"A US Food and Drug Administration (FDA) advisory panel has backed a new biologic for psoriasis, though the panelists recommended strong warnings about the potential for suicide and self-injurious behavior (SIB) with the drug.
(methoxsalen) Capsules , USP, 10 mg
CAUTION: METHOXSALEN IS A POTENT DRUG. READ ENTIRE BROCHURE PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.
Methoxsalen with UV radiation should be used only by physicians who have special competence in the diagnosis and treatment of psoriasis and who have special training and experience in photochemotherapy. The use of Psoralen and ultraviolet radiation therapy should be under constant supervision of such a physician. For the treatment of patients with psoriasis, photochemotherapy should be restricted to patients with severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis is certain. Because of the possibilities of ocular damage, aging of the skin, and skin cancer (including melanoma), the patient should be fully informed by the physician of the risks inherent in this therapy.
CAUTION: Oxsoralen-Ultra® (Methoxsalen Soft Gelatin Capsules) should not be used interchangeably with regular Oxsoralen or 8-MOP (Methoxsalen Hard Gelatin Capsules). This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Patients should be treated in accordance with the dosimetry specifically recommended for this product. The minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photochemotherapy with this dosage form should be determined.
Oxsoralen-Ultra (methoxsalen capsules, USP) contains 10 mg. methoxsalen (8-methoxsalen). Methoxsalen occurs as white to pale yellow crystals and can be obtained naturally from seeds of Ammimajus and roots of Heracleum Candicans or through synthesis. Methoxsalen is practically insoluble in water, freely soluble in chloroform, soluble in boiling alcohol, in acetone, in acetic acid, in propylene glycol, and in benzene, sparingly soluble in boiling water and in ether. The chemical name of methoxsalen is 9-methoxy-7H-furo [3,2-g]  benzopyran-7-one; its empirical formula is C12H8O4 and the molecular weight is 216.19. The structural formula is:
Oxsoralen-Ultra is available as soft gelatin capsules containing the following inactive ingredients: polyethylene glycol 400, sorbital special, gelatin, glycerin, water, titanium dioxide, methyl & propylparaben, D&C yellow 10, FD&C blue 1, FD&C yellow 6.
What are the possible side effects of methoxsalen (8-Mop, Oxsoralen-Ultra)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Methoxsalen is expected to produce skin redness that may not occur until several hours after your UVA treatment. This redness may last for 2 or 3 days. You may also have slight swelling. These are normal effects of the medication and UVA treatment.
Call your doctor at once if you have a serious side effect such as:
- severe skin redness within 24 hours after UVA treatment;
What are the precautions when taking methoxsalen capsules (Oxsoralen-Ultra)?
Before taking methoxsalen, tell your doctor or pharmacist if you are allergic to it; 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: conditions that make you sensitive to light (such as lupus, certain porphyrias, xeroderma pigmentosum, albinism), skin cancer (melanoma, basal cell or squamous cell carcinomas), removal of natural lens in the eye, coal tar/UVB treatment, radiation treatment, arsenic treatment, cataracts, liver disease, heart disease, kidney disease.
Before having surgery, tell your doctor or dentist about all the products you use...
Last reviewed on RxList: 5/5/2016
This monograph has been modified to include the generic and brand name in many instances.
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