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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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Calcipotriol (calcipotriene): Drug information

Calcipotriol (calcipotriene): Drug information
(For additional information see "Calcipotriol (calcipotriene): Patient drug information" and see "Calcipotriol (calcipotriene): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Calcitrene;
  • Dovonex;
  • Sorilux
Brand Names: Canada
  • Dovonex
Pharmacologic Category
  • Topical Skin Product;
  • Vitamin D Analog
Dosing: Adult
Plaque psoriasis

Plaque psoriasis: Topical:

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.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

(For additional information see "Calcipotriol (calcipotriene): Pediatric drug information")

Plaque psoriasis; mild to moderate

Plaque psoriasis; mild to moderate: Note: Vitamin D analogs (eg, calcipotriene) are recommended treatment options in pediatric patients (particularly to minimize corticosteroid exposure) with or without topical corticosteroids (AAD [Menter 2020]; de Jager 2010; Zeichner 2010).

Foam: Sorilux: Children ≥4 years and Adolescents: Topical: Apply a thin layer to affected areas of scalp and body twice daily (manufacturer's labeling).

Cream, ointment: Limited data available: Children ≥2 years and Adolescents: Topical: Apply a thin layer to affected areas of scalp and body twice daily; ointment dosing based on multicenter trials including over 100 children ≥2 years of age and adolescents with mild to moderate psoriasis covering <30% BSA; significant improvement (based on psoriasis scores) was reported in over 60% of patients in an open-labeled trial; similar efficacy (>50% improvement) was reported in a placebo-controlled study; however, this was not statistically significant (Darley 1996; Oranje 1997); cream dosing based on a small trial, experience with ointment formulation, and expert recommendations (AAD [Menter 2009]; Duweb 2003; Schachner 2011; Zeichner 2010).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing; use with caution.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Dovonex: 0.005% (60 g, 120 g [DSC]) [contains cetearyl alcohol, disodium edta]

Generic: 0.005% (60 g, 120 g)

Foam, External:

Sorilux: 0.005% (60 g, 120 g) [contains cetyl alcohol, edetate (edta) disodium, propylene glycol]

Generic: 0.005% (60 g)

Ointment, External:

Calcitrene: 0.005% (60 g, 120 g [DSC]) [contains disodium edta, propylene glycol]

Generic: 0.005% (60 g, 120 g)

Solution, External:

Generic: 0.005% (60 mL)

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Dovonex: 0.005% (30 g, 120 g) [contains disodium edta, propylene glycol]

Administration: Adult

Topical: 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 (AAD/NPF [Elmets 2021]).

Administration: Pediatric

Topical: For external use only. Avoid contact with face and eyes (rinse thoroughly with water if contact occurs). If the use of multiple topical agents is necessary, consider application of the various agents at separate times throughout the day; calcipotriene may be inactivated by acidic topical agents (eg, salicylic acid, lactic acid, hydrocortisone valerate preparations) (AAD [Menter 2009]; Zeichner 2010).

Cream, foam, ointment: Apply to affected skin; rub in gently and completely. Wash hands thoroughly after use, unless hands are the site being treated. For scalp psoriasis, foam should be applied when hair is dry; prior to using, comb hair to remove debris.

Use: Labeled Indications

Plaque psoriasis: Treatment of plaque psoriasis of the body (cream, ointment) or of the scalp (solution) in adults; treatment of plaque psoriasis of the body or of the scalp in patients ≥4 years of age (foam).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Dermatologic: Burning sensation of skin (≤23%), pruritus (1% to 15%; including application-site pruritus), skin irritation (1% to 15%), skin rash (1% to 11%), stinging of the skin (≤23%)

Nervous system: Tingling of skin (≤23%)

1% to 10%:

Dermatologic: Dermatitis, desquamation, erythema of skin, exacerbation of psoriasis (including facial/scalp psoriasis), xeroderma

Local: Application-site erythema (2%), application-site pain (3%)

<1%:

Dermatologic: Folliculitis, hyperpigmentation, skin atrophy

Endocrine & metabolic: Hypercalcemia

Frequency not defined: Local: Application-site pruritus

Postmarketing:

Dermatologic: Allergic contact dermatitis, contact dermatitis, dyschromia (at application site), exfoliation of skin, skin photosensitivity, urticaria

Hypersensitivity: Hypersensitivity reaction

Local: Application-site vesicles

Contraindications

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).

Canadian labeling: Additional contraindications (not in the US labeling): Ophthalmic use; known disorders of calcium metabolism; pregnancy.

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.

Warnings/Precautions

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.

Special populations:

• Older adult: Use with caution in elderly patients; severity of skin-related adverse reactions may be increased compared to younger adults.

• Pediatric: Children may be at higher risk of systemic side effects due to a greater skin surface area:body weight ratio. In an off-label trial of pediatric patients (2 to 14 years of age) with psoriasis affecting <30% BSA, no serious adverse effects (including calcium or bone metabolism changed) were observed with calcipotriene ointment application for 8 weeks of therapy (Oranje 1997). With foam application in older pediatric patients (5 to <17 years of age), pharmacokinetic studies have not shown significant evidence of systemic calcipotriene absorption or any effects on indices of calcium metabolism.

Dosage form specific issues:

• Foam, solution: Flammable; keep the foam and the solution away from fire, flame, or smoking during and immediately following application.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP ["Inactive" 1997]; Zar 2007).

