|indication=severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. It should be used with long wave ultraviolet radiation
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions= erythema, pain of skin, pruritus, nausea, dizziness, headache, fatigue
|blackBoxWarningBody=Methoxsalen with UV radiation should be used only by physicians who have special competence in the diagnosis and treatment of psoriasis and vitiligo and who have special training and experience in photochemotherapy. 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. 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.
* Content
CAUTION: 8-MOP® Capsules (Methoxsalen Hard Gelatin Capsules) may not be interchanged with Oxsoralen-Ultra® Capsules (Methoxsalen Soft Gelatin Capsules) without retitration of the patient.
<!--Adult Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult======Condition1=====
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<!--Brand Names-->
<!--Brand Names-->
|brandNames=* OXSORALEN-ULTRA®<ref>{{Cite web | title =OXSORALEN-ULTRA- methoxsalen capsule, liquid filled | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae951dc4-9031-43bf-943c-cb2366951f23 }}</ref>
|brandNames=* OXSORALEN-ULTRA®<ref>{{Cite web | title =OXSORALEN-ULTRA- methoxsalen capsule, liquid filled | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae951dc4-9031-43bf-943c-cb2366951f23 }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
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Black Box Warning
WARNING:
See full prescribing information for complete Boxed Warning.
Methoxsalen with UV radiation should be used only by physicians who have special competence in the diagnosis and treatment of psoriasis and vitiligo and who have special training and experience in photochemotherapy. 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. 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.
CAUTION: 8-MOP® Capsules (Methoxsalen Hard Gelatin Capsules) may not be interchanged with Oxsoralen-Ultra® Capsules (Methoxsalen Soft Gelatin Capsules) without retitration of the patient.
Overview
Methoxsalen (oral) is a naturally occurring photoactive substance that is FDA approved for the treatment of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. It should be used with long wave ultraviolet radiation. There is a Black Box Warning for this drug as shown here. Common adverse reactions include erythema, pain of skin, pruritus, nausea, dizziness, headache, fatigue.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Methoxsalen (oral) in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Methoxsalen (oral) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Methoxsalen (oral) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Methoxsalen (oral) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Methoxsalen (oral) in pediatric patients.
Contraindications
Condition1
Warnings
WARNING:
See full prescribing information for complete Boxed Warning.
Methoxsalen with UV radiation should be used only by physicians who have special competence in the diagnosis and treatment of psoriasis and vitiligo and who have special training and experience in photochemotherapy. 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. 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.
CAUTION: 8-MOP® Capsules (Methoxsalen Hard Gelatin Capsules) may not be interchanged with Oxsoralen-Ultra® Capsules (Methoxsalen Soft Gelatin Capsules) without retitration of the patient.
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Methoxsalen (oral) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Methoxsalen (oral) in the drug label.
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