ARIKAYCE- amikacin suspension

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Amikacin (UNII: 84319SGC3C) (Amikacin - UNII:84319SGC3C)

Beschikbaar vanaf:

Insmed Incorporated

Toedieningsweg:

RESPIRATORY (INHALATION)

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients. This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established [see Clinical Studies (14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitati

Product samenvatting:

ARIKAYCE (amikacin liposome inhalation suspension), 590 mg/8.4 mL, is supplied in a sterile, unit-dose 10-mL glass vial. The product is dispensed as a 28-vial kit. Each carton contains a 28-day supply of medication (28 vials). In addition to the ARIKAYCE vials in the carton, one Lamira Nebulizer Handset and four Lamira Aerosol Heads are provided. NDC 71558-590-28 The Lamira Nebulizer System contains a controller, a spare Aerosol Head, a spare Handset, Power Cord and accessories. Store ARIKAYCE vials refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date on vial. Do not freeze. Once expired, discard any unused drug. ARIKAYCE can be stored at room temperature up to 25°C (77°F) for up to 4 weeks. Once at room temperature, any unused drug must be discarded at the end of 4 weeks.

Autorisatie-status:

New Drug Application

Bijsluiter

Insmed Incorporated
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Issued
2/2023
MEDICATION GUIDE
ARIKAYCE (ar' i kase) LIMITED POPULATION
(amikacin liposome inhalation suspension)
for oral inhalation use
Important: For oral inhalation only.
What is the most important information I should know about ARIKAYCE?
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
•
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.
•
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
•
noisy high-pitched
breathing (stridor)
•
cough
•
nausea
•
vomiting
•
diarrhea
•
fast heart rate
•
feeling light headed
•
feeling faint
•
loss of control of the
bowels or bladder
(incontinence)
wheezing
•
shortness of breath
•
feel cramps in your
stomach area
•
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 ta

Productkenmerken

ARIKAYCE- AMIKACIN SUSPENSION
INSMED INCORPORATED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARIKAYCE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARIKAYCE.
ARIKAYCE (AMIKACIN LIPOSOME INHALATION SUSPENSION), FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2018
LIMITED POPULATION
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ARIKAYCE HAS BEEN ASSOCIATED WITH A RISK OF INCREASED RESPIRATORY
ADVERSE REACTIONS,
INCLUDING, HYPERSENSITIVITY PNEUMONITIS, HEMOPTYSIS, BRONCHOSPASM, AND
EXACERBATION
OF UNDERLYING PULMONARY DISEASE THAT HAVE LED TO HOSPITALIZATIONS IN
SOME CASES. (5.1,
5.2, 5.3, 5.4)
RECENT MAJOR CHANGES
Warnings and Precautions, Ototoxicity (5.6)
2/2023
INDICATIONS AND USAGE
LIMITED POPULATION: ARIKAYCE is an aminoglycoside antibacterial
indicated in adults who have limited or
no alternative treatment options, for the treatment of _Mycobacterium
avium_ complex (MAC) lung disease
as part of a combination antibacterial drug regimen in patients who do
not achieve negative sputum
cultures after a minimum of 6 consecutive months of a multidrug
background regimen therapy. As only
limited clinical safety and effectiveness data for ARIKAYCE are
currently available, reserve ARIKAYCE for use
in adults who have limited or no alternative treatment options. This
drug is indicated for use in a limited
and specific population of patients. (1)
This indication is approved under accelerated approval based on
achieving sputum culture conversion
(defined as 3 consecutive negative monthly sputum cultures) by Month
6. Clinical benefit has not yet been
established. (1)
Limitation of Use:
ARIKAYCE has only been studied in patients with refractory MAC lung
disease defined as patients who did
not achieve negative sputum cultures after a minimum of 6 consecutive
months of a multidrug
background regimen therapy. The use of ARIKAYCE is not recommended for
patients with non-re