indacaterol, inhaled (Rx)Brand and Other Names:Arcapta Neohaler

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule, powder for inhalation

  • 75mcg/capsule
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COPD

Long-acting beta2-agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

75 mcg inhaled orally qDay; not to exceed once daily

Limitations of use

  • Not indicated for acute deteriorations of COPD
  • Not indicated for asthma

Administration

For oral inhalation only

Do not swallow the capsules for inhalation; if swallowed, intended effects on the lungs will not be obtained

For use with Neohaler inhaler device only

Administer qDay at the same time of the day by the oral inhalation route only

If a dose is missed, the next dose should be taken as soon as it is remembered

Not to exceed once daily administration

Store capsule in the blister pack it comes in until immediately before use

Safety and efficacy not established

No dosage adjustment is required for geriatric patients, patients with mild-to-moderate hepatic impairment, or patients with renal impairment

Data are not available for severe hepatic impairment

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Interactions

Interaction Checker

indacaterol, inhaled and

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Post-inhalation cough (24% compared with 7% on placebo)

            1-10%

            Cough (6.5%)

            Nasopharyngitis (5.3%)

            Headache (5.1%)

            Nausea (2.4%)

            Oropharyngeal pain (2.2%)

            Postmarketing Reports

            Hypersensitivity reactions

            Paradoxical bronchospasm

            Tachycardia/heart rate increase/palpitations

            Pruritus/rash

            Dizziness

            Pruritus

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            Warnings

            Black Box Warnings

            Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death

            Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol

            This finding with salmeterol is considered a class effect of LABA, including indacaterol

            The safety and efficacy of indacaterol in patients with asthma have not been established

            Indacaterol is NOT indicated for the treatment of asthma

            Contraindications

            Hypersensitivity

            All long-acting beta2-adrenergic agonists (LABAs) are contraindicated in patients with asthma without use of a long-term asthma control medication

            Cautions

            Do not initiate in acutely deteriorating COPD patients

            Do not use for relief of acute symptoms; prescribe concomitant short-acting beta2-agonists for acute exacerbations

            Do not exceed recommended daily dose; excessive doses may result in cardiovascular effects and may be fatal

            Life-threatening paradoxical bronchospasm can occur; discontinue use immediately

            Immediate hypersensitivity reactions reported; discontinue immediately and initiate alternate therapy

            Data from a large placebo-controlled study in asthma patients showed that long-acting beta2-adrenergic agonists may increase the risk of asthma-related death (see Black Box Warnings)

            Caution with CV disease, epilepsy, thyrotoxicosis, or sensitivity to sympathomimetics

            Contains trace levels of milk protein

            Tolerance to the effects of inhaled beta-agonists can occur with regularly-scheduled, chronic use

            Increased sympathomimetic effects may occur if coadministered with other adrenergic drugs

            May cause hypokalemia; this effect may be potentiated if coadministered with xanthine derivatives, corticosteroids, or diuretics

            ECG changes or hypokalemia that may result from non-potassium sparing diuretics (eg, thiazides or loop diuretics) can be acutely worsened by beta-agonists, especially with high doses; use caution

            Caution with coadministration of MOAIs, TCAs, and drugs that prolong QTc interval

            Beta blockers may antagonize the effect of indacaterol

            Strong dual inhibitors of CYP3A4 and P-gp (ie, ketoconazole, erythromycin, verapamil, ritonavir) may delay systemic clearance of indacaterol (AUC increased 1.9-fold); no dose adjustment is warranted with 75 mcg/day

            Beta2 agonists may increase serum glucose; use caution in patients with diabetes mellitus

            Use caution in patients with seizure disorders

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            Pregnancy & Lactation

            Pregnancy Category: C

            Beta-agonists are known to inhibit uterine contractility

            Lactation: Unknown whether distributed in human breast milk; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Long-acting beta2-adrenergic agonist; when inhaled, acts locally in the lung as a bronchodilator

            Stimulates intracellular adenyl cyclase, causing conversion of ATP to cyclic AMP; increased cyclic AMP levels cause relaxation of bronchial smooth muscle

            In vitro studies have shown that indacaterol has more than 24-fold greater agonist activity at beta2-receptors compared to beta1-receptors (selectivity profile is similar to formoterol)

            Absorption

            Bioavailability: 43-45% following inhalation (composite of pulmonary and intestinal absorption)

            Peak Plasma Time: 15 min

            Distribution

            Protein Bound: 95% (after IV administration)

            Vd: 2361-2557 L (after IV administration)

            Metabolism

            Metabolized by UGT1A1, CYP3A4 (predominant for hydroxylation), CYP1A1, CYP2D6

            Low affinity for efflux pump P-gp

            In vitro investigations indicated that indacaterol has negligible potential to cause metabolic interactions with medications (by inhibition or induction of cytochrome P450 enzymes, or induction of UGT1A1)

            Elimination

            Half-life (terminal): 45.5-126 hr, multiphasic half-life

            Half-life (effective): 40-56 hr, calculated from accumulation after repeated dosing

            Renal clearance: 0.46-1.2 L/hr

            Total body clearance: 18.8-23.3 L/hr

            Excretion: feces (54% unchanged, 23% hydroxylated metabolites), urine (<2%)

            Pharmacogenomics

            Pharmacokinetics were prospectively investigated in individuals with the UGT1A1 (TA)7/(TA)7 genotype (low UGT1A1 expression; also referred to as *28) and the (TA)6, (TA)6 genotype

            Steady-state AUC and Cmax were 1.2-fold higher in the [(TA)7, (TA)7] genotype, suggesting no relevant effect of UGT1A1 genotype of indacaterol exposure

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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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