Attero
Generic: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
Basic Information
Manufacturer
Perfero Pharma, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
328148a1-f32e-47a8-99ec-1614c291a450
Indications & Usage
1 INDICATIONS AND USAGE ATTERO™ Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older.
Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension.
However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information.
ATTERO™ Topical Suspension is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients age 18 years and older.
( 1 )
Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension.
However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information.
ATTERO™ Topical Suspension is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients age 18 years and older.
( 1 )
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 Perfero Pharma, Inc.
at 1-973-629-0109 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension.
However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information.
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 Calcipotriene and Betamethasone Dipropionate 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) Calcipotriene and Betamethasone Dipropionate Topical Suspension Betamethasone Dipropionate in vehicle Calcipotriene in vehicle Vehicle N=173 N=1,953 N=1,214 N=979 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 Calcipotriene and Betamethasone Dipropionate 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 Calcipotriene and Betamethasone Dipropionate 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 Calcipotriene and Betamethasone Dipropionate 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 Calcipotriene and Betamethasone Dipropionate 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) ].
Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension.
However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information.
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 included atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria.
Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported during use of topical corticosteroids, including topical betamethasone products.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Perfero Pharma, Inc.
at 1-973-629-0109 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension.
However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information.
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 Calcipotriene and Betamethasone Dipropionate 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) Calcipotriene and Betamethasone Dipropionate Topical Suspension Betamethasone Dipropionate in vehicle Calcipotriene in vehicle Vehicle N=173 N=1,953 N=1,214 N=979 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 Calcipotriene and Betamethasone Dipropionate 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 Calcipotriene and Betamethasone Dipropionate 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 Calcipotriene and Betamethasone Dipropionate 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 Calcipotriene and Betamethasone Dipropionate 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) ].
Additional pediatric use information is approved for LEO Pharma A/S's Taclonex ® (calcipotriene and betamethasone dipropionate) Topical Suspension.
However, due to LEO Pharma A/S's marketing exclusivity rights, this drug product is not labeled with that information.
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 included atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria.
Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported during use of topical corticosteroids, including topical betamethasone products.