TACLONEX

TACLONEX- calcipotriene hydrate and betamethasone dipropionate suspension
LEO Pharma Inc.

1 INDICATIONS AND USAGE

Taclonex® Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older.

2 DOSAGE AND ADMINISTRATION

Instruct patients to shake bottle prior to using Taclonex Topical Suspension. Apply Taclonex Topical Suspension to affected areas on the scalp and body once daily for up to 8 weeks. Taclonex Topical Suspension should be discontinued when control is achieved. Instruct patients to wash their hands after applying the product. Inform patients that they should not take a bath or shower or wash their hair right after application of Taclonex Topical Suspension.

Patients 12 to 17 years should not use more than 60 grams per week and patients 18 years and older should not use more than 100 grams per week.

Taclonex Topical Suspension should not be:

  • Used with occlusive dressings unless directed by a healthcare provider.
  • Used on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
  • Applied to the scalp in the 12 hours before or after any chemical treatments to the hair.

Taclonex Topical Suspension is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Topical Suspension: 0.005%/0.064% — each gram contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate in a viscous, nearly odorless, almost clear, colorless to slightly off-white suspension.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Hypercalcemia and Hypercalciuria

Hypercalcemia and hypercalciuria have been observed with use of Taclonex Topical Suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. The incidence of hypercalcemia and hypercalciuria following Taclonex Topical Suspension treatment of more than 8 weeks has not been evaluated [see Clinical Pharmacology (12.2)].

5.2 Effects on Endocrine System

Hypothalamic-Pituitary-Adrenal Axis Suppression

Taclonex Topical Suspension 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 steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. If HPA axis suppression is documented, gradually withdraw Taclonex Topical Suspension, reduce the frequency of application, or substitute with a less potent corticosteroid.

The following trials evaluated the effects of Taclonex Topical Suspension on HPA axis suppression:

  • In a trial evaluating the effects of Taclonex Topical Suspension and Taclonex Ointment on the HPA axis, 32 adult subjects applied both Taclonex Topical Suspension on the scalp and Taclonex Ointment on the body. Adrenal suppression was identified in 5 of 32 subjects (16%) after 4 weeks of treatment and in 2 of 11 subjects (18%) who continued treatment for 8 weeks. In another trial, 36 adult subjects applied Taclonex Topical Suspension on the body and scalp and 7 subjects applied Taclonex Topical Suspension on the body. Adrenal suppression occurred in 3 out of 43 subjects (7%) after 4 weeks of treatment and in none of the 36 subjects who continued treatment for 8 weeks [see Clinical Pharmacology (12.2) ].
  • In two trials, the effects of Taclonex Topical Suspension on the HPA axis were evaluated in 31 and 30 pediatric subjects aged 12 to 17 years old who applied Taclonex Topical suspension on the scalp and the scalp/body, respectively. Adrenal suppression occurred in 1 of 30 evaluable subjects (3%) after 4 weeks of treatment (scalp) and 5 of 31 evaluable subjects (16%) after up to 8 weeks of treatment (scalp and body) [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)].

Cushing’s Syndrome and Hyperglycemia

Cushing’s syndrome and hyperglycemia may occur due to the systemic effects of the topical corticosteroid. These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

Additional Considerations for Endocrine Adverse Reactions

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) and 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 Allergic Contact Dermatitis with Topical Corticosteroids

Allergic contact dermatitis to a topical corticosteroid is usually diagnosed by observing a failure to heal rather than a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.

5.4 Allergic Contact Dermatitis with Topical Calcipotriene

Allergic contact dermatitis has been observed with use of topical calcipotriene. Such an observation should be corroborated with appropriate diagnostic patch testing.

5.5 Ophthalmic Adverse Reactions

Use of topical corticosteroids, including Taclonex® Topical Suspension, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported with the postmarketing use of topical corticosteroid products [see Adverse Reactions (6.2)]. Avoid contact of Taclonex Topical Suspension with eyes. Taclonex Topical Suspension may cause eye irritation. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

6 ADVERSE REACTIONS

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 observed in practice.

Clinical Trials Conducted in Subjects 18 years and older with Psoriasis of the Scalp

The rates of adverse reactions described below were from randomized, multicenter, vehicle- and/or active controlled clinical trials in adult subjects with psoriasis of the scalp [see Clinical Studies (14)]. Subjects applied study product once daily for 8 weeks, and the median weekly dose was 12.6 grams.

Adverse reactions that occurred in 1% of subjects treated with Taclonex Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1.

Table 1. Number and Percentage of Subjects with Adverse Reactions in Scalp Psoriasis Trials (Events Reported by ≥1% of Subjects and for Which a Relationship is Possible)
Taclonex Topical Suspension Betamethasone Dipropionate in vehicle Calcipotriene in vehicle Vehicle
N=1,953 N=1,214 N=979 N=173
Event # of subjects (%)
Folliculitis 16 (1%) 12 (1%) 5 (1%) 0 (0%)
Burning sensation of skin 13 (1%) 10 (1%) 29 (3%) 0 (0%)

Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash.

In a 52-week trial, adverse reactions that were reported by >1% of subjects treated with Taclonex Topical Suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%).

Clinical Trials Conducted in Subjects 18 years and older with Psoriasis of the Body

In randomized, multicenter, vehicle- and/or active controlled clinical trials in adult subjects with plaque psoriasis on non-scalp areas, 824 subjects applied Taclonex Topical Suspension once daily for 8 weeks [see Clinical Studies (14)]. The median weekly dose was 22.6 grams.

There were no adverse reactions that occurred in ≥1% of subjects treated with Taclonex Topical Suspension and at a rate higher than in subjects treated with vehicle. Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: rash and folliculitis.

Clinical Trials Conducted in Subjects 12 to 17 years with Psoriasis of the Scalp

In two uncontrolled clinical trials, 109 subjects aged 12 to 17 years with plaque psoriasis of the scalp applied Taclonex® Topical Suspension once daily for up to 8 weeks. The median weekly dose was 40 grams. Adverse reactions included acne, acneiform dermatitis and application site pruritus (0.9% each) [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)].

Clinical Trial Conducted in Subjects 12 to 17 years with Psoriasis of the Scalp and Body

In an uncontrolled clinical trial, 107 subjects aged 12 to 17 years with plaque psoriasis of the scalp and body applied Taclonex Topical Suspension once daily for up to 8 weeks. The median weekly dose was 26.6 grams. Adverse reactions were folliculitis, acne, and erythema (0.9% each) [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)].

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