Pulmonary Disorders and Adult Immunizations PDF

Pulmonary Disorders and Adult Immunizations I. ASTHMA Guidelines: Expert Panel Working Group of the NHLBI administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC). 2020 Focused Updates to the Asthma Management Guidelines: A Report from the N...

Pulmonary Disorders and Adult Immunizations I. ASTHMA Guidelines: Expert Panel Working Group of the NHLBI administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC). 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. Available at https://www.nhlbi.nih.gov/health-topics-asthma-managementguidelines-2020-updates.  Global Initiative for Asthma (GINA): Global Strategy for Asthma Management and Prevention 2022. Available at www.ginasthma.org/. A. Definition: Asthma is a chronic inflammatory disorder of the airways causing recurrent episodes of wheezing, breathlessness, cough, and chest tightness, particularly at night or early in the morning. During episodes, there is variable airway obstruction, often reversible spontaneously or with treatment. There is also increased bronchial hyperresponsiveness to a variety of stimuli. B. Diagnosis 1. Episodic symptoms of airflow obstruction are present. 2. Airway obstruction is reversible (FEV1 improves by 12% or more after short-acting β2-agonists [SABAs]). Table 1 provides additional information for interpretation of spirometry results. 3. Alternative diagnoses are excluded. 4. Asthma versus COPD: a. Cough is usually nonproductive with asthma and productive with COPD. b. FEV1 is reversible with asthma but irreversible with COPD. c. Cough is worse at night and early in the morning with asthma; it occurs throughout the day with COPD. d. Asthma is often related to allergies and environmental triggers; patients with COPD have a common history of smoking or exposure to other irritants. e. Asthma can be reversible; lung damage from COPD is irreversible. 5. Asthma-COPD overlap (ACO) a. No single definition of ACO is well defined or commonly accepted. b. ACO does not refer to a single disease state; rather, it is a clinical phenotype with shared clinical features of two separate diseases. c. Characterized by persistent airflow limitation and features associated with both asthma and COPD d. Table 2 includes clinical features of patients with asthma and/or COPD with recommended initial treatments. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-358 Pulmonary Disorders and Adult Immunizations Table 1. Interpreting Spirometry Component FEV1 FVC What It Measures Volume of air exhaled forcefully in the first second of maximal expiration Maximum volume of air that can be exhaled after full inspiration FEV1/FVC ratio Percentage of lung capacity able to be expelled in one second Normal Values Normal is ≥ 80% In asthma, reversibility is shown by an increase in FEV1 ≥ 12% or FVC > 200 mL after SABA Reported in liters and percentage predicted Adults with normal lung function can empty 80% of air in < 6 seconds Normal: Within 5% of predicted range, which varies with age; usually 75%–80% in adults Decreased in obstructive disease (asthma, COPD) (< 70%) COPD = chronic obstructive pulmonary disease; FEV1 = forced expiratory volume in 1 second; FVC = forced vital capacity; SABA = short-acting β2-agonist. Table 2. Initial Treatment Approach in Patients with Asthma and/or COPD Adults with Chronic Respiratory Symptoms (dyspnea, cough, chest tightness, and wheeze) Treat as asthma if several of Treat as asthma if features of both the following features are present: asthma and COPD are present: History – – – – Lung function  ymptoms vary over time S and in intensity Triggers: