Calcipotriene

What it is used for

Pellix™ (calcipotriene) Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

How to take it

Comb the hair to remove scaly debris and after suitably parting, apply Pellix™ Topical Solution, 0.005% (Scalp Solution), twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Pellix™ Topical Solution, 0.005% (Scalp Solution), have been demonstrated in patients treated for eight weeks. Keep Pellix™ Topical Solution, 0.005% (Scalp Solution), well away from the eyes. Avoid application of the solution to uninvolved scalp margins. Always wash hands thoroughly after use.

Side effects, and when to stop

In controlled clinical trials, the most frequent adverse reactions reported to be related to Pellix™ Topical Solution, 0.005% (Scalp Solution), use were transient burning, stinging and tingling, which occurred in approximately 23% of patients. Rash was reported in about 11% of patients. Dry skin, irritation and worsening of psoriasis were reported in 1-5% of patients, Skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis were not observed in these studies, but cannot be excluded.

To report SUSPECTED ADVERSE REACTIONS, contact Perfero Pharma, Inc. at 1-973-629-0109 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Who should not take it

Pellix™ Topical Solution, 0.005% (Scalp Solution), is contraindicated in those patients with acute psoriatic eruptions or 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.

Warnings

Avoid contact with the eyes or mucous membranes. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops on uninvolved skin areas.

Drug product is flammable. Keep away from open flame.

Storing it

Store at 20°-25°C (68°-77°F). Avoid sunlight. Do not freeze.

General

Use of Pellix™ Topical Solution, 0.005% (Scalp Solution), may cause transient irritation of both lesions and surrounding uninvolved skin. If irritation develops, Pellix™ Topical Solution, 0.005% (Scalp Solution), should be discontinued.

For external use only. Keep out of the reach of children. Always wash hands thoroughly after use.

Reversible elevation of serum calcium has occurred with use of topical calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.