amikacin liposome inhalation (Rx)

Brand and Other Names:Arikayce
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Dosing & Uses

AdultPediatric

Dosing Forms & Strengths

liposome suspension for oral inhalation

590mg/8.4mL; single-use vial (623mg/8.4mL amikacin sulfate equivalent)

Mycobacterium Avium Complex Lung Disease

Indicated for Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in adults who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy

Limited data available on safety and efficacy; reserve use in adults who have limited or no alternative treatment options; drug is indicated for use in a limited and specific population of patients

590 mg/8.4 mL inhaled orally qDay

Dosage Modifications

Hepatic impairment

  • Not studied
  • No dose adjustments since amikacin is not hepatically metabolized

Renal impairment

  • Not studied
  • Given low systemic exposure to amikacin following administration, clinically relevant accumulation of amikacin is unlikely to occur
  • Monitor renal function in patients with known or suspected renal impairment, including elderly patients with potential age-related decreases in renal function

Dosing Considerations

Accelerated approval

  • Indication approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by month 6
  • Clinical benefit has not yet been established; continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials

Limitation of use

  • Use only studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy
  • Not recommended for patients with nonrefractory MAC lung disease

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and amikacin liposome inhalation

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            Adverse Effects

            >10%

            Dysphonia (47%)

            Cough (39%)

            Bronchospasm (29%)

            Hemoptysis (18%)

            Ototoxicity (17%)

            Upper airway irritation (17%)

            Musculoskeletal pain (17%)

            Fatigue and asthenia (16%)

            Exacerbation of underlying pulmonary disease (15%)

            Diarrhea (13%)

            Nausea (12%)

            1-10%

            Pneumonia (10%)

            Headache (10%)

            Pyrexia (7%)

            Vomiting (7%)

            Rash (6%)

            Weight decreased (6%)

            Change in sputum (5%)

            Chest discomfort (5%)

            Anxiety (4.5%)

            Oral fungal infection (4%)

            Bronchitis (3.6%)

            Hypersensitivity pneumonitis (3.6%)

            Dysgeusia (3.1%)

            Respiratory failure (2.7%)

            Epistaxis (2.7%)

            Neuromuscular disorder (2.2%)

            Dry mouth (2.2%)

            Pneumothorax (2.2%)

            Exercise tolerance decreased (1.3%)

            Balance disorder (1.3%)

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            Warnings

            Black Box Warnings

            Associated with risk of increased respiratory adverse reactions, including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations

            Contraindications

            Hypersensitivity to any aminoglycoside

            Cautions

            Hypersensitivity pneumonitis (eg, allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction) reported; if hypersensitivity pneumonitis occurs, discontinue drug and manage as medically appropriate

            Hemoptysis reported; if hemoptysis occurs, manage as medically appropriate

            Bronchospasm (eg, asthma, bronchial hyperreactivity, bronchospasm, dyspnea, exertional dyspnea, prolonged expiration, throat tightness, wheezing) reported; if bronchospasm occurs, treat as medically appropriate

            Exacerbations of underlying pulmonary disease (eg, chronic obstructive pulmonary disease, infective exacerbation of chronic obstructive pulmonary disease, infective exacerbation of bronchiectasis) reported in clinical trials; if exacerbations of underlying pulmonary disease occur, treat as medically appropriate

            Ototoxicity (eg, deafness, dizziness, presyncope, tinnitus, vertigo) reported in clinical trials; closely monitor patients with known or suspected auditory or vestibular dysfunction; if ototoxicity occurs, manage as medically appropriate, including potentially discontinuing treatment

            Nephrotoxicity observed during clinical trials in patients with MAC lung disease; nephrotoxicity has been associated with the aminoglycosides; closely monitor patients with known or suspected renal dysfunction

            Patients with neuromuscular disorders were not enrolled in clinical trials; closely monitor patients with known or suspected neuromuscular disorders (eg, myasthenia gravis) since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions

            Fetal harm may occur when administered to a pregnant woman (see Pregnancy)

            Drug interactions overview

            • Avoid use with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity
            • Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue; avoid use with ethacrynic acid, furosemide, urea, or IV mannitol
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            Pregnancy

            Pregnancy

            There are no data on use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Although systemic absorption of amikacin following oral inhalation is expected to be low, systemic exposure to aminoglycoside antibacterial drugs, including inhaled amikacin, may be associated with total, irreversible, bilateral congenital deafness when administered to pregnant women

            Advise pregnant women of the potential risk to a fetus

            Animal data

            • Animal reproductive toxicology studies have not been conducted with inhaled amikacin
            • SC administration of amikacin to pregnant rats (up to 100 mg/kg/day) and mice (up to 400 mg/kg/day) during organogenesis was not associated with fetal malformations
            • Ototoxicity was not adequately evaluated in offspring in animal studies

            Lactation

            There is no information regarding presence of inhaled amikacin in human milk, effects on the breastfed infant, or effects on milk production

            Although limited published data on other routes of administration indicate that amikacin is present in human milk, systemic absorption following inhaled administration is expected to be low

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child or from the underlying maternal condition

            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

            Bactericidal aminoglycoside enters bacterial cell by disrupting overall cell wall architecture

            Disrupts and inhibits protein synthesis in target bacteria by binding to the 30S ribosomal subunit

            Mechanism of resistance to amikacin in Mycobacteria linked to mutations in rrs gene of the 16S rRNA

            Absorption

            Bioavailability is expected to vary primarily from individual difference in nebulizer efficiency and airway pathology

            Sputum concentrations (1-4 hr post inhalation): 1720 mcg/g (1 month), 884 mcg/g (3 months), and 1300 mcg/g (6 months)

            Peak plasma concentration: 2.8 mcg/mL AUC: 23.5 mcg·hr/mL

            After 48-72 hr post inhalation, amikacin sputum concentrations decreased to ~5% of those at 1-4 hr post inhalation

            Distribution

            Protein bound: ≤10%

            Metabolism

            Does not undergo appreciable metabolism

            Elimination

            Half-life: 5.9-19.5 hr

            Excretion: Urine (7.42%, unchanged)

            Systemically absorbed amikacin following administration is eliminated principally via glomerular filtration

            Unabsorbed amikacin, following inhalation, is probably eliminated primarily by cellular turnover and expectoration

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            Administration

            Oral Inhalation Preparation

            Suspension should be at room temperature before use

            Shake vial well for at least 10-15 seconds until contents appear uniform and well mixed

            Pour suspension into medication reservoir of nebulizer handset

            Oral Inhalation Administration

            For oral inhalation use only

            Administer by nebulization only with Lamira Nebulizer System (refer to prescribing information)

            If patient also uses a bronchodilator, instruct them to first use bronchodilator (according to bronchodilator instructions) before using amikacin liposome inhalation

            Consider pretreatment with short-acting selective beta-2 agonists for patients with known hyperreactive airway disease, chronic obstructive pulmonary disease, asthma, or bronchospasm

            Missed dose: Administer next dose the next day; do not double dose to make up for missed dose

            Storage

            Refrigerate 2-8°C (36-46°F) until expiration date on vial; do not freeze

            May be stored at room temperature (up to 25°C [77°F]) for up to 4 weeks

            Once at room temperature, discard any unused drug at end of 4 weeks

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            Formulary

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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.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            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.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.