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A doctor weighs in on the treatment journey
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A doctor weighs in on the treatment journey

Prescribing Information & Boxed Warning at http://bit.ly/2Ly8qj9 ARIKAYCE is used in combination with multidrug therapy for adults who still test positive for MAC lung disease after at least 6 months on multidrug treatment alone. ARIKAYCE 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. ARIKAYCE was studied in adult patients. It is not known if ARIKAYCE is safe and effective in children younger than 18 years of age. 𝗜𝗠𝗣𝗢𝗥𝗧𝗔𝗡𝗧 𝗦𝗔𝗙𝗘𝗧𝗬 𝗜𝗡𝗙𝗢𝗥𝗠𝗔𝗧𝗜𝗢𝗡 & 𝗕𝗢𝗫𝗘𝗗 𝗪𝗔𝗥𝗡𝗜𝗡𝗚 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 https://fda.gov/medwatch. Visit: https://ARIKAYCE.com

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