In a clinical study, adding ARIKAYCE to a multidrug treatment helped 29% (65/224) of people with difficult-to-treat MAC (Mycobacterium avium complex) lung disease test MAC-negative at 6 months compared to 8.9% (10/112) of people on a multidrug treatment alone. After 6 months, people on ARIKAYCE did not see an improvement in their 6-minute walk test and St George’s Respiratory Questionnaire measurements.
MAC lung disease is caused by MAC bacteria. It is a serious condition that, if left untreated, can worsen over time. That’s why it’s important to talk to your doctor about treatment options. You may be prescribed a multidrug treatment to help you test MAC-negative.
If you continue to test positive for MAC lung disease with your multidrug treatment, you may still be at risk for permanent lung damage—even if you are feeling better.
Treatment guidelines strongly recommend adding ARIKAYCE, the first and only FDA-approved treatment used in combination with multidrug therapy for adults who still test positive for MAC 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.
you have MAC lung disease
you’ve been on a multidrug treatment for at least 6 months
your sputum test shows you’re still testing positive for MAC
ARIKAYCE is an inhaled antibiotic taken with a nebulizer. It’s different because the antibiotic is contained inside tiny particles called liposomes that are designed to target the MAC infection directly in the lungs.
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING 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:
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:
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:
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.
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.