Laughing, exercise, allergens, seasonal Onset < 40 yr of age Symptoms improve with bronchodilators or ICS within days to weeks – – – –  ariable expiratory airflow – V limitation – Persistent airflow limitation – may be present – Initial – treatment – – I CS-containing treatment essential Do not give LABA and/or LAMA without ICS Avoid maintenance OCS – – – – Treat as COPD if several of the following features are present:  ymptoms intermittent or S episodic Age at onset varies May have history of smoking and/or toxic exposures, low birth weight, or respiratory illness (e.g., tuberculosis) A ny asthma features listed in the column to the left (e.g., triggers, symptom improvement with bronchodilators or ICS, current asthma diagnosis or previous diagnosis as a child) –  ersistent expiratory airflow P limitation With or without bronchodilator reversibility – I CS-containing treatment essential Additional COPD treatments per GOLD recommendations Do not give LABA and/or LAMA without ICS Avoid maintenance OCS – – – – – – – – – –  ersistent dyspnea on most P days Onset > 40 yr of age Limitation of physical activity May have been preceded by cough or sputum Bronchodilator provides limited relief History of smoking and/or toxic exposures, low birth weight, or respiratory illness (e.g., tuberculosis) No past/current asthma diagnosis  ersistent expiratory airflow P limitation With or without bronchodilator reversibility  reat as COPD per GOLD T recommendations Avoid high-dose ICS, avoid maintenance OCS Reliever containing ICS is not recommended Reevaluate in 2–3 mo. Specialist referral if diagnosis remains uncertain or treatment response is inadequate COPD = chronic obstructive pulmonary disease; GOLD = Global Initiative for Chronic Obstructive Lung Disease; ICS = inhaled corticosteroids; LABA = long-acting β2-agonist; LAMA = long-acting anticholinergic/muscarinic antagonist; OCS = oral corticosteroid. Information from: Global Initiative for Asthma (GINA). 2022 GINA Report. Global Strategy for Asthma Management and Prevention. Available at https://ginasthma.org/gina-reports/. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-359 Pulmonary Disorders and Adult Immunizations C. Classification of Asthma Severity and Control (Tables 3 and 4) 1. GINA 2022 assessment of asthma in adults a. Assess symptom control from frequency of day- and nighttime symptoms, reliever inhaler use, and activity limitation. b. Consider symptom tools such as the Asthma Control Test and Asthma Control Questionnaire. c. Assess risk of future exacerbations, even when control is good. 2. GINA 2022 assessment of asthma control in children 6–11 years old a. Symptom control on the basis of symptoms, limitation of activities (daily activities, sports, play, social life, school attendance), and use of rescue medication b. Parents may report irritability, tiredness, and mood changes when asthma is uncontrolled. c. Asthma control scores for children include Childhood Asthma Control Test, Asthma Control Questionnaire, and Test for Respiratory and Asthma Control in Kids. 3. Categories of asthma severity a. Mild: Well controlled on step 1 or step 2 treatment b. Moderate: Well controlled on step 3 treatment c. Severe: Requires step 4 or step 5 treatment to prevent it from being “uncontrolled” or if it remains uncontrolled despite step 4 or 5 treatment Table 3. Classification of Asthma Severity in Adults and Children According to NAEPP EPR3a Components Frequency of symptoms Nighttime awakening SABA; used for symptom control Interference with normal activity FEV1/FVCb FEV1 (% of normal) Exacerbations requiring oral steroids Age Group (yr) All ages Intermittent ≤ 2 days/wk Moderate