ARIKAYCE Inhalation suspension (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Insmed Incorporated

Λέξεις κλειδιά

71558-590

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BOXED WARNING SECTION

WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS ARIKAYCE has been associated with an increased risk of respiratory adverse reactions including, hypersensitivity pneumonitis, hemoptysis, ...

1. Indications and Usage

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 ...

2. Dosage and Administration

2.1 Important Administration Instructions ARIKAYCE is for oral inhalation use only. Administer by nebulization only with the Lamira Nebulizer System. Refer to the Instructions for Use for full administration ...

3. Dosage Forms and Strengths

ARIKAYCE is supplied as a sterile, white, milky, aqueous, liposome suspension for oral inhalation in a unit-dose glass vial containing amikacin 590 mg/8.4 mL (equivalent to amikacin sulfate 623 mg/8.4 ...

4. Contraindications

ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

5. Warnings and Precautions

5.1 Hypersensitivity Pneumonitis Hypersensitivity pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, ...

6. Adverse Reactions

The following clinically significant adverse reactions are described in greater detail in other sections of labeling: Hypersensitivity pneumonitis [see Boxed Warning and Warnings and Precautions (5.1)] ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified from postmarketing surveillance. Because these adverse reactions are reported voluntarily from a population of unknown size, precise estimates of frequency ...

7. Drug Interactions

7.1 Drugs with Neurotoxic, Nephrotoxic, or Ototoxic Potential Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. 7.2 Ethacrynic Acid, Furosemide, ...

8.1. Pregnancy

Risk Summary There are no data on ARIKAYCE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Although systemic absorption ...

8.2. Lactation

Risk Summary There is no information regarding the presence of ARIKAYCE in human milk, the effects on the breastfed infant, or the effects on milk production after administration of ARIKAYCE by inhalation. ...

8.4. Pediatric Use

Safety and effectiveness of ARIKAYCE in pediatric patients below 18 years of age have not been established.

8.5. Geriatric Use

In the NTM clinical trials, of the total number of patients receiving ARIKAYCE, 208 (51.5%) were ≥65 years and 59 (14.6%) were ≥75 years. No overall differences in safety and effectiveness were observed ...

8.6. Hepatic Impairment

ARIKAYCE has not been studied in patