"(Reuters) - Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said"...
The propellant in SORILUX (calcipotriene foam) is flammable. Instruct the patient to avoid fire, flame, and/or smoking during and immediately following application.
Effects on Calcium Metabolism
Transient, rapidly reversible elevation of serum calcium has occurred with use of calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.
Ultraviolet Light Exposure
Instruct the patient to avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning booths and sun lamps. Physicians may wish to limit or avoid use of phototherapy in patients who use SORILUX (calcipotriene foam) Foam. [See Nonclinical Toxicology]
SORILUX (calcipotriene foam) Foam has not been evaluated in patients with erythrodermic, exfoliative, or pustular psoriasis.
Patient Counseling Information
[See FDA-Approved Patient Labeling]
The patient should be instructed as follows:
- Do not place SORILUX (calcipotriene foam) Foam in the refrigerator or freezer.
- Avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning beds and sun lamps.
- If SORILUX (calcipotriene foam) Foam gets in or near their eyes, to rinse thoroughly with water.
- Talk to their doctor if their skin does not improve after treatment with SORILUX (calcipotriene foam) Foam for 8 weeks.
- Wash their hands after applying SORILUX (calcipotriene foam) Foam unless their hands are the affected site
- Avoid fire, flame, or smoking during and immediately following application since SORILUX (calcipotriene foam) Foam is flammable.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Calcipotriene topically administered to mice for up to 24 months at dose levels of 3, 10, or 30 mcg/kg/day (corresponding to 9, 30, or 90 mcg/m2/day) showed no significant changes in tumor incidence when compared to controls. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors. [See WARNINGS AND PRECAUTIONS]
The genotoxic potential of calcipotriene was evaluated in an Ames assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, and a mouse micronucleus assay. All assay results were negative.
Studies in rats at doses up to 54 mcg/kg/day (318 mcg /m2/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.
Use In Specific Populations
Teratogenic Effects, Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Therefore, SORILUX (calcipotriene foam) Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. Increased rabbit maternal and fetal toxicity was noted at 12 mcg/kg/day (132 mcg/m2/day). Rabbits administered 36 mcg/kg/day (396 mcg/m2/day) resulted in fetuses with a significant increase in the incidences of incomplete ossification of pubic bones and forelimb phalanges. In a rat study, doses of 54 mcg/kg/day (318 mcg/m2/day) resulted in a significantly higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The maternal and fetal no-effect exposures in the rat (43.2 mcg/m2/day) and rabbit (17.6 mcg/m2/day) studies are approximately equal to the expected human systemic exposure level (18.5 mcg/m2/day) from dermal application.
It is not known whether calcipotriene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SORILUX (calcipotriene foam) Foam is administered to a nursing woman.
Safety and effectiveness of SORILUX (calcipotriene foam) Foam in pediatric patients less than 18 years of age have not been established.
Clinical studies of SORILUX (calcipotriene foam) Foam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/2/2010
Additional Sorilux Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.