ARIKAYCE was studied in patients who did not respond to other treatments

Living with MAC lung disease can be challenging. You may have tried treatments in the past and not seen results. ARIKAYCE is the only FDA-approved treatment designed for people like you.

224 patients took ARIKAYCE 12-month treatment

ARIKAYCE + multidrug regimen was studied in 224 patients with MAC lung disease who either stopped responding or never responded to their previous treatment.

Culture conversion: Testing negative for MAC

One of the key goals was culture conversion. Culture conversion means you no longer test positive for MAC bacteria in your lungs.

Additional measures

Additional measures evaluated in the ARIKAYCE study included:

  • Improvement in the distance walked after 6 minutes (6-minute walk test)
  • Improvement in response to the St George's Respiratory Questionnaire, designed to measure impact on overall health, daily life, and perceived well-being in patients with lung disease

After testing negative

In the clinical study, patients continued ARIKAYCE treatment for 12 months after testing MAC-negative.

In a clinical study, patients on ARIKAYCE tested MAC-negative, even after stopping treatment

Group 2 with ARIKAYCE + multidrug regimen 29% (65/224) VS multidrug regimen alone 8.9% (10/112) AS MANY PATIENTS TESTED NEGATIVE 3X with ARIKAYCE + multidrug regimen 18.3% (41/224) VS multidrug regimen alone 2.7% (3/112) AS MANY PATIENTS TESTED NEGATIVE 7X with ARIKAYCE + multidrug regimen 16.1% (36/224) VS multidrug regimen alone 0% (0/112) 16X AS MANY PATIENTS TESTED NEGATIVE End of treatment 3 months after stopping treatment PRIMARY STUDY RESULTS PROVEN RESULTS: More ARIKAYCE patients tested negative for 12 months—and beyond ADDITIONAL STUDY RESULTS
A2_GRAPHIC_MOBILE End of treatment 3 months after stopping treatment with ARIKAYCE + multidrug regimen 16.1% (36/224) multidrug regimen alone 0% (0/112) VS AS MANY PATIENTS TESTED NEGATIVE AS MANY PATIENTS TESTED NEGATIVE 16X with ARIKAYCE + multidrug regimen 18.3% (41/224) multidrug regimen alone 2.7% (3/112) VS AS MANY PATIENTS TESTED NEGATIVE 7X with ARIKAYCE + multidrug regimen 29% (65/224) multidrug regimen alone 8.9% (10/112) VS AS MANY PATIENTS TESTED NEGATIVE 3X PROVEN RESULTS: More ARIKAYCE patients tested negative for 12 months—and beyond ADDITIONAL STUDY RESULTS PRIMARY STUDY RESULTS

Among those who tested negative, more ARIKAYCE patients remained negative, even after stopping treatment

Graphic 36/41 vs 0/3 41/65 vs 3/10 65/224 vs 10/112 36 36 patients remained negative 41 patients stayed negative 41 65 65 patients tested negative 0 patients remained negative 0 3 3 patients stayed negative 10 patients tested negative 10 Multidrug regimen alone 112 patients ARIKAYCE + multidrug regimen 224 patients VS VS VS End of treatment 3 months after stopping treatment ADDITIONAL STUDY RESULTS PRIMARY STUDY RESULTS
C1 GRAPHIC_MOBILE 65 65 patients tested negative 65/224 10 10 patients tested negative 10/112 3 3 patients stayed negative 3/10 0 patients remained negative 0/3 0 41 41 patients stayed negative 41/65 36 36 patients remained negative 36/41 Multidrug regimen alone 112 patients ARIKAYCE + multidrug regimen 224 patients VS VS VS End of treatment 3 months after stopping treatment PRIMARY STUDY RESULTS ADDITIONAL STUDY RESULTS Among those who tested negative, more ARIKAYCE patients remained negative, even after stopping treatment

Additional study results

In the ARIKAYCE clinical study, there was no improvement in the 6-minute walk test and St George's Respiratory Questionnaire measurements at the end of 6 months.

An inhaled treatment delivered directly to your lungs

ARIKAYCE is an inhaled antibiotic you take with a nebulizer. It is different from other inhaled antibiotics because the amikacin is contained inside tiny particles called liposomes. These liposomes are designed to help the medicine reach the lungs.

Lungs

The inhaled, liposomal formulation of ARIKAYCE targets MAC bacteria within the lungs, giving you a different way to fight MAC lung disease

How does ARIKAYCE work?

When you inhale ARIKAYCE, the liposomes containing the medicine travel into your lungs. There, they enter the body's cells, called macrophages, where the MAC bacteria can live. Once inside the lungs, they release the medicine to fight the infection.

Watch the video below to see ARIKAYCE in action. For the best quality, please view the video in full-screen mode.

Hear from expert physicians about their experience with ARIKAYCE

Next, learn about

Possible Side Effects
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IMPORTANT SAFETY INFORMATION AND INDICATION ARIKAYCE is associated with: risk of increased respiratory adverse reactions including allergic inflammation of lungs, coughing up blood, severe breathing problems and worsening of COPD.

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
  • serious allergic reactions. Serious allergic reactions that may lead to death have happened to people who take ARIKAYCE. Stop taking ARIKAYCE right away and get emergency medical help if you have any of the following symptoms of a serious allergic reaction: hives, itching, redness or blushing of the skin (flushing), swollen lips, tongue or throat, trouble breathing or wheezing, shortness of breath, noisy high-pitched breathing (stridor), cough, nausea, vomiting, diarrhea, feel cramps in your stomach area, fast heart rate, feeling light headed, feeling faint, loss of control of the bowels or bladder (incontinence), and dizziness

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), cough during or after a dose of ARIKAYCE, especially in the first month after starting treatment, muscle pain, sore throat, tiredness (fatigue), diarrhea, nausea, headache, fever, decreased weight, vomiting, rash, increased sputum, or chest discomfort.

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.