Amikacin liposome suspension for inhalation

What is this medication?

AMIKACIN (am i KAY sin) is an aminoglycoside antibiotic. It is used to treat certain kinds of bacterial infections in the lungs. It will not work for colds, flu, or other viral infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ARIKAYCE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• hearing problems
• kidney disease
• lung or breathing disease, like asthma
• myasthenia gravis
• Parkinson's disease
• an unusual or allergic reaction to amikacin, other aminoglycosides or medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for inhalation using a nebulizer. Nebulizers make a liquid into an aerosol that you breathe in through your mouth or your mouth and nose and into your lungs. You will be taught how to use your nebulizer. Follow the directions on your prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cidofovir

This medicine may also interact with the following medications:

• aspirin and aspirin-like medicines
• birth control pills
• cisplatin
• cyclosporine
• diuretics
• medicines for infection like acyclovir, adefovir, amphotericin B, bacitracin, foscarnet, ganciclovir, gentamicin, pentamidine, vancomycin
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• pamidronate
• zoledronic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Do not treat diarrhea with over the counter products. Contact your doctor if you have diarrhea that lasts more than 2 days or if it is severe and watery.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• coughing up blood
• decreased hearing or ringing of the ears
• dizziness
• loss of balance or coordination
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• unusually weak or tired

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• changes in taste
• changes in voice
• cough
• diarrhea
• dry mouth
• fever
• headache
• muscle pain
• nausea, vomiting
• sore throat
• tiredness
• weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

You will be instructed on how to store this medicine.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.