TACLONEX SIDE EFFECTS
- Generic Name: calcipotriene and betamethasone dipropionate
- Brand Name: Taclonex
- Drug Class: Antipsoriatics, Topical
SIDE EFFECTS
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.
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 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
| Taclonex® 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 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.
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.
SRC: NLM .