Methoxsalen (Oral)

Methoxsalen 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 PUVA to help treat vitiligo, a condition where skin color is lost, and psoriasis, which is a skin condition that causes red and scaly patches.

Methoxsalen is also used with ultraviolet light in a treatment called photopheresis to help treat skin problems linked to mycosis fungoides, a type of lymphoma.

Methoxsalen may also be used for other conditions as decided by your doctor.

This medicine is available only with a prescription from your doctor.

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

This medicine increases the sensitivity of your skin and lips to sunlight. Therefore, exposure to the sun, even through window glass or on a cloudy day, could cause a serious burn. If you must go out during the daylight hours:

• Before each treatment, cover your skin for at least 24 hours by wearing protective clothing, such as long-sleeved shirts, full-length slacks, a wide-brimmed hat, and gloves. Also, protect your lips with a special sun block lipstick that has a skin protection factor (SPF) 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 are to be treated.
• After each treatment, cover your skin for at least 8 hours by wearing protective clothing. Also, use a sun block product that has a skin protection factor (SPF) 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, check with your health care professional.

Your skin may continue to be sensitive to sunlight for some time after treatment with this medicine. Use extra caution for at least 48 hours following each treatment if you plan to spend any time in the sun. Additionally, do not sunbathe anytime during your course of treatment with methoxsalen.

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

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 think about the risks of taking the medicine compared to the benefits it may provide. For this medicine, consider the following:

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

Allergies

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

Pediatric

Some side effects are more likely to happen in children up to 12 years old, as these children may be more sensitive to the effects of methoxsalen.

Geriatric

Many medicines have not been studied specifically in older adults. Therefore, it may not be known if they work the same way in older people 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 methoxsalen in elderly patients with 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 can be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when using this medicine. The following interactions are based on their potential significance and do not include all possible interactions.

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 how often you use one or both of the 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

Certain medicines should not be used near the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. 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 or
• Stomach problems—Using PUVA may worsen the condition

• Eye problems, such as cataracts or loss of the lens of the eye—Light treatment may worsen the condition or damage the eye

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

• Liver disease—This condition may increase blood levels of the medicine and lead to more side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do occur they may need 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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

Treatment with this medicine usually causes a slight reddening of your skin 24 to 48 hours after the treatment. This is an expected effect and is no cause for concern. However, check with your doctor right away if your skin becomes sore and red or blistered.

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

Premature aging of the skin may occur as a result of prolonged methoxsalen 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.

In the U.S.

• 8-Mop
• Oxsoralen-Ultra

Available Dosage Forms:

• Capsule, Liquid Filled

Therapeutic Class: Antipsoriatic

Chemical Class: Psoralen

Eating certain foods while you are taking 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.

Methoxsalen usually comes with patient directions. Read them carefully before using this medicine.

This medicine may take 6 to 8 weeks to really help your condition. Do not increase the amount of methoxsalen 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:

• Patients taking the hard gelatin capsules may take them with food or milk.
• Patients taking the soft gelatin capsules may take them with low-fat food or low-fat 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 (hard gelatin capsule): For treating mycosis fungoides and psoriasis: Adults and children 12 years of age and over—Dose is based on body weight and must be determined by your doctor. However, the usual dose is 0.6 mg per kilogram (kg) (0.27 mg per pound) of body weight taken two hours before UVA exposure. This treatment (methoxsalen and UVA) is given two or three times a week with the treatment spaced at least forty-eight hours apart. Children up to 12 years of age—Dose must be determined by your doctor. For vitiligo: Adults and children 12 years of age and over—20 milligrams (mg) per day taken two to four hours before ultraviolet light A (UVA) exposure. This treatment (methoxsalen and UVA) is given two or three times a week with the treatment spaced at least forty-eight hours apart. Children up to 12 years of age—Dose must be determined by your doctor.
• For oral dosage form (soft gelatin capsule): For psoriasis: Adults and children 12 years of age and over—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.4 mg per kg (0.18 mg per pound) of body weight taken one and one-half to two hours before UVA exposure. This treatment (methoxsalen and UVA) is given two or three times a week, with the treatment 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.

If you are late in taking, or miss taking, a dose of this medicine, notify your doctor so your light treatment can be rescheduled. Remember that exposure to sunlight or ultraviolet light must take place a certain number of hours after you take the medicine or it will not work. For patients taking the hard gelatin capsules, this is 2 to 4 hours. For patients taking the soft gelatin capsules, this is 1½ to 2 hours. If you have any questions about this, check with your doctor.

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.