Arikayce is a brand-name prescription medication. It’s FDA-approved to treat mycobacterium avium complex (MAC) lung disease in certain adults. (MAC lung disease is a type of lung infection.)

Specifically, Arikayce is prescribed for adults who have MAC-positive sputum cultures after at least 6 months of MAC treatment. Arikayce is used in combination with other antibiotics.

The manufacturer of Arikayce advises against prescribing the drug for people who do not meet the criteria above. For more information, see the “Arikayce uses” section below.

Drug details

Arikayce contains the active drug amikasin. It belongs to a drug class called aminoglycosides, which are a type of antibiotic.

Arikayce comes as a liposomal suspension inside single-use vials. This is a type of liquid mixture that carries the active drug inside fat-like particles. The drug is inhaled once per day using a specific nebulizer.

Arikayce comes in one strength: 590 milligrams (mg) per 8.4 milliliters (mL) of suspension.

FDA approval

The Food and Drug Administration (FDA) approved Arikayce in 2018. It’s important to note that the drug received accelerated approval from the FDA.

Accelerated approval means that Arikayce became available for the public to use before its clinical trials were completed. This type of approval is sometimes given to drugs used for conditions that do not have many treatment options, such as MAC lung disease.

The FDA will decide whether to give Arikayce full approval after clinical trials of the drug have been completed.

Effectiveness

For information about the effectiveness of Arikayce, see the “Arikayce uses” section below.

Arikayce is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.

As with all medications, the cost of Arikayce can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Arikayce at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Arikayce, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Arikayce, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Arikayce, or if you need help understanding your insurance coverage, help is available.

A copay savings program and a patient support program are available for Arikayce. For more information and to find out whether you’re eligible for support, call 833-ARIKARE (833-274-5273) or visit the drug website.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Arikayce may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Arikayce is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Arikayce can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while using Arikayce. These lists do not include all possible side effects.

For more information about the possible side effects of Arikayce, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Arikayce, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Arikayce. To learn about other mild side effects, talk with your doctor or pharmacist, or view Arikayce’s prescribing information.

Mild side effects of Arikayce can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Arikayce, see “Allergic reaction” below.

Serious side effects

Serious side effects from Arikayce can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* Arikayce has a boxed warning for this side effect. This is a serious warning from the FDA. To learn more, see the “Arikayce precautions” section below.
† For details about allergic reaction and Arikayce, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after using Arikayce. This side effect wasn’t reported in clinical trials of this drug. However, it has occurred since Arikayce was approved.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare. However, it is possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Arikayce, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Arikayce may also cause allergic inflammation of the lungs. In fact, the drug has a boxed warning about this risk and other respiratory side effects. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Arikayce precautions” section below.

The following information describes Arikayce dosages that are commonly used or recommended. However, be sure to use the dosage your doctor prescribes for you. Your doctor will determine the best dosing to fit your needs.

Drug forms and strengths

Arikayce comes as a liposomal suspension inside single-use vials. This is a type of liquid mixture that carries the active drug inside fat-like particles. The drug is inhaled using a specific nebulizer called the Lamira Nebulizer System.

Arikayce comes in one strength: 590 milligrams (mg) per 8.4 milliliters (mL) of suspension.

Dosage for mycobacterium avium complex lung disease

Arikayce is approved to treat mycobacterium avium complex (MAC) lung disease. For this use, you’ll inhale the contents of one vial once per day.

What if I miss a dose?

If you miss a dose of Arikayce, wait until your next scheduled dose is due. Do not use any extra doses to make up for a missed dose. Doing so can increase your risk of side effects from the drug. (For information about side effects, see the “Arikayce side effects” section above.)

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to use this drug long term?

Arikayce is meant to be a long-term treatment. If you and your doctor determine that Arikayce is safe and effective for you, you’ll likely use it long term.

Treatment guidelines for MAC lung disease recommend using Arikayce for at least 1 year after your sputum cultures are no longer positive for MAC.* However, be sure to use Arikayce for the amount of time your doctor advises.

