Eucrisa

IMPORTANT SAFETY INFORMATION

Contraindications
EUCRISA is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation.

Warnings and Precautions
Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with EUCRISA and should be suspected in the event of severe pruritus, swelling and erythema at the application site or at a distant site. Discontinue EUCRISA immediately and initiate appropriate therapy if signs and symptoms of hypersensitivity occur.

Adverse Reactions
The most common adverse reaction occurring in ≥1% of subjects in clinical trials was application site pain, such as burning or stinging.

INDICATION
EUCRISA is indicated for topical treatment of mild-to-moderate atopic dermatitis in patients 2 years of age and older.

Please see Full Prescribing Information and Patient Information.


References
  1. EUCRISA® (crisaborole) Full Prescribing Information. October 2017.
  2. Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.e4.
References
  1. EUCRISA® (crisaborole) Full Prescribing Information. October 2017.
  2. Jarnagin K, Chanda S, Coronado D, et al. Crisaborole topical ointment, 2%: a nonsteroidal, topical, anti-inflammatory phosphodiesterase 4 inhibitor in clinical development for the treatment of atopic dermatitis. J Drugs Dermatol. 2016;15(4):390-396.
  3. Chan SC, Reifsnyder D, Beavo JA, Hanifin JM. lmmunochemical characterization of the distinct monocyte cyclic AMP-phosphodiesterase from patients with atopic dermatitis. J Allergy Clin Immunol. 1993;91(6):1179-1188.
  4. Hanifin JM, Chan SC, Cheng JB, et al. Type 4 phosphodiesterase inhibitors have clinical and in vitro anti-inflammatory effects in atopic dermatitis. J Invest Dermatol. 1996;107(1):51-56.
  5. Sawai T, Ikai K, Uehara M. Cyclic adenosine monophosphate phosphodiesterase activity in peripheral blood mononuclear leucocytes from patients with atopic dermatitis: correlation with respiratory atopy. Br J Dermatol. 1998;138(5):846-848.
  6. Freund YR, Akama T, Alley MRK, et al. Boron-based phosphodiesterase inhibitors show novel binding of boron to PDE4 bimetal center. FEBS Lett. 2012;586(19):3410-3414.
  7. Dong C, Virtucio C, Zemska O, et al. Treatment of skin inflammation with benzoxaborole phosphodiesterase inhibitors: selectivity, cellular activity, and effect on cytokines associated with skin inflammation and skin architecture changes. J Pharmacol Exp Ther. 2016;358(3):413-422.
  8. Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.e4.
  9. Data on file. Pfizer Inc, New York, NY.
  10. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1):116-132.
References
  1. EUCRISA® (crisaborole) Full Prescribing Information. October 2017.
  2. Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.e4.
  3. Data on file. Pfizer Inc, New York, NY.
  4. Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351.
  5. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71 (1):116-132.
References
  1. EUCRISA® (crisaborole) Full Prescribing Information. October 2017.
  2. Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.e4.
  3. Data on File. Pfizer Inc, New York, NY.
  4. Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AV. Translating the science of quality of life into practice: what do Dermatology Life Quality Index scores mean? J Invest Dermatol. 2005;125(4):659-664.
  5. Waters A, Sandhu D, Beattie P, Ezughah F, Lewis-Jones S. Severity stratification of Children's Dermatology Life Quality Index (CDLQI) scores. Br J Dermatol. 2010;163(suppl 1):121.
  6. Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984-992.
  7. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQl)-a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216.
  8. Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AV. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33.
  9. Schünemann HJ, Guyatt GH. Commentary goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res. 2005;40(2):593-597.
  10. Langley RG, Paller AS, Hebert AA, et al. Patient-reported outcomes in pediatric patients with psoriasis undergoing etanercept treatment: 12-week results from a phase III randomized controlled trial. J Am Acad Dermatol. 2011;64(1):64-70.
  11. Lewis-Jones MS, Finlay AV. The children's dermatology life quality index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;19(3):210-216.
References
  1. EUCRISA® (crisaborole) Full Prescribing Information. October 2017.
  2. Data on File. Pfizer Inc, New York, NY.
  3. Eichenfield LF, Call RS, Forsha DW, et al. Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis. J Am Acad Dermatol. 2017;77(4):641-649.e5.
  4. Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.e4.
References
  1. EUCRISA® (crisaborole) Full Prescribing Information. October 2017.
  2. Data on File. Pfizer Inc, New York, NY.
  3. Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.e4.
References
  1. EUCRISA® (crisaborole) Full Prescribing Information. October 2017.
  2. Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.e4.
  3. Data on file. Pfizer Inc, New York, NY.