Calcipotriene And Betamethasone Dipropionate Side Effects

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 Perrigo at 1-866-634-9120 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 calcipotriene and betamethasone dipropionate ointment in 2448 subjects with plaque psoriasis, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks.

Calcipotriene and betamethasone dipropionate 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 calcipotriene and betamethasone dipropionate 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 Calcipotriene and betamethasone dipropionate ointment N = 2448 Calcipotriene N = 3197 Betamethasone dipropionate N = 1164 Vehicle 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 Calcipotriene and betamethasone dipropionate ointment N = 2448 Calcipotriene N = 3197 Betamethasone dipropionate N = 1164 Vehicle 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 calcipotriene and betamethasone dipropionate ointment, 7 days for calcipotriene, 5 days for betamethasone dipropionate, and 3 days for vehicle.