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Generic Name: Calcipotriene
Class: Skin and Mucous Membrane Agents, Miscellaneous
ATC Class: D05AX02
VA Class: DE820
Chemical Name: (1α,3β,5Z,7E,22E,24S) - 24 - Cyclopropyl - 9,10 - secochola - 5,7,10(19),22 - tetraene - 1,3,24 - triol
Molecular Formula: C27H40O3
CAS Number: 112965-21-6

Introduction

Antipsoriatic agent; a synthetic vitamin D3 derivative.2 3 5 6

Uses for Dovonex

Psoriasis

Used alone or in fixed combination with betamethasone dipropionate for the topical treatment of plaque psoriasis (psoriasis vulgaris) in adults.2 5

Used alone or in fixed combination with betamethasone dipropionate for the topical treatment of chronic, moderately severe scalp psoriasis in adults.3 6

Dovonex Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a 0.005% cream or as a fixed-combination ointment containing calcipotriene 0.005% and betamethasone dipropionate 0.064% (equivalent to 0.05% of betamethasone);2 5 apply to the scalp as a 0.005% solution or as a fixed-combination suspension containing calcipotriene 0.005% and betamethasone dipropionate 0.064% (equivalent to 0.05% of betamethasone).3 6

For dermatologic use only; not intended for oral, ophthalmic, or intravaginal use.2 3 5 6 Avoid contact with face, eyes, axillae, groin, and other mucous membranes.2 3 5 6

Apply cream in a thin film and rub gently and completely into affected area.2

Apply calcipotriene and betamethasone dipropionate fixed-combination ointment and rub gently and completely into affected area.5

For scalp psoriasis, comb hair to remove scaly debris; part the hair and apply calcipotriene solution to affected area; rub gently and completely into scalp.3 4 Avoid contact with forehead or uninvolved scalp margins.3

For scalp psoriasis, apply calcipotriene and betamethasone dipropionate fixed-combination suspension to affected areas; part the hair before applying the suspension.6 Shake bottle prior to each use.6

Wash hands thoroughly after application process.2 3 5 6

Dosage

Adults

Psoriasis
Plaque Psoriasis
Topical

Apply 0.005% cream sparingly to affected area twice daily.2

Apply ointment containing calcipotriene 0.005% and betamethasone 0.05% to the affected area(s) once daily.5

Scalp Psoriasis
Topical

Apply 0.005% scalp solution to affected area twice daily.3

Apply suspension containing calcipotriene 0.005% and betamethasone 0.05% to affected area(s) of the scalp once daily for 2 weeks or until cleared.6

Prescribing Limits

Adults

Psoriasis
Plaque Psoriasis
Topical

Use of 0.005% cream >8 weeks not evaluated.2

Maximum 100 g weekly of the fixed-combination calcipotriene 0.005% and betamethasone 0.05% ointment.5 Do not apply to >30% of body surface area.5 Do not exceed 4 consecutive weeks of therapy.5

Scalp Psoriasis
Topical

Use of 0.005% scalp solution >8 weeks not evaluated.3

Maximum 100 g weekly of the fixed-combination calcipotriene 0.005% and betamethasone 0.05% suspension.6 Do not exceed 8 consecutive weeks of therapy.6

Special Populations

No special population dosage recommendations at this time.2 3 5 6

Cautions for Dovonex

Contraindications

  • Demonstrated hypercalcemia or evidence of vitamin D toxicity.2 3

  • 0.005% scalp solution: Acute psoriatic eruptions of the scalp.3

  • Application to face.2 (See Topical Administration under Dosage and Administration.)

  • Known or suspected hypersensitivity to calcipotriene or any ingredient in the formulation.2 3 5

  • Calcipotriene and betamethasone dipropionate ointment or suspension: Known or suspected disorders of calcium metabolism.5

  • Calcipotriene and betamethasone dipropionate ointment or suspension: Erythrodermic, exfoliative, and pustular psoriasis.5

Warnings/Precautions

Warnings

Flammable Product

Scalp solution is flammable; keep away from open flame.3

Sensitivity Reactions

Discontinue therapy if sensitivity reaction or excessive irritation occurs.3 5

General Precautions

Dermatologic Effects

Possible irritation of lesions and surrounding skin; discontinue therapy and initiate appropriate treatment if irritation occurs.2 3 5

Metabolic Effects

Reversible elevated serum calcium concentrations reported; discontinue calcipotriene until normal calcium concentrations restored.2 3 5 6

Do not use in patients with demonstrated hypercalcemia or evidence of vitamin D toxicity (hypervitaminosis D).2 3 (See Contraindications.)