* Sputum is a thick mucus made by your lungs. A culture is a laboratory test that helps identify bacteria. To learn more about MAC and sputum cultures, see “Arikayce uses” section below.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Arikayce, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Alternatives for mycobacterium avium complex lung disease

Examples of other drugs that may be used to treat mycobacterium avium complex lung disease include:

  • forms of amikacin other than Arikayce
  • azithromycin (Zithromax)
  • clarithromycin
  • ethambutol (Myambutol)
  • streptomycin

Here are answers to some frequently asked questions about Arikayce.

Do I need to use a specific type of nebulizer with Arikayce?

Yes, Arikayce is inhaled using a specific nebulizer called the Lamira Nebulizer System.

At the start of Arikayce treatment, one Lamira nebulizer will be provided to you. A healthcare professional will show you how to use the nebulizer to give yourself doses of the drug.

For detailed instructions on how to use the Lamira nebulizer, visit the manufacturer’s site. You can also talk with your doctor.

Can I take other medications while I’m using Arikayce?

Yes, you’ll take other medications while you’re using Arikayce.

Arikayce is a type of antibiotic called an aminoglycoside. The drug is approved for use in combination with other antibiotics.

To learn more, see the “Arikayce use with other drugs” section below.

Should I avoid any activities during Arikayce treatment?

Yes, it’s important that you avoid certain activities until you know how Arikayce will affect you. Examples include activities such as driving, operating heavy machinery, or performing dangerous tasks.

This is because Arikayce may cause dizziness or certain respiratory side effects.* These side effects could increase your risk of accidentally harming yourself or others if they occur while you’re performing the activities above.

If you have other questions about activities to avoid during Arikayce treatment, talk with your doctor.

* Arikayce has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Arikayce precautions” section below.

You should use Arikayce according to the administration instructions your doctor gives you.

Arikayce comes as a liposomal suspension inside single-use vials. This is a type of liquid mixture that carries the active drug inside fat-like particles. The drug is inhaled using a specific nebulizer called the Lamira Nebulizer System.

At the start of Arikayce treatment, one Lamira nebulizer will be provided to you. A healthcare professional will show you how to use the nebulizer to give yourself doses of the drug.

For detailed instructions on how to use the Lamira nebulizer, visit the manufacturer’s site. For more information about how to use Arikayce, see these detailed instructions. You can also talk with your doctor.

When to use

You’ll likely inhale the contents of one Arikayce vial once per day.

Using the medication around the same time of day helps keep a steady level of the drug in your body. This helps Arikayce work effectively.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Accessible labels and containers

If your prescription label is hard to read, talk with your doctor or pharmacist. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist may be able to direct you to one that does.

The Food and Drug Administration (FDA) approves prescription drugs such as Arikayce to treat certain conditions.

Arikayce for Mycobacterium avium complex lung disease

Arikayce is approved to treat Mycobacterium avium complex (MAC) lung disease in certain adults.

Specifically, Arikayce is used when sputum cultures continue to be positive for MAC after at least 6 months of MAC treatment. Arikayce is prescribed in combination with other antibiotics.

Note: Arikayce has a limitation of use. The manufacturer of Arikayce advises against prescribing the drug for people who do not meet the criteria above. To learn more, talk with your doctor.

MAC lung disease explained

MAC lung disease is a type of lung infection. It’s caused by a group of bacteria called MAC, which are commonly found in water and soil.

Most people exposed to MAC bacteria will not develop an infection. However, people with lung problems or weakened immune systems may be more prone to infection with these bacteria. For example, people with chronic obstructive pulmonary disease (COPD) or HIV may develop MAC lung disease after they’re exposed to MAC bacteria.

Symptoms of MAC lung disease can include:

Doctors can use a sputum culture to test for MAC lung disease. Sputum is a thick mucus made by your lungs. A culture is a laboratory test that helps identify bacteria. Having a sputum culture that’s positive for MAC means this laboratory test has detected MAC bacteria in your sputum.

Doctors can prescribe a combination of antibiotics to treat MAC lung disease. However, despite several months of treatment, your sputum cultures may remain positive for MAC.

In this case, your doctor may prescribe Arikayce. They’ll prescribe this drug only if your sputum cultures continue to be positive for MAC after at least 6 months of treatment with other antibiotics.

