All About Arikayce

If you have Mycobacterium avium complex (MAC) lung disease, your doctor may suggest treatment with Arikayce. It’s a prescription drug used together with other drugs to treat MAC lung disease that’s refractory (difficult to treat).

Specifically, Arikayce is used in adults who still have a MAC-positive sputum (mucus) test despite receiving at least 6 months of other MAC treatments. For more information on how Arikayce is used to treat MAC lung disease, check out the “Arikayce uses” section below.

Arikayce basics

Arikayce contains the active ingredient amikacin. (An active ingredient is what makes a drug work.) It’s a kind of antibiotic drug called an aminoglycoside.

Arikayce comes as a liquid suspension (a kind of liquid mixture) inside a vial that you inhale using a specific nebulizer. Arikayce isn’t currently available as a generic.

Keep reading to learn more about Arikayce, including the drug’s side effects, cost, dosage, and more.

Like most drugs, Arikayce may cause mild to serious side effects. The lists below contain some of the more common side effects this drug may cause, but don’t include all possible side effects.

Preventable medical errors kill about 22,000 patients a year, according to research from the Yale School of Medicine. That’s much less than a previously reported number of 250,000 deaths a year where medical error is to blame.

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Arikayce. They can also suggest ways to help manage them.

Mild side effects

Below is a list of some of the mild side effects that Arikayce can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read the drug’s prescribing information.

Mild side effects of Arikayce that have been reported include:

• cough
• diarrhea
• discomfort in your chest
• fatigue (low energy)
• fever
• headache
• changes in the amount or color of your mucus
• nausea and vomiting
• pain, including muscle or joint pain
• skin rash
• sore or irritated throat
• voice changes or hoarseness
• weakness
• weight loss
• mild allergic reaction*

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

* To learn more about this side effect, see the “Allergic reaction” section below.

Serious side effects

Serious side effects from Arikayce can occur, but they aren’t common. If you have serious side effects from this drug, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Arikayce that have been reported include:

• coughing up blood
• ear damage, including hearing loss or ringing in your ears
• kidney damage
• severe breathing problems, including bronchospasm (sudden tightening of your airway muscles)
• boxed warning : risk of increased respiratory side effects*
• severe allergic reaction†

* For more information, see “What should be considered before taking Arikayce?” below.
† To learn more about this side effect, see the “Allergic reaction” section just below.

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

• low blood pressure
• fainting
• dizziness
• fast heart rate

• cough
• wheezing
• shortness of breath
• fever
• fast breathing

The cost of prescription drugs can vary depending on many factors, including what your insurance plan covers. If you need help paying for Arikayce, a patient support program may be available to you. You can also check out this article to learn more about saving money on prescriptions.

If you have other questions about how to pay for your medication, talk with your doctor or pharmacist.

Your doctor will recommend the dosage of Arikayce that’s right for you. Below is the commonly used dosage, but always take the dosage your doctor prescribes.

Form and strength

Arikayce comes as a liquid suspension (a kind of liquid mixture) inside a vial that you inhale using a specific nebulizer. This suspension is available in one strength of 590 milligrams (mg) per 8.4 milliliters (mL), or 590 mg/8.4 mL.

Recommended dosage

For treating Mycobacterium avium complex (MAC) lung disease, you’ll inhale the contents of one 590 mg/8.4 mL vial once per day.

Questions about Arikayce’s dosing

Below are some common questions about Arikayce’s dosing.

• What if I miss a dose of Arikayce? If you miss a dose of Arikayce, skip the missed dose. Take your dose the next day as scheduled. Do not “double up” by taking more than one dose of Arikayce at once.
• Will I need to use Arikayce long term? Yes, if you and your doctor agree that the drug is safe and working well for you, you’ll use Arikayce long term. Guidelines for treating MAC lung disease suggest continuing treatment with Arikayce for at least 1 year after a mucus test is no longer positive for MAC. (Your doctor can provide more information about the mucus tests they’ll order and how often they’ll order them for you while you’re using Arikayce.)
• How long does Arikayce take to work? Arikayce begins working with your first dose, but you likely won’t notice it working. Your doctor will order tests during your treatment to check whether the drug is working to clear your infection.

Find answers to some commonly asked questions about Arikayce.

How does Arikayce compare with amikacin?

Amikacin is the active ingredient in Arikayce. (The active ingredient is what makes a drug work.) So side effects of the two drugs are expected to be the same. But Arikayce is the only form of amikacin that’s inhaled using a nebulizer. Arikayce isn’t available as generic amikacin.

Generic amikacin comes as a liquid solution given by injection. It’s used to treat certain serious infections and is only given by healthcare professionals, usually in a hospital.

Talk with your doctor or pharmacist if you have more questions about how Arikayce compares with amikacin.

Does Arikayce cause long-term side effects?