Carcinogenicity

May increase the effect of UV radiation to induce skin tumors; patients who apply calcipotriene to exposed areas of the body should minimize exposure to sunlight or artificial UV irradiation (e.g., sunlamps, tanning booths).2 3 5 6

The manufacturer states that clinicians may want to limit or avoid use of phototherapy in patients using calcipotriene alone or in fixed combination with betamethasone dipropionate.2 3 5 6

Use of Fixed Combinations

When used in fixed combination with betamethasone dipropionate, consider the cautions, precautions, and contraindications associated with topical corticosteroids.5 6

Specific Populations

Pregnancy

Category C.2 3 5 6

Lactation

Not known if topical calcipotriene is distributed into milk.2 3 5 6 Caution advised if topical calcipotriene used.2 3 5 6

Pediatric Use

Safety and efficacy not established.2 3 5 6

Children may be more susceptible to systemic adverse effects because of greater skin surface area-to-body weight ratio.2 3 5 6

Geriatric Use

No substantial differences in safety or efficacy relative to younger adults,2 3 5 6 but increased sensitivity cannot be ruled out.2 3

Hepatic Impairment

Use of fixed-combination ointment or suspension containing calcipotriene and betamethasone dipropionate has not been studied in patients with severe hepatic disorders;5 do not use the drug in such patients.6

Renal Impairment

Use of fixed-combination ointment or suspension containing calcipotriene and betamethasone dipropionate has not been studied in patients with severe renal insufficiency;5 do not use the drug in such patients.6

Common Adverse Effects

0.005% cream: Skin irritation, rash, pruritus, dermatitis, worsening of psoriasis.2

0.005% scalp solution: Transient burning, stinging, and tingling; rash, dry skin, irritation, worsening of psoriasis.3

Interactions for Dovonex

No formal drug interaction studies to date.2 3 5 6

Dovonex Pharmacokinetics

Absorption

Bioavailability

Topically applied ointment and scalp solution can be absorbed through normal intact skin;2 3 absorption may increase when applied to psoriasis plaques.2 Systemic absorption of calcipotriene cream not evaluated.2

Following topical application of ointment to psoriasis plaques or normal skin, about 6% or 5%, respectively, of the drug reaches systemic circulation.2

Following topical application of scalp solution to normal skin or psoriatic plaques on the scalp, <1% of the drug reaches systemic circulation.3

Distribution

Extent

Topical calcipotriene may cross the placenta; not known if distributed into milk.2 3 5 6

Elimination

Metabolism

Rapidly metabolized by the liver to inactive metabolites.2 3 5 6

Elimination Route

Excreted principally in bile.2 3

Stability

Storage

Topical

Cream, Ointment

15–25°C; do not freeze.2

Fixed-combination calcipotriene-betamethasone dipropionate ointment: 20–25°C (may be exposed to 15–30°C).5

Scalp Solution, Suspension

15–25°C; do not freeze.3 Avoid sunlight.3

Fixed-combination calcipotriene-betamethasone dipropionate suspension: 20–25°C (may be exposed to 15–30°C).6 Do not refrigerate.6 Store bottle in outer carton when not in use and use within 3 months after opening.6

Actions

  • Exact mechanism of antipsoriatic action not fully understood; however, roughly equipotent to natural vitamin D in effects on proliferation and differentiation of various cell types.3

Advice to Patients

  • Importance of providing patient a copy of manufacturer’s patient information.5 6

  • Importance of using only as directed; avoid contact with the eyes, face, groin, and axillae, and only apply externally as directed.2 3 5 6

  • Importance of shaking fixed-combination calcipotriene-betamethasone dipropionate suspension before each use.6

  • Importance of washing hands thoroughly after use.2 3 5 6

  • Importance of avoiding exposure of treated skin to either natural or artificial sunlight (e.g., sunlamps, tanning beds).2 3 5 6

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.2 3

  • If a dose is missed, apply as soon as it is remembered; apply the next dose on schedule.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.2 3

  • Importance of informing patients of other important precautionary information.5 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Calcipotriene

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

0.005%

Dovonex

Warner Chilcott

Solution

0.005%

Dovonex Scalp Solution (with isopropyl alcohol 51% and propylene glycol)

Warner Chilcott

Calcipotriene Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Ointment

0.005% with Betamethasone Dipropionate 0.064% (0.05% of betamethasone)

Taclonex

Warner Chilcott

Suspension

0.005% with Betamethasone Dipropionate 0.064% (0.05% of betamethasone)

Taclonex Scalp Topical Suspension

Warner Chilcott

AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions July 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Bristol-Myers Squibb. Dovonex (calcipotriene) 0.005% ointment prescribing information. Princeton, NJ; 2000 Nov.

2. Warner Chilcott (US), LLC. Dovonex (calcipotriene) 0.005% cream prescribing information. Rockaway, NJ; 2008 Feb.

3. Warner Chilcott (US), LLC. Dovonex (calcipotriene) 0.005% scalp solution prescribing information. Rockaway, NJ; 2008 Jan.

4. Westwood-Squibb, Buffalo, NY: Personal communication.

5. Warner Chilcott (US), LLC. Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment prescribing information. Rockaway, NJ; 2008 Jul.

6. Warner Chilcott (US), LLC. Taclonex Scalp (calcipotriene 0.005% and betamethasone dipropionate 0.064%) topical suspension prescribing information. Rockaway, NJ; 2008 May.

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