(am i kay' sin)

Brand Name(s): Arikayce^®

IMPORTANT WARNING:

Amikacin oral inhalation may cause serious lung problems, including bronchospasm (breathing difficulties), allergic lung reactions, coughing up blood, and worsening of existing lung disease. Tell your doctor if you have or have ever had asthma, chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema), shortness of breath or wheezing, or other lung problems. If you experience any of the following symptoms, call your doctor immediately: coughing, wheezing, or chest tightness during or after inhalation; difficulty, fast, or noisy breathing; shortness of breath; fever; or coughing up blood.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with amikacin oral inhalation and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during treatment to check your body's response to amikacin.

WHY is this medicine prescribed?

Amikacin oral inhalation is used in combination with other antibiotics to treat Mycobacterium avium complex lung disease (MAC; a bacterial infection that may cause serious symptoms) that has not responded well to other antibiotics. Amikacin is in a class of medications called aminoglycoside antibiotics. It works by killing bacteria.

Antibiotics such as amikacin oral inhalation will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Amikacin oral inhalation comes as a suspension to inhale by mouth using a special nebulizer (machine that turns medication into a mist that can be inhaled). It is usually inhaled once a day. Use amikacin oral inhalation at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use amikacin oral inhalation exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Use amikacin oral inhalation until you finish the prescription, even if you feel better. If you stop using amikacin oral inhalation too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Before you use amikacin inhalation for the first time, carefully read the written instructions that come with it. These instructions describe how to prepare and inhale a dose of amikacin oral inhalation and how to use the nebulizer. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about how to prepare or inhale this medication or how to use or store the nebulizer.

If you are using other inhaled medications, you should talk to your doctor about how you should use them during your treatment with amikacin oral inhalation. Do not use the nebulizer to inhale any other medications.

To inhale the suspension using a nebulizer, follow these steps:

1. Remove one vial of amikacin suspension from the refrigerator and allow it to rest for at least 45 minutes so that it can warm to room temperature.
2. Shake the vial well for at least 10–15 seconds to mix the medication evenly.
3. Flip off the plastic top of the vial, pull the metal ring downward, and then remove the metal ring and rubber stopper from the vial. Pour all of the liquid into the nebulizer reservoir and attach the medication cap.
4. Sit in an upright, comfortable position. Place the mouthpiece in your mouth.
5. Turn on the controller.
6. Make sure you hold the nebulizer handset level and breathe in calmly, normally, and evenly for about 14 to 20 minutes. The controller will beep 2 times when your treatment is over.

Clean your nebulizer regularly. Follow the manufacturer's directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your nebulizer.

What SPECIAL PRECAUTIONS should I follow?

Before using amikacin oral inhalation,

• tell your doctor and pharmacist if you are allergic to amikacin; other aminoglycoside antibiotics such as gentamicin, neomycin, plazomicin, streptomycin, or tobramycin; any other medications; or any of the ingredients in amikacin oral inhalation. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you or a family member have hearing loss not related to normal aging or have a history of hearing loss due to use of any medication. Also, tell your doctor if you have or have ever had dizziness, vertigo, ringing in the ears, a neuromuscular disorder such as myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness), or kidney problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using amikacin oral inhalation, call your doctor. Amikacin may cause deafness in newborns if it is taken during pregnancy.

• you should know that amikacin may make you dizzy. Do not drive a car or operate machinery until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Amikacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• tiredness
• muscle or bone pain
• sore throat
• dry mouth
• taste changes
• decreased weight
• coughing up sputum
• changes in your voice or hoarseness
• anxiety
• nose bleeds

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• burning, tingling, or numbness in the hands, arms, feet, or legs; muscle twitching or weakness; or seizures
• decreased urination; swelling of the face, arms, hands, feet, ankles, or lower legs; or unusual tiredness or weakness
• hearing loss, roaring or ringing in the ears, loss of balance, or dizziness
• rash; itching, hives; flushing; swelling of the eyes, face, throat, tongue, or lips; difficulty swallowing; or fast heartbeat
• nausea, vomiting, diarrhea, or stomach cramping
• loss of control over your bladder or bowels
• feeling lightheaded or fainting
• white patches in the mouth or throat

Amikacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in a refrigerator. If it is removed from the refrigerator, it can be stored at room temperature in the original container for up to 4 weeks. Dispose of amikacin oral inhalation if it has been left at room temperature more than 4 weeks. Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2023.