Persistent Daily ≥ 12 5–11 ≤ 2 times/mo Mild Persistent > 2 days/wk but not daily 3 or 4 times/mo 0–4 0 1 or 2 times/mo 3 or 4 times/mo All ages ≤ 2 days/wk Daily All ages None > 2 days/wk but not daily Minor limitation More than once weekly Several times a day Some limitations Extremely limited ≥ 12 5–11 0–4 ≥ 12 5–11 0–4 ≥ 12 5–11 0–4 Normal > 85% Normal > 80% Reduced 5% 75%–80% Reduced > 5% < 75% > 80% (normal) > 80% (normal) More than once weekly but not nightly N/A > 60% to < 80% Severe Persistent Throughout the day Often 7 times/wk < 60% N/A 0 or 1/yr ≥2/yrc 0 or 1/yr ≥2 in 6 mo or ≥4 wheezing episodes lasting > 1 day per yeard ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-360 Pulmonary Disorders and Adult Immunizations Table 3. Classification of Asthma Severity in Adults and Children According to NAEPP EPR3a (Cont’d) Components Recommended step for initiating treatment (see Table 5) Age Group (yr) Intermittent Mild Persistent ≥ 12 Step 1 Step 2 5–11 Moderate Persistent Step 3e and consider short course of oral steroids 0–4 Severe Persistent Step 4 or 5 and consider short course of oral steroids Step 3d or 4 and consider short course of oral steroids Step 3 and consider short course of oral steroids The patient is classified according to the sign or symptom that is in the most severe category. Normal FEV1/FVC: 8–19 yr old, 85%; 20–39 yr old, 80%; 40–59 yr old, 75%; 60–80 yr old, 70%. c Considered the same as in patients who have persistent asthma, even without impairment levels consistent with persistent asthma. d Episodes lasting > 1 day and risk factors for persistent asthma. e For ages 5–11, initial step 3 therapy should be medium-dose ICS. EPR = Expert Panel Report; FEV1 = forced expiratory volume in 1 second; FVC = forced vital capacity; National Asthma Education and Prevention Program (NAEPP); SABA = short-acting β2-agonist. N/A = not applicable. Adapted from: NIH Asthma Guidelines. National Institutes of Health National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program (NAEPP) guidelines. NAEPP Expert Panel Report 3. NIH Publication 08-5846. Available at https://www.nhlbi.nih.gov/ health-topics/guidelines-for-diagnosis-management-of-asthma. a b Table 4. Assessing Asthma Control in Adults and Children ≥ 6 Yr In the past 4 wk, has the patient had: Daytime asthma symptoms more than twice/week? Any night waking because of asthma? SABA needed for symptoms more than twice/week? Any activity limitation because of asthma? Well Controlled Partly Controlled Yes No Yes No Yes No Yes No None of these 1 or 2 of these Uncontrolled 3 or 4 of these SABA = short-acting β2 -agonist. Adapted from: Global Initiative for Asthma (GINA): Global Strategy for Asthma Management and Prevention, 2022. Available at www.ginasthma.org/. D. Treatment Goals 1. Minimal or no chronic symptoms day or night 2. Minimal or no exacerbations 3. No limitations on activities, no school or work missed 4. Maintenance of (near) normal pulmonary function 5. Minimal use of reliever medications 6. Minimal or no adverse effects from medications E. Risk Factors for Poor Outcomes 1. Uncontrolled asthma symptoms 2. Medication factors: No inhaled corticosteroid (ICS), poor adherence, incorrect inhaler technique, short-acting β2-agonist (SABA) use greater than 1 x 200 dose canister/month 3. Comorbid conditions: Obesity, gastroesophageal reflux disease, anxiety, depression, pregnancy 4. Environmental exposure: Smoking, allergens, air pollution 5. Lung function: FEV1 less than 60% predicted, higher degree of reversibility 6. Fractional exhaled nitric oxide (FeNO) in allergic adults taking ICSs ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-361 