Pellix
Generic: CALCIPOTRIENE
Basic Information
Manufacturer
Perfero Pharma, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
492ea9cf-0117-4d84-a964-9c0121706ed3
Indications & Usage
INDICATIONS AND USAGE 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.
The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
Warnings
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.
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.
Adverse Reactions
ADVERSE REACTIONS 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 .
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 .