Calcipotriene
FDA Drug Information • Also known as: Calcipotriene, Calcitrene, Sorilux
- Brand Names
- Calcipotriene, Calcitrene, Sorilux
- Drug Class
- Vitamin D Analog [EPC]
- Route
- TOPICAL
- Dosage Form
- AEROSOL, FOAM
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION SORILUX Foam contains the compound calcipotriene, a synthetic vitamin D3 analog, in an aqueous-based emulsion foam vehicle for topical dermatologic use. 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: Molecular Formula: C27H40O3 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. Chemical Structure
What Is Calcipotriene Used For?
1 INDICATIONS AND USAGE SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. SORILUX ® Foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. ( 1 )
Dosage and Administration
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. For topical use only; not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply twice daily. ( 2 )
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS 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 and application site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . ( 6 ) 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 adult 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. In an open-label study, 19 pediatric subjects age 12 to less than 17 years applied SORILUX Foam twice daily for 14 days and once on Day 15. Adverse reactions included application site pain, application site pruritus and pruritus [see Clinical Pharmacology (12.2 and 12.3) and Pediatric Use (8.4) ] . In an open-label study, 36 pediatric subjects age 4 to less than 12 years applied SORILUX Foam twice daily for up to 8 weeks. Adverse reactions included application site pain and contact dermatitis [see Clinical Pharmacology (12.2 and 12.3) and Pediatric Use (8.4) ] . 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of SORILUX Foam. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and Subcutaneous: application site vesicles
Contraindications
4 CONTRAINDICATIONS SORILUX Foam should not be used by patients with known hypercalcemia. Do not use in patients with known hypercalcemia. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Although there are no available data on the drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes in pregnant women exposed to SORILUX Foam, systemic exposure to calcipotriene is likely to be low [see Clinical Pharmacology (12.2 , 12.3) ] . In animal reproduction studies, oral administration of calcipotriene to pregnant rats and rabbits during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs in rats and an increased incidence of minor skeletal abnormalities, including incomplete ossification of pubic bones and forelimb phalanges in rabbits (see Data ) . The available data do not allow the calculation of relevant comparisons between the systemic exposure of calcipotriene observed in animal studies to the systemic exposure that would be expected in humans after topical use of SORILUX Foam. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Embryofetal development studies were conducted with calcipotriene after oral administration in rats and rabbits. Pregnant rats received daily oral administration of calcipotriene during the period of organogenesis. Fetuses from dams dosed with 54 mcg/kg/day (318 mcg/m 2 /day) exhibited a significantly increased incidence of minor skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. There were no effects on the incidence of major malformations in fetuses. Pregnant rabbits received daily oral administration of calcipotriene...
Overdosage
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) ] .
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied SORILUX (calcipotriene) Foam, 0.005%, is supplied as follows: 120 g aluminum can NDC 51862-376-12 16.2 Storage and Handling Store at 20ºC to 25°C (68°F to 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F). Flammable. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Keep out of reach of children.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.