8/11/18 - cdn.ymaws.com...8/11/18 3 inhaled corticosteroids (ics) •mechanism of action/benefits...

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HOW TO CONFIDENTLY PRESCRIBE INHALED

STEROIDS FOR YOUR ASTHMATIC PATIENTS

• Michelle Dickens RN FNP-C AE-C

• Nurse Practitioner / Certified Asthma Educator

• Ferrell-Duncan Clinic, Department of Allergy & Immunology

• Coordinator, CoxHealth Asthma Center

• [email protected]

Objectives• Review the NHLBI EPR-3 guidelines regarding the medication management of asthma

• Identify the various inhaled steroids available for use in asthma, including mechanism of action, benefits, and risks

• Explore clinical pearls related to ICS selection in the treatment of asthma

Definitions

• MDI – metered dose inhaler• DPI – dry powder inhaler

• HFA – specific type of propellant used for MDI’s• ICS – inhaled corticosteroid

• LABA – long acting bronchodilator

• LTRA – leukotriene receptor antagonist(example: montelukast/Singulairä)

EPR-3 GUIDELINE REVIEW

EPR-3 Guidelines• Guidelines from the National Asthma Education and Prevention Program

• Expert Panel Report 3 (3rd revision published in 2007)• Published by the NHLBI• Evidenced-based care after review of 50,000+ studies

EPR-3 Guidelines

https://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf

• Easy to find—just Google “asthma guidelines quick reference”

• 12 page concise overview• Available as a .pdf to print

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Medication Management for Asthma per EPR-3• At time of initial diagnosis, classify severity

• Mild intermittent• Mild persistent• Moderate persistent• Severe persistent

• Choose starting therapy based on severity• Vision analogy

Medication Management for Asthma per EPR-3• At all follow up visits, determine level of control

• Well controlled• Not well controlled• Very poorly controlled

• Adjust therapy based on control

• Performed at the time of diagnosis

• Determined by the item the farthest to the right (even 1 item in a column defines that level of severity)

• The classification guides which therapy step to start

• Performed at each follow up visit

• Determined by the item the farthest to the right (even 1 item in a column defines that level of control)

• The classification guides adjustments in therapy

• Treatment is individualized for each age group

• Steps are recommendations, not hard rules

• Choices exist at several steps• We’ll revisit this after discussing the

medications

INHALED CORTICOSTEROIDS (ICS)

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Inhaled Corticosteroids (ICS)• Mechanism of action/benefits• Risks• Available medications in this class• Case scenarios using EPR-3 guidelines• Practice pearls

Inhaled Corticosteroids (ICS)üMost consistently effective long-term control medication at all steps of care for persistent asthma

üImproves asthma control more effectively in both children and adults more than any other single, long-term control medication

Mechanism of Action• Reduces airway hyper-responsiveness• Inhibits inflammatory cell migration and activation• Blocks late phase reaction to allergen

Inhaled Corticosteroids (ICS)

Laitinen et al. J Allergy Clin Immunol. 1992;90:32-42.

Inhaled Corticosteroids (ICS)Risks• May slow linear growth in children§Likely occurs in first year of therapy§Avg reduction of 1 cm, not cumulative even if med continued, appears to be dose-dependent

§Must weigh against need for oral steroid use

Inhaled Corticosteroids (ICS)Risks• Cataracts and bone density issues can occur with long-term use of high dose ICS

• Oral thrush possible

Inhaled Corticosteroids (ICS)Reducing the Risks• Always use a spacer/valved-holding chamber to reduce oropharyngeal deposition

• Rinse mouth and spit after use• Step down dose whenever possible• Monitor height in children at every visit, watch for falling height percentiles

• Document discussion of risks especially in children

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AVAILABLE ICS MEDICATIONS

Disclaimer• All available ICS products with indications for asthma will be reviewed, presented alphabetically by generic

• Any opinions expressed about preference are my own, your mileage may vary

Inhaled Corticosteroids (ICS)Generic Name:Beclomethasone dipropionateTrade Name: QVarä RedihalerStrength: 40 mcg, 80 mcgType: Breath-Actuated Metered Dose InhalerTips/Tricks: As of Spring 2018, MDI replaced by Redihaler

Cannot be used with a spacer as isNot appropriate for small childrenCan twist off cap to use as a traditional MDI

Qvar ä Redihaler “Hack”• Peel up or score label on back of inhaler

• Hold inhaler firmly at base, twist cap off counter-clockwise (takes a little force)

• May remove mouthpiece cover at the hinges if desired

• Use with spacer like standard MDI (canister

Inhaled Corticosteroids (ICS)Generic Name:BudesonideTrade Name: Pulmicort Flexhalerä; Pulmicort RespulesäStrength: 90 mcg, 180 mcg; 0.25 mg, 0.5 mg, 1.0 mgType: Powdered Inhaler; Solution for NebulizerTips/Tricks: The 0.25 mg and 0.5 mg strengths for the

nebulizer are available generic. Still can beexpensive but may qualify for generic co-pay.Powder contains lactose.