Effectiveness for MAC lung disease

Arikayce has been found effective for treating MAC lung disease. The drug is recommended as a treatment option in the American Thoracic Society and Infectious Diseases Society of America guidelines for MAC lung disease.

To find out how the drug performed in clinical trials, see Arikayce’s prescribing information.

Arikayce and children

Arikayce is not FDA-approved for use in children. Clinical trials of the drug only included adults. It’s not known for sure whether Arikayce is safe or effective for children.

Arikayce is used to treat mycobacterium avium complex (MAC) lung disease in certain situations. (To learn more, see the “Arikayce uses” section above.)

For this use, your doctor will prescribe Arikayce in combination with other antibiotics. Examples include:

  • azithromycin (Zithromax)
  • clarithromycin
  • ethambutol (Myambutol)
  • streptomycin

Your doctor will prescribe the exact combination of antibiotics that’s right for you. If you have questions about using Arikayce with other drugs, talk with your doctor.

Arikayce isn’t known to interact with alcohol.

If you have questions about drinking alcohol during treatment with Arikayce, talk with your doctor.

Arikayce can interact with several other medications. However, it’s not known to interact with supplements or foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe. Drug-condition interactions can also cause certain effects. For information about these interactions, see the “Arikayce precautions” section below.

Arikayce and other medications

Below is a list of medications that can interact with Arikayce. This list does not contain all drugs that may interact with Arikayce.

Before using Arikayce, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Drugs that cause nerve damage. Doctors may not prescribe Arikayce with medications that can cause nerve damage. This is because Arikayce may worsen nerve damage in people who already have a nerve problem such as myasthenia gravis. And using Arikayce with other drugs that cause nerve damage can further increase this risk. Examples of these medications include:

Drugs that cause kidney damage. Doctors may not prescribe Arikayce with drugs that cause kidney damage. Arikayce may worsen kidney damage in people who already have a kidney problem, such as kidney failure. Using Arikayce with other medications that cause kidney damage can increase this risk even more. Examples of these drugs include:

  • certain pain relievers, such as acetaminophen (Tylenol) and naproxen (Aleve, Naprosyn)
  • certain antibiotics, such as penicillin g (Pfizerpen) and tetracycline (Achromycin V)
  • certain proton pump inhibitors, such as lansoprazole (Prevacid) and omeprazole (Prilosec)
  • statins, such as simvastatin (Zocor) and rosuvastatin (Crestor)

Drugs that cause ear damage. Doctors may not prescribe Arikayce with medications that cause ear damage. Arikayce may cause ear damage as a side effect, which could worsen this condition in people who already have ear damage. Examples of these medications include:

Certain diuretics. Doctors may not prescribe Arikayce with certain diuretics. Taking these drugs with Arikayce could cause Arikayce to build up in your body. And this could increase your risk of side effects with Arikayce. Examples of these diuretics include:

  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • mannitol (Osmitrol)

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Arikayce and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Arikayce. However, you should still check with your doctor or pharmacist before using any of these products while using Arikayce.

Arikayce and foods

There aren’t any foods that have been specifically reported to interact with Arikayce. If you have any questions about eating certain foods with Arikayce, talk with your doctor.

Arikayce is used to treat mycobacterium avium complex (MAC) lung disease in certain situations. MAC lung disease is a type of lung infection. (To learn more, see the “Arikayce uses” section above.)

Arikayce belongs to a drug class called aminoglycosides, which are a type of antibiotic. It comes as a liposomal suspension, which is a type of liquid mixture that carries the active drug inside fat-like particles. The drug is inhaled using a specific nebulizer.

When inhaled, Arikayce travels to the lungs, where the fat-like particles enter the body’s cells. Once inside the cells, the drug treats the infection by killing the MAC bacteria.

How long does it take to work?

Arikayce starts working as soon as you inhale your first dose. However, you may not notice the drug working in your body. Your doctor can order tests, including sputum cultures, during Arikayce treatment to check whether the drug is working.*

* Sputum is a thick mucus made by your lungs. A culture is a laboratory test that helps identify bacteria. To learn more about MAC and sputum cultures, see “Arikayce uses” above.

