ARIKAYCE is designed to be taken with the Lamira® Nebulizer System
Watch the video below for a complete guide to taking ARIKAYCE
Read the step-by-step instructions for using ARIKAYCE at the end of the Medication Guide and the full Instructions for Use provided in your kit.
Treating MAC lung disease involves taking more than 1 medication. These medications work together to fight the MAC bacteria
For instructions to take with you,
Receiving your ARIKAYCE treatment
At the start of your treatment, you will receive 2 shipments from a specialty pharmacy.
They will include:
- A 28-day supply of ARIKAYCE
- A one-time shipment of the Lamira Nebulizer System
Going forward, you will receive monthly shipments of a 28-day supply of ARIKAYCE.
Things to remember about taking ARIKAYCE
- Store ARIKAYCE vials refrigerated between 36°F to 46°F (2°C to 8°C) until the expiration date on the vial. Do not freeze
- After ARIKAYCE has been stored in the refrigerator, any unused medicine must be thrown away after the expiration date on the vial
- ARIKAYCE can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 4 weeks
- Once at room temperature, any unused medicine must be thrown away at the end of 4 weeks
- Use an opened ARIKAYCE vial right away
- Throw away the ARIKAYCE vial right away after use
- Keep ARIKAYCE and all medicines out of the reach of children
- You will have to clean and disinfect your Lamira Handset and Aerosol Head before using them for the first time, as well as after every time you use them
- Always make sure to wash your hands before assembling your Lamira Handset
- Always use the new replacement Aerosol Heads and Lamira Handset parts that come with each ARIKAYCE refill prescription
- After 7 uses, be sure to replace the Aerosol Head with a new one, and be sure to clean and disinfect it before use
- Do not use ARIKAYCE after the expiration date on the vial. If you forget to take your daily dose of ARIKAYCE, take your next dose at your usual time the next day
- Do not double the dose to make up for the missed dose
- Do not use more than 1 vial in a day
- If you use too much ARIKAYCE, call your healthcare provider or go to the nearest emergency room right away
- Inhale each daily dose of ARIKAYCE 1 time each day through the Lamira Nebulizer Handset
Administer ARIKAYCE once daily, in your own home, or anywhere with a clean, flat surface
- Administering ARIKAYCE takes about 14 minutes but could take up to 20 minutes
- Inhale each once-daily dose of ARIKAYCE around the same time each day
- The medicine in the ARIKAYCE vial should be a white milky suspension. Shake the ARIKAYCE vial well for at least 10-15 seconds, until the medicine looks the same throughout and is well mixed
- Be sure to replace with a new Aerosol Head after 7 days of use
- After you have tested negative for MAC, your doctor may suggest that you remain on ARIKAYCE + combination antibacterial drug treatment plan for approximately 12 additional months. This is to make sure the MAC bacteria is cleared from your lungs.
- Do not use ARIKAYCE unless you understand the directions provided. If you have questions, talk to your doctor or call the Arikares Support Program at 1-833-ARIKARE (1-833-274-5273) or at 1-973-437-2376.
- Use ARIKAYCE exactly as your doctor tells you to use it. Do not use ARIKAYCE more often than prescribed to you
- Only use ARIKAYCE with the Lamira Nebulizer System
- Do not inject or drink the ARIKAYCE medicine
Next, find out how to get support during treatment with the
ARIKAYCE can cause serious side effects, including:
- allergic inflammation of the lungs. These respiratory problems may be symptoms of allergic inflammation of the lungs and often come with fever, wheezing, coughing, shortness of breath, and fast breathing
- coughing up of blood (hemoptysis). Coughing up blood is a serious and common side effect of ARIKAYCE
- severe breathing problems. Severe breathing problems can be symptoms of bronchospasm. Bronchospasm is a serious and common side effect of ARIKAYCE. Bronchospasm symptoms include shortness of breath, difficult or labored breathing, wheezing, and coughing or chest tightness
- worsening of chronic obstructive pulmonary disease (COPD). This is a serious and common side effect of ARIKAYCE
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.
Do not use ARIKAYCE if you are allergic to any aminoglycoside, or any of the ingredients in ARIKAYCE.
Before using ARIKAYCE, tell your healthcare provider about all medical conditions, including if you:
- have asthma, COPD, shortness of breath, or wheezing (bronchospasm)
- have been told you have poor lung function
- have hearing problems, such as ringing in your ears or hearing loss
- have dizziness or a sense of the room spinning
- have kidney problems
- have neuromuscular disease, such as myasthenia gravis
- are pregnant or plan to become pregnant. It is not known if ARIKAYCE can harm your unborn baby. ARIKAYCE is in a class of medicines that may be connected with complete deafness in babies at birth. The deafness affects both ears and cannot be changed
- are breastfeeding or plan to breastfeed. It is not known if the medicine in ARIKAYCE passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ARIKAYCE
Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements.
ARIKAYCE may cause serious side effects, including:
- hearing loss or ringing in the ears (ototoxicity). Ototoxicity is a serious and common side effect of ARIKAYCE. Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears, such as ringing or hissing. Tell your healthcare provider if you start having problems with balance or dizziness (vertigo)
- worsening kidney problems (nephrotoxicity). ARIKAYCE is in a class of medicines which may cause worsening kidney problems. Your healthcare provider may do a blood test to check how well your kidneys are working during your treatment with ARIKAYCE
- worsening muscle weakness (neuromuscular blockade). ARIKAYCE is in a class of medicines which can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis)
The most common side effects of ARIKAYCE include: changes in voice and hoarseness (dysphonia), sore throat, diarrhea, muscle pain, nausea, tiredness (fatigue), fever, vomiting, headache, decreased weight, increased sputum, rash, chest discomfort, or cough during or after a dose of ARIKAYCE, especially in the first month after starting treatment.
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 or www.fda.gov/medwatch.
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.