Generic Name:CiclesonideTrade Name: AlvescoäStrength: 80 mcg, 160 mcg

Type: Metered Dose InhalerTips/Tricks: Pro-drug formulation, so active metabolite

isn’t present until med gets into the lungs.Has the potential to reduce oral systemicabsorption, unclear clinical benefit.

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Inhaled Corticosteroids (ICS)Generic Name:FlunisolideTrade Name: AerospanäStrength: 80 mcgType: Metered Dose InhalerTips/Tricks: Has small built-in spacer

Limited formulary coverage

Inhaled Corticosteroids (ICS)Generic Name:Fluticasone furoateTrade Name: Arnuity ElliptaäStrength: 100 mcg, 200 mcgType: Dry Powder InhalerTips/Tricks: Once daily dosing. Contains lactose.


Generic Name:Fluticasone propionate

Trade Name: Flovent DiskusäStrength: 50 mcg, 100 mcg, 250 mcg

Type: Dry Powder Inhaler

Tips/Tricks: Contains lactose.

Inhaled Corticosteroids (ICS)Generic Name:Fluticasone propionateTrade Name: Flovent HFAäStrength: 44 mcg, 110 mcg, 220 mcgType: Metered Dose InhalerTips/Tricks: Consider using higher dose inhaler with

fewer puffs to reduce cost to patient

Inhaled Corticosteroids (ICS)Generic Name:Mometasone furoateTrade Name: Asmanex TwisthaleräStrength: 110 mcg, 220 mcgType: Powdered InhalerTips/Tricks: Once daily dosing, contains lactose

Ensure proper priming technique220 mcg strength comes in severalquantities (14, 30, 60 puffs)

Inhaled Corticosteroids (ICS)Generic Name:Mometasone furoateTrade Name: Asmanex HFAäStrength: 100 mcg, 200 mcgType: Metered Dose InhalerTips/Tricks: Insurance coverage may be less widespread

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Putting the Pieces Together: Selecting an ICS

1. Determine appropriate step of therapy from chart, including recommended dose range (low/medium/high)

2. Choose med based on:

• Insurance coverage/cost considerations/coupons

•Age: MDI vs DPI vs nebulizer, ability to properly use device, dosing intervals

3. From med dosing chart, determine total daily dose

4. Choose strength, # of puffs, times/day to equal total dose

ICS: EPR-3 vs FDA RecommendationsMedication Form EPR-3 Dose Ranges FDA Approval

Beclomethasone dipropionate (QVarä) MDI 5-11 years, ³12 years 5 years and older

Budesonide (Pulmicort Flexhalerä) DPI 5-11 years, ³12 years 6 years and older

Budesonide (Pulmicort Respulesä) NEB 0-4 years, 5-11 years 12 months and older

Ciclesonide (Alvescoä) MDI 5-11 years, ³12 years 12 years and older

Flunisolide (Aerospanä) MDI 5-11 years, ³12 years 6 years and older

Fluticasone furoate (Arnuity Elliptaä) DPI Not listed (released since 2007) 12 years and older

Fluticasone propionate (Flovent Diskusä) DPI 5-11 years, ³12 years 4 years and older

Fluticasone propionate (Flovent HFAä) MDI 0-4 years, 5-11 years, ³12 years 4 years and older

Mometasone furoate (Asmanex Twisthalerä) DPI 5-11 years, ³12 years 4 years and older

Mometasone furoate (Asmanex HFAä) MDI Not listed (released since 2007) 12 years and older

ICS: Doses for children under 5

**Use clinical judgment and level of comfort to determine best medication for younger children


Brandon:• 15 year old male• New diagnosis of asthma

Refer to Step Therapy Chart

Rationale:ü Meds circled are

preferred on his insurance

ü Fluticasone (Floventä) is a good option (HFA)

ü Beclomethasone(Qvarä) could be dosed 80 mcg, 1 puff twice daily, which would make canister last for 60 days. Reduces co-pays for some insurances, but need to consider Redihaler technique issues.

ü Might use mometasone(Asmanexä) if we need a once-daily dose, but it is a DPI, so consider technique issues.

