calcipotriene (Rx)

Brand and Other Names:Dovonex, Calcitrene Ointment, more...Sorilux
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical solution

  • 0.005% (generic)

topical ointment

  • 0.005% (generic)

topical cream

  • 0.005% (Dovonex, generic)

topical foam

  • 0.005% (Sorilux)

Plaque Psoriasis

Ointment/Cream

  • Indicated for plaque psoriasis
  • Apply a thin layer of cream BID to affected area
  • Safety and efficacy have been established in patients treated for 8 weeks

Solution

  • Indicated for chronic, moderately severe psoriasis of the scalp
  • Apply solution BID to affected area
  • Safety and efficacy have been established in patients treated for 8 weeks

Foam

  • Indicated for plaque psoriasis of the scalp and body for patients ≥12 years
  • Apply a thin layer of foam BID to affected area

Dosing Considerations

Limitation of use

  • Safety and efficacy in dermatoses other than psoriasis have not been established

Dosage Forms & Strengths

topical foam

  • 0.005% (Sorilux)

Plaque Psoriasis

Indicated for plaque psoriasis of the scalp and body for patients ≥12 years

Apply a thin layer of foam BID to affected area

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Interactions

Interaction Checker

and calcipotriene

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Burning

            Itching

            Skin irritation

            1-10%

            Dermatitis

            Dry skin

            Erythema

            Peeling

            Worsening of psoriasis including facial/scalp

            Rash

            <1%

            Folliculitis

            Hypercalcemia

            Hyperpigmentation

            Skin atrophy

            Postmarketing Reports

            Contact dermatitis, including allergic contact dermatitis

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            Warnings

            Contraindications

            Hypersensitivity

            Hypercalcemia

            Evidence of vitamin D toxicity

            Topical use on the face

            Cautions

            Transient, rapidly reversible elevations of serum calcium has occurred; if serum calcium is above normal levels during therapy, discontinue treatment

            For cream only: Contact dermatitis (eg, allergic contact dermatitis) has been observed

            Flammability

            • Foam contains a flammable propellant; advise patients to avoid fire, flames, and smoking during and immediately following application
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            Pregnancy & Lactation

            Pregnancy

            No data available on drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes in pregnant women exposed to calcipotriene

            Foam: Systemic exposure to calcipotriene is likely to be low

            Animal data

            • In animal reproduction studies, oral administration of calcipotriene to pregnant rats and rabbits during organogenesis resulted in an increased minor skeletal abnormalities, including enlarged fontanelles and extra ribs in rats and an increased incidence of minor skeletal abnormalities, including incomplete ossification of pubic bones and forelimb phalanges in rabbits

            Lactation

            There are no data on the presence of topically administered calcipotriene in human or animal milk, the effects on the breastfed infant, or the effects on milk production

            After topical administration, plasma concentrations of calcipotriene are low, and therefore, concentrations in human milk are likely to be low

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            In vitro evidence suggests drug is roughly equipotent to natural vitamin D in its effects on proliferation & differentiation of various cell types

            Absorption

            Absorption: 5-6% systemically

            Metabolism

            Metabolism: converted to inactive metabolites within 24 hr

            Excretion

            Excretion: bile

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            Administration

            Topical Administration

            For topical use only

            Not for ophthalmic, oral or intravaginal use

            Avoid contact with face and eyes

            Wash hands after applying foam, cream, or solution

            Cream or ointment: Apply a thin layer of cream to affected area and gently rub in completely

            Foam

            • Apply a thin layer of foam to affected area and gently rub in completely
            • Apply to the scalp when hair is dry
            • Avoid fire, flame, and smoking during and immediately following application

            Solution

            • Comb hair to remove scaly debris and after suitably parting, apply solution only to the lesions, and gently rub in completely, taking care to prevent the solution spreading onto the forehead

            Storage

            Cream/ointment: Store at room temperature 15- 25°C (59-77°F); do not freeze

            Solution: Store at 20-25°C (68-77°F)

            Foam

            • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F); flammable
            • Contents under pressure
            • Do not puncture or incinerate
            • Do not refrigerate or freeze
            • Do not expose to heat or store at temperatures >120°F (49°C)
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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.