ARIKAYCE Dosage & Rx Info | Uses, Side Effects

Arikayce Generic Name & Formulations

Legal Class

General Description

Amikacin 590mg/8.4mL; per vial; liposome susp for oral inh.

Pharmacological Class

Aminoglycoside.

How Supplied

Kit—1 (28-vials [10mL] + Lamira Nebulizer w. supplies)

Manufacturer

Insmed Incorporated

Generic Availability

Mechanism of Action

The primary mechanism of action of amikacin is the disruption and inhibition of protein synthesis in the target bacteria by binding to the 30S ribosomal subunit.

Arikayce Indications

Indications

Treatment of Mycobacterium avium complex (MAC) lung disease, as part of a combination antibacterial regimen, in adults with limited or no alternative treatment options who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen.

Limitations of Use

Only studied in patients with refractory MAC lung disease. Not recommended for patients with non-refractory MAC lung disease.

Arikayce Dosage and Administration

Adult

Use with Lamira Nebulizer system only. Consider pre-treatment with short-acting selective beta-2 agonist in known hyperreactive airway disease, COPD, asthma or bronchospasm. ≥18yrs: Inhale orally contents of 1 vial (590mg) once daily.

Children

<18yrs: not established.

Arikayce Contraindications

Not Applicable

Arikayce Boxed Warnings

Boxed Warning

Risk of increased respiratory adverse reactions.

Arikayce Warnings/Precautions

Warnings/Precautions

Increased risk for respiratory adverse reactions potentially leading to hospitalizations. Discontinue if hypersensitivity pneumonitis, anaphylaxis or hypersensitivity reaction occurs; manage appropriately. Auditory/vestibular dysfunction; monitor closely; if ototoxicity occurs, manage and discontinue if appropriate. Risk for ototoxicity (known maternal history of ototoxicity due to aminoglycoside use or mitochondrial DNA variants); consider alternative therapies. Renal dysfunction or neuromuscular disorders (eg, myasthenia gravis); monitor closely. Elderly: monitor renal function. Embryo-fetal toxicity. Pregnancy: avoid use. Nursing mothers.

Arikayce Pharmacokinetics

Absorption

The bioavailability of Arikayce is expected to vary primarily from individual differences in nebulizer efficiency and airway pathology.

Distribution

Serum protein bound: ≤10%.

Metabolism

Amikacin does not undergo appreciable metabolism.

Elimination

Principally via glomerular filtration. Renal (7.42%). Half-life: ~5.9–19.5 hours.

Arikayce Interactions

Interactions

Avoid concomitant with neurotoxic, nephrotoxic, and ototoxic drugs. Avoid concomitant furosemide, ethacrynic acid, urea, IV mannitol. Diuretics may increase toxicity.

Arikayce Adverse Reactions

Adverse Reactions

Dysphonia, cough, bronchospasm, hemoptysis, ototoxicity, upper airway irritation, musculoskeletal pain, fatigue/asthenia, exacerbation of underlying pulmonary disease, diarrhea, nausea, pneumonia, headache, pyrexia, vomiting, rash, weight decreased, change in sputum, chest discomfort; nephrotoxicity, neuromuscular blockade, anaphylaxis.

Arikayce Clinical Trials

See Literature

Arikayce Note