direct supervision of your doctor.

It is important that you visit your doctor as directed for treatments and to have your progress checked.

This medicine increases how sensitive the treated areas of your skin are to sunlight. Therefore, being in the sun, even through window glass or on a cloudy day, could lead to a serious burn. After each light treatment, wash the treated areas of your skin thoroughly. Also, if you need to go out during the day, cover the treated areas of your skin for at least 12 to 48 hours after treatment by wearing protective clothing or using a sun block product with a skin protection factor (SPF) of at least 15. Some patients may need a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, ask your health care professional.

The treated areas of your skin may stay sensitive to sunlight for some time after treatment with this medicine. Use extra caution for at least 72 hours after each treatment if you plan to be in the sun. Additionally, do not sunbathe at any time during your treatment with methoxsalen.

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 issue.

In deciding to use a medicine, you and your doctor will need to weigh the risks against the benefits. For this medicine, consider the following:

Methoxsalen is a very strong medicine that makes your skin more sensitive to sunlight. If not used properly, it can cause serious sunburns and may increase the chance of skin cancer. Like too much sunlight, PUVA can also lead to premature aging of the skin. Therefore, methoxsalen should only be used as directed and not just for tanning. Make sure to discuss its use with your doctor before starting this medicine.

Allergies

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

Pediatric

Studies on this medicine have only been done in adult patients, and there is no specific information comparing the use of methoxsalen in children up to 12 years of age with use in other age groups.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust the dose or take other precautions. When taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been highlighted for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both medicines.

• Anagrelide
• Tegafur

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fosphenytoin
• Phenytoin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to sunlight (or family history of) or
• Infection or
• Lupus erythematosus or
• Porphyria or
• Skin cancer (history of) or
• Other skin conditions—Using PUVA may worsen the condition

• Severe heart or blood vessel disease—The heat or prolonged standing during each light treatment may worsen the condition.

Along with its necessary effects, a medicine may 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 right away if you notice any of the following side effects:

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

There is a higher risk of developing skin cancer after using methoxsalen. You should regularly check the treated areas of your body and show your doctor any skin sores that do not heal, new skin growths, and skin growths that have changed in appearance or feel.

Premature aging of the skin may happen with long-term use of methoxsalen. This effect is permanent and is similar to the result of prolonged sun exposure.

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

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

In the U.S.

• Oxsoralen

In Canada

• Ultramop

Chemical Class: Psoralen

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

Use this medicine only under the direct supervision of your doctor.

After UVA exposure, wash the treated area of skin with soap and water. Then use a sunscreen or wear protective clothing to protect the area.

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 topical solution dosage form: For vitiligo: Adults and children 12 years of age and over—Apply to the affected area of the skin and allow to dry for one to two minutes, then apply again within two to two and one-half hours before UVA exposure. Children under 12 years of age—Use and dose must be determined by your doctor.