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Arikayce

Last reviewed on RxList: 10/10/2018
Arikayce Side Effects Center

Last reviewed on RxList 10/10/2018

Arikayce (amikacin liposome inhalation suspension) is an aminoglycoside antibacterial 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. This drug is indicated for use in a limited and specific population of patients. Common side effects of Arikayce include:

  • difficulty speaking,
  • cough,
  • bronchospasm,
  • coughing up blood,
  • damage to the inner ear,
  • upper airway irritation,
  • musculoskeletal pain,
  • fatigue,
  • weakness,
  • worsening of underlying lung disease,
  • diarrhea, and
  • nausea

The recommended dosage of Arikayce in adults is once daily oral inhalation of the contents of one 590 mg/8.4 mL Arikayce vial. Use Arikayce vials only with the Lamira Nebulizer System. Arikayce may interact with ethacrynic acid, furosemide, urea, intravenous mannitol, or medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Arikayce; it may harm a fetus. It is unknown if Arikayce passes into breast milk. Consult your doctor before breastfeeding.

Our Arikayce (amikacin liposome inhalation suspension), for Oral Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Arikayce Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • cough (especially during the first month of using amikacin liposome);
  • trouble speaking;
  • ringing in your ears, changes in hearing;
  • dizziness, spinning sensation;
  • a light-headed feeling, like you might pass out;
  • breathing problems--chest tightness, wheezing, shortness of breath, coughing up blood; or
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

  • fever, cough, increased mucus, sore throat;
  • hoarse voice, breathing problems;
  • headache, muscle pain, chest discomfort;
  • nausea, vomiting, diarrhea;
  • rash;
  • weight loss; or
  • feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Arikayce (Amikacin Liposome Inhalation Suspension)

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Arikayce Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described in greater detail in other sections of labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Overview Of Clinical Trials For Safety Evaluation

Within the refractory NTM clinical program, 388 patients that participated in three clinical trials were treated with ARIKAYCE at the dose of 590 mg/day (median duration of exposure to ARIKAYCE was 169 days).

Trial 1 (NCT#02344004) was an open-label, randomized (2:1), multi-center Phase 3 trial in patients with refractory Mycobacterium avium complex (MAC) lung disease . Patients were randomized to either 8 months of ARIKAYCE plus a background regimen (n=223) or background regimen alone (n=112).

Trial 2 was a single-arm extension of Trial 1 for refractory MAC lung disease patients that failed to achieve negative sputum cultures after 6 months of treatment or had a relapse or recurrence by Month 6 from either study arm of Trial 1. A total of 133 patients (n=74 from the prior background regimen alone arm of Trial 1, and n=59 from the prior ARIKAYCE plus background regimen arm in Trial 1) participated in the trial.

Trial 3 (NCT#01315236) was a double-blind, randomized, placebo-controlled Phase 2 study in patients with refractory nontuberculous mycobacterial (NTM) lung disease caused by MAC and Mycobacterium abscessus. Patients were randomized to either ARIKAYCE plus background regimen or an inhaled diluted empty liposome placebo plus background regimen for 84 days.

Across all clinical trials of patients with and without refractory NTM lung infection, 802 patients were exposed to multiple doses of ARIKAYCE.

Adverse Reactions Leading To Treatment Discontinuation

In the three NTM studies, there was a higher incidence of premature discontinuation of ARIKAYCE. In Trial 1, 33.5% discontinued ARIKAYCE prematurely; most were due to adverse reactions (17.4%) and withdrawal by subject (9.4%).In the comparator arm 8% of subjects discontinued theirbackground regimen, with 0.9% due to adverse reactions and 5.4% due to withdrawal by subject. In Trial 2 (the single-arm extension of Trial 1), 20.3% of patients starting on ARIKAYCE discontinued prematurely with 14.9% discontinuing due to adverse reactions. In Trial 3, all 9 (20.5%) premature discontinuations occurred in the ARIKAYCE plus background regimen -treated patients and there were no premature discontinuations in the placebo plus background regimen arm.

Serious Adverse Reactions In Trials 1 And 3

In the two randomized trials (Trial 1 and Trial 3), there were more serious adverse reactions (SARs) reported in the ARIKAYCE-treated arm as compared to the respective control arm. In Trial 1, 20.2% of patients treated with ARIKAYCE plus background regimen reported SAR as compared to 16.1% of patients treated with background regimen alone. In addition, in Trial 1 [2 to 1 randomization, ARIKAYCE plus background regimen versus background regimen alone], there were 82 hospitalizations in 41 patients (18.4%) treated with ARIKAYCE plus background regimen compared to 23 hospitalizations in 15 patients (13.4%) treated with background regimen alone. The most common SARs and reasons for hospitalization in the ARIKAYCE plus background regimen arm were related to exacerbation of underlying pulmonary disease and lower respiratory tract infections, such as pneumonia.

