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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypercalcemia and hypercalciuria have been observed. If either occurs, discontinue treatment until parameters of calcium metabolism normalize. ( 5.1 ) Taclonex ® Ointment can produce 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 occlusion, prolonged use, concomitant use of more than one corticosteroid-containing product, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. ( 5.2 , 8.4 ) Taclonex ® Ointment may increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.3 ) 5.1 Hypercalcemia and Hypercalciuria Hypercalcemia and hypercalciuria have been observed with use of Taclonex ® Ointment. If hypercalcemia or hypercalciuria develops, treatment should be discontinued until parameters of calcium metabolism have normalized. In the trials that included assessment of the effects of Taclonex ® Ointment on calcium metabolism, such testing was done after 4 weeks of treatment. The effects of Taclonex ® Ointment on calcium metabolism following treatment durations of longer than 4 weeks have not been evaluated [see Clinical Pharmacology ( 12.2 )]. 5.2 Effects on Endocrine System Taclonex ® Ointment can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, concomitant use of more than one corticosteroid-containing product, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the cosyntropin stimulation test [see Clinical Pharmacology ( 12.2 )]. In a trial evaluating the effects of Taclonex ® Topical Suspension and Taclonex ® Ointment on the HPA axis, 32 adult subjects were treated with Taclonex ® Topical Suspension on the scalp and Taclonex ® Ointment on the body. Adrenal suppression was identified in 5 of 32 subjects (15.6%) after 4 weeks of treatment [see Clinical Pharmacology ( 12.2 )] . The effects of Taclonex ® Ointment on the HPA axis following treatment durations of longer than 4 weeks have not been adequately studied. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Cushing's syndrome and hyperglycemia may also occur due to the systemic effects of topical corticosteroids. These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids. Pediatric patients may be more susceptible to systemic toxicity due to their higher skin surface to body mass ratios [see Use in Specific Populations ( 8.4 ), Clinical Pharmacology ( 12.2 )] . Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. 5.3 Ophthalmic Adverse Reactions Use of topical corticosteroids, including Taclonex ® Ointment, may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products, including topical clobetasol products. Avoid contact of Taclonex ® Ointment with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.4 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.5 Allergic Contact Dermatitis with Topical Calcipotriene Allergic contact dermatitis has been observed with use of topical calcipotriene. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.6 Skin Irritation If irritation develops, treatment with Taclonex ® Ointment should be discontinued and appropriate therapy instituted. 5.7 Risk of Ultraviolet Light Exposure Patients who apply Taclonex ® Ointment to exposed skin 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 who use Taclonex ® Ointment.
6 ADVERSE REACTIONS 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 observed in practice. The most common adverse reactions (≥1%) are pruritus and scaly rash. (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 Clinical Trials Conducted in Subjects 18 years and older with Plaque Psoriasis The data described below reflect exposure to Taclonex ® Ointment in 2448 subjects with plaque psoriasis, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. Taclonex ® Ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe. Most subjects received once daily application, and the median weekly dose was 24.5 g. The percentage of subjects reporting at least one adverse event was 27.1% in the Taclonex ® Ointment group, 33.0% in the calcipotriene group, 28.3% in the betamethasone group, and 33.4% in the vehicle group. Table 1 Adverse Events Reported by ≥1% of Subjects by Preferred Term Taclonex ® Ointment Calcipotriene Betamethasone dipropionate Vehicle N = 2448 N = 3197 N = 1164 N = 470 Any Adverse Event 663 (27.1) 1055 (33.0) 329 (28.3) 157 (33.4) Preferred Term # of subjects (%) Pruritus 75 (3.1) 183 (5.7) 38 (3.3) 43 (9.1) Headache 69 (2.8) 75 (2.3) 44 (3.8) 12 (2.6) Nasopharyngitis 56 (2.3) 77 (2.4) 34 (2.9) 9 (1.9) Psoriasis 30 (1.2) 47 (1.5) 14 (1.2) 5 (1.1) Rash scaly 30 (1.2) 40 (1.3) 0 (0.0) 1 (0.2) Influenza 23 (0.9) 34 (1.1) 14 (1.2) 6 (1.3) Upper respiratory tract infection 20 (0.8) 19 (0.6) 12 (1.0) 3 (0.6) Erythema 15 (0.6) 54 (1.7) 3 (0.3) 5 (1.1) Application site pruritus 13 (0.5) 24 (0.8) 10 (0.9) 6 (1.3) Skin irritation 11 (0.4) 60 (1.9) 8 (0.7) 5 (1.1) Pain 7 (0.3) 12 (0.4) 3 (0.3) 5 (1.1) Burning sensation 6 (0.2) 30 (0.9) 3 (0.3) 6 (1.3) A lesional/perilesional adverse event was generally defined as an adverse event located ≤ 2 cm from the lesional border. Table 2 Lesional/Perilesional Adverse Events Reported by ≥1% of Subjects Taclonex ® Ointment Calcipotriene Betamethasone dipropionate Vehicle N = 2448 N = 3197 N = 1164 N = 470 Any Adverse Event 213 (8.7) 419 (13.1) 85 (7.3) 76 (16.2) Preferred Term # of subjects (%) Pruritus 69 (2.8) 170 (5.3) 31 (2.7) 41 (8.7) Rash scaly 29 (1.2) 38 (1.2) 0 (0.0) 0 (0.0) Application site pruritus 12 (0.5) 24 (0.8) 10 (0.9) 6 (1.3) Erythema 9 (0.4) 36 (1.1) 2 (0.2) 4 (0.9) Skin irritation 9 (0.4) 51 (1.6) 8 (0.7) 5 (1.1) Burning sensation 6 (0.2) 25 (0.8) 3 (0.3) 5 (1.1) For subjects who reported lesional/perilesional adverse events, the median time to onset was 7 days for Taclonex ® Ointment, 7 days for calcipotriene, 5 days for betamethasone dipropionate, and 3 days for vehicle. Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence, folliculitis, rash papular, rash pustular, and skin hypopigmentation. Skin atrophy, telangiectasia and skin hyperpigmentation were reported infrequently (0.1%). In a separate trial, subjects (N = 207) with at least moderate disease severity were given Taclonex® Ointment intermittently on an "as needed" basis for up to 52 weeks. The median use was 15.4 g per week. The effects of Taclonex ® Ointment on calcium metabolism were not studied and the effects on the HPA axis were not adequately studied. The following adverse reactions were reported by 1% or more of the subjects: pruritus (7.2%), psoriasis (3.4%), skin atrophy (1.9%), folliculitis (1.4%), burning sensation (1.4%), skin depigmentation (1.4%), ecchymosis (1.0%), erythema (1.0%) and hand dermatitis (1.0%). One case of serious flare-up of psoriasis was reported. 6.2 Postmarketing Experience The following adverse reactions associated with the use of Taclonex ® Ointment have been identified post-approval: pustular psoriasis and rebound effect. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids may also include: striae, dryness, acneiform eruptions, perioral dermatitis, secondary infection and miliaria.