Data from FDA - Curated by Toby Galbraith - Last updated 11 January 2017
FDA (Food and Drug Administration, USA)
IV. CONTRAINDICATIONS A. Patients exhibiting idiosyncratic reactions to psoralen compounds.
B. Patients possessing a specific history of
Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism.
C. Patients exhibiting melanoma or possessing a history of melanoma.
D. Patients exhibiting
E. Patients with aphakia, because of
VI. PRECAUTIONS A. GENERAL - APPLICABLE TO BOTH VITILIGO AND PSORIASIS TREATMENT: 1.
BEFORE METHOXSALEN INGESTION Patients must not sunbathe during the 24 hours prior to methoxsalen ingestion and UV exposure.
The presence of a sunburn may prevent an
Cataracts form when enough of the binding occurs.
If sun exposure can not be
These chemical sunscreens should be applied to
Sunscreens should not be applied to areas affected by psoriasis until after the patient has been treated in the UVA chamber.
DURING PUVA THERAPY a. Total UVA-absorbing/blocking goggles mechanically designed to give
b. Abdominal skin, breasts, genitalia, and
c. Unless affected by disease, male genitalia should be shielded.
AFTER COMBINED METHOXSALEN/UVA
b. Patients should not sunbathe for 48 hours after therapy.
VITILIGO THERAPY a.
b. Eye and skin sun protection as described in the Precautions - General section should be observed.
B. INFORMATION FOR PATIENTS: See accompanying Patient Package Insert.
C. LABORATORY TESTS: 1.
Patients should have an ophthalmologic examination prior to the start of therapy, and thence yearly.
Patients should have the following tests prior to the start of therapy and should be retested 6-12 months subsequently.
a. Complete Blood Count (Hemoglobin or Hematocrit; White Blood Count - if
b. Anti-nuclear Antibodies.
c. Liver Function Tests.
d. Renal Function Tests (Creatinine or Blood Urea Nitrogen).
D. DRUG INTERACTIONS: See Warnings Section.
E. CARCINOGENESIS: See Warnings Section.
F. PREGNANCY: Pregnancy Category C. Animal reproduction studies have not been conducted with methoxsalen.
It is also not known whether methoxsalen can cause fetal
Methoxsalen should be given to a woman only if clearly needed.
G. NURSING MOTHERS: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk,
H. PEDIATRIC USE:
This effect may be minimized or
Other effects include
B. COMBINED METHOXSALEN/UVA THERAPY: 1.
In most cases, pruritus can be alleviated with frequent application of
PUVA therapy is an expected reaction and indicates that a therapeutic interaction between methoxsalen and UVA occurred.
Any area showing
IMPORTANT DIFFERENCES BETWEEN PUVA ERYTHEMA AND SUNBURN: PUVA-induced inflammation differs from sunburn or UVB phototherapy in several ways.
The in_situ depth of photochemistry is deeper within the tissue because UVA is transmitted further into the skin.
The DNA lesions induced by PUVA are very different from UV-induced thymine dimers and may lead to a DNA crosslink.
The time course of
PUVA-induced redness may be just beginning at 24 hours, when UVB erythema has already passed its peak.
IX. DRUG DOSAGE & ADMINISTRATION A. VITILIGO THERAPY 1.
DRUG DOSAGE: Two capsules (10 mg each) in one dose taken with milk or in food two to four hours before ultraviolet light exposure.
LIGHT EXPOSURE: The exposure time to sunlight should comply with the following guide:
Second Exposure 20 min. 25 min. 30 min.
Third Exposure 25 min. 30 min. 35 min.
Fourth Exposure 30 min. 35 min. 40 min. Subsequent Exposure: Gradually
Therapy should be on alternate days and never two consecutive days.
B. PSORIASIS THERAPY 1.
DRUG DOSAGE - INITIAL THERAPY: The methoxsalen capsules should be taken 2 hours before UVA exposure with some food or milk according to the following table: Patient 's Weight Dose (kg) (lbs) (mg) <30 <66 10 30-50 66-110 20 51-65 112-143 30 66-80 146-176 40 81-90 179-198 50 91-115 201-254 60 >115 >254 70
a. Weight Change: In the event that the weight of a patient changes during treatment such that he/she
If, in the physician 's opinion, however,
b. Dose/Week: The number of doses per week of methoxsalen capsules will be determined by the patient 's schedule of UVA exposures.
after the fifteenth treatment under the conditions outlined in section XI.B.4.b.
|Agency product number||U4VJ29L7BQ|
|Date Last Revised||01-09-2013|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Store at 25°C (77°F); excursions permitted to 15°C- 30°C (59°F- 86°F).|
|Marketing authorisation holder||Valeant Pharmaceuticals North America LLC|
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,
Because of the possibilities of ocular damage, aging of the skin, and skin
When methoxsalen is used in combination with photopheresis, refer to the UVAR * System Operator 's Manual for specific warnings,