Sponsored by: Insmed Incorporated
When 70-year-old Julie V. was running one of her many marathons in December of 2011, she started feeling fatigued.
“At mile 20, I could barely go on, which was unusual for me,” recalls the avid runner.
Julie pushed through and finished the race—but that night, she awoke coughing up blood. Given that Julie had been diagnosed in her thirties with pulmonary hemangioma (a rare benign lung tumor), her doctor recommended hospitalization. In the hospital, Julie tested positive for tuberculosis. But her pulmonologist suspected another culprit— Mycobacterium avium complex (MAC) lung disease—and referred her to an infectious disease specialist who confirmed a MAC diagnosis through a bronchoscopy.
What Is MAC Lung Disease?
MAC, the most common form of nontuberculous mycobacteria (NTM), is a serious condition that—if left untreated—can cause damage to the lungs which worsens over time. The disease is caused by bacteria commonly found in soil and water that are easily inhaled during everyday activities. Studies show that a MAC infection can have a serious, long-term health impact if left unaddressed. In fact, one study that reviewed medical claims data for both people with MAC lung disease and those without found that people with MAC were nearly twice as likely to be hospitalized than those without the disease.
This is why experts recommend starting treatment rather than waiting—especially for people with a more severe infection, a compromised immune system, severe fatigue or other signs of decreased quality of life, or cavitary disease.
Treatment Challenges
While doctors now know a lot more about MAC and how to treat it, limited information existed when Julie was first diagnosed, and the medical community lacked consensus on the best treatment path.
“When I was diagnosed with MAC, no one knew anything about it, not even the doctors,” says Julie. “My initial doctor told me that it’s something I’d just have to live with for the rest of my life.”
After consulting several specialists, Julie felt relief when she was told her MAC was curable if she took antibiotics for several years. Three years after her initial diagnosis, Julie tested negative for MAC and thought she was cured. However, that relief was short-lived. After 18 months, MAC struck again.
A Turning Point
After another six months of frustratingly unsuccessful multidrug treatment, Julie’s doctor recommended adding ARIKAYCE® (amikacin liposome inhalation suspension) in combination with her antibiotic regimen. ARIKAYCE is the first and only FDA-approved treatment for adults who still test positive for MAC after six months on a multidrug treatment alone and have limited or no alternative treatment options.
Julie followed his advice, started taking ARIKAYCE, and finally tested negative a few months later.
ARIKAYCE can cause serious side effects including: allergic inflammation of the lungs, coughing up blood (hemoptysis), severe breathing problems, worsening of COPD (chronic obstructive pulmonary disorder), serious allergic reactions, hearing loss or ringing in the ears (ototoxicity), worsening kidney problems (nephrotoxicity) or worsening muscle weakness (neuromuscular blockade).
While everyone’s results on ARIKAYCE may vary, for Julie, it’s now been almost two years since she stopped treatment altogether and she continues to test negative. ARIKAYCE proved to be the turning point in Julie’s treatment, providing a ray of hope and a path toward recovery. But what makes it different?
Adding ARIKAYCE to Your Treatment Plan
Julie’s physician, Catherine Smith O’Neal, MD, an infectious disease specialist and Chief Medical Officer of Our Lady of the Lake Health in Baton Rouge, La., notes that, “The journey to combat MAC lung disease starts with an oral antibiotic regimen — according to clinical studies, for about two-thirds of patients, this initial treatment will be sufficient to offer them a path to recovery. However, for the remaining one-third of patients, the initial treatment will not be enough.”
This is where ARIKAYCE may fit into the treatment journey. Says Dr. O’Neal: “It’s important for patients to see their doctor every 4-6 weeks and provide sputum cultures. If you’re out of other options and you’re still remaining culture-positive after a minimum of 6 consecutive months of a multidrug background antibiotic regimen therapy, international treatment guidelines strongly recommend adding ARIKAYCE.”
As an inhaled antibiotic taken with a nebulizer, ARIKAYCE delivers tiny particles (called liposomes) to the lungs where it releases the antibiotic to fight MAC bacteria where it lives.
The most common side effects of ARIKAYCE are 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.
Life After MAC Treatment
After more than a decade of battling MAC lung disease, Julie continues to lead an active lifestyle by running five miles a day, playing tennis, and practicing Pilates. She also works full-time as a showroom manager*.
Julie remained optimistic and proactive in her journey to fight MAC lung disease. Her advice to others? “Go to your doctor. Do your sputum samples. Don’t be afraid to hear the news because there is hope,” she encourages. Everyone’s experience may be different. Julie says, “While I did experience some initial nausea, working with my doctor, I was able to continue treatment and I’m doing great now*.”
It’s important to have informed conversations with your doctor and understand treatment options. And, when introducing any new medication, it’s important to discuss side effects and what you may be able to do if you have them.
If you’re being treated for MAC lung disease, multidrug treatment may not be enough. If you’re still testing positive for MAC after 6 months of multidrug therapy, talk to your doctor about adding ARIKAYCE in combination with multidrug treatment.
Visit https://www.arikayce.com/info
*Individual results may vary.
What is ARIKAYCE?
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.
MAC=Mycobacterium avium complex.
Julie is a compensated ARIKAYCE patient ambassador.
IMPORTANT SAFETY INFORMATION AND BOXED WARNING
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.
Please see full Prescribing Information.
