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Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Dovonex: 0.005% (60 g, 120 g) [contains cetearyl alcohol, disodium edta]
Generic: 0.005% (60 g, 120 g)
Sorilux: 0.005% (60 g, 120 g) [contains cetyl alcohol, edetate disodium, propylene glycol]
Calcitrene: 0.005% (60 g, 120 g) [contains disodium edta, propylene glycol]
Generic: 0.005% (60 g, 120 g)
Dovonex: 0.005% (60 mL [DSC]) [contains menthol, propylene glycol]
Generic: 0.005% (60 mL)
Brand Names: U.S.
- Topical Skin Product
- Vitamin D Analog
Synthetic vitamin D3 analog which regulates skin cell production and proliferation. Binds to vitamin D receptors and inhibits keratinocyte proliferation and enhances keratinocyte differentiation (Menter 2009).
When applied to psoriasis plaques: Cream, foam: Undetermined; Ointment: ~6%; Solution: <1%
Absorbed calcipotriene is converted to inactive metabolites
Onset of Action
Improvement begins after 2 weeks; marked improvement seen after 8 weeks
Use: Labeled Indications
Plaque psoriasis: Treatment of plaque psoriasis of the body (cream, foam, ointment) or of the scalp (foam, solution)
Hypersensitivity to calcipotriene or any component of the formulation; patients with demonstrated hypercalcemia or evidence of vitamin D toxicity; use on the face (cream, ointment); patients with acute psoriatic eruptions (scalp solution)
Documentation of allergenic cross-reactivity for Vitamin D derivatives is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Plaque psoriasis: Topical:
US labeling: Adults:
Cream: Apply a thin film to the affected skin twice daily
Foam: Apply a thin film to the affected skin or scalp twice daily
Ointment: Apply a thin film to the affected skin once or twice daily
Solution: Apply to the affected scalp twice daily
Children and Adolescents: Cream, ointment: Apply a thin film to the affected skin twice daily; decrease application to once daily for maintenance treatment when appropriate. Maximum weekly dose:
2 to 5 years: 25 g per week
6 to 10 years: 50 g per week
11 to 14 years: 75 g per week
>14 years: 100 g per week
Adults: Cream, ointment, solution: Apply a thin film to the affected skin twice daily; decrease application to once daily for maintenance treatment when appropriate. If used in combination with a moderately potent to very potent topical corticosteroid apply calcipotriene and the steroid once daily at alternate times (ie, morning versus evening application). Maximum weekly dose:
Cream: 100 g per week
Ointment: 100 g per week
Solution: 60 mL per week
Dosage adjustment in renal impairment: There are no dosage adjustments provided in the manufacturer’s labeling.
Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling.
For external use only. Avoid contact with face and eyes (rinse thoroughly with water if contact occurs).
Cream, foam, ointment: Apply to affected skin; rub in gently and completely. Wash hands thoroughly after use.
Foam, solution (scalp psoriasis): Prior to using, comb hair to remove debris; apply only to scalp lesions. Rub in gently and completely. Wash hands thoroughly after use. Foam should be applied when hair is dry.
If the use of multiple topical agents is necessary, apply the various agents at separate times throughout the day (Menter 2009).
Cream, ointment: Store at 15°C to 25°C (59°F to 77°F); do not freeze.
Foam: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F); do not refrigerate or freeze. Contents are flammable; keep away from heat and flame. Do not puncture or incinerate. Do not expose to temperatures >49°C (120°F).
Solution: Store at 15°C to 25°C (59°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F); do not freeze. Solution should be kept away from open flame; avoid sunlight.
Aluminum Hydroxide: Vitamin D Analogs may increase the serum concentration of Aluminum Hydroxide. Specifically, the absorption of aluminum may be increased, leading to increased serum aluminum concentrations. Avoid combination
Calcium Salts: May enhance the adverse/toxic effect of Vitamin D Analogs. Monitor therapy
Cardiac Glycosides: Vitamin D Analogs may enhance the arrhythmogenic effect of Cardiac Glycosides. Monitor therapy
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs. Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Vitamin D Analogs. Avoid combination
Sucralfate: Vitamin D Analogs may increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration. Avoid combination
Thiazide Diuretics: May enhance the hypercalcemic effect of Vitamin D Analogs. Monitor therapy
Vitamin D Analogs: May enhance the adverse/toxic effect of other Vitamin D Analogs. Avoid combination
Frequency may vary with site of application. Frequency not always defined.
Central nervous system: Tingling of skin (≤23%)
Dermatologic: Burning sensation of skin (≤23%), stinging of the skin (≤23%), skin rash (1% to 11%), dermatitis, desquamation, erythema, exacerbation of psoriasis, pruritus, skin irritation, xeroderma
Local: Application site pain (3%), application site erythema (2%)
<1%: (limited to important or life-threatening): Allergic contact dermatitis, contact dermatitis, hypercalcemia, skin atrophy
Concerns related to adverse effects:
• Contact dermatitis: Contact dermatitis, including allergic contact dermatitis, may occur.
• Hypercalcemia: May cause transient increases in serum calcium (reversible); if hypercalcemia occurs, discontinue treatment until calcium levels return to normal.
• Irritation: Transient irritation of both lesions and surrounding uninvolved skin may occur; discontinue use if irritation occurs.
• Elderly: Use with caution in elderly patients; severity of skin-related adverse reactions may be increased compared to younger adults.
Dosage form specific issues:
• Foam, solution: Flammable; keep the foam and the solution away from fire, flame, or smoking during and immediately following application.
• Appropriate use: For external use only; not for ophthalmic, oral, or intravaginal use. Avoid or limit excessive exposure to natural or artificial sunlight, or phototherapy. Thoroughly wash hands after use. The safety and effectiveness in dermatoses other than psoriasis have not been established. Do not use concurrently with products that may alter the pH of the vehicle (eg, topical lactic acid); if the use of multiple topical agents is necessary, apply the various agents at separate times throughout the day (Menter 2009).
Pregnancy Risk Factor
Adverse events have been observed in some animal reproduction studies. If treatment during pregnancy is needed, other agents may be preferred (Hsu 2012; Zeichner 2010).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience xeroderma or skin paresthesia. Have patient report immediately to prescriber signs of hypercalcemia or severe skin irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about calcipotriene topical
- Calcipotriene (AHFS Monograph)
- Calcipotriene (FDA)
- Calcipotriene Cream (FDA)
- Calcipotriene Ointment (FDA)