Pulmonary Disorders and Adult Immunizations F. Treatment Guidelines (Table 5) Table 5. Stepwise Approach for Management of Asthma in Individuals Age 12 Years and Older Guideline NAEPP 2020 Focused Update Step 1 Controller Reliever SABA PRN SABA PRN Step 2 Low-dose ICSLow-dose ICS formoterola or concomitant low-dose ICS and Alternative: SABA PRNa Medium-dose Alternative: ICS or low-dose LTRA or ICS-LABA cromolyn or or low-dose theophyllineb ICS + LAMAa or LTRAb or low-dose ICS + theophylline or zileutonb Low-dose ICSLow-dose ICS and SABA PRNa formoterol PRNa Alternative: SABA PRN GINA Step 3 Alternative: SABA PRN Step 4 Medium-dose ICS-formoterola Alternative: Medium-dose ICS-LABA or medium-dose ICS + LAMAa or medium-dose ICS + LTRA, theophylline, or zileutonb Medium-dose ICS-formoterol PRNa Step 5 Medium/ highdose ICS-LABA + LAMAa Step 6c High-dose ICS-LABA + OCS Alternative: Medium/high dose ICS-LABA or high-dose ICS + LTRAb SABA PRN SABA PRN Alternative: SABA PRN Conditionally recommend adjunct subcutaneous Consider adding asthma immunotherapy in patients with controlled asthma biologics Track 1: Preferred; especially if likely to be poorly adherent with daily ICS-containing controller therapy Controller Low dose ICS-formoterol PRN Low-dose ICS-formoterol Medium-dose ICS-formoterol Add-on LAMA Refer for phenotypic assessment ± asthma biologics Consider high-dose ICS-formoterol Reliever Controller Low dose ICS-formoterol PRN Track 2: Assess likelihood of adherence Take ICS whenever SABA taken Low-dose ICS Low-dose ICS-LABA Medium/high Add-on LAMA dose ICS-LABA Refer for phenotypic assessment ± asthma biologics Consider highdose ICS-LABA Reliever SABA PRN Alternative controllers for either track Low dose ICS whenever SABA taken, or daily LTRA or HDM SLIT Medium-dose ICS, or add LTRA, or add HDM SLIT Add LAMA or LTRA or HDM SLIT, or switch to high dose ICS Add azithromycin (adults) or LTRA; add low dose OCS GINA = Global Initiative for Asthma; HDM = house dust mite; ICS = inhaled corticosteroid; LABA = long-acting β2-agonist; LTRA = leukotriene receptor antagonist; National Asthma Education and Prevention Program (NAEPP); OCS = oral corticosteroid; PRN = as needed; RTI = respiratory tract infection; SABA = short-acting β2-agonist; SLIT = sublingual immunotherapy. a Updates based on the 2020 guidelines. b Cromolyn, LTRAs, and theophylline were not considered in 2020 update and/or have limited availability in the United States, and/or have increased risk of adverse drug reactions and need for monitoring making use less desirable. c Data on the use of LAMA therapy in Step 6 was not reviewed; therefore, no recommendation was made. Information from: 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. Available at www.nhlbi.nih.gov/health-topics/asthma-management-guidelines-2020-updates; Global Initiative for Asthma (GINA): Global Strategy for Asthma Management and Prevention 2022. Available at www.ginasthma.org/. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-362 Pulmonary Disorders and Adult Immunizations G. Pharmacologic Therapy for Asthma (Tables 6 and 7) Table 6. Pharmacologic Agents Used for Asthma and COPD Generic Brand Dose Adverse Effects Beclomethasone MDI 40 mcg/puff 80 mcg/puff QVAR RediHaler (breath activated) See ICS dosing Oral candidiasis table Hoarseness May slow bone growth in children but similar adult height Budesonide DPI 90 mcg/puff 180 mcg/puff Budesonide inhalation solution 0.25-mg/2 mL 0.5-mg/2 mL 1-mg/2-mL Pulmicort Flexhaler Ciclesonide MDI 80 mcg/puff 160 mcg/puff Alvesco HFA Fluticasone propionate MDI 44 mcg/puff 110 mcg/puff 220 mcg/puff Fluticasone propionate