SORILUX

SORILUX- calcipotriene aerosol, foam
Mayne Pharma LLC

1 INDICATIONS AND USAGE

SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older.

2 DOSAGE AND ADMINISTRATION

SORILUX Foam is for topical use only. SORILUX Foam is not for oral, ophthalmic, or intravaginal use.

Apply a thin layer of SORILUX Foam twice daily to the affected areas and rub in gently and completely. Avoid contact with the face and eyes.

3 DOSAGE FORMS AND STRENGTHS

0.005%, white foam

4 CONTRAINDICATIONS

SORILUX Foam should not be used by patients with known hypercalcemia.

5 WARNINGS AND PRECAUTIONS

5.1 Flammability

The propellant in SORILUX Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.

5.2 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.

5.3 Risk of 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 Foam. [See Nonclinical Toxicology (13.1).]

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

SORILUX Foam was studied in four vehicle-controlled trials. A total of 1094 subjects with plaque psoriasis, including 654 exposed to SORILUX Foam, were treated twice daily for 8 weeks.

Adverse reactions reported in ≥1% of subjects treated with SORILUX Foam and at a higher incidence than subjects treated with vehicle were application site erythema (2%) and application site pain (3%). The incidence of these adverse reactions was similar between the body and scalp.

7 DRUG INTERACTIONS

No drug interaction studies were conducted with SORILUX Foam.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects, Pregnancy Category C:

There are no adequate and well-controlled trials in pregnant women. Therefore, SORILUX 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.

8.3 Nursing Mothers

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 Foam is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of SORILUX Foam in pediatric patients less than 18 years of age have not been established.

8.5 Geriatric Use

Clinical trials of SORILUX 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.

8.6 Unevaluated Uses

SORILUX Foam has not been evaluated in patients with erythrodermic, exfoliative, or pustular psoriasis.

10 OVERDOSAGE

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with use of topical calcipotriene [See Warnings and Precautions (5.2).]

11 DESCRIPTION

SORILUX Foam contains the compound calcipotriene, a synthetic vitamin D3 analog.

Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene- 1α,3β,24-triol. The structural formula is represented below:

Chemical Structure

Molecular Formula: C27 H40 O3 Molecular Weight: 412.6

Calcipotriene is a white or off-white crystalline substance. SORILUX Foam contains calcipotriene 50 mcg/g in an aqueous-based emulsion foam vehicle consisting of cetyl alcohol, dibasic sodium phosphate, dl-α-tocopherol, edetate disodium, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, stearyl alcohol, and white petrolatum. SORILUX Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Calcipotriene is a synthetic vitamin D3 analog that has a similar receptor binding affinity as natural vitamin D3 . However, the exact mechanism of action contributing to the clinical efficacy in the treatment of psoriasis is unknown.

12.2 Pharmacodynamics

The pharmacodynamics of SORILUX Foam are unknown.

12.3 Pharmacokinetics

The systemic absorption of calcipotriene in subjects with psoriasis of the body was evaluated at steady state following application of either SORILUX Foam or calcipotriene ointment to a body surface area of 5% to 10%. In the SORILUX Foam treatment group, 15 out of 16 subjects had calcipotriene plasma concentrations below the limit of quantitation (10 pg/mL), while in the calcipotriene ointment treated group, 5 out of 16 subjects had measurable calcipotriene plasma concentrations at various time points. All measurable plasma calcipotriene concentrations were below 25 pg/mL.

The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin D. Absorbed calcipotriene is known to be converted to inactive metabolites within 24 hours of application and the metabolism occurs via a similar pathway to the natural hormone.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: 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 with 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 (5.3).]

Mutagenesis: 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.

Impairment of Fertility: 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.

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