ARIKAYCE KIT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ARIKAYCE KIT (ARIKAYCE KIT).
Amikacin is an aminoglycoside antibiotic that binds to the 30S ribosomal subunit of susceptible bacteria, causing misreading of mRNA and inhibiting protein synthesis.
| Metabolism | Amikacin undergoes minimal hepatic metabolism; primarily excreted unchanged in urine via glomerular filtration. |
| Excretion | Amikacin is primarily eliminated unchanged by glomerular filtration; renal excretion accounts for approximately 94-98% of the dose within 24 hours. Biliary/fecal elimination is minimal (<1%). |
| Half-life | The terminal elimination half-life of amikacin from plasma is approximately 2-3 hours in patients with normal renal function. In the liposomal formulation (ARIKAYCE), after inhalation, the half-life in epithelial lining fluid is prolonged, with a terminal half-life of approximately 23 hours. Clinical context: accumulation may occur with renal impairment. |
| Protein binding | Amikacin is approximately 0-11% bound to plasma proteins. |
| Volume of Distribution | Amikacin has a volume of distribution of approximately 0.25 L/kg (range 0.18-0.33 L/kg) in adults, indicating distribution primarily in extracellular fluid. Clinical meaning: loading dose may be needed to achieve therapeutic concentrations. |
| Bioavailability | Inhaled administration of ARIKAYCE: absolute bioavailability is approximately 77% of the nominal dose deposited in the lungs, but systemic bioavailability is low (approximately 10% of administered dose reaches the systemic circulation). |
| Onset of Action | Inhaled administration: time to peak concentration in epithelial lining fluid is approximately 1-2 hours; clinical antimycobacterial effect is expected within days to weeks of continuous therapy. For intravenous administration (not indicated with this kit): immediate. |
| Duration of Action | Inhaled: drug remains above MIC for most of the dosing interval (24 hours) in epithelial lining fluid; clinical duration supports once-daily dosing. Systemic amikacin has a duration of 8-12 hours based on serum concentrations. |
590 mg (contents of one kit) administered as inhalation via the Lamira Nebulizer System once daily.
| Dosage form | SUSPENSION, LIPOSOMAL |
| Renal impairment | No dose adjustment recommended for mild to moderate renal impairment. Not studied in severe renal impairment (CrCl <30 mL/min) or ESRD. |
| Liver impairment | No dose adjustment recommended for mild to moderate hepatic impairment. Not studied in severe hepatic impairment (Child-Pugh Class C). |
| Pediatric use | Safety and efficacy not established in pediatric patients below 18 years. |
| Geriatric use | No specific dose adjustment; use with caution due to greater frequency of hepatic, renal, or cardiac dysfunction and concomitant disease or drug therapy. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ARIKAYCE KIT (ARIKAYCE KIT).
| Breastfeeding | Unknown if distributed in human milk. No M/P ratio available. Weigh benefits of breastfeeding against potential infant exposure. Consider alternative agents. |
| Teratogenic Risk | Insufficient human data; animal studies show fetal harm at high doses. Avoid in first trimester unless benefit outweighs risk. Risk cannot be excluded for second and third trimesters. |
| Fetal Monitoring |
■ FDA Black Box Warning
WARNING: INCREASED RISK OF NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE, AND FETAL HARM. Amikacin can cause nephrotoxicity, ototoxicity, and neuromuscular blockade. Avoid use in pregnancy due to risk of fetal harm.
| Serious Effects |
Hypersensitivity to amikacin or any aminoglycoside; myasthenia gravis (risk of neuromuscular blockade); pregnancy (teratogenic effects).
| Precautions | Nephrotoxicity (monitor renal function), ototoxicity (hearing loss, tinnitus, vertigo), neuromuscular blockade (use caution with neuromuscular disorders), hypersensitivity reactions, respiratory adverse reactions (cough, hemoptysis, dyspnea), and superinfection. |
| Food/Dietary | No specific food interactions reported. However, avoid grapefruit and grapefruit juice as they may affect drug metabolism (per general caution). Maintain adequate hydration to reduce risk of renal toxicity. |
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| Monitor maternal liver function tests, renal function, and auditory/vestibular function. Fetal ultrasound for growth and anatomy if exposure during pregnancy. |
| Fertility Effects | No human fertility studies. Animal studies show impaired fertility at high doses. Potential for reversible ovarian toxicity based on aminoglycoside class effects. |
| Clinical Pearls | ARIKAYCE (amikacin liposome inhalation suspension) is a once-daily inhaled antibiotic for Mycobacterium avium complex (MAC) lung disease in adults with limited treatment options. Administer via the Lamira nebulizer system only. Pre-treatment with a bronchodilator is recommended to reduce risk of bronchospasm. Monitor for hemoptysis, hypersensitivity, and nephrotoxicity. Obtain baseline pulmonary function tests and audiometry. Dose adjustment required in renal impairment (CrCl < 30 mL/min: avoid use). Do not mix with other drugs in the nebulizer. |
| Patient Advice | Use only with the Lamira nebulizer system; do not substitute with other nebulizers. · Take once daily as prescribed; do not double the dose if a dose is missed. · Use a bronchodilator 15-30 minutes before each dose unless contraindicated. · Report any signs of allergic reaction (rash, hives, difficulty breathing) or blood in sputum immediately. · You may experience temporary cough, dysphonia, or metallic taste; these often improve with continued use. · Store unopened vials in refrigerator; do not freeze. Vials must be used within 7 days of removal from refrigerator. |