DPI 50 mcg/puff 100 mcg/puff 250 mcg/puff Fluticasone furoate DPI 50 mcg/puff 100 mcg/puff 200 mcg/puff Fluticasone propionate DPI 55 mcg/puff 113 mcg/puff 232 mcg/puff Flovent HFA Mometasone DPI 110 mcg/puff 220 mcg/puff Asmanex Twisthaler Can be used once daily Asmanex HFA Comments ICSs Mometasone MDI 50 mcg/puff 100 mcg/puff 200 mcg/puff Pulmicort Respules ICSs are first line for persistent asthma Use holding chambers only if needed for technique; not needed or well studied with HFA inhalers; holding chambers are only for MDIs, cannot be used for DPIs; holding chamber with a mask can be used for young children Per GINA guideline update rinsing of mouth not required Onset of improvement is 5–7 days; additional benefit may occur over several weeks Pulmicort Respules are the only nebulized steroid available Arnuity Ellipta inhalation powder is contraindicated in severe hypersensitivity to milk proteins Flovent Diskus Arnuity Ellipta 1 inhalation once daily ArmonAir Digihaler SAMAs Ipratropium MDI 17 mcg/puff Ipratropium inhalation solution 0.5 mg/2.5 mL Atrovent HFA 2 puffs QID (up to 12 puffs/24 hr) 0.5 mg every 6–8 hr Headache Flushed skin Blurred vision Tachycardia Palpitations Used mainly for COPD and for acute asthma exacerbations necessitating emergency treatment ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-363 Pulmonary Disorders and Adult Immunizations Table 6. Pharmacologic Agents Used for Asthma and COPD (Cont’d) Generic Brand Dose Adverse Effects Comments Aclidinium bromide DPI 400 mcg/puff Tudorza Pressair 1 puff BID Headache Flushed skin Blurred vision Tachycardia Palpitations Acute urinary retention Cough (Respimat device) LAMA for COPD Glycopyrrolate inhalation solution 25 mcg/vial Lonhala Magnair Inhale one vial (25 mcg) twice daily Revefenacin inhalation solution 175 mcg/vial Yupelri Inhale 1 vial Cough, nasopharyngitis, Once-daily nebulized LAMA; for (175 mcg) once URTI, headache, back pain use with standard jet nebulizer daily Tiotropium DPI 18 mcg/capsule Spiriva HandiHaler Inhale contents of 1 capsule/day Tiotropium inhalation spray 1.25 mcg/spray (asthma) 2.5 mcg/spray (COPD) Spiriva Respimat 2 puffs once daily Umeclidinium DPI 62.5 mcg/blister Incruse Ellipta 1 inhalation once daily LAMAs LAMA approved for COPD Only used with PARI nebulizer Spiriva Respimat is the only LAMA indicated for long-term maintenance treatment of asthma for those ≥ 12 Once-daily LAMA for COPD SABAs Albuterol MDI 90 mcg/spray Albuterol inhalation solution 0.63 mg/3 mL 2.5 mg/3 mL 2.5 mg/0.5 mL Levalbuterol MDI 45 mcg/spray Levalbuterol inhalation solution 0.63 mg/3 mL; also available in 0.31 mg/ 3 mL, 1.2 mg/3 mL, and 1.25 mg/0.5 mL Proventil HFA 2 puffs every 4–6 hr PRN Ventolin HFA ProAir HFA ProAir RespiClick DPI ProAir Digihaler DPI 2.5 mg three or four times daily PRN Xopenex, generic Tremor Tachycardia (less with levalbuterol) Hypokalemia Hypomagnesemia Hyperglycemia Tachyphylaxis R-enantiomer of albuterol Duration (MDI): 3–4 hr (<6) Used for acute bronchospasm; regular use indicates poor control Duration of effect (MDI): 3–4 hr (< 6) 2 puffs every 4–6 hr PRN 0.63 mg TID every 6–8 hr Maximum: 1.25 mg TID ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-364 Pulmonary Disorders and Adult Immunizations Table 6. Pharmacologic Agents Used for Asthma and COPD (Cont’d) Generic Brand Dose Adverse Effects Comments Arformoterol inhalation solution 15 mcg/2 mL Brovana Inhale 1 vial BID Arformoterol is the R,R-isomer of racemic formoterol Formoterol inhalation solution 20 mcg/2 mL Perforomist Inhale 1 vial BID Onset of action 1–3 min but should not be used as acute therapy Should not be used as