Every
Day,
Their
Way

See for yourself with once‑daily
ACZONE® (dapsone) Gel, 7.5%

  • Proven efficacy and tolerability1
  • Topical dapsone, only available by prescription1,2
  • Once-daily dosing1
ACZONE® Gel, 7.5%
Studied in 4,340 patients1,3
Largest pivotal trial program used for FDA approval
of a topical acne drug (N = 4,340)1,5
4,340
patients
studied1,3
99.9%
of patients studied
had moderate acne†,3

vs 58.4% of patients
studied in ACZONE®
(dapsone) Gel, 5%
pivotal trials6
(4338/4340)3
Proven efficacy across all
three co-primary endpoints3,4
Reductions in inflammatory lesions at week 12‡,4
Significant improvement in inflammatory lesions
Reductions in noninflammatory (comedonal) lesions at week 12‡,4
Reductions in noninflammatory (comedonal) lesions at week 12
Percentage of patients reaching GAAS success (0 or 1) at week 12‡§1,3-4
Percentage of patients reaching Gaas success (0 or 1) at week 12
Patient Experience
  • Female patients have rated visible red
    bumps as a top concern7,*
  • By the time they see a dermatologist,
    female patients have tried 12+ products
    on average7*
  • Discussing treatment options with their dermatologist is a top priority for teen males7,‡
  • Half of teen male patients surveyed said they want a prescription product with an ingredient they haven't tried before8,§
*A total of 310 acne patients, 190 of whom were females aged 16 to 45 years, completed an Internet survey between December 11, 2013 and January 3, 2014.
A total of 310 acne patients, 120 of whom were males aged 16 to 45 years, completed an Internet survey between December 11, 2013 and January 3, 2014.
§Seventy-five male acne patients aged 14 to 18 years under a dermatologist's care completed online interviews in October 2015.
Proven tolerability3
Application-site reactions occurring in at least
0.9% of ACZONE® Gel, 7.5% patients vs vehicle were
pruritus (0.9% vs 0.5%), and dryness (1.1% vs 1.0%)
(n=2,161 and n=2,175, respectively).1
INDICATIONS AND USAGE

ACZONE® (dapsone) Gel 7.5% is indicated for the topical treatment of acne vulgaris in patients aged 12 years and older.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Hematological Effects
Methemoglobinemia: Cases of methemoglobinemia with resultant hospitalization have been reported post marketing in association with twice-daily dapsone gel 5% treatment. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia. Avoid use of ACZONE® Gel 7.5% in patients with congenital or idiopathic methemoglobinemia.

Signs and symptoms of methemoglobinemia may be delayed some hours after exposure. Initial signs and symptoms of methemoglobinemia are characterized by a slate-gray cyanosis seen in, eg, buccal mucous membranes, lips, and nail beds. Advise patients to discontinue ACZONE® Gel 7.5% and seek immediate medical attention in the event of cyanosis.

Dapsone can cause elevated methemoglobin levels, particularly in conjunction with methemoglobin-inducing agents.

Hemolysis: Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.

In clinical trials, there was no evidence of clinically relevant hemolysis or hemolytic anemia in subjects treated with topical dapsone. Some subjects with G6PD deficiency using dapsone gel 5% twice daily developed laboratory changes suggestive of hemolysis.

Discontinue ACZONE® Gel 7.5% if signs and symptoms suggestive of hemolytic anemia occur. Avoid use of ACZONE® Gel 7.5% in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of ACZONE® Gel 7.5% with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency.

Peripheral Neuropathy
Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical dapsone treatment.

Skin Reactions
Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical dapsone treatment.

ADVERSE REACTIONS

The most common adverse reactions of ACZONE® Gel 7.5% are dryness and pruritus at the application site.

Methemoglobinemia has been identified during postmarketing use of topical dapsone.

DRUG INTERACTIONS

Topical application of dapsone gel followed by benzoyl peroxide in patients with acne vulgaris may result in a temporary local yellow or orange discoloration of the skin and facial hair.

Please see ACZONE® Gel full Prescribing Information.

References:

1. ACZONE® Gel 7.5% Prescribing Information 2016. 2. US Food and Drug Administration. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. US Food and Drug Administration website. http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Updated October 2016. Accessed December 2016. 3. Data on file, Allergan, 2016; NDA. Summary of Clinical Efficacy and Safety. 4. Data on file, Allergan, 2016; Integrated Summary of Effectiveness. 5. Acne vulgaris pivotal trials. ClinicalTrials.gov website: http://www.clinicaltrials.gov. Accessed April 11, 2016. 6. Draelos ZD. Carter E, Maloney JM, et al; for United States/Canada Dapsone Gel Study Group. Two randomized studies demonstrated the efficacy and safely of dapsone gel, 5% for the treatment of acne vulgaris. J Am Acad Dermatol. 2007;56(3):439.e1-439.e10. 7. Data on file, Allergan, January 10, 2014. Defining Acne Treatment: Final Report. 8. Data on file, Allergan, October 2015; Teen Boy Acne Conversation Tool Report.

ACZONE® (dapsone) Gel, 7.5% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
INDICATIONS AND USAGE

ACZONE® (dapsone) Gel 7.5% is indicated for the topical treatment of acne vulgaris in patients aged 12 years and older.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Hematological Effects
Methemoglobinemia: Cases of methemoglobinemia with resultant hospitalization have been reported post marketing in association with twice-daily dapsone gel 5% treatment. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia. Avoid use of ACZONE® Gel 7.5% in patients with congenital or idiopathic methemoglobinemia.

Signs and symptoms of methemoglobinemia may be delayed some hours after exposure. Initial signs and symptoms of methemoglobinemia are characterized by a slate-gray cyanosis seen in, eg, buccal mucous membranes, lips, and nail beds. Advise patients to discontinue ACZONE® Gel 7.5% and seek immediate medical attention in the event of cyanosis.

Dapsone can cause elevated methemoglobin levels, particularly in conjunction with methemoglobin-inducing agents.

Hemolysis: Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.

In clinical trials, there was no evidence of clinically relevant hemolysis or hemolytic anemia in subjects treated with topical dapsone. Some subjects with G6PD deficiency using dapsone gel 5% twice daily developed laboratory changes suggestive of hemolysis.

Discontinue ACZONE® Gel 7.5% if signs and symptoms suggestive of hemolytic anemia occur. Avoid use of ACZONE® Gel 7.5% in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of ACZONE® Gel 7.5% with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency.

Peripheral Neuropathy
Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical dapsone treatment.

Skin Reactions
Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical dapsone treatment.

ADVERSE REACTIONS

The most common adverse reactions of ACZONE® Gel 7.5% are dryness and pruritus at the application site.

Methemoglobinemia has been identified during postmarketing use of topical dapsone.

DRUG INTERACTIONS

Topical application of dapsone gel followed by benzoyl peroxide in patients with acne vulgaris may result in a temporary local yellow or orange discoloration of the skin and facial hair.

Please see ACZONE® Gel full Prescribing Information.