Amikacin Liposome (a-mi-KAY-sin LYE-poh-some)

Treats Mycobacterium avium complex (MAC) lung disease. This medicine is an aminoglycoside antibiotic.

Brand Name(s):

Arikayce

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid Under Pressure

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is given through the Lamira™ Nebulizer System. Follow the instructions carefully on how to use it. Do not use the nebulizer system with any other medicine.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and take your next dose at your usual time. Do not double doses.
• Store the vials in the refrigerator. Do not freeze. You may also store the vials at room temperature for up to 4 weeks. Throw away any unused medicine after 4 weeks.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how amikacin liposome works. Tell your doctor if you are using ethacrynic acid, furosemide, intravenous mannitol, or urea.
• If you are using a bronchodilator (reliever) medicine, you should take it first before using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. This medicine may cause hearing loss in your baby if used during pregnancy.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, lung or breathing problems (including asthma, COPD, hyperreactive airway disease), ear or hearing problems, or nerve or muscle problems (including myasthenia gravis).
• This medicine may cause the following problems:
  • Lung or breathing problems (including pneumonitis, interstitial lung disease, bronchospasm)
  • Hearing problems
  • Kidney problems
• This medicine may cause dizziness or difficulty with breathing. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful or difficult urination, lower back or side pain
• Changes in hearing, ringing in the ears, dizziness, hearing loss
• Coughing up blood, trouble breathing, chest pain or tightness
• Difficulty speaking or loss of the ability to speak

If you notice these less serious side effects, talk with your doctor:

• Decreased weight
• Diarrhea
• Headache
• Nausea, vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088