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Eucrisa > Eucrisa PI > Flashcards

Eucrisa PI Flashcards

1
Q

What is the indication for Eucrisa?

A

indicated for the topical treatment of mild to moderate atopic dermatitis in adults and children aged 2 and older.

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2
Q

What is the dosage and administration of Eucrisa?

A

Apply a thin layer of Eucrisa twice daily to affected areas. For topical use only and not for oral, intravaginal or eyes.

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3
Q

Eucrisa is an———that is ———————-in color. Each gram of Eucrisa contains ——of crisaborole.

A

ointment, white of off white, 20mg

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4
Q

What are the contraindications for Eucrisa?

A

Eucrisa is contraindicated in patients with a know hypersensitivity to crisaborole or any component of the formulation.

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5
Q

What are the warning and precautions for Eucrisa?

A

Hypersensitivity reactions including contact urticarial have occurred. Hypersensitivity should be suspected if in the event of severe pruritus, swelling, and erythema at the application sight or at a distant site. If signs and symptoms occur then discontinue use immediately and initiate appropriate therapy.

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6
Q

Which adverse event was reported more than 1% of the time?

A

Application site pain.

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7
Q

What % of patients who received Eucrisa in the clinical trials report application pain as a side effect?

A

4% (45)

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8
Q

What percent of patients who received vehicle in the clinical trials reported application site pain?

A

1%(6)

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9
Q

In Both Trials How many patients received vehicle in the clinical trial?

A

499

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10
Q

In Both Trials How many patients received Eucrisa in the clinical trial ?

A

1012

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11
Q

What are the specific populations mentioned in the PI?

A

Pregnant women, Nursing mothers, Pediatric use, and geriatric use.

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12
Q

Summarize the key information that pertains to pregnant women as a specific population.

A

There is no available data in pregnant women. There were not development effects observed in rats at does up to 3 times and 5 times the recommended human dose.

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13
Q

Summarize the key information that pertains to lactating mothers as a specific population.

A

There is no available data on the presence of Eucrisa in human milk, the effects of the drug on breastfed infants or the effects of the drug on milk production.

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14
Q

Summarize the key information that pertains to pediatric use as a specific population.

A

The safety and effectiveness of Eucrisa have been established in pediatric patients age 2 and older. below the age of 2 has not been established.

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15
Q

Summarize the key information that pertains to geriatric use as a specific population.

A

Clinical studies did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects.

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16
Q

Describe Eucrisa.

A

Eucrisa contains 2% crisaborole, in a petrolatum based white to off white ointment and is for topical use. the active ingredient crisaborole is a PDE-4 inhibitor.

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17
Q

Each gram of Eucrisa contains…

A

20 mgs of cisaborole, petroleum, propylene glycol, mono and di glycerides, paraffin, butylated hydroxytulene, and edetate calcium disodium.

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18
Q

What is the mechanism of action for crisaborole?

A

The specific MOA by which Eucrisa exerts action for the treatment of atopic Dermatitis is not well defined but Eucrisa is a PDE-4 inhibitor, PDE-4inhibiotion results in increased intracellular cAMP levels.

19
Q

The Pharmacokinetics of Eucrisa were investigated in —-pediatric patients aged —- to —- with mild to moderate atopic dermatitis These subjects applied ——- of Eucrisa ointment topically —— daily for —days.

A 
33
2
17
3mg/cm2 (dose range 6g to 30g per application)
twice
8
20
Q

Plasma concentrations were—– in all subjects.

A

Quantifiable.

21
Q

Systemic concentrations of Crisaborole were steady at day—-.

A

8

22
Q

The mean maximum plasma concentration for crisaborole on day 8 was…

A

127 plus or minus 196 ng/ml

23
Q

what does ng/ml stand for?

A

nanograms per milliliter.

24
Q

what does ng*h/ml stand for?

A

hours times nanograms per milliliter.

25
Q

The Mean Area under the concentration time curve from 0-12 hours post dose for crisaborole on day 8 was…

A

949 plus or minus 1240 ng*h/milliliter

26
Q

based on an in vitro study crisaborole is —– bound to plasma proteins.

A

97%

27
Q

Crisaborole is substantially metabolized into ————-metabolites.

A

inactive

28
Q

The ————-metabolite 5-(4-cyanophenoxy)-2-hydroxyl benzylalcohol( metabolite 1), is formed via——. This metabolite is further metabolized in to ————-metabolites. one which 5-(4-cyanophenoxy)-2-hydroxyl benzoic acid( Metabolite 2) formed via ——- and is also a major metabolite.

A

Major
Hydrolysis
down stream
oxidation

29
Q

Metabolites 1 and n2 were assessed and the systemic concentrations were at or near ———– by day 8.

A

stead state

30
Q

———– excretion of metabolites is a major route of elimination.

A

renal

31
Q

The potential for drug interactions were studied in vitro by examining the ability of crisaborole to inhibit or induce CYP enzymes as well as a trial using warafin as cYP2c9 substrate. What were the findings?

A

These studies found no drug interaction potential.

32
Q

what were the finding in the dermal carcinogenicity study in mice?

A

no evidence of crisaborole - induced tumors were observed.

33
Q

Describe the parameters of the clinical trials?

A

two multi centered, randomized, double blind, parallel group vehicle controlled.

34
Q

a total of —– subject were included in both trials

A

1522

35
Q

The range in aged of both trials were from —– to —–.

A

2,79

36
Q

——-% of subjects were — to —- years of age with a —% to –% treatable body surface area.

A

86.3, 2, 17, 5,95

37
Q

At baseline —-% of subjects had an ISGA score of ——–2 ( mild) and —-% had an ISGA score of 3 (moderate.)

A

38.5, 61.5

38
Q

What does ISGA stand for?

A

Investigators static global Assessment.

39
Q

In both trial subjects were randomized—– to receive Eucrisa or Vehicle applied twice daily fro 28 days.

A

2:1

40
Q

What was the primary efficacy endpoint in both studies?

A

The proportion of subjects who achieved success. Defined as a ISGA grade of clear(0) or almost clear(1) with a 2 grade or greater improvement from baseline.

41
Q

What are the efficacy results from Trial 1?

A
  1. 8%( 504) Eucrisa

25. 4%(256) Vehicle

42
Q

What are the efficacy results from Trial 2?

A
  1. 4%(513) Eucrisa

18. 0%(250) Vehicle

43
Q

Eucrisa should be stored at ———- with excursions permitted to ——-

A

68-77

59-86

44
Q

Describe the Pharmacodynamics of Eucrisa.

A

At therapeutic doses Eucrisa ointment is not expected to prolong QTc to any clinically relevant extent.

Eucrisa (4 decks)

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