Potent Drug, Read Brochure Prior to Prescribing or Dispensing
- 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.
- 8-MOP: When methoxsalen is used in combination with photopheresis, refer to the UVAR* System Operator's Manual for specific warnings, cautions, indications, and instructions related to photopheresis.
DO NOT INTERCHANGE PRODUCTS
- Oxsoralen-Ultraï¿½ (Methoxsalen Soft Gelatin Capsules) should not be used interchangeably with regular Oxsoralenï¿½ or 8-MOPï¿½ (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.
- 8-MOP capsules (methoxsalen hard gelatin capsules) may not be interchanged with Oxsoralen-ultra capsules (methoxsalen soft gelatin capsules) without the retitration of the patient.
Patient Counseling Information
Updated January 2018