calcipotriene (Rx)

>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

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

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.

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

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)