Arikayce

Arikayce is an antibiotic prescription medication used to treat Mycobacterium avium complex (MAC) lung disease in patients who have limited or no alternative antibiotic treatment options. Arikayce belongs to a group of drugs called aminoglycoside antibiotics. These work by binding to the bacterial small ribosomal subunit, 30S. The medication prevents protein production in bacteria.

This medication comes as a suspension to be inhaled through a Lamira nebulizer system once a day.

Common side effects include cough, difficulty speaking, body aches, diarrhea, nausea, and headaches. Arikayce can also cause drowsiness or dizziness. Do not drive or operate heavy machinery until you know how Arikacye affects you.

Arikayce is a prescription medicine 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). It is not known if Arikayce is safe and effective in children younger than 18 years of age.

This product was approved by FDA using the Limited Population pathway. This means FDA has approved this drug for a limited and specific patient population, and studies on the drug may have only answered focused questions about its safety and effectiveness.

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

Arikayce may cause serious side effects. See "Drug Precautions" section.

The most common side effects of Arikayce include:

• changes in your voice and hoarseness (dysphonia)
• tiredness (fatigue)
• headache
• rash
• cough during or after a dose of Arikayce, especially in the first month after starting treatment.
• sore throat
• diarrhea
• fever
• decreased weight
• chest discomfort
• muscle pain
• nausea
• vomiting
• increased sputum

These are not all of the possible side effects of Arikayce. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

• Lasix (furosemide)
• Intravenous (IV) Mannitol
• Urea
• Edecrin (ethacrynic Acid)

This is not a complete list of Arikayce drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Arikayce including the following:

• allergic inflammation of the lungs. These respiratory problems may be symptoms of allergic inflammation of the lungs and often come with fever, wheezing, coughing, shortness of breath, and fast breathing
• coughing up of blood (hemoptysis). Coughing up blood is a serious and common side effect of Arikayce
• severe breathing problems. Severe breathing problems can be symptoms of bronchospasm. Bronchospasm is a serious and common side effect of Arikayce. Bronchospasm symptoms include shortness of breath, difficult or labored breathing, wheezing, and coughing or chest tightness
• worsening of chronic obstructive pulmonary disease (COPD). This is a serious and common side effect of Arikayce

While using Arikayce, these side effects may become serious enough that treatment in a hospital is needed. Call your healthcare provider or get medical help right away if you have any of these serious side effects while taking Arikayce. Your healthcare provider may ask you to stop using Arikayce for a short period of time or completely stop using Arikayce.

Do not use Arikayce if you are allergic to any aminoglycoside, or any of the ingredients in Arikayce.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Arikayce, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Arikayce, tell your healthcare provider about all of your medical conditions, including if you:

• have asthma, chronic obstructive pulmonary disease (COPD), shortness of breath or wheezing (bronchospasm).
• havebeentoldyouhavepoorlungfunction.
• havehearingproblemssuchasringinginyourearsorhearingloss.
• have dizziness or sense of the room spinning.
• havekidneyproblems.
• haveneuromusculardiseasesuchasmyastheniagravis.
• are pregnant or plan to become pregnant. It is not known if Arikayce can harm your unborn baby. Arikayce is
• in a class of medicines that may be connected with complete deafness in babies at birth. The deafness affects both
• ears and cannot be changed.
• are breastfeeding or plan to breastfeed. It is not known if the medicine in Arikayce passes into your breast milk
• and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Arikayce.

Tell your healthcare provider about all the medicines you take, including prescription medicines and over- the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no studies that have been done in pregnant women. Absorption of Arikayce into the blood is expected to be low. Arikayce, like other aminoglycoside antibiotics, can cause complete and permanent deafness from birth if exposed to the fetus. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

There are no studies that have been done to determine the presence of Arikayce in human milk.  Absorption of Arikayce into the blood is expected to be low. Studies of amikacin use via injection showed presence of the medication in human milk. Amikacin has been detected in human milk when used via injection. Because of the possibility for adverse reactions in nursing infants from Arikayce, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Arikayce exactly as prescribed.

• The manufacturer’s Instructions for Use provides complete information about how to put together (assemble), prepare, use, clean, and disinfect your Lamira Nebulizer System.
• Do not use Arikayce unless you understand the directions provided. If you have questions talk to your health care provider or call Arikares Support at 1-833-ARIKARE (1-833-274-5273).
• Use Arikayce exactly as your healthcare provider tells you to use it. Do not use Arikayce more often than prescribed for you.
• Only use Arikayce with the Lamira Nebulizer System.
• Inhale each daily dose of Arikayce 1 time each day through the Lamira Nebulizer Handset. Do not use more
• than 1 vial of Arikayce in a day.
• Do not use Arikayce after the expiration date on the vial. If you forget to take your daily dose of Arikayce, take your next dose at your usual time the next day.
• Do not double the dose to make up for the missed dose.
• Do not stop using Arikayce or other medicines to treat your MAC lung disease unless told to do so by your healthcare provider.

Arikayce comes in a suspension for inhalation form and is taken via nebulizer once daily. If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Arikayce at the same time.

Take this medication exactly as prescribed by your doctor.

Follow the directions on your prescription label carefully. The recommended dose of Arikayce (amikacin) for the treatment of Mycobacterium avium complex (MAC) lung disease is 590 mg, one vial, once daily.

If you use too much Arikayce, call your healthcare provider or go to the nearest emergency room right away.

Store Arikayce vials refrigerated between 36°F to 46°F (2°C to 8°C) until the expiration date on the vial. Do not freeze.

• After Arikayce has been stored in the refrigerator, any unused medicine must be thrown away (disposed of) after the expiration date on the vial.
• Store Arikayce vials at room temperature between 68°Fto 77°F (20°C to 25°C) for up to 4 weeks.
• After Arikayce has been stored at room temperature any unused medicine must be thrown away (disposed of) at the end of 4 weeks.
• Use an opened Arikayce vial right away.
• Throw away the Arikayce vial right away after use.

Keep Arikayce and all medicines out of the reach of children.

This page was written by Jessica Ochoa, PharmD Candidate 2020 | UT Austin College of Pharmacy

Warning: Increased Risk of Respiratory Adverse Reactions 

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