Taclonex

TACLONEX — calcipotriene hydrate and betamethasone dipropionate ointment
Physicians Total Care, Inc.

1 INDICATIONS AND USAGE

1.1 Indication

Taclonex® (calcipotriene and betamethasone dipropionate) Ointment is indicated for the topical treatment of psoriasis vulgaris in adults 18 years of age and older for up to 4 weeks.

1.2 Limitations of Use

  • Taclonex® Ointment should not be applied to the face, axillae or groin.
  • Taclonex® Ointment should not be used if there is skin atrophy at the treatment site.

2 DOSAGE AND ADMINISTRATION

2.1 Usual Dosage and Administration

Apply an adequate layer of Taclonex® Ointment to the affected area(s) once daily for up to 4 weeks. The maximum weekly dose should not exceed 100 g. Treatment of more than 30% body surface area is not recommended. Taclonex® Ointment should be rubbed in gently and completely. Patients should wash their hands after applying Taclonex® Ointment.

Taclonex® Ointment is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Ointment. Soft white (off white to yellow) paraffin based ointment with calcipotriene 0.005% and betamethasone dipropionate 0.064%.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Effects on Calcium Metabolism

Hypercalcemia and hypercalciuria have been reported with use of Taclonex®. If hypercalcemia or hypercalciuria develop, 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.

5.2 Effects on Endocrine System

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

HPA axis suppression has been observed with Taclonex® Ointment [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.

In a study of 32 subjects concomitantly treated with Taclonex® Scalp 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 Pharmacodynamics (12.2) ].

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids [see Use in Specific Populations (8.4) ].

5.3 Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

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 Concomitant Skin Infections

Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Taclonex® Ointment should be discontinued until the infection has been adequately treated.

5.7 Skin Irritation

If irritation develops, treatment with Taclonex® Ointment should be discontinued and appropriate therapy instituted.

5.8 Unevaluated Uses

The safety and efficacy of Taclonex® Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated.

The safety and efficacy of Taclonex® Ointment in patients with erythrodermic, exfoliative, or pustular psoriasis have not been evaluated.

The safety and efficacy of Taclonex® Ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.

5.9 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.

6.1 Clinical Study Experience

The data described below reflect exposure to Taclonex® Ointment in 2448 subjects, 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® OintmentN = 2448CalcipotrieneN = 3197Betamethasone dipropionateN = 1164VehicleN = 470
Any Adverse Event663 (27.1)1055 (33.0)329 (28.3)157 (33.4)
Preferred Term# of subjects (%)
Pruritis75 (3.1)183 (5.7)38 (3.3)43 (9.1)
Headache69 (2.8)75 (2.3)44 (3.8)12 (2.6)
Nasopharyngitis56 (2.3)77 (2.4)34 (2.9)9 (1.9)
Psoriasis30 (1.2)47 (1.5)14 (1.2)5 (1.1)
Rash scaly30 (1.2)40 (1.3)0 (0.0)1 (0.2)
Influenza23 (0.9)34 (1.1)14 (1.2)6 (1.3)
Upper respiratory tract infection20 (0.8)19 (0.6)12 (1.0)3 (0.6)
Erythema15 (0.6)54 (1.7)3 (0.3)5 (1.1)
Application site pruritus13 (0.5)24 (0.8)10 (0.9)6 (1.3)
Skin irritation11 (0.4)60 (1.9)8 (0.7)5 (1.1)
Pain7 (0.3)12 (0.4)3 (0.3)5 (1.1)
Burning sensation6 (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® OintmentN = 2448CalcipotrieneN = 3197Betamethasone dipropionateN = 1164VehicleN = 470
Any Adverse Event213 (8.7)419 (13.1)85 (7.3)76 (16.2)
Preferred Term# of subjects (%)
Pruritis69 (2.8)170 (5.3)31 (2.7)41 (8.7)
Rash scaly29 (1.2)38 (1.2)0 (0.0)0 (0.0)
Application site pruritus12 (0.5)24 (0.8)10 (0.9)6 (1.3)
Erythema9 (0.4)36 (1.1)2 (0.2)4 (0.9)
Skin irritation9 (0.4)51 (1.6)8 (0.7)5 (1.1)
Burning sensation6 (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 study, 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.
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