Yes, it’s possible for Arikayce to cause long-term side effects. These are side effects that either:

• start during your treatment and continue for a long time, possibly after you stop using Arikayce
• start after you’ve been using Arikayce for a long time or after your treatment ends

Long-term side effects reported with Arikayce include:

Side effect	When is it most likely to occur?	Will stopping Arikayce make it go away?
ear damage, such as • hearing loss • ringing in your ears	may occur at any time during treatment, even if you’ve used Arikayce for a long time	• may go away if Arikayce is stopped, but hearing loss caused by the drug can be permanent • unlikely to happen after stopping Arikayce
kidney damage	may occur at any time during treatment, even if you’ve used Arikayce for a long time	• may go away if Arikayce is stopped, especially if kidney damage is caught early, but damage may be permanent if it’s severe • unlikely to happen after stopping Arikayce

Talk with your doctor or pharmacist if you’d like to learn more about Arikayce and possible long-term side effects the drug may cause.

Will Arikayce cure MAC lung disease?

It’s possible for Arikayce treatment to cure Mycobacterium avium complex (MAC) lung disease. But this result isn’t guaranteed for everyone who uses the drug.

MAC is very hard to cure because the infection happens deep in your lungs, where it’s difficult for medications to reach. Arikayce is reserved for treating MAC in people who have had other treatments for MAC that have not cleared the infection.

Your doctor will order sputum (mucus) tests for you while you’re taking Arikayce to find out whether the MAC infection is still present. The cure rate for MAC is above 90% when the mucus tests don’t show signs of infection for at least 12 months.

If you have more questions about Arikayce and its ability to cure MAC, ask your doctor.

Arikayce is prescribed along with other drugs to treat Mycobacterium avium complex (MAC) lung disease that’s refractory (difficult to treat). Specifically, it’s used in adults who still have a MAC-positive sputum (mucus) tests despite receiving at least 6 months of other MAC treatments.

How Arikayce works

Arikayce contains the active ingredient amikacin. (An active ingredient is what makes a drug work.) Amikacin is a kind of antibiotic called an aminoglycoside. Aminoglycosides kill bacteria by blocking the production of certain proteins that bacteria need to make to survive and grow.

Arikayce comes as a liquid suspension (a kind of liquid mixture) inside a vial that you’ll inhale using a nebulizer. This delivers the drug directly to your lungs to help it reach the MAC bacteria.

Limitation of use for treating MAC

Arikayce is used along with other drugs to treat refractory MAC lung disease. Specifically, it’s used in adults who still have a MAC-positive sputum (mucus) test despite having had at least 6 months of other MAC treatments.

For this use, Arikayce has received accelerated approval from the Food and Drug Administration (FDA). Accelerated approval is based on information from early studies of the drug. The FDA will make a decision regarding the drug’s full approval after more studies are completed.

Arikayce received this approval through the Limited Population Pathway . This means the FDA has approved the drug only for a specific use, and limited information is available regarding its safety and effectiveness.

About MAC lung disease

MAC lung disease is an infection caused by bacteria commonly found in soil and water. For most people, exposure to MAC won’t cause infection. But it can cause infection in people with:

• a weakened immune system, such as people with HIV
• lung problems, such as people with chronic obstructive pulmonary disease (COPD)

Symptoms of MAC infection include:

• cough that doesn’t go away
• coughing up blood
• shortness of breath
• weight loss
• night sweats

MAC lung disease is difficult to treat because the infection is deep within your lungs, where it’s hard for drugs to reach. Arikayce delivers the drug directly to your lungs via a nebulizer to help it reach the MAC bacteria.

Your doctor will explain how you should take Arikayce, including how much to take and how often. Be sure to follow your doctor’s instructions.

Taking Arikayce

Arikayce comes as a liquid suspension (a kind of liquid mixture) inside a vial that you inhale using a specific nebulizer called the Lamira Nebulizer System. This nebulizer will be sent to you with your first Arikayce prescription.

You’ll take Arikayce by inhaling the contents of one vial once per day using the nebulizer. You can view a video with step-by-step instructions on how to do this on the drugmaker’s website.

Accessible medication containers and labels

If it’s hard for you to read the label on your prescription, tell your doctor or pharmacist. The specialty pharmacy that ships Arikayce to you may be able to provide medication labels that:

• have large print
• use braille
• contain a code you can scan with a smartphone to change the text to audio

Taking Arikayce with other drugs

For treating Mycobacterium avium complex (MAC) lung disease, you’ll use Arikayce along with other antibiotic drugs.

Examples of other drugs that may be prescribed together with Arikayce include:

• a macrolide antibiotic, such as:
  • azithromycin (Zithromax)
  • clarithromycin (Biaxin XL)
  • erythromycin (Ery-Tab)

  Your doctor will explain how to take each of the medications they prescribe to treat MAC lung disease.

