Amikacin liposome is an antibiotic that is used to treat Mycobacterium avium complex (MAC) lung disease in adults who have few or no other treatment options. Amikacin liposome is given in combination with other antibiotics.

Amikacin liposome is given only to certain adults, when other antibiotics have failed to clear their MAC infections after 6 months of treatment.

Amikacin liposome was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to amikacin liposome, but further studies are needed.

Amikacin liposome may also be used for purposes not listed in this medication guide.

Amikacin liposome can cause a life-threatening allergic reaction. Stop using amikacin liposome and get emergency medical help if you have symptoms such as: cough, trouble breathing, itching or hives, vomiting, diarrhea, fast heartbeats, feeling light-headed, or swelling in your face or throat.

Amikacin liposome can cause breathing problems. Call your doctor if you have chest tightness, cough, wheezing, trouble breathing, fever, or if you cough up blood.

Certain breathing disorders may become worse while you are using amikacin liposome.

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

Use amikacin liposome only with 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.

Amikacin liposome 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.

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.

Store amikacin liposome vials in the refrigerator and use them before the expiration date. Do not freeze amikacin liposome.

You may also store amikacin liposome at room temperature for up to 4 weeks. Throw away any unused vial that has been kept at room temperature for longer than 4 weeks.

Usual Adult Dose for Mycobacterium avium-intracellulare -- Treatment:

590 mg inhaled via Lamira (TM) nebulizer once a day

Comments:
-Patients using bronchodilators should use the bronchodilator prior to 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 this medicine if you are allergic to amikacin liposome 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 problems;

• hearing problems;

• vertigo (a spinning sensation);

• kidney disease; or

• a nerve-muscle disorder, such as myasthenia gravis.

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

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

amikacin liposome 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.

Amikacin liposome 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).

Amikacin liposome may cause 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 amikacin liposome);

• 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 amikacin liposome 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 amikacin liposome, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.