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Caleb:• 7 year old male• Presents for 6 month f/u• Current medication:Fluticasone (Floventä)44 mcg, 2 puffs BID

Fluticasone HFA (Floventä)44 mcg, 2 puffs BID

Total daily dose = 176 mcg (44 x 2 x 2)

This would be considered a low dose

Determine dose range of current medication:

Current step Recommended step

So which option to choose?

Putting the Pieces Together: Selecting an ICSWhat if there are options for a step?

Dosing Option Reasons to UseLow-dose ICS + LABA

• Lower dose ICS desired (growth issues, ptconcerns)

• Exercise is a primary trigger• No persistent obstruction on spirometry• Studies show may be more helpful in patients >12

years of age compared with medium-dose ICS

Low-dose ICS + LRTA

• Significant nasal allergy symptoms• *be aware of potential behavior side effects

Low-dose ICS +theophylline

• Rarely used due to narrow therapeutic index and risk of side effects/drug interactions

Medium-dose ICS • Persistent obstruction noted on spirometry• Studies show may be more helpful in patients <12

years of age compared with low-dose ICS + LABA

Putting the Pieces Together: Selecting an ICSWhat if there are options for a step?

Dosing Option Reasons to UseLow-dose ICS + LABA

• Lower dose ICS desired (growth issues, ptconcerns)

• Exercise is a primary trigger• No persistent obstruction on spirometry• Studies show may be more helpful in patients >12

years of age compared with medium-dose ICS

Low-dose ICS + LRTA

• Significant nasal allergy symptoms• *be aware of potential behavior side effects

Low-dose ICS +theophylline

• Rarely used due to narrow therapeutic index and risk of side effects/drug interactions

Medium-dose ICS • Persistent obstruction noted on spirometry• Studies show may be more helpful in patients <12

years of age compared with low-dose ICS + LABA



ü Fluticasone (Floventä) could be dosed 110 mcg, 1 puff twice daily, which would make canister last for 60 days. Reduces co-pays for some insurances, also allows easy dose increase if needed.

ü Beclomethasone(Qvarä) could also work

ü DPI not always a good option for 7 year olds, need to assess technique.

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Lauren:• 2 year old female


preferred on her insurance

ü Fluticasone (Floventä) 44 mcg, 2 puffs twice daily

ü Beclomethasone(Qvarä) could be used, would need to estimate dose for this age group

ü Budesonide via nebulizer is an option, but must be willing to sit quietly for the full neb treatment. Is available in generic form, so may be less expensive.

Putting the Pieces Together: Selecting an ICSPractice Pearls:• Consistent technique for daily and rescue inhalers can be helpful (both MDI, both powder)

• Be selective about using DPI, ensure adequate technique• After-school or dinner-time dosing may be better than bedtime

• Consider once daily dosing options for teenagers• Save costs by using stronger strength with fewer puffs

ICS/LABA COMBINATION MEDS

ICS/Long-Acting Beta Agonists (LABA) Combination Meds

• Mechanism of action/benefits• Risks• Available medications in this class• Case scenarios using EPR-3 guidelines• Practice pearls

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Long-Acting Beta Agonists (LABA)üAdd-on therapy in additional to ICS for asthmatics

Mechanism of Action• Reduces bronchial hyper-responsiveness• Effect is long-acting (12-24 hours depending on drug)• Does not replace SABA for quick relief of asthma symptoms

Long-Acting Beta Agonists (LABA)Risks• May cause jitteriness, tremor, headache• Previously had a black box warning in US—removed in late 2017. Initial studies showed increased risk of asthma death. Follow up studies (SMART trial) did not demonstrate this.

• Risk decreased when combined with ICS• Available as solo agent, but not licensed for asthma use(examples given here all combo meds used for asthma)

ICS/LABA Combination Products

Generic Name:Fluticasone Propionate/SalmeterolTrade Name: Advair Diskusä,

Strength: 100/50 mcg, 250/50 mcg, 500/50 mcgType: Dry Powder Inhaler

Tips/Tricks: Max 1 puff twice daily

Contains lactose

ICS/LABA Combination ProductsGeneric Name:Fluticasone Proprionate/SalmeterolTrade Name: Advair HFAäStrength: 45/21 mcg, 115/21 mcg, 230/21 mcgType: Metered Dose InhalerTips/Tricks: 2 puffs twice a day needed to get full dose

of LABA (1 puff with Diskus)


Generic Name:Fluticasone Proprionate/SalmeterolTrade Name: AirDuoäStrength: 55/14 mcg, 113/14 mcg, 232/14 mcg