Other warnings/precautions:

• 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.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities, which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults, including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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. Management: Consider avoiding chronic use of aluminum and aluminum-containing products in patients who are also taking vitamin D analogs. If coadministered, monitor aluminum status and for signs and symptoms of aluminum-related toxicities. Risk D: Consider therapy modification

Calcium Salts: May enhance the adverse/toxic effect of Vitamin D Analogs. Risk C: Monitor therapy

Cardiac Glycosides: Vitamin D Analogs may enhance the arrhythmogenic effect of Cardiac Glycosides. Risk C: Monitor therapy

Hydrocortisone (Topical): May diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with hydrocortisone valerate. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy

Lactic Acid: May diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with lactic acid. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination

Salicylic Acid: May diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with salicylic acid. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy

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. Management: Consider avoiding chronic use of aluminum and aluminum-containing products, such as sucralfate, in patients who are also taking vitamin D analogs. If combined, monitor for signs and symptoms of aluminum-related toxicities. Risk D: Consider therapy modification

Thiazide and Thiazide-Like Diuretics: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy

Vitamin D Analogs: May enhance the adverse/toxic effect of other Vitamin D Analogs. Risk X: Avoid combination

Pregnancy Considerations

Information related to use in pregnancy has not been located. If treatment during pregnancy is needed, other agents may be preferred (Hsu 2012; Zeichner 2010). When other alternatives are not available, limit application area (Murase 2014).

Breastfeeding Considerations

It is not known if calcipotriene is present in breast milk.

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Because the risk of significant systemic absorption is limited, breastfeeding is considered compatible with maternal therapy (Butler 2014). In general, topical agents should not be applied around the nipple area in nursing women (Zeichner 2010).

Monitoring Parameters

Serum calcium

Mechanism of Action

Synthetic vitamin D3 analog which regulates skin cell production and proliferation. Binds to vitamin D receptors and inhibits keratinocyte proliferation and enhances keratinocyte differentiation (AAD/NPF [Elmets 2021]).

Pharmacokinetics

Onset of action: Improvement begins after 2 weeks; marked improvement seen after 8 weeks

Absorption: When applied to psoriasis plaques: Cream, foam: Undetermined; Ointment: ~6%; Solution: <1%

Metabolism: Absorbed calcipotriene is converted to inactive metabolites

Pricing: US

Cream (Calcipotriene External)

0.005% (per gram): $7.06 - $10.15

Cream (Dovonex External)

0.005% (per gram): $15.83

Foam (Calcipotriene External)

0.005% (per gram): $14.69 - $19.13

Foam (Sorilux External)

0.005% (per gram): $21.28

Ointment (Calcipotriene External)

0.005% (per gram): $6.03 - $6.88

Ointment (Calcitrene External)

0.005% (per gram): $6.38

Solution (Calcipotriene External)

0.005% (per mL): $3.92 - $5.66

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Aofuqing (CN);
  • Calciprol (EG);
  • Calskin (TW);
  • Cipocal (TR);
  • Cipostril (VN);
  • Daivonex (AE, AR, AU, BB, BG, BH, BM, BR, BS, BZ, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EC, EE, ES, FR, GT, GY, HK, HN, ID, IL, IN, IT, JM, JO, KR, KW, LT, MT, MX, MY, NL, NZ, PA, PH, PK, PL, PR, PT, QA, RU, SA, SE, SI, SK, SR, SV, TH, TT, TW, UY, VE, VN);
  • Dipsotrex (PH);
  • Dovonex (GB, IE, JP, MT, ZA);
  • Dyvon (BD);
  • Dyvon Cream (BD);
  • Kolkatriol (ID);
  • Kolkatriol F (ID);
  • Psorcutan (AT, DE, TR);
  • Psoritop (EG);
  • Scepos (TW);
  • Xamiol (GB)


For country code abbreviations (show table)
  1. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  2. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014;70(3):417.e1-417.e10; quiz 427. doi: 10.1016/j.jaad.2013.09.009. [PubMed 24528912]
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  5. Calcitrene ointment (calcipotriene) [prescribing information]. Hawthorne, NY: Taro Pharmaceuticals; November 2011.
  6. Darley CR, Cunliffe WJ, Green CM, Hutchinson PE, Klaber MR, Downes N. Safety and efficacy of calcipotriol ointment (Dovonex) in treating children with psoriasis vulgaris. Br J Dermatol. 1996;135(3):390-393. [PubMed 8949431]
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  8. Dovonex (calcipotriene) cream [prescribing information]. Madison, NJ: Leo Pharma; June 2017.
  9. Dovonex (calcipotriene) cream [prescribing information]. Madison, NJ: Leo Pharma; June 2021.
  10. Dovonex (calcipotriene) ointment [prescribing information]. Parsippany, NJ: Leo Pharma; March 2015.
  11. Dovonex (calcipotriene) ointment [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; December 2021.
  12. Duweb G, Aldebani S, Elzorghany A, Benghazil M, Alhaddar J. Calcipotriol ointment versus cream in psoriasis vulgaris. Int J Clin Pharmacol Res. 2003;23(2-3):47-51. [PubMed 15018018]
  13. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):432-470. doi:10.1016/j.jaad.2020.07.087 [PubMed 32738429]
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  17. Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation: Part I. Pregnancy. J Am Acad Dermatol. 2014;70(3):401.e1-401.e14; quiz 415. doi: 10.1016/j.jaad.2013.09.010. [PubMed 24528911]
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  21. Sorilux (calcipotriene) [prescribing information]. Greenville, NC: Mayne Pharma; May 2019.
  22. Sorilux foam (calcipotriene) [prescribing information]. Greenville, NC: Mayne Pharma; November 2019.
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