Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 26 January 2017

Indication(s)

INDICATIONS AND USAGE Calcitrene® (calcipotriene) ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

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Advisory information

contraindications
CONTRAINDICATIONS Calcitrene® (calcipotriene) ointment, 0.005%, is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene should not be used on the face.
Special warnings and precautions

PRECAUTIONS General Use of calcipotriene may cause irritation of lesions and surrounding uninvolved skin.

If irritation develops, calcipotriene should be discontinued.

For external use only.

Keep out of the reach of children.

Always wash hands thoroughly after use.

Transient, rapidly reversible elevation of serum calcium has occurred with use of calcipotriene.

If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.

Information for Patients Patients using calcipotriene should receive the following information and instructions: This medication is to be used as directed by the physician.

It is for external use only.

Avoid contact with the face or eyes.

As with any topical medication, patients should wash hands after application.

This medication should not be used for any disorder other than that for which it was prescribed.

Patients should report to their physician any signs of local adverse reactions.

Patients that apply calcipotriene to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.)

Carcinogenesis, Mutagenesis, Impairment of Fertility When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 µg/ kg/day (corresponding to 9, 30 and 90 µg/ m2/day), no significant changes in tumor incidence were observed when compared to control.

In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to indicate the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors.

Patients that apply calcipotriene to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).

Physicians may wish to limit or avoid use of phototherapy in patients that use calcipotriene.

Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice.

Studies in rats at doses up to 54 µg/ kg/day (324 µg/ m2/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.

Pregnancy Teratogenic Effects Pregnancy Category C Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60 % of the administered dose.

In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 µg/ kg/day (132 µg/ m2/day); a dosage of 36 µg/ kg/day (396 µg/ m2/day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses.

In a rat study, a dosage of 54 µg/ kg/day (318 µg/ m2/day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs).

The enlarged fontanelles are most likely due to calcipotriene 's effect upon calcium metabolism.

The estimated maternal and fetal no-effect exposure levels in the rat (43.2 µg/ m2/day) and rabbit (17.6 µg/ m2/day) studies are approximately equal to the expected human systemic exposure level (18.5 µg/ m2/day) from dermal application.

There are no adequate and well-controlled studies in pregnant women.

Therefore, Calcitrene® (calcipotriene) ointment, 0.005 % should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers It is not known whether calcipotriene is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Calcitrene® (calcipotriene) ointment, 0.005 % is administered to a nursing woman.

Pediatric Use Safety and effectiveness of calcipotriene in pediatric patients have not been established.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.

Geriatric Use Of the total number of patients in clinical studies of Calcitrene® (calcipotriene) ointment, 0.005 %, approximately 12 % were 65 or older, while approximately 4 % were 75 and over.

The results of an analysis of severity of skin-related adverse events showed a statistically significant difference for subjects over 65 years (more severe) compared to those under 65 years (less severe).

Adverse reactions

ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10-15 % of patients.

Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10 % of patients.

Other experiences reported in less than 1 % of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis.

Once daily dosing has not been shown to be superior in safety to twice daily dosing.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Apply a thin layer of Calcitrene® (calcipotriene) ointment, 0.005% once or twice daily and rub in gently and completely.
Pregnancy and lactation
Nursing Mothers It is not known whether calcipotriene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcitrene® (calcipotriene) ointment, 0.005% is administered to a nursing woman.

More information

Category Value
Authorisation number ANDA090633
Agency product number 143NQ3779B
Orphan designation No
Product NDC 51672-5278
Date Last Revised 26-04-2012
Type HUMAN PRESCRIPTION DRUG
RXCUI 198373
Storage and handling STORAGE Store at controlled room temperature 15°C-25°C (59°F-77°F). Do not freeze.
Marketing authorisation holder Taro Pharmaceuticals U.S.A., Inc.