monotherapy for asthma Olodaterol inhalation spray 2.5 mcg/spray Striverdi Respimat 2 puffs once daily Indicated only for COPD Duration of action: 24 hr Salmeterol DPI 50 mcg/puff Serevent Diskus Inhale 1 blister/puff BID Not for acute symptoms Should not be used as monotherapy for asthma Duration: 8–12 hr LABAs Combination SABA/SAMA Albuterol/ipratropium Combivent 100 mcg/20 mcg/puff Respimat Ipratropium/albuterol inhalation solution 0.5 mg–3 mg/3 mL Generic 1 puff QID Maximum dose 6 puffs/ day 1 vial every 4–6 hr Cough Dyspnea HA Bronchitis Nasopharyngitis URTI Used primarily for COPD Used for maintenance of COPD Combination LAMA/LABA Aclidinium/formoterol DPI 400 mcg/12 mcg Duaklir Pressair 1 inhalation BID URTIs, headache, back pain Glycopyrrolate/ formoterol fumarate DPI 9 mcg/4.8 mcg/spray Bevespi Aerosphere 2 inhalations BID Urinary tract infections Cough Tiotropium/olodaterol Stiolto inhalation spray Respimat 2.5 mcg/2.5 mcg/spray 2 inhalations once daily Umeclidinium/ Anoro Ellipta vilanterol DPI 62.5 mcg/25 mcg/puff 1 inhalation once daily ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-365 Pulmonary Disorders and Adult Immunizations Table 6. Pharmacologic Agents Used for Asthma and COPD (Cont’d) Generic Brand Combination ICS/LABA Budesonide/formoterol Symbicort (generic MDI 80 mcg/4.5 mcg/puff available) 160 mcg/4.5 mcg/puff Fluticasone/salmeterol DPI 100 mcg/50 mcg/puff 250 mcg/50 mcg/puff 500 mcg/50 mcg/puff Advair Diskus Wixela Inhub (generic available) Fluticasone/salmeterol MDI 45 mcg/21 mcg/puff 115 mcg/21 mcg/puff 230 mcg/21 mcg/puff Advair HFA Fluticasone propionate/ salmeterol DPI 55 mcg/14 mcg/puff 113 mcg/14 mcg/puff 232 mcg/14 mcg/puff Fluticasone furoate/ vilanterol DPI 100 mcg/25 mcg 200 mcg/25 mcg AirDuo RespiClick AirDuo Digihaler Breo Ellipta Dulera Mometasone/ formoterol DPI 100 mcg/5 mcg/puff 200 mcg/5 mcg/puff Combination ICS/LAMA/LABA Trelegy Fluticasone furoate/ Ellipta umeclidinium/ vilanterol DPI 100 mcg/62.5 mcg/ 25 mcg/blister Budesonide/ glycopyrrolate/ formoterol MDI 160 mcg/9 mcg/ 4.8 mcg/puff Breztri Aerosphere Dose Adverse Effects 2 puffs BID Nasopharyngitis HA URTI Sinusitis Oral candidiasis Vomiting Influenza Back pain URTI Pharyngitis Dysphonia Oral candidiasis Cough HA N/V 2 puffs BID URTI Throat irritation Dysphonia HA Dizziness N/V One inhalation Nasopharyngitis twice daily Oral candidiasis Back pain HA Cough 1 inhalation Nasopharyngitis once daily URTI HA Oral candidiasis Back pain Influenza Dysphonia Cough Pharyngitis 2 puffs BID Nasopharyngitis Sinusitis HA Comments Single maintenance and reliever therapy (SMART) for asthma: 5–11 years: 1–2 puffs as needed up to a total daily maintenance and reliever dose of 8 puffs (36 mcg) 12 years and older: 1–2 puffs as needed up to a total daily maintenance and reliever dose of 12 puffs (54 mcg) 1 puff BID Not FDA-approved for COPD Generic equivalent of AirDuo is available Not FDA-approved for COPD One inhalation URTI once daily Pneumonia Bronchitis Oral candidiasis HA Back pain Arthralgia Influenza Sinusitis 2 puffs BID URTI Pneumonia Back pain Oral candidiasis Influenza Muscle spasm Cough Sinusitis ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-366 Pulmonary Disorders and Adult Immunizations Table 6. Pharmacologic Agents Used for Asthma and COPD (Cont’d) Generic Brand Dose Singulair Dose in the evening Adults and those ≥ 15 yr: 10 mg/day Children 6 to < 15 yr: 5 mg/day Children 1 to < 6 yr: 4 mg/day Adverse Effects Comments LTRAs Montelukast Oral 10-mg tablet Chewable 4- and 5-mg tablets Oral granules 4 mg/ packet Zafirlukast 10-mg tablet 20-mg tablet Accolate Zileuton 600-mg ER tablet Zyflo Headache GI upset