Arikayce (amikacin liposome) is a prescription antibiotic medicine that is used for difficult to treat Mycobacterium avium complex (MAC) lung disease in adults who have few or no other treatment options. Arikayce is a suspension that is inhaled into the lungs using the Lamira Nebulizer System. Arikayce is a once-daily treatment that should be used as part of a combination antibacterial drug regimen.

What is Arikayce used to treat?

Arikayce is FDA-approved to be used by adults who:

• have limited or no alternative treatment options
• do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy.

Arikayce was FDA-approved to be used for this limited and specific population, on an "accelerated" basis. In clinical studies, some people responded to Arikayce, but further studies are needed and clinical benefit has not yet been established.

Mycobacterium avium complex (MAC) lung disease is caused by a group of common bacteria that can easily be inhaled during normal daily activities. For many people these bacteria cause no harm however, people who have weakened immune systems, or have lung conditions such as bronchiectasis and COPD, may become very sick. Symptoms of MAC lung disease include persistent cough, fatigue, weight loss, night sweats, and occasionally shortness of breath and coughing up of blood.

Arikayce can cause serious side effects. Call your healthcare provider or get medical help right away if you have any of these serious side effects or symptoms while taking this medicine. These side effects may become serious enough that treatment in a hospital is needed.

Life-threatening allergic reactions. Stop using this medicine and get emergency medical help if you have symptoms such as a cough, trouble breathing, itching or hives, vomiting, diarrhea, fast heartbeats, feeling light-headed, or swelling in your face or throat.

Allergic inflammation of the lungs: Symptoms of allergic inflammation of the lungs are fever, coughing, fast breathing, wheezing, and shortness of breath.

Coughing up of blood (hemoptysis): Coughing up blood is a serious and common side effect of this medicine.

Severe breathing problems: Severe breathing problems can be symptoms of bronchospasm which is a serious and common side effect of this medicine. Bronchospasm symptoms include shortness of breath, wheezing, difficult or labored breathing, coughing, or chest tightness.

Worsening of chronic obstructive pulmonary disease (COPD): This is a serious and common side effect of Arikayce.

See below Side Effect section for more side effect information.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Arikayce is a suspension that is inhaled orally using the Lamira Nebulizer System. Read and carefully follow all Instructions for Use provided with your medicine and nebulizer. Ask your doctor or pharmacist if you do not understand these instructions.

Arikayce should be at room temperature when you use it.

Shake the vial (bottle) for 10 to 15 seconds before opening it and pouring the medicine into the nebulizer medicine reservoir.

Do not use more than 1 vial of Arikayce in a day.

Each vial is for one use only. Throw it away after one use, even if there is still medicine left inside.

You may be given other medications if you have asthma, COPD, or certain other lung disorders. Keep using these medicines for as long as your doctor has prescribed.

Click here for full instructions for use with diagrams: Arikayce Instructions for Use

Usual Adult Dose for Mycobacterium avium-intracellulare:

• 590 mg inhaled via Lamira nebulizer once a day

Comments:

• Patients that are using bronchodilators should use their bronchodilator before using this drug.

• Pretreatment with short-acting beta-2 agonists should be considered in patients with specific patient populations (e.g., asthma, bronchospasm, chronic obstructive pulmonary disease, hyperactive airway disease).

Use: Patients 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

You should not use Arikayce if you are allergic to amikacin or similar antibiotics (gentamicin, kanamycin, neomycin, paromomycin, streptomycin, or tobramycin).

Tell your doctor if you have ever had:

• asthma, chronic obstructive pulmonary disease (COPD), wheezing, or other breathing or lung function problems;
• have or have had hearing issues (including noises in your ears such as ringing or hissing), hearing loss, or your mother has had hearing problems after taking an aminoglycoside.
• vertigo (dizziness or a spinning sensation);
• kidney disease; or
• a nerve-muscle disorder, such as myasthenia gravis.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.
Taking amikacin in oral form during pregnancy may cause the baby to be born deaf. The deafness affects both ears and cannot be changed. It is not known whether amikacin as an inhaled medicine will harm an unborn baby. 

Breastfeeding

Tell your doctor if you are breastfeeding or planning to breastfeed.
It may not be safe to breastfeed while using Arikayce. Talk to your healthcare provider about the best way to feed your baby while being treated with this medicine

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

If you use too much Arikayce, call your healthcare provider or go to the nearest emergency room right away.

Arikayce may cause dizziness or breathing problems, and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Also see Warnings section above.

Arikayce 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).

Arikayce can cause other serious side effects:

Call your doctor at once if you have:

• ringing in your ears, changes in hearing;
• cough (especially during the first month of using Arikayce);
• 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 of Arikayce 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.

Amikacin can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

This list is not complete. Other drugs may affect Arikayce, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. To check for interactions with Arikayce click the Arikayce drug interaction link below.