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Calcipotriene


General


Pronunciation

(kal si POE try een)


Brand Names: U.S.

  • Calcitrene
  • Dovonex
  • Sorilux

Indications


Use: Labeled Indications

Plaque psoriasis: Treatment of plaque psoriasis of the body (cream, foam, ointment) or of the scalp (foam, solution)


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)

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.


Dosing and Administration


Dosing: Adult

Plaque psoriasis: Topical:

US labeling:

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

Canadian labeling: 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


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Plaque psoriasis: Children and Adolescents: Canadian labeling: Topical: 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


Dosing: Renal Impairment

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


Dosing: Hepatic Impairment

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


Administration

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).


Storage

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.


Dosage Forms/Strengths


Dosage Forms

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

Cream, External:

Dovonex: 0.005% (60 g, 120 g) [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 disodium, propylene glycol]

Ointment, External:

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

Generic: 0.005% (60 g, 120 g)

Solution, External:

Generic: 0.005% (60 mL)


Drug Interactions

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 and Thiazide-Like 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


Monitoring Parameters

Serum calcium


Adverse Reactions


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


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:

- 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.

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. 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

C


Pregnancy Considerations

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).


Actions


Pharmacology

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).


Absorption

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


Metabolism

Absorbed calcipotriene is converted to inactive metabolites


Onset of Action

Improvement begins after 2 weeks; marked improvement seen after 8 weeks


Patient and Family Education


Patient Education

- 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 dry skin, peeling, burning, stinging, or skin tingling. Have patient report immediately to prescriber signs of high calcium (weakness, confusion, feeling tired, headache, nausea and vomiting, constipation, or bone pain) 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.

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