  Questions about taking Arikayce

  Below are some common questions about taking Arikayce.

  • Should I take Arikayce with food? You can take Arikayce regardless of meals. (But do not eat or drink while actively inhaling a vial of the drug.)
  • Is there a best time of day to take Arikayce? There’s no best time of day to take this medication. The most important thing is to take it once per day as instructed by your doctor.

  Before you start using Arikayce, there are important considerations to discuss with your doctor. This includes telling them about your medical history and any medications you take. They’ll use this information to check for any interactions with Arikayce.

  Interactions

  Taking a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.

  Before taking Arikayce, be sure to tell your doctor about all drugs you take, including prescription and over-the-counter kinds. Also, describe any vitamins, herbs, or supplements you take. Your doctor or pharmacist can tell you about any interactions these items may cause with Arikayce.

  For information about drug-condition interactions, see the “Other warnings” section below.

  Interactions with drugs or supplements

  Arikayce can interact with several kinds of drugs. These include:

  • nonsteroidal anti-inflammatory drugs, such as ibuprofen (Advil)
  • certain diuretics (water pills), such as:
    • furosemide (Lasix)
    • bumetanide (Bumex)
    • ethacrynic acid (Edecrin)
    • vancomycin
    • penicillin V (Penicillin VK)

    This list does not contain all the kinds of drugs that may interact with Arikayce. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with use of Arikayce.

    Boxed warning

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

    Risk of increased respiratory side effects. Treatment with Arikayce can cause respiratory side effects. While rare, these may be severe and could require treatment in a hospital. Examples include:

    • coughing up blood
    • bronchospasm (sudden tightening of your airway muscles)
    • allergic inflammation in the lungs

    Your risk of these side effects is higher if you have an existing lung problem, such as asthma or chronic obstructive pulmonary disease (COPD). And Arikayce may worsen symptoms of these other conditions.

    Let your doctor know if you develop respiratory symptoms that become more severe than usual while taking Arikayce. They’ll recommend the best treatment for your symptoms.

    Other warnings

    Arikayce can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Arikayce is a good treatment option for you.

    Talk with your doctor about your health history before starting this drug. Factors to consider include those described below.

    Ear or kidney problem. Arikayce can damage your ears or kidneys as a side effect. Your risk may be higher if you already have ear or hearing problems or an existing kidney problem such as chronic kidney disease. Your doctor can determine whether Arikayce is safe for you to take in these situations.

    Nerve problem, such as myasthenia gravis. If you have an existing nerve problem, such as myasthenia gravis, Arikayce could make your condition worse. Because people with nerve problems weren’t included in the drug’s studies, the effects of the drug in this population aren’t known. Talk with your doctor about the possible risks and benefits of Arikayce if you have a nerve problem or condition.

    Allergic reaction. If you’ve had an allergic reaction to Arikayce or any of its ingredients, your doctor will likely not prescribe it for you. Ask them about other medications that might be better options.

    Arikayce and alcohol

    There are no known interactions between Arikayce and alcohol. Talk with your doctor if you have questions about consuming alcohol during your treatment with this drug.

    Pregnancy and breastfeeding

    It’s not known whether Arikayce is safe to take while pregnant because there aren’t enough studies of the drug’s use in pregnant people. Other forms of amikacin (the active ingredient* in Arikayce) are known to cause hearing loss in children born to people who took the drug during pregnancy. But it’s not known whether Arikayce also causes this side effect.

    Talk with your doctor to learn more about the risks and benefits of using Arikayce while pregnant.

    It’s also not known whether it’s safe to use Arikayce while breastfeeding. While other forms of amikacin may appear in breast milk, it’s not known whether this is also the case with Arikayce. Your doctor can discuss the best feeding options for your child with you if you’re taking this medication.

    * An active ingredient is what makes a drug work.

    Do not take more Arikayce than your doctor prescribes. This can lead to serious side effects. For example, too much Arikayce can increase your risk of kidney damage, a serious side effect this drug can cause.

    What to do in case you take too much Arikayce

    Call your doctor if you think you’ve taken too much Arikayce. You can also call 800-222-1222 to reach America’s Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or go to the nearest emergency room.

    Arikayce is prescribed along with other drugs to treat Mycobacterium avium complex (MAC) lung disease that’s difficult to treat. Specifically, it’s used in adults who still have a MAC-positive sputum (mucus) test despite receiving at least 6 months of other MAC treatments.

    If you have questions about Arikayce, talk with your doctor or pharmacist. Questions you may want to ask include:

    • How does Arikayce compare with other treatments for MAC lung disease?
    • If I have side effects from Arikayce that can’t be managed, what are my other treatment options?
    • What should I do if my insurance coverage changes while I’m using Arikayce?

    To get information on different conditions and tips for improving your health, subscribe to any of Austra Health’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.

    Disclaimer: Austra Health 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.