Pronunciation:

a-mi-KAY-sin LYE-poh-some

Brand Names:

• Arikayce

Dosage Forms:

• Suspension

Warnings:

Amikacin liposome has been associated with an increased risk of respiratory adverse reactions, including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases .

Classifications:

Therapeutic—

Antibiotic

Chemical—

Aminoglycoside

Uses of This Medicine:

Amikacin liposome is used to treat adults with refractory (difficult to treat) Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug treatment plan (regimen). This medicine is an aminoglycoside antibiotic.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of amikacin liposome in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amikacin liposome in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Emtricitabine
• Ethacrynic Acid
• Furosemide
• Mannitol
• Tenofovir Alafenamide
• Urea

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Bronchospasm or
• Chronic obstructive pulmonary disease (COPD) or
• Hyperreactive airway disease—Must be treated first before using this medicine.

• Ear or hearing problems or
• Lung or breathing problems or
• Nerve or muscle problems (eg, myasthenia gravis)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is given through the Lamira™ Nebulizer System. Follow the instructions carefully on how to use it. Do not use the nebulizer system with any other medicine.

If you are using a bronchodilator (reliever) medicine for your lung or breathing problem, you should take it first before using this medicine.

Keep using this medicine for the full treatment time even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (suspension):
  • For Mycobacterium avium complex lung disease:
    • Adults—One inhalation once a day using the Lamira™ Nebulizer System. Each dose contains 590 milligrams (mg) per 8.4 milliliters (mL) of amikacin.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store unopened vials of this medicine in the refrigerator. Do not freeze. An open vial of medicine must be used right away.

You may also store the vials at room temperature for up to 4 weeks. Throw away any unused medicine after 4 weeks.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

This medicine may cause hearing loss in your baby if used during pregnancy. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause allergic lung disease or worsen existing breathing problems. Check with your doctor right away if you cough up blood, have difficult, fast, or labored breathing, fever, or chest pain or tightness.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have chest tightness, cough, dizziness, fast heartbeat, hives, rash, itching, puffiness or swelling of the eyelids, or around the eyes, face, lips, or tongue, trouble breathing or swallowing, or unusual tiredness or weakness while you are using this medicine.

Check with your doctor right away if you have dizziness, feeling of fullness in the ears, loss of balance, loss of hearing, ringing or buzzing in the ears, or trouble in hearing. These may be symptoms of a serious hearing or balance problem.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Chest tightness

cough

coughing or spitting up blood

difficulty breathing

dizziness

feeling of fullness in the ears

fever

loss of balance

loss of hearing

noisy breathing

ringing or buzzing in the ears

sore throat

trouble hearing

upper airway irritation

voice changes

Less common

Balance disorder

blue lips, fingernails, or skin

change in sputum

chest discomfort or pain

chills

cough producing mucus

general feeling of discomfort or illness

irregular, fast or slow, or shallow breathing

nosebleed

severe pain in the chest

sudden onset of severe breathing difficulty

thickening of bronchial secretions

Incidence not known

Difficulty swallowing

hives, itching, skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bone or muscle pain

decreased weight

diarrhea

headache

lack or loss of strength

nausea

rash

vomiting

Less common

Anxiety

change in taste

dry mouth

loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.