Drug Information



(ARIKAYCE) This medication is used along with other medications to treat a certain lung infection (Mycobacterium avium complex-MAC) after other treatments have not worked. Amikacin belongs to a class of drugs known as aminoglycoside antibiotics. This medication works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How should I use ARIKAYCE?

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using amikacin and each time you get a refill. This medication is used with a special machine called a nebulizer that changes the solution to a fine mist that you inhale. Learn and follow all instructions for the use of this medication and the nebulizer. If you have any questions, ask your doctor, pharmacist, or respiratory therapist. Use this medication with the nebulizer as directed by your doctor, usually once daily. If this medication has been stored in the refrigerator, take the vial out of the refrigerator and let it warm up to room temperature for at least 45 minutes before use. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Shake the vial well for at least 10 to 15 seconds, until the medicine looks the same throughout and well mixed. Use all of the contents of the vial for each dose. Do not mix amikacin liposomal with any other medicines in the nebulizer. Each treatment usually lasts about 14 to 20 minutes. For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time every day. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition does not get better or if it gets worse.

What should I tell my health care provider before I take ARIKAYCE?

Before using amikacin liposomal, tell your doctor or pharmacist if you are allergic to it; or to amikacin; or to other aminoglycoside antibiotics (such as gentamicin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other breathing problems (such as asthma, chronic obstructive pulmonary disease-COPD), hearing problems (including deafness, decreased hearing), kidney problems, myasthenia gravis, Parkinson's disease. Amikacin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using amikacin before having any immunizations/vaccinations. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if inhaled amikacin liposomal passes into breast milk. However, other forms of this drug pass into breast milk in very small amounts. Consult your doctor before breastfeeding.

What may interact with ARIKAYCE?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

What should I watch for while using ARIKAYCE?

Amikacin liposomal may increase the risk of serious breathing or lung problems. Tell your doctor right away if you have symptoms such as new or worsening shortness of breath/trouble breathing, fever, cough, wheezing, or coughing up blood or blood-tinged sputum.

What if I miss a dose of ARIKAYCE?

If you miss a dose, use it as soon as you remember. If you don't remember until the next day, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

What side effects may I notice from receiving ARIKAYCE?

See also Warning section. Hoarseness, changes in your voice, nausea, diarrhea, headache, tiredness, decreased weight, or muscle/joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of hearing damage (such as ringing/roaring sounds in the ears, hearing loss, dizziness), signs of kidney problems (such as change in the amount of urine). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/unusual trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep ARIKAYCE?

Store this medication in the refrigerator away from light. Do not freeze. This medication may also be stored at room temperature for up to 4 weeks. If stored at room temperature, use or discard after 4 weeks. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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