Hepatotoxicity (zafirlukast and zileuton only) Zafirlukast: Monitor symptoms, may consider regular LFT monitoring but not needed Zileuton: Monitor LFTs (baseline, every 10–20 mg BID month × 3 mo, every 2–3 mo for remainder of first year) 1200 mg BID Also indicated in exercise-induced bronchospasm and seasonal and perennial allergic rhinitis FDA approved for use in children ≥ 1 yr; used in children ≥ 6 mo Churg-Strauss syndrome associated with tapering doses of steroids *I n March 2020, FDA added a boxed warning for montelukast because of the risk of serious neuropsychiatric events Drug interactions: Warfarin, erythromycin, theophylline FDA approved for children ≥ 5 yr Bioavailability decreases with food; take 1 hr before or 2 hr after meals Drug interactions: warfarin, theophylline Only for those ≥ 12 yr Less desirable for asthma treatment due to limited studies as adjunctive therapy and the need to monitor liver function Monoclonal antibody/IgE–binding inhibitor Omalizumab Xolair 150–375 mg SC every 2–4 wk Dose and frequency based on baseline IgE and weight in kilograms Do not inject > 150 mg per injection site Injection site reactions: Urticaria Thrombocytopenia (transient) Anaphylaxis (rare) Malignancy September 2014: FDA Drug Safety Communication. Slightly increased risk of cardiovascular and cerebrovascular serious adverse events, including MI, unstable angina, TIA, PE/DVT, pulmonary HTN; no increased risk of stroke or CV death Used in severe persistent allergyrelated asthma Use in those ≥ 12 yr Half-life: 26 days Second-line therapy Expensive No longer required to be only administered in a healthcare setting Prefilled syringe available for home use ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-367 Pulmonary Disorders and Adult Immunizations Table 6. Pharmacologic Agents Used for Asthma and COPD (Cont’d) Generic Brand Dose Adverse Effects Comments Dupixent 400 mg SC x 1; then 200 mg SC every other week OR 600 mg SC x 1; then 300 mg SC every other week (use higher dose if concomitant OCS required) Hypersensitivity reaction Conjunctivitis and keratitis Injection site reactions Oropharyngeal pain Eosinophilia Use in those ≥ 12 yr Indicated as add-on in those with eosinophilic asthma or who are OCS-dependent Avoid use of live vaccines Nucala 100 mg SC every 4 wk in the upper arm, thigh, or abdomen (≥ 12 yr) Injection-site reactions: Headache Fatigue Herpes zoster infection Hypersensitivity reaction (rare) FDA-approved November 2015 Add-on maintenance therapy in severe asthma in ages ≥ 6 with an eosinophilic phenotype No eosinophil threshold is listed. However, data suggest that the absolute blood eosinophil count should be ≥ 150/mm3 if patient is not taking daily systemic corticosteroids Reduces rate of asthma exacerbations by > 50%; reduces corticosteroid dose by 50% IL-4 antagonist Dupilumab IL-5 antagonist Mepolizumab 40 mg SC every 4 wk (6–11 yr) Reslizumab Cinqair 3 mg/kg IV infusion over 20–50 min every 4 wk Increased creatine kinase concentration Myalgia Throat pain Anaphylaxis (rare) FDA approval in March 2016 Add-on maintenance therapy in severe asthma in those ≥ 18 with an eosinophilic phenotype In clinical trials, the eosinophilic phenotype was defined as a peripheral blood absolute eosinophil count of ≥ 400/mm3 if patient not taking daily systemic corticosteroids Reduces rate of asthma exacerbations by about 50% in these patients Benralizumab Fasenra 30 mg SC every 4 wk for the first 3 doses, followed by once every 8 wk in upper arm, thigh, or abdomen Headache Pharyngitis Fever Hypersensitivity reaction FDA-approved November 2017 Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-368