Amikacin Sulphate Injection

LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options . This drug is indicated for use in a limited and specific population of patients. …

• For oral inhalation use only
• Use ARIKAYCE vials only with the Lamira Nebulizer System
• Pre-treatment with inhaled bronchodilator should be considered in patients with a history of hyperreactive airway disease
• The recommended dosage
• In adults is once daily oral inhalation of the contents of one 590 mg/8.4 mL ARIKAYCE vial
• 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 ]
• Recommended Dosage The recommended dosage of ARIKAYCE
• In adults is once daily inhalation of the contents of one 590 mg/8.4 mL ARIKAYCE vial (590 mg of amikacin) using the Lamira Nebulizer System [see Clinical Studies ]
• Administer ARIKAYCE with the Lamira Nebulizer System only
• ARIKAYCE should be at room temperature before use

ARIKAYCE is supplied as a sterile, white, milky, aqueous, liposome suspension for oral inhalation in a unit-dose glass vial containing amikacin 590 mg/8.4 mL (equivalent to amikacin sulfate 788 mg/8.4 mL). ARIKAYCE is supplied as a sterile, aqueous, liposome suspension for oral inhalation in a unit-dose glass vial containing amikacin 590 mg/8.4 mL. ( 3 )

• Safety and effectiveness of ARIKAYCE
• In pediatric patients below 18 years of age have not been established

In the NTM clinical trials, of the total number of patients receiving ARIKAYCE, 208 (51.5%) were ≥ 65 years and 59 (14.6%) were ≥ 75 years. No overall differences in safety and effectiveness were observed between elderly subjects and younger subjects. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see Warnings and Precautions (5.7) ].

• Advise the patient to read the FDA-approved patient labeling (Medication Guide and Patient Instructions for Use)
• Important Instructions for Administration of ARIKAYCE Instruct patients to read the Instructions for Use before starting ARIKAYCE
• Instruct patients to only use the Lamira ® Nebulizer System to administer ARIKAYCE
• Advise the patient or caregiver not to use the Lamira Nebulizer System with any other medicine
• Hypersensitivity Pneumonitis and Bronchospasm (Difficulty Breathing) Advise patients to inform their healthcare provider if they experience shortness of breath or wheezing after administration of ARIKAYCE. …

• ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside
• ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside

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.

Hypersensitivity Pneumonitis : Reported with ARIKAYCE treatment; if hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate. ( 5.1 ) Hemoptysis : Higher frequency of hemoptysis has been reported with ARIKAYCE treatment. If hemoptysis occurs, manage the patients as medically appropriate. ( 5.2 ) Bronchospasm : Higher frequency of bronchospasm has been reported with ARIKAYCE treatment. Treat patients as medically appropriate if this occurs during treatment with ARIKAYCE. ( 5.3 ) Exacerbations of Underlying Pulmonary Disease: Higher frequency of exacerbations of underlying pulmonary disease has been reported with ARIKAYCE treatment. …

The following clinically significant adverse reactions are described in greater detail in other sections of labeling: Hypersensitivity pneumonitis [see Boxed Warning and Warnings and Precautions (5.1) ] Hemoptysis [see Boxed Warning and Warnings and Precautions (5.2) ] Bronchospasm [see Boxed Warning and Warnings and Precautions (5.3) ] Exacerbation of Underlying Pulmonary Disease [see Boxed Warning and Warnings and Precautions (5.4) ] Anaphylaxis and Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Ototoxicity [see Warnings and Precautions (5.6) ] Nephrotoxicity [see Warnings and Precautions (5.7) ] Neuromuscular Blockade [see Warnings and Precautions (5.8) ] Most common adv …

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, bilatera …

Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. In the case of any overdosage, the possibility of drug interactions with alterations in drug disposition should be considered.

Store ARIKAYCE vials refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date on vial. Do not freeze. Once expired, discard any unused drug. ARIKAYCE can be stored at room temperature up to 25°C (77°F) for up to 4 weeks. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.