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Brand Name
Arikayce
Generic Name
Amikacin
View Brand Information FDA approval date: December 24, 2013
Classification: Aminoglycoside Antibacterial
Form: Injection, Suspension
What is Arikayce (Amikacin)?
LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex 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 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. LIMITED POPULATION: ARIKAYCE is an aminoglycoside antibacterial indicated in adults who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex 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 by Month 6. Clinical benefit has not yet been established. Limitation of Use: ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease. Limitation of Use : ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease.
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Brand Information
ARIKAYCE (Amikacin)
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
1INDICATIONS AND USAGE
LIMITED POPULATION: ARIKAYCE
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
2DOSAGE FORMS AND STRENGTHS
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).
3CONTRAINDICATIONS
ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
4ADVERSE REACTIONS
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
4.1Clinical 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.
4.2Postmarketing Experience
The following adverse reactions have been identified from postmarketing surveillance. Because these adverse reactions are reported voluntarily from a population of unknown size, precise estimates of frequency cannot be made and a causal relationship to drug exposure cannot be established.
Gastrointestinal disorders: dysphagia, glossitis, glossodynia, salivary hypersecretion, stomatitis, abdominal pain, abdominal distension
Immune system disorders: hypersensitivity, anaphylaxis, pharyngeal swelling
Renal and urinary disorders: acute kidney injury, renal failure
Respiratory, thoracic, and mediastinal disorders: nasal dryness, rhinorrhea, sneezing, nasal congestion
5OVERDOSAGE
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.
6DESCRIPTION
The active ingredient in ARIKAYCE (amikacin liposome inhalation suspension) is amikacin sulfate USP, an aminoglycoside antibacterial. Its chemical name is D-Streptamine,
ARIKAYCE is a white milky suspension consisting of amikacin sulfate encapsulated in liposomes and is supplied in a unit-dose 10 mL clear glass vial containing amikacin 590 mg/8.4 mL (equivalent to amikacin sulfate 788 mg/8.4 mL) as a sterile aqueous liposomal suspension for oral inhalation. ARIKAYCE consists of amikacin sulfate encapsulated in liposomes at a targeted concentration of 70 mg amikacin/mL with the pH range of 6.1 to 7.1 and lipid to amikacin weight ratio in the range of 0.60 to 0.79. The inactive ingredients are cholesterol, dipalmitoylphosphatidylcholine (DPPC), sodium chloride, sodium hydroxide (for pH adjustment), and water for injection.
ARIKAYCE is administered only using a Lamira Nebulizer System
7CLINICAL STUDIES
Trial 1 (NCT#02344004) was an open-label, randomized (2:1), multi-center trial in patients with refractory
A total of 336 patients were randomized (ARIKAYCE plus background regimen, n=224; background regimen alone, n=112) (ITT population), with a mean age of 64.7 years and there was a higher percentage of females (69.3%) than males (30.7%) in the study. At the time of enrollment, of the 336 subjects in the ITT population, 302 (89.9%) were either on a guideline-based regimen for MAC or off guideline-based therapy for MAC for less than 3 months while 34 (10.1%) were off treatment for 3 to 12 months prior to enrollment. At screening, patients were stratified by smoking status (current smoker or not) and by whether patients were on treatment or off treatment for at least 3 months. Most patients at screening were not current smokers (89.3%) and had underlying bronchiectasis (62.5%). At baseline, 329 patients were on a multidrug background regimen that included a macrolide (93.3%), a rifamycin (86.3%), or ethambutol (81.4%). Overall, 55.6% of subjects were receiving a triple-drug background regimen consisting of a macrolide, a rifamycin and ethambutol.
The proportion of patients achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 was significantly (p<0.0001) greater for ARIKAYCE plus background regimen (65/224, 29.0%) compared to background regimen alone (10/112, 8.9%). Of those receiving ARIKAYCE plus background regimen, 18.3% (41/224) achieved culture conversion by Month 6 and sustained sputum culture conversion (defined as consecutive negative sputum cultures with no positive culture on solid media or no more than 2 consecutive positive cultures on liquid media following culture conversion) for up to 12 months of treatment after the first culture that defined culture conversion, compared to 2.7% (3/112) of patients receiving background regimen alone (p<0.0001). At 3 months after the completion of treatment, 16.1% (36/224) of patients who had received ARIKAYCE plus background regimen maintained durable culture conversion, compared to 0% of patients who had received background regimen alone (p<0.0001).
In Trial 1, 23/224 (10.3%) of patients had MAC isolates that developed MIC of > 64 mcg/mL while receiving treatment with ARIKAYCE. In the background regimen alone arm, 4/112 (3.6%) of patients had MAC isolates that developed amikacin MIC of > 64 mcg/mL.
Additional endpoints to assess the clinical benefit of ARIKAYCE, for example, change from baseline in six-minute walk test distance and the Saint George's Respiratory Questionnaire, did not demonstrate clinical benefit by Month 6.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Patient Instructions for Use).
9Instructions for Use
ARIKAYCE
For oral inhalation use
Before using your Lamira Nebulizer System, be sure you read and understand the detailed information in the full Instructions for Use that comes with the Lamira Nebulizer System. This will provide more complete information about how to put together (assemble), prepare, use, clean, and disinfect your Lamira Nebulizer System. If you do not understand any part of the instructions, contact
Cleaning and Disinfecting
Before first use, rinse, clean, and disinfect your Handset and Aerosol Head. Moving forward, rinse, clean, and disinfect the Handset including the Aerosol Head after every use.
When you receive your Handset and Aerosol Head, they will not be sterile. Cleaning and disinfecting your Handset and Aerosol Head is important to reduce the risk of infection, illness, and contamination.
Assembling Your Handset
Taking ARIKAYCE
Your ARIKAYCE should be at room temperature before use to make sure that your Lamira Nebulizer System operates properly.
Bring ARIKAYCE to room temperature by removing it from the refrigerator
Cleaning your Lamira Handset and Aerosol Head After Use
- Rinse, clean, and disinfect handset right away after each use to reduce infection, illness, and contamination.
- Disinfect the Handset and Aerosol Head after every use.
- See "
© 2018 Insmed Incorporated. All rights reserved. Insmed
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
10PRINCIPAL DISPLAY PANEL - 8.4 mL Vial Carton
1-833-LIGHT-00
Contains 28 sterile unit-dose vials
For oral inhalation only
ARIKAYCE
Limited Population*
insmed
Attention Patients:
*See the full prescribing information for ARIKAYCE
ARIKAYCE.COM
