Data from FDA - Curated by EPG Health - Last updated 28 September 2017

Indication(s)

1 INDICATIONS AND USAGE Taclonex® Topical Suspension is indicated for the topical treatment of: Plaque psoriasis of the scalp and body in patients 18 years and older Plaque psoriasis of the scalp in patients 12 to 17 years Taclonex® Topical Suspension is a vitamin D analog and a corticosteroid combination product indicated for the topical treatment of: Plaque psoriasis of the scalp and body in patients 18 years and older (1) Plaque psoriasis of the scalp in patients age 12 to 17 years (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS None. None (4)
Adverse reactions
6 ADVERSE REACTIONS The most common adverse reactions (≥ 1%) are folliculitis and burning sensation of skin (6.1) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 Scalp Psoriasis The rates of adverse reactions given below were derived from randomized, multicenter, prospective vehicle- and/or active controlled clinical trials in adult 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® Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1: Table 1 Number and Percentage with Adverse Reactions in Scalp Psoriasis Trials (Events Reported by 1% of Subjects and for Which a Relationship is Possible) Taclonex® 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%) 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 on the Body In randomized, multicenter, prospective vehicle- and/or active controlled clinical trials in adult subjects with plaque psoriasis on non-scalp areas, subjects applied study product once daily for 8 weeks. A total of 824 subjects were treated with Taclonex® Topical Suspension and the median weekly dose was 22.6 g. 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 Scalp Psoriasis In two uncontrolled prospective clinical trials, a total of 109 subjects aged 12-17 years with plaque psoriasis of the scalp were treated with Taclonex® Topical Suspension once daily for up to 8 weeks. The median weekly dose was 40 g. Adverse reactions included acne, acneiform dermatitis and application site pruritus (0.9% each). 6.2 Postmarketing Experience Because adverse 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: atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Instruct patients to shake bottle prior to using Taclonex® Topical Suspension and to wash their hands after applying the product. Apply Taclonex® Topical Suspension to affected areas once daily for up to 8 weeks. Therapy should be discontinued when control is achieved. Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week. Taclonex® Topical Suspension should not be used with occlusive dressings unless directed by a physician. Taclonex® Topical Suspension is not for oral, ophthalmic, or intravaginal use. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Shake bottle before use. (2) Apply Taclonex® Topical Suspension to affected areas once daily for up to 8 weeks. Discontinue therapy when control is achieved. (2) Adult patients should not use more than 100 g per week. (2) Patients age 12 to 17 years should not use more than 60 g per week. (2) Do not use with occlusive dressings unless directed by a physician. (2) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. (2)
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C Animal reproduction studies have not been conducted with Taclonex® Topical Suspension. Taclonex® Topical Suspension contains calcipotriene that has been shown to be fetotoxic and betamethasone dipropionate that has been shown to be teratogenic in animals when given systemically. There are no adequate and well-controlled studies in pregnant women. Taclonex® Topical Suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Teratogenicity studies with calcipotriene were performed by the oral route in rats and rabbits. In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 mcg/kg/day (144 mcg/m2/day); a dosage of 36 mcg/kg/day (432 mcg/m2/day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 mcg/kg/day (324 mcg/m2/day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles were most likely due to the effect of calcipotriene upon calcium metabolism. The estimated maternal and fetal no-adverse effect levels (NOAEL) in the rat (108 mcg/m2/day) and rabbit (48 mcg/m2/day) derived from oral studies are lower than the maximum topical dose of calcipotriene in man (460 mcg/m2/day). Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in mice and rabbits when given by the subcutaneous route at doses of 156 mcg/kg/day (468 mcg/m2/day) and 2.5 mcg/kg/day (30 mcg/m2/day), respectively. Those dose levels are lower than the maximum topical dose in man (about 5,950 mcg/m2/day). The abnormalities observed included umbilical hernia, exencephaly and cleft palate. 8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Topical Suspension is administered to a nursing woman. The patient should be instructed not to use Taclonex® Topical Suspension on the breast when nursing. 8.4 Pediatric Use Safety and effectiveness of the use of Taclonex® Topical Suspension in pediatric patients under the age of 12 years have not been established. The safety and effectiveness of Taclonex® Topical Suspension for the treatment of plaque psoriasis of the scalp have been established in the age group 12 to 17 years. Two prospective, uncontrolled trials (N=109) were conducted in pediatric subjects age 12 to 17 years with scalp psoriasis, including assessment of HPA axis suppression in 30 subjects. [See Warnings and Precautions (5.2), Adverse Reactions (6.1) and Clinical Pharmacology (12.2)] Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids. [ See Warnings and Precautions (5.2) ] Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients. 8.5 Geriatric Use Clinical studies of Taclonex® Topical Suspension in plaque psoriasis on non-scalp areas included 124 subjects who were 65 years of age or over, and 36 were 75 years of age or over. Clinical studies of Taclonex® Topical Suspension in scalp psoriasis included 334 subjects who were 65 years or over and 84 subjects who were 75 years or over. No overall differences in safety or effectiveness of Taclonex®Topical Suspension were observed between these subjects and younger subjects, and other reported clinical experience has not identified any differences in response between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.
Pregnancy and lactation
8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Topical Suspension is administered to a nursing woman. The patient should be instructed not to use Taclonex® Topical Suspension on the breast when nursing.

More information

Category Value
Authorisation number NDA022185
Agency product number 826Y60901U
Orphan designation No
Product NDC 50222-501
Date Last Revised 21-09-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder LEO Pharma Inc.