TACLONEX

AbsorptionThe systemic effect of Taclonex Topical Suspension in psoriasis was investigated in Trials A, B, and D [see Clinical Pharmacology (12.2) ]. In Trial A, the serum levels of calcipotriene and betamethasone dipropionate and their major metabolites were measured after 4 and 8 weeks of once daily application of Taclonex ® Topical Suspension on the scalp in combination with Taclonex Ointment on the body. Calcipotriene and betamethasone dipropionate were below the lower limit of quantificati...

Clinical Trials Conducted in Subjects 18 Years and Older with Psoriasis of the Scalp Two multicenter, randomized, double-blind trials were conducted in adult subjects with moderate to very severe psoriasis of the scalp. In Trial One, 1,407 subjects were randomized to 1 of 4 treatment groups: Taclonex ® Topical Suspension, betamethasone dipropionate in the same vehicle, calcipotriene in the same vehicle, or the vehicle alone. In Trial Two, 1,280 subjects were randomized to 1 of 3 treatment groups: Taclonex Topical Suspension, betamethasone dipropionate in the same vehicle, or calcipotriene in t...

The most common adverse reactions (≥ 1%) are folliculitis and burning sensation of skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates...

None. None. ( 4 )

Hypercalcemia and Hypercalciuria: Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize. ( 5.1 ) Effects on Endocrine System: Can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over a large surface area or to areas under occlu...