Arikayce Patient Information Including Side Effects

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Brand Names: Arikayce

Generic Name: amikacin liposome

What is amikacin liposome (Arikayce)?
What are the possible side effects of amikacin liposome (Arikayce)?
What is the most important information I should know about amikacin liposome (Arikayce)?
What should I discuss with my healthcare provider before using amikacin liposome (Arikayce)?
How should I use amikacin liposome (Arikayce)?
What happens if I miss a dose (Arikayce)?
What happens if I overdose (Arikayce)?
What should I avoid while using amikacin liposome (Arikayce)?
What other drugs will affect amikacin liposome (Arikayce)?
Where can I get more information (Arikayce)?

What is amikacin liposome (Arikayce)?

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 this medicine, but further studies are needed.

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

What are the possible side effects of amikacin liposome (Arikayce)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

cough (especially during the first month of using amikacin liposome);
trouble speaking;
ringing in your ears, changes in hearing;
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 may include:

fever, cough, increased mucus, sore throat;
hoarse voice, breathing problems;
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.

What is the most important information I should know about amikacin liposome (Arikayce)?

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

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Arikayce Patient Information including How Should I Take

What should I discuss with my healthcare provider before using amikacin liposome (Arikayce)?

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), or other breathing disorders;
hearing problems;
kidney disease; or
a nerve-muscle disorder, such as myasthenia gravis.

If you use amikacin liposome while you are pregnant, your baby could be born deaf. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

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

How should I use amikacin liposome (Arikayce)?

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 this medicine.

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.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer

Arikayce Patient Information including If I Miss a Dose

What happens if I miss a dose (Arikayce)?

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

What happens if I overdose (Arikayce)?

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

What should I avoid while using amikacin liposome (Arikayce)?

This medicine 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.

What other drugs will affect amikacin liposome (Arikayce)?

Tell your doctor about all your other medicines, especially:

other medicines to treat infections;
heart or blood pressure medication;
a diuretic or "water pill";
chemotherapy;
osteoporosis medication;
medicine to prevent organ transplant rejection;
medicine to treat a bowel disorder; or
pain or arthritis medicine (including aspirin, Tylenol, Advil, 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.

Where can I get more information (Arikayce)?

Your doctor or pharmacist can provide more information about amikacin liposome.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Arikayce