It may not be safe to use Arikayce during pregnancy.

There haven’t been enough clinical trials of Arikayce in pregnancy to know for certain whether the drug is safe to use while pregnant.

However, other forms of amikacin (the active drug in Arikayce) are not safe to use while pregnant. Other forms of amikacin are known to cause hearing loss in children born to people who took the drug while pregnant. However, it isn’t known for certain whether Arikayce may cause congenital anomalies (commonly known as birth defects).

If you’re pregnant or planning a pregnancy, talk with your doctor. They’ll advise you on the risks and benefits of using Arikayce during pregnancy.

It may not be safe to use Arikayce during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Arikayce.

For more information about using Arikayce during pregnancy, see the “Arikayce and pregnancy” section above.

It’s not known whether Arikayce passes into breast milk.

Other forms of amikacin (the active drug in Arikayce) are known to pass into breast milk. However, it isn’t known for certain whether the drug causes side effects in a child who is breastfed.

If you’re breastfeeding or planning to do so, talk with your doctor. They can advise on the risks and benefits of using Arikayce while breastfeeding.

This drug comes with several precautions. These are known as drug-condition interactions.

FDA warning: Risk of increased respiratory side effects

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Using Arikayce may increase your risk of certain respiratory side effects. These side effects were common in clinical trials of the drug.

Respiratory side effects and their symptoms can include:

  • Allergic inflammation of the lungs. Symptoms can include:
    • cough
    • wheezing
    • shortness of breath
    • fast breathing
  • Coughing up blood. Symptoms can include sputum that is frothy, red, or looks similar to coffee grounds.
  • Bronchospasm (sudden tightening of the muscles that line your airways). Symptoms can include:
    • shortness of breath or trouble breathing
    • wheezing
    • cough
    • chest tightness
  • Worsening of lung problems, such as chronic obstructive pulmonary disease (COPD). Symptoms can include:
    • wheezing
    • chest tightness
    • shortness of breath
    • wet cough

If you have symptoms of respiratory side effects with Arikayce, tell your doctor right away. They can talk with you about how to manage these side effects if they happen.

Other precautions

Before using Arikayce, talk with your doctor about your health history. Arikayce may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Ear problems. Before using Arikayce, tell your doctor if you have ear problems. Arikayce may cause ear damage as a side effect, which could worsen any ear problems you already have. Your doctor can advise whether Arikayce is a safe treatment option for you.
  • Nerve problems. Arikayce may worsen nerve damage in people who already have a nerve problem such as myasthenia gravis. Before starting Arikayce treatment, tell your doctor if you have a nerve problem. They’ll determine whether Arikayce is the right treatment option for you.
  • Kidney problems. Before using Arikayce, tell your doctor if you have a kidney problem such as kidney failure. The drug may worsen any kidney problems you already have. Your doctor can tell you whether Arikayce is a safe treatment option for you.
  • Allergic reaction. If you’ve had an allergic reaction to Arikayce or any of its ingredients, your doctor will likely not prescribe Arikayce. Ask your doctor what other medications may be better options for you.
  • Pregnancy. It isn’t known whether Arikayce is safe to use during pregnancy. For more information, see the “Arikayce and pregnancy” section above.
  • Breastfeeding. It isn’t known whether Arikayce passes into breast milk. For more information, see the “Arikayce and breastfeeding” section above.

Note: For more information about the potential negative effects of Arikayce, see the “Arikayce side effects” section above.

Do not use more Arikayce than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you use too much Arikayce

If you think you’ve used too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Arikayce from the pharmacy, the pharmacist will add an expiration date to the label on the packaging. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good to use can depend on many factors, including how and where you store the medication.

You’ll store Arikayce vials in the refrigerator at a temperature of 36°F to 46°F (2°C to 8°C) until you use them. You can store them this way until the expiration date.

Alternatively, you may store Arikayce vials at a room temperature of 77°F (25°C) for up to 4 weeks. When stored at room temperature, be sure to dispose of any unused vials after 4 weeks.

Disposal

If you no longer need to use Arikayce and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from ingesting the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.