Attero

Attero is an FDA-registered drug product whose active ingredient is CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE. It is labelled by Perfero Pharma, Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 87143-100, application ANDA210765, label effective 20260518. It is one of 5 FDA drug label records sharing the active ingredient CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE are most often described in connection with: plaque psoriasis, topical suspension, patients years, leo pharma, betamethasone dipropionate, usage attero, older additional, information approved. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

2 DOSAGE AND ADMINISTRATION Instruct patients to shake bottle prior to using ATTERO™ Topical Suspension. Apply ATTERO™ Topical Suspension to affected areas on the scalp and body once daily for up to 8 weeks. ATTERO™ 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 ATTERO™ 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. ATTERO™ 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. ATTERO™ Topical Suspension is not for oral, ophthalmic, or intravaginal use. Shake bottle before use. ( 2 ) Apply ATTERO™ Topical Suspension to affected areas on the scalp and body once daily for up to 8 weeks. Discontinue therapy when control is achieved. ( 2 ) Patients age 12 to 17 years should not use more than 60 grams per week. ( 2 ) Adult patients should not use more than 100 grams per week. ( 2 ) Do not use with occlusive dressings unless directed by a healthcare provider. ( 2 ) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )

4 CONTRAINDICATIONS None. None. ( 4 )

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.

FDA lists 5 drug label records with CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Attero used for?
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 …

Who makes Attero?
Perfero Pharma, Inc. is the labeler of record for Attero. 5 FDA label records share the active ingredient CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Attero come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Attero prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE?
Yes. 5 FDA drug label records list CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Attero been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.