Brand Name

      US Brand Name

      Uvadex


      Description

      Methoxsalenbelongs to the group of medicines called psoralens. It is used along with ultraviolet light (found in sunlight and some special lamps) to treat the white blood cells from your blood in a process called photopheresis. The treated white blood cells are returned to your body to control skin problems associated with cutaneous T-cell lymphoma, a cancer of the lymph system.

      Methoxsalen is to be administered only by or under the supervision of your doctor or other health care professional.

      This product is available in the following dosage forms:

      • Solution

      Before Using

      In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

      Allergies

      Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, 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 been done only in adult patients, and there is no specific information comparing use of methoxsalen in children with use in other age groups.

      Geriatric

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

      Breastfeeding

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

      Drug Interactions

      Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are 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 selected on the basis of their potential significance and are not necessarily all-inclusive.

      Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

      • Fezolinetant

      Using this medicine with any of the following medicines is usually not recommended, but may be required 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
      • Vorasidenib
      • Warfarin

      Using this medicine with any of the following medicines may cause an increased 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

      Other Interactions

      Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

      Other Medical Problems

      The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

      • Albinism (pigment lacking in the skin, hair, and eyes, or eyes only) or
      • Erythropoietic protoporphyria or
      • Lupus erythematosus or
      • Porphyria cutanea tarda or
      • Skin cancer or
      • Variegate porphyria or
      • Xeroderma pigmentosum—Methoxsalen treatment may make condition worse
      • Eye problems, such as cataracts or loss of the lens of the eye—Methoxsalen and light treatment may make these conditions worse or may cause damage to the eye

      Proper Use

      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.


      Precautions

      Eating certain foods while you are receiving methoxsalen treatment 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.

      Your doctor should check your progress at regular visits to make sure this treatment is working and that it does not cause unwanted effects. You also should have regular eye examinations.

      This medicine increases the sensitivity of your skin to sunlight and also may cause premature aging of the skin. 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:

      • After each treatment, cover your skin with protective clothing for at least 24 hours. In addition, use a sun block product that has a skin protection factor (SPF) of at least 15 on those areas of your body that cannot be covered. If you have any questions about this, check with your health care professional.

      For 24 hours after your methoxsalen treatment, 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 a window, or on a cloudy day.


      Side Effects

      Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

      Rare

      • Fever
      • irregular heartbeat
      • redness or pain at catheter site

      Symptoms of overdose

      • Blistering and peeling of skin
      • reddened, sore skin

      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:

      • Reddening of skin, slight

      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, or 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.






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