Taclonex Scalp

TACLONEX SCALP — calcipotriene and betamethasone dipropionate suspension
Physicians Total Care, Inc.

1 INDICATIONS AND USAGE

1.1 Indication

Taclonex Scalp® Topical Suspension is indicated for the topical treatment of moderate to severe psoriasis vulgaris of the scalp in adults 18 years and older.

1.2 Limitations of Use

  • Taclonex Scalp® Topical Suspension should not be used on the face, axillae or groin
  • Taclonex Scalp® Topical Suspension should not be used if there is atrophy at the treatment site

2 DOSAGE AND ADMINISTRATION

2.1 Usual Dosage and Administration

Apply Taclonex Scalp® Topical Suspension to affected areas on the scalp once daily for 2 weeks or until cleared. Treatment may be continued for up to 8 weeks. The maximum weekly dose should not exceed 100 g. Patients should shake the bottle prior to using the product. Patients should wash their hands after applying Taclonex Scalp® Topical Suspension.

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

3 DOSAGE FORMS AND STRENGTHS

Suspension.

Each gram of Taclonex Scalp® Topical Suspension contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone).

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Effects on Calcium Metabolism

Hypercalcemia and hypercalciuria have been observed with use of Taclonex Scalp® Topical Suspension. If hypercalcemia or hypercalciuria develop, treatment should be discontinued until parameters of calcium metabolism have normalized. The effects of Taclonex Scalp® Topical Suspension on calcium metabolism following treatment durations of more than 8 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.

In a study of 32 subjects 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 and in 2 of 11 subjects (18.2%) who continued treatment for 8 weeks. [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 Scalp® Topical Suspension should be discontinued until the infection has been adequately treated.

5.7 Unevaluated Uses

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

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

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

5.8 Eye Exposures

Avoid eye exposures. Taclonex Scalp® Topical Suspension may cause eye irritation.

5.9 Ultraviolet Light Exposures

Patients who apply Taclonex Scalp® Topical Suspension to exposed skin (e.g. a bald scalp) 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 to the scalp in patients who use Taclonex Scalp® Topical Suspension.

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 Studies Experience

The rates of adverse reactions given below were derived from randomized, multicenter, prospective vehicle- and/or active-controlled clinical studies in subjects with scalp psoriasis. Subjects applied study product once daily for 8 weeks, and the median weekly

dose was 12.6 g.

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

Table 1

Number and Percentage of Patients with Adverse Reactions in Scalp

Psoriasis Studies

(Events Reported by1% of Subjects and for Which a Relationship is Possible)

Taclonex Scalp ® Topical Suspension N=1,953

Betamethasone dipropionate in vehicle

N=1,214
Calcipotriene in vehicle N=979

Vehicle

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 (0.0%)

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

In a 52-week study, adverse reactions that were reported by greater than 1% of subjects treated with Taclonex Scalp® Topical Suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%). The effects of Taclonex Scalp® Topical Suspension on calcium metabolism and the HPA axis were not investigated in the 52-week study.

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