In Trial 3, 18.2% of patients treated with ARIKAYCE plus background regimen reported SARs compared to 8.9% of patients treated with background regimen plus inhaled placebo.

Common Adverse Reactions

The incidence of adverse reactions in Trial 1 are displayed in Table 1. Only those adverse reactions with a rate of at least 5% in the ARIKAYCE plus background regimen group and greater than the background regimen alone group, are shown.

Table 1: Adverse Reactions in ≥ 5% of ARIKAYCE-treated MAC Patients and More Frequent than Background Regimen Alone in Trial 1

Adverse Reaction ARIKAYCE plus Background Regimen
(n=223)
n (%)
Background Regimen Alone
(n=112)
n (%)
Dysphoniaa 105 (47) 1 (1)
Coughb 87 (39) 19 (17)
Bronchospasmc 64 (29) 12 (11)
Hemoptysis 40 (18) 14 (13)
Ototoxicityd 38 (17) 11 (10)
Upper airway irritatione 37 (17) 2 (2)
Musculoskeletal painf 37 (17) 9 (8)
Fatigue and asthenia 36 (16) 11 (10)
Exacerbation of underlying pulmonary diseaseg 33 (15) 11 (10)
Diarrhea 28 (13) 5 (5)
Nausea 26 (12) 4 (4)
Pneumoniah 22 (10) 9 (8)
Headache 22 (10) 5 (5)
Pyrexia 16 (7) 5 (5)
Vomitingi 15 (7) 4 (4)
Rashj 14 (6) 2 (2)
Weight decreased 14 (6) 1 (1)
Change in sputumk 12 (5) 1 (1)
Chest discomfort 12 (5) 3 (3)
aIncludes aphonia and dysphonia
bIncludes cough, productive cough and upper airway cough syndrome
cIncludes asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing
dIncludes deafness, deafness neurosensory, deafness unilateral, dizziness, hypoacusis, presyncope, tinnitus, vertigo
eIncludes oropharyngeal pain, oropharyngeal discomfort, throat irritation, pharyngeal erythema, upper airway inflammation, pharyngeal edema, vocal cord inflammation, laryngeal pain, laryngeal erythema, laryngitis
f Includes back pain, arthralgia, myalgia, pain/body aches, muscle spasm and musculoskeletal g Includes COPD, infective exacerbation of COPD, infective exacerbation of bronchiectasis
hIncludes atypical pneumonia, empyema, infection pleural effusion, lower respiratory tract infection, lung infection, lung infection pseudomonas, pneumonia, pneumonia aspiration, pneumonia pseudomonas, pseudomonas infection and respiratory tract infection
iIncludes vomiting and post-tussive vomiting
jIncludes rash, rash maculo-papular, drug eruption and urticaria
kIncludes increased sputum, sputum purulent and sputum discolored

Selected adverse drug reactions that occurred in <5% of patients and at higher frequency in ARIKAYCE-treated patients in Trial 1 are presented in Table 2.

Table 2: Selected Adverse Reactions in < 5% of ARIKAYCE-treated MAC Patients and More Frequent than Background Regimen Alone in Trial 1

  ARIKAYCE plus Background Regimen
N=223
Background Regimen Alone
N=112
Anxiety 10 (4.5) 0 (0)
Oral fungal infectiona 9 (4) 2 (1.8)
Bronchitis 8 (3.6) 3 (2.7)
Hypersensitivity pneumonitisb 8 (3.6) 0 (0)
Dysgeusia 7 (3.1) 0 (0)
Respiratory failurec 6 (2.7) 1 (0.9)
Epistaxis 6 (2.7) 1 (0.9)
Neuromuscular disorderd 5 (2.2) 0 (0)
Dry mouth 5 (2.2) 0 (0)
Pneumothoraxe 5 (2.2) 1 (0.9)
Exercise tolerance decreased 3 (1.3) 0 (0)
Balance disorder 3 (1.3) 0 (0)
aIncludes oral candidiasis and oral fungal infection
bIncludes allergic alveolitis, interstitial lung disease, and pneumonitis
cIncludes acuter respiratory failure and respiratory failure
dIncludes muscle weakness, neuropathy peripheral, and balance disorder
eIncludes pneumonthorax, pneumothorax spontaneous and pneumomediastinum

Refer to Table 1 and Table 2 for the incidence rate of hypersensitivity pneumonitis, bronchospasm, cough, dysphonia, exacerbation of underlying disease, hemoptysis, ototoxicity, upper airway irritation, and neuromuscular disorders [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Arikayce (Amikacin Liposome Inhalation Suspension)

Related Resources for Arikayce

© Arikayce Patient Information is supplied by Cerner Multum, Inc. and Arikayce Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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