Type: Dry Powder InhalerTips/Tricks: AirDuo has generic fluticasone/salmeterol

option available, released with brandedSame device as ProAir RespiclickMax 1 puff twice daily, Contains lactose


Generic Name:Fluticasone Furoate/VilanterolTrade Name: BreoäStrength: 100/25 mcg, 200/25

Type: Dry Powder InhalerTips/Tricks: Once daily dosing, max 1 puff a day

Contains lactose

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Generic Name:Budesonide/FormoterolTrade Name: SymbicortäStrength: 80/4.5 mcg, 160/4.5 mcgType: Metered Dose InhalerTips/Tricks: At max dose (2 puffs twice daily), can only

achieve a low/medium ICS dose for 12+

ICS/LABA Combination Products ICS/LABA Combination ProductsGeneric Name:Mometasone Furoate/FormoterolTrade Name: DuleraäStrength: 100/5 mcg, 200/5 mcgType: Metered Dose InhalerTips/Tricks: Typically dosed 2 puffs twice daily

ICS/LABA: EPR-3 vs FDA RecommendationsMedication EPR-3 Dose Ranges based on ICS FDA Approval

Budesonide/Formoterol MDI(Symbicortä)

Not specifically listed for MDI. All ages 12 mo+ covered by budesonide via respules or DPI

6 years+ 80/4.512 years+ 160/4.5

Fluticasone propionate/Salmeterol(Advair Diskusä)

5-11 years, ³12 years 4 years and older

Fluticasone propionate/Salmeterol(Advair HFAä)

0-4 years, 5-11 years, ³12 years 12 years and older

Fluticasone furoate/Vilanterol(Breo Elliptaä)

Specific ranges for fluticasone propionate, furoate not on the market in 20070-4 years, 5-11 years, ³12 years

18 years and older

Mometasone furoate/Formoterol(Dulera HFAä)

5-11 years, ³12 years 12 years and older

*ICS/LABA therapy is recommended for all age groups in either Step 3 or 4 by EPR-3 guidelines

ICS/LABA: DosingGuidelines

DISCLAIMER***Adapted from the EPR-3 guidelines chart for ICS single agents. Some dosing ranges are extrapolated based on other forms of the medication, since no dose range studies exist.

Putting the Pieces Together: Selecting an ICS/LABA

Becky:• 32 year old female• New diagnosis of asthma

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Rationale:ü Meds circled are preferred

on her insuranceü Medium dose ICS is

recommended, but several options aren’t available in a medium dose

ü Mometasone/formoterol(Duleraä) would give us a stronger medium dose than Budesonide/formoterol(Symbicortä) – clinical judgment call on which to use.

Putting the Pieces Together: Selecting an ICS/LABA Putting the Pieces Together: Selecting an ICS/LABA

Caleb:• 7 year old male• Presents for 3 month f/u• Current medication:Fluticasone (Floventä) 110 mcg, 1 puff BID

Fluticasone (Floventä) 110 mcg, 1 puff BID


This would be considered a medium dose


Current stepRecommended step



ü Budesonide/formoterol(Symbicortä) at its highest strength is only a lower medium dose, likely not strong enough in this situation.

ü Fluticasone proprionate/ salmetrol (Advair HFAä) 115/21, 2 puffs BID or mometasone furoate/ formoterol (Duleraä200/5, 2 puffs BID either would be appropriate.

ü DPI not always a good option for 7 year olds, need to assess technique.


Joey:• 4 year old male• Presents as a new patient• Current medication:

Fluticasone (Floventä) 110 mcg, 1 puff twice daily, has been on this for past 6 months

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Fluticasone (Floventä) 110 mcg, 1 puff BID


This would be considered a medium dose


Current stepRecommended step


preferred on her insurance

ü Fluticasone proprionate/salmetrol(Advairä) 115/21 mcg, 2 puffs twice daily might be a logical choice

ü At this step, referral to a specialist would be advisable


Practice Pearls:• Can consider using a lower-dose ICS/LABA and adding a second inhaler with just an ICS to achieve a higher ICS dose if not commercially available (more hassle, more cost)

• Be selective about using DPI, ensure adequate technique• Adding a LABA instead of increasing ICS dose helpful for patients with exertional symptoms

• Common practice in Europe to flex dose ICS/LABA meds, stay tuned for adoption here

NEXT STEPS

Next Steps

• Download and print the EPR-3 Quick Reference Guidehttps://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf

• Research formulary meds for your common insurance carriers

• Start calculating dose ranges for your patients on inhaled steroids to get familiar with common ranges

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Michelle Dickens RN FNP-C [email protected]

QUESTIONS?

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