Amikacin (inhaled)
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS ARIKAYCE has been associated with an increased risk of respiratory adverse reactions including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4) ] . WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS See full prescribing information for complete boxed warning.
ARIKAYCE has been associated with a risk of increased respiratory adverse reactions, including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases. ( 5.1 , 5.2 , 5.3 , 5.4 )
Aminoglycoside Antibacterial
Dosing in kidney impairment
Renal Impairment ARIKAYCE has not been studied in patients with renal impairment. Given the low systemic exposure to amikacin following administration of ARIKAYCE, clinically relevant accumulation of amikacin is unlikely to occur in patients with renal impairment. However, renal function should be monitored in patients with known or suspected renal impairment, including elderly patients with potential age-related decreases in renal function [see Warnings and Precautions , Use in Specific Populations ].
Dosing in liver impairment
Hepatic Impairment ARIKAYCE has not been studied in patients with hepatic impairment. No dose adjustments based on hepatic impairment are required since amikacin is not hepatically metabolized [see Clinical Pharmacology ].
Preparation and administration
Important Administration Instructions ARIKAYCE is for oral inhalation use only. Administer by nebulization only with the Lamira ® Nebulizer System. Refer to the Instructions for Use for full administration information on use of ARIKAYCE with the Lamira Nebulizer System. Instruct patients using a bronchodilator ('reliever') to first use the bronchodilator following the bronchodilator leaflet for use information before using ARIKAYCE.
Pre-treatment with short-acting selective beta-2 agonists should be considered for patients with known hyperreactive airway disease, chronic obstructive pulmonary disease, asthma, or bronchospasm [see Warnings and Precautions ] .
Drug interactions
Check amikacin (inhaled) against a medication listLabel text (3 paragraphs)
7 DRUG INTERACTIONS
7.1 Drugs with Neurotoxic, Nephrotoxic, or Ototoxic Potential Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity.
7.2 Ethacrynic Acid, Furosemide, Urea, or Mannitol Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol.
Contraindications
4 CONTRAINDICATIONS ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside. ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no data on ARIKAYCE 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 [see Clinical Pharmacology (12.3) ], systemic exposure to aminoglycoside antibacterial drugs, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness when administered to pregnant women [see Warnings and Precautions (5.9) ] . Advise pregnant women of the potential risk to a fetus. Animal reproductive toxicology studies have not been conducted with inhaled amikacin.
Subcutaneous 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. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data No animal reproductive toxicology studies have been conducted with ARIKAYCE or non-liposomal amikacin administered by inhalation. Amikacin was subcutaneously administered to pregnant rats (Gestation Days 8-14) and mice (Gestation Days 7-13) at doses of 25, 100, or 400 mg/kg to assess developmental toxicity. These doses did not cause fetal visceral or skeletal malformations in mice. The high dose was excessively maternally toxic in rats (nephrotoxicity and mortality were observed), precluding the evaluation of offspring at this dose. Fetal malformations were not observed at the low or mid dose in rats.
Postnatal development of the rats and mice exposed to these doses of amikacin in utero did not differ significantly from control. Ototoxicity was not adequately evaluated in offspring in animal developmental toxicology studies.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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