ARIKAYCE (Page 5 of 7)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ARIKAYCE (amikacin liposome inhalation suspension), 590 mg/8.4 mL, is supplied in a sterile, unit-dose 10-mL glass vial. The product is dispensed as a 28-vial kit.
Each carton contains a 28-day supply of medication (28 vials). In addition to the ARIKAYCE vials in the carton, one Lamira Nebulizer Handset and four Lamira Aerosol Heads are provided.
NDC 71558-590-28
The Lamira Nebulizer System contains a controller, a spare Aerosol Head, a spare Handset, Power Cord and accessories.
16.2 Storage and Handling
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. Once at room temperature, any unused drug must be discarded at the end of 4 weeks.
17 PATIENT COUNSELING INFORMATION
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 [see Warnings and Precautions (5.1, 5.3)].
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 [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
Exacerbations of Underlying Pulmonary Disease
Advise patients to inform their healthcare provider if they experience worsening of their lung disease after starting ARIKAYCE [see Warnings and Precautions (5.4)].
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 [see Adverse Reactions (6.1)].
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 [see Warnings and Precautions (5.5)].
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 [see Warnings and Precautions (5.6)] .
Advise the patient not to operate heavy machinery or do dangerous activities while inhaling ARIKAYCE through the Lamira Nebulizer System because ARIKAYCE can cause symptoms such as dizziness or respiratory symptoms.
Nephrotoxicity or Kidney Damage
Advise patients to inform their health care provider if they have kidney problems because kidney damage has been reported with aminoglycosides [see Warnings and Precautions (5.7)] .
Neuromuscular Blockade
Advise patients to inform their healthcare provider of known neuromuscular disease (e.g., myasthenia gravis) [see Warnings and Precautions (5.8)].
Embryo-Fetal Toxicity
Advise pregnant women that aminoglycosides, including ARIKAYCE, may cause irreversible congenital deafness when administered during pregnancy [see Warnings and Precautions (5.9) and Use in Special Populations (8.1)].
Manufactured for:
Insmed® , Bridgewater, NJ 08807
Insmed® and, ARIKAYCE® are trademarks of Insmed Incorporated. Lamira® is a trademark of PARI Pharma GmbH.
© Insmed Incorporated. All rights reserved. 2010 7,718,189; 2012 8,226,975; 2014 8,632,804, 8,642,075, 8,679,532 and 8,802,137; 2017 9,566,234 and 9,827,317 and 2018 9,895,385.
This Medication Guide has been approved by the U.S. Food and Drug Administration | Issued2/2023 | |||
MEDICATION GUIDEARIKAYCE (ar’ i kase) LIMITED POPULATION (amikacin liposome inhalation suspension) for oral inhalation use | ||||
Important: For oral inhalation only. | ||||
What is the most important information I should know about ARIKAYCE? | ||||
ARIKAYCE can cause serious side effects, including:
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While using ARIKAYCE these side effects may become serious enough that treatment in a hospital is needed. | ||||
Call your healthcare provider or get medical help right away if you have any of these serious side effects while taking ARIKAYCE. Your healthcare provider may ask you to stop using ARIKAYCE for a short period of time or completely stop using ARIKAYCE. | ||||
What is ARIKAYCE? | ||||
ARIKAYCE is a prescription medicine used to treat adults with refractory (difficult to treat) Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug treatment plan (regimen). | ||||
It is not known if ARIKAYCE is safe and effective in children younger than 18 years of age. | ||||
This product was approved by FDA using the Limited Population pathway. This means FDA has approved this drug for a limited and specific patient population, and studies on the drug may have only answered focused questions about its safety and effectiveness. | ||||
Do not use ARIKAYCE if you:
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Before using ARIKAYCE, tell your healthcare provider about all of your medical conditions, including if you:
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Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. | ||||
How should I use ARIKAYCE?
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What are the possible side effects of ARIKAYCE? | ||||
ARIKAYCE may cause serious side effects, including:
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The most common side effects of ARIKAYCE include: | ||||
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These are not all of the possible side effects of ARIKAYCE. | ||||
Call your doctor or pharmacist for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||||
How should I store ARIKAYCE?
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Keep ARIKAYCE and all medicines out of the reach of children. | ||||
General information about safe and effective use of ARIKAYCE | ||||
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ARIKAYCE for a condition for which it was not prescribed. Do not give ARIKAYCE to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ARIKAYCE that is written for health professionals. | ||||
What are the ingredients in ARIKAYCE? | ||||
Active ingredient: amikacin sulfate | ||||
Inactive ingredients: Dipalmitoylphosphatidylcholine (DPPC), cholesterol, sodium chloride, sodium hydroxide (for pH adjustment), and water for injection | ||||
Manufactured for: Insmed Incorporated, 700 US Highway 202/206, Bridgewater, NJ 08807-1704 | ||||
Insmed Incorporated, All rights reserved. | ||||
For more information, call Insmed Arikares Support at: 1- 833-ARIKARE (1-833-274-5273) |
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