Calcitrene

Calcipotriene is a prescription medication used to treat plaque psoriasis. Calcipotriene belongs to a group of drugs called synthetic vitamin D3 derivatives. The exact way calcipotriene works to treat plaque psoriasis is unknown.

This medication comes in the form of a foam. It is usually applied to the affected skin twice daily.

Common side effects of calcipotriene foam are irritation, redness, and itching of the skin treated.

No calcipotriene drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Tell your doctor if you are taking vitamin D or calcium supplements, lithium (Lithobid, Eskalith), or thiazide diuretics. All of these medications can increase calcium levels in the blood and when combined with calcipotriene, may lead to too high blood calcium levels (hypercalcemia).

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if calcipotriene passes into breast milk. Do not apply calcipotriene to the chest area if you are breastfeeding a baby. This will help to prevent the baby from accidentally getting calcipotriene into their mouth.

Calcipotriene is a man-made form of vitamin D. It is involved in the growth and development of skin cells.

Calcipotriene topical (for the skin) is used to treat plaque psoriasis (psoriasis with scaly patches).

Calcipotriene topical may also be used for purposes not listed in this medication guide.

You should not use calcipotriene topical if you have high levels of calcium or vitamin D in your body. Do not apply this medicine to your face.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

FOR TOPICAL DERMATOLOGIC USE ONLY.
Not for Ophthalmic, Oral or Intravaginal Use.

Rx Only

Calcitrene® (calcipotriene) ointment, 0.005% contains the compound calcipotriene, a synthetic vitamin D3 derivative for topical dermatological use.

Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol-, with the empirical formula C27H40O3, a molecular weight of 412.6, and the following structural formula:

Calcipotriene is a white or off-white crystalline substance. Calcitrene® (calcipotriene) ointment, 0.005% contains calcipotriene 50 µg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, petrolatum, propylene glycol, α-tocopherol, steareth-2 and purified water.

Calcitrene® (calcipotriene) ointment, 0.005% is available in:

60 gram aluminum tube NDC (51672-5278-3)
120 gram aluminum tube NDC (51672-5278-4)

STORAGE

Store at controlled room temperature 15°C-25°C (59°F-77°F). Do not freeze.

Manufactured by:
Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Distributed by:
TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

TaroPharma® and Calcitrene® are trademarks of Taro Pharmaceuticals U.S.A., Inc and/or its affiliates.

November 2011

PPE150010710-1

Applies to calcipotriene topical: topical cream, topical foam, topical ointment, topical solution

General

The most commonly reported side effects were burning, stinging, tingling, and skin irritation.[Ref]

Hypersensitivity

Very rare (less than 0.01%): Allergic reactions (including angioedema)[Ref]

Dermatologic

Very common (10% or more): Transient burning (about 23%), stinging (about 23%), tingling (about 23%), skin irritation (up to 15%), rash (11%)
Common (1% to 10%): Pruritus, dermatitis, contact dermatitis (including facial and perioral), dry skin, irritation, worsening of psoriasis, erythema, peeling
Uncommon (0.1% to 1%): Skin atrophy, hyperpigmentation, folliculitis, eczema
Frequency not reported: Transient changes in skin pigmentation, transient photosensitivity, urticaria, angioedema, skin exfoliation[Ref]

Metabolic

Uncommon (0.1% to 1%): Hypercalcemia
Rare (less than 0.1%): Transient increases in serum calcium
Very rare (less than 0.01%): Hypercalcemia, hypercalciuria (especially if the total recommended dose is exceeded)[Ref]

Local

Very common (10% or more): Lesional/perilesional irritation (up to 39%), face and/or scalp irritation (up to 25%)[Ref]

Other

Frequency not reported: Periorbital or face edema[Ref]

Some side effects of Calcitrene may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.