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Crisaborole (Eucrisa)

Trade Name : Eucrisa

Pfizer Laboratories Div Pfizer Inc

OINTMENT

Strength 20 mg/g

CRISABOROLE Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Crisaborole (Eucrisa) which is also known as Eucrisa and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 20 mg/g per ml. Read more

Crisaborole (Eucrisa) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.
  • EUCRISA is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. ()
  • Apply a thin layer of EUCRISA twice daily to affected areas.
  • EUCRISA is for topical use only and not for ophthalmic, oral, or intravaginal use.
  • Apply a thin layer twice daily to affected areas. ()
  • For topical use only. ()
  • Not for ophthalmic, oral, or intravaginal use. ()
  • Ointment: 20 mg of crisaborole per gram (2%) of white to off-white ointment.
  • Ointment, 2%. ()
  • EUCRISA is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation. n
  • Known hypersensitivity to crisaborole or any component of the formulation. ()
  • Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with EUCRISA. Hypersensitivity should be suspected in the event of severe pruritus, swelling and erythema at the application site or at a distant site. If signs and symptoms of hypersensitivity occur, discontinue EUCRISA immediately and initiate appropriate therapy.
  • Hypersensitivity reactions
  • 5.1
  • The most common adverse reaction occurring in u22651% in subjects is application site pain. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or .
  • No data
  • EUCRISA contains 2% crisaborole (w/w) in a petrolatum-based, white to off-white ointment and is for topical use. The active ingredient, crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor.
  • Crisaborole is described chemically as 5-(4-cyanophenoxy)-1,3-dihydro-1-hydroxy-[2,1]-benzoxaborole. The empirical formula is CHBNO and the molecular weight is 251.1 g/mol.
  • The structural formula is represented below:
  • Crisaborole drug substance is freely soluble in common organic solvents such as isopropyl alcohol and propylene glycol, and insoluble in water.
  • Each gram of EUCRISA contains 20 mg of crisaborole in an ointment containing white petrolatum, propylene glycol, mono- and di-glycerides, paraffin, butylated hydroxytoluene, and edetate calcium disodium.
  • No data
  • In an oral carcinogenicity study in Sprague-Dawley rats, oral doses of 30, 100, or 300 mg/kg/day crisaborole were administered to rats once daily. A crisaborole-related increased incidence of benign granular cell tumors in the uterus with cervix and vagina (combined) was noted in 300 mg/kg/day crisaborole treated female rats (2 times the MRHD on an AUC comparison basis). The clinical relevance of this finding is unknown.
  • In a dermal carcinogenicity study in CD-1 mice, topical doses of 2%, 5%, or 7% crisaborole ointment were administered once daily. No crisaborole-related neoplastic findings were noted at topical doses up to 7% crisaborole ointment (1 times the MRHD on an AUC comparison basis).
  • Crisaborole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and human lymphocyte chromosomal aberration assay) and one in vivo genotoxicity test (rat micronucleus assay).
  • No effects on fertility were observed in male or female rats that were administered oral doses up to 600 mg/kg/day crisaborole (13 times the MRHD on an AUC comparison basis) prior to and during early pregnancy.
  • Two multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials (Trials 1 and 2) treated a total of 1522 subjects 2 to 79 years of age (86.3% of subjects were 2 to 17 years of age) with a 5% to 95% treatable BSA. At baseline, 38.5% of the subjects had an Investigator's Static Global Assessment [ISGA] score of 2 (mild), and 61.5% had an ISGA score of 3 (moderate), in the overall assessment of atopic dermatitis (erythema, induration/papulation, and oozing/crusting) on a severity scale of 0 to 4.
  • In both trials, subjects were randomized 2:1 to receive EUCRISA or vehicle applied twice daily for 28 days. The primary efficacy endpoint was the proportion of subjects at Day 29 who achieved success, defined as an ISGA grade of Clear (score of 0) or Almost Clear (score of 1) with a 2-grade or greater improvement from baseline, comparing EUCRISA-treated subjects to vehicle-treated subjects.
  • Efficacy results from the two trials are summarized in Table 2.
  • The success rates over time are presented in Figure 1.
  • No data
  • Advise the patient or caregivers to read the FDA-approved patient labeling (Patient Information).
  • This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
  • LAB-0916-5.0
  • No data
  • eucrisa
  • NDC 55724-211-2160 gn n
  • For Topical Use Only.
  • Not for ophthalmic, oral, or intravaginal use.
  • eucrisa
  • For Topical Use Only.
  • NDC 55724-211-21
  • 60 gn n
  • eucrisa
  • PROFESSIONAL SAMPLE - NOT FOR SALE
  • 60 gn n
  • For Topical Use Only.
  • Not for ophthalmic, oral, or intravaginal use.
  • eucrisa
  • PROFESSIONAL SAMPLE - NOT FOR SALE
  • For Topical Use Only.
  • NDC 55724-211-23
  • 60 gn n

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