Understanding possible ARIKAYCE side effects
When you and your doctor discuss a MAC (Mycobacterium avium complex) treatment plan, it’s important to understand potential side effects and possible ways to help manage them. Being prepared may help you to take your treatment as prescribed. Remember, everyone responds to treatment differently. If you have questions about the possible side effects associated with ARIKAYCE, be sure to speak with your doctor.
- 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
- 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)
19.7% of people in the study who took ARIKAYCE + multidrug treatment experienced serious side effects
vs
16.1% of people who took multidrug treatment alone
- 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
ARIKAYCE can cause serious side effects, including:
While using ARIKAYCE these side effects may become serious enough that treatment in a hospital is needed.
In a study, these were the common side effects experienced by ≥5% of people taking ARIKAYCE in combination with multidrug treatment compared to people taking multidrug treatment alone.
Cough was first reported most often during the first month of treatment.
Common Side Effect
% of 223 people taking
ARIKAYCE + multidrug treatment
% of 112 people
taking
multidrug treatment alone
Changes in voice and hoarseness
48%
2%
Cough
40%
17%
Chest tightness/wheezing/
shortness of breath
29%
11%
Coughing up blood
(hemoptysis)
18%
13%
Muscle pain
(musculoskeletal pain)
18%
9%
Upper airway irritation
18%
2%
Hearing loss
(ototoxicity)
17%
10%
Tiredness
(fatigue and asthenia)
16%
10%
Worsening of COPD and bronchiectasis
15%
10%
Diarrhea
13%
5%
Nausea
12%
4%
Headache
10%
5%
Pneumonia
9%
9%
Fever
(pyrexia)
8%
5%
Weight decreased
7%
1%
Vomiting
7%
4%
Rash
6%
1%
Change in sputum
6%
1%
Chest discomfort
5%
3%
“I had some hoarseness. I lost my voice during some of my treatment. Everybody’s side effects are different.”
—Elisse, a real patient
Findings from a side effects management survey
A telephone survey (conducted during a 2-month period at 2 academic centers) of 26 people on ARIKAYCE looked at how to help manage certain respiratory-related side effects while on treatment.
Survey disclosures
Below are the potential techniques and strategies people used in the survey for certain side effects. Always talk to your doctor before starting any management techniques.
Increased
coughing
Changes in voice
and hoarseness
(dysphonia)
Shortness
of breath
(dyspnea)
Increased sputum
production
Management Strategy
Lozenges
Soothing fluid intake
Warm water or glycerin gargle post dosing
Limiting physical activity
Changing ARIKAYCE administration to evening
Brief interruptions of ARIKAYCE
Bronchodilator use
(medicine that increases airflow to the lungs)
Antitussive agents
(cough medicine)
Increased supplemental oxygen, if already administering
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.
These are not all of the possible side effects of ARIKAYCE.
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.
Call your doctor or pharmacist for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).
