Arikayce
- Generic Name: amikacin liposome inhalation suspension
- Brand Name: Arikayce
Arikayce (Amikacin Liposome Inhalation Suspension) side effects drug center
Arikayce Side Effects Center
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.
Arikayce Consumer Information
Amikacin liposome can cause a serious allergic reaction that may lead to death. Stop using this medicine and get emergency medical help if you have signs of an allergic reaction:
- wheezing, noisy breathing, cough, feeling short of breath;
- itching, hives, swelling of your face, lips, tongue, or throat;
- fast heart rate, feeling light-headed;
- loss of bladder or bowel control;
- nausea, vomiting, diarrhea, stomach cramps;
- flushing (sudden warmth, redness, or tingly feeling).
Call your doctor at once if you have:
- ringing in your ears, changes in hearing;
- cough (especially during the first month of using amikacin liposome);
- trouble speaking;
- 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;
- 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)
Arikayce Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are described in greater detail in other sections of labeling:
- Hypersensitivity pneumonitis [see BOX WARNING and WARNINGS AND PRECAUTIONS]
- Hemoptysis [see BOX WARNING and WARNINGS AND PRECAUTIONS]
- Bronchospasm [see BOX WARNING and WARNINGS AND PRECAUTIONS]
- Exacerbation of Underlying Pulmonary Disease [see BOX WARNING and WARNINGS AND PRECAUTIONS]
- Ototoxicity [see WARNINGS AND PRECAUTIONS]
- Nephrotoxicity [see WARNINGS AND PRECAUTIONS]
- Neuromuscular Blockade [see WARNINGS AND PRECAUTIONS]
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 |
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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 |
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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)
© 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.