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

Slideshow: Psoriasis - Treatment Options to Manage Your Symptoms

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.

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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Calcipotriene 0.005% Ointment (TARO): 60/$280.80 or 180/$809.98

Calcipotriene 0.005% Solution (SANDOZ): 60/$339.44 or 120/$663.84

Dovonex 0.005% Cream (LEO PHARMA INC): 60/$361.01 or 180/$1,033.96

Dovonex 0.005% Cream (LEO PHARMA INC): 120/$690.01 or 360/$2,039.87

Dovonex 0.005% Solution (WARNER CHILCOTT PROF PROD DIV): 60/$323.98 or 180/$947.95

Taclonex 0.005-0.064% Ointment (LEO PHARMA INC): 60/$573.00 or 180/$1,591.01

Taclonex 0.005-0.064% Ointment (LEO PHARMA INC): 100/$884.96 or 300/$2,579.08

Taclonex Scalp 0.005-0.064% Suspension (LEO PHARMA INC): 60/$530.98 or 180/$1,577.89

AHFS DI Essentials. © Copyright, 2004-2014, 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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