MedCallyLooking up the FDA label…
Looking up the FDA label…
Aminoglycoside Antibacterial
Also sold as Arikayce, Amikacin Sulfate
FDA 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. 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.
1 INDICATIONS AND USAGE 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. This indication is 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 for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. …
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. Advise patients with a history of reactive airway disease, asthma, or bronchospasm, to administer ARIKAYCE after using a short-acting bronchodilator. Hemoptysis or Cough Advise patients to inform their healthcare provider if they cough up blood or experience episodic cough either during or after ARIKAYCE administration particularly in the first month after starting ARIKAYCE. Exacerbations of Underlying Pulmonary Disease Advise patients to inform their healthcare provider if they experience worsening of their lung disease after starting ARIKAYCE. Dysphonia or Difficulty Speaking Advise patients to inform their healthcare provider if they have difficulty speaking. Difficulty speaking or loss of ability to speak has been reported with ARIKAYCE. Anaphylaxis and Hypersensitivity Reactions Advise patients and caregivers that serious and potentially life-threatening hypersensitivity reactions, that require immediate treatment could occur. Advise the patient to discontinue ARIKAYCE and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur. Ototoxicity (Ringing in the Ears) Advise patients to inform their healthcare provider if they experience ringing in the ears, dizziness, or any changes in hearing because ARIKAYCE has been associated with hearing loss. …
The following clinically significant adverse reactions are described in greater detail in other sections of labeling: Hypersensitivity pneumonitis Hemoptysis Bronchospasm Exacerbation of Underlying Pulmonary Disease Anaphylaxis and Hypersensitivity Reactions Ototoxicity Nephrotoxicity Neuromuscular Blockade Most common adverse reactions (incidence ≥10% and higher than control) in the patients with refractory MAC lung disease were: dysphonia, cough, bronchospasm, hemoptysis, musculoskeletal pain, upper airway irrita…
Having one of these?
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Ask a doctor — $19.994 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.
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. 2.1 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…
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.
Taking something else alongside it?
Interaction warnings are written per drug, not for your particular combination. A doctor can check yours.
Ask about my combinationSame medicine, sold as
Works in a similar way — other antibiotics for topical use
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.