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Knowing the possible side effects of ARIKAYCE

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Everyone responds to treatment differently. If you have questions about the possible side effects associated with ARIKAYCE, be sure to speak with your doctor

ARIKAYCE can cause serious side effects, such as:

  • allergic inflammation of the lungs. These respiratory problems may be symptoms of allergic inflammation of the lungs and often come with:

    • fever
    • coughing
    • fast breathing
    • wheezing
    • shortness of breath
  • 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
    • wheezing
    • difficult or labored breathing
    • 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.

ARIKAYCE may cause serious side effects, including:

  • hearing loss or ringing in the ears (ototoxicity). Ototoxicity is a serious and common side effect of ARIKAYCE. Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears, such as ringing or hissing. Tell your healthcare provider if you start having problems with balance or dizziness (vertigo)
  • worsening kidney problems (nephrotoxicity). ARIKAYCE is in a class of medicines which may cause worsening kidney problems. Your healthcare provider may do a blood test to check how well your kidneys are working during your treatment with ARIKAYCE
  • worsening muscle weakness (neuromuscular blockade). ARIKAYCE is in a class of medicines which can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis)
20.2% of patients taking ARIKAYCE had side effects and 16.1% of patients taking combination therapy alone had side effects

19.7% of patients taking ARIKAYCE + a multidrug regimen experienced serious side effects compared to 16.1% of patients taking a multidrug regimen alone

Common side effects

The most common side effects of ARIKAYCE are:

  • changes in voice and hoarseness (dysphonia)
  • cough during or after a dose of ARIKAYCE
  • muscle pain
  • sore throat
  • tiredness (fatigue)
  • diarrhea
  • nausea
  • headache
  • fever
  • decreased weight
  • vomiting
  • rash
  • increased sputum
  • chest discomfort

Cough during or after a dose of ARIKAYCE was reported most by patients during the first month of treatment

83%

Most patients who experienced side effects did not stop treatment

81% (182/224) of patients taking ARIKAYCE + a multidrug regimen did not stop treatment even though they had at least one side effect

If you experience any side effects while taking ARIKAYCE, be sure to talk to your doctor about them

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 the FDA at 1-800-FDA-1088 (1-800-332-1088).

Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of the medicines you take and show your doctor and pharmacist when you get a new medicine.

Side effect management survey

A recent survey reported potential techniques and strategies to help manage certain respiratory-related side effects when taking ARIKAYCE.

The survey was conducted via telephone with 26 patients prescribed ARIKAYCE during a 2-month period at 2 academic medical centers in the United States.

Survey disclosures

  • This information is not included in the ARIKAYCE full Prescribing Information
  • Writing assistance was provided to the authors through funding from Insmed Incorporated
  • Insmed was not involved with the conceptualization, development, conduct, or analyses of the study

Below are potential management strategies used in the survey for certain side effects. Always talk to your doctor before starting any management techniques.

Increased coughing

Management strategies included:

  • bronchodilator use
  • changing ARIKAYCE administration to the evening
  • brief interruptions of ARIKAYCE
  • antitussive agents
  • lozenges
  • warm water or glycerin gargle post-dosing
  • soothing fluid intake
  • bronchodilator use
  • changing ARIKAYCE administration to the evening
  • brief interruptions of ARIKAYCE
  • antitussive agents
  • lozenges
  • warm water or glycerin gargle post-dosing
  • soothing fluid intake

Changes in voice and hoarseness (dysphonia)

Management strategies included:

  • changing ARIKAYCE administration to the evening
  • brief interruptions of ARIKAYCE
  • antitussive agents
  • lozenges
  • warm water or glycerin gargle post-dosing
  • soothing fluid intake
  • changing ARIKAYCE administration to the evening
  • brief interruptions of ARIKAYCE
  • antitussive agents
  • lozenges
  • warm water or glycerin gargle post-dosing
  • soothing fluid intake

Shortness of breath (dyspnea)

Management strategies included:

  • bronchodilator use
  • brief interruptions of ARIKAYCE
  • limiting physical activity
  • increasing supplemental oxygen, if already administering
  • bronchodilator use
  • brief interruptions of ARIKAYCE
  • limiting physical activity
  • increasing supplemental oxygen, if already administering

Increased sputum production

Management strategies included:

  • airway clearance* (eg, specific breathing techniques, chest percussion, and positive expiratory pressure therapy)

*Increased sputum production may be a form of airway clearance in itself.

Remember, management strategies should be discussed with your doctor, as they may vary patient by patient.

Find sample questions to help you start a conversation about ARIKAYCE with your doctor by downloading this

Doctor discussion guide

Next, learn about taking ARIKAYCE by watching the

Device Video
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IMPORTANT SAFETY INFORMATION AND INDICATION ARIKAYCE is associated with: risk of increased respiratory adverse reactions including allergic inflammation of lungs, coughing up blood, severe breathing problems and worsening of COPD.

ARIKAYCE can cause serious side effects, including:

  • 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
  • serious allergic reactions. Serious allergic reactions that may lead to death have happened to people who take ARIKAYCE. Stop taking ARIKAYCE right away and get emergency medical help if you have any of the following symptoms of a serious allergic reaction: hives, itching, redness or blushing of the skin (flushing), swollen lips, tongue or throat, trouble breathing or wheezing, shortness of breath, noisy high-pitched breathing (stridor), cough, nausea, vomiting, diarrhea, feel cramps in your stomach area, fast heart rate, feeling light headed, feeling faint, loss of control of the bowels or bladder (incontinence), and dizziness

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.

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

  • have asthma, COPD, shortness of breath, or wheezing (bronchospasm)
  • have been told you have poor lung function
  • have hearing problems, such as ringing in your ears or hearing loss
  • have dizziness or a sense of the room spinning
  • have kidney problems
  • have neuromuscular disease, such as myasthenia gravis
  • 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.

ARIKAYCE may cause serious side effects, including:

  • hearing loss or ringing in the ears (ototoxicity). Ototoxicity is a serious and common side effect of ARIKAYCE. Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears, such as ringing or hissing. Tell your healthcare provider if you start having problems with balance or dizziness (vertigo)
  • worsening kidney problems (nephrotoxicity). ARIKAYCE is in a class of medicines which may cause worsening kidney problems. Your healthcare provider may do a blood test to check how well your kidneys are working during your treatment with ARIKAYCE
  • worsening muscle weakness (neuromuscular blockade). ARIKAYCE is in a class of medicines which can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis)

The most common side effects of ARIKAYCE include: changes in voice and hoarseness (dysphonia), cough during or after a dose of ARIKAYCE, especially in the first month after starting treatment, muscle pain, sore throat, tiredness (fatigue), diarrhea, nausea, headache, fever, decreased weight, vomiting, rash, increased sputum, or chest discomfort.

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 or www.fda.gov/medwatch.

What is ARIKAYCE?

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.