Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 25 January 2017

Indication(s)

1 INDICATIONS AND USAGE Enter section text here Taclonex Scalp® Topical Suspension is a vitamin D analog and corticosteroid combination product indicated for the topical treatment of moderate to severe psoriasis vulgaris of the scalp in adults 18 years and older (1.1) Limitations of Use: Do not use on the face, axillae or groin (1.2) • Do no use if atrophy is present at the treatment site (1.2) 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

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Psoriasis

Psoriasis

See information on psoriasis pathophysiology, signs and symptoms, comorbidities, treatment options, and more.

+ 2 more

Psoriasis Academy

Psoriasis Academy

Learn about the burden of psoriasis, unmet needs, the tools used to assess severity and treatment response, what we know about the pathophysiology behind the condition and what the current guidelines say.

+ 1 more

EADV 2018 Highlights

EADV 2018 Highlights

EADV Congress 2018: Bringing you the latest news and insights from 27th EADV Congress, 12-16 September 2018 Paris, France.

Load more

Related Content

Advisory information

contraindications
4 CONTRAINDICATIONS None. None (4)
Adverse reactions

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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 Phone 1-8877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 by?

1 % 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.

Usage information

Dosing and administration

2 DOSAGE AND ADMINISTRATION Enter section text here 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 (2.1).

The maximum weekly dose should not exceed 100 g (1.2).

Shake before use (2).

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

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.

Use in special populations

8 USE IN SPECIFIC POPULATIONS Enter section text here 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C Animal reproduction studies have not been conducted with Taclonex Scalp® Topical Suspension.

Taclonex Scalp® 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 Scalp® 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 are generally 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 (468 mcg/ m2/day) and 2.5 mcg/ kg (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.

Pregnant women were excluded from the clinical studies conducted with Taclonex Scalp® Topical Suspension.

8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could 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 Scalp® Topical Suspension is administered to a nursing woman.

8.4 Pediatric Use Safety and effectiveness of the use of Taclonex Scalp® Topical Suspension in pediatric patients have not been studied.

Because of a higher ratio of skin surface area to body mass, children under the age of 12 years may be at particular risk of systemic adverse effects when they are treated with topical corticosteroids.

[See Warnings and Precautions (5.2)] HPA axis suppression, Cushing 's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.

Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

8.5 Geriatric Use Of the total number of patients in the controlled clinical studies of Taclonex Scalp® Topical Suspension, 334 were 65 years or older, while 84 were 75 years or older.

No overall differences in safety or effectiveness of Taclonex Scalp® Topical Suspension were observed between these patients and younger patients.

All other reported clinical experience has not identified any differences in response between elderly and younger patients.

Pregnancy and lactation

8.3 Nursing Mothers Systemically administered corticosteroids appear in human milk and could 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 Scalp® Topical Suspension is administered to a nursing woman.

More information

Category Value
Authorisation number NDA022185
Agency product number 9842X06Q6M
Orphan designation No
Product NDC 54868-6091
Date Last Revised 18-08-2010
Type HUMAN PRESCRIPTION DRUG
RXCUI 833463
Storage and handling 16.2 Storage Store between 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F). Do not refrigerate. Keep the bottle in the outer carton when not in use. The product should be used within three months after it has been opened.
Marketing authorisation holder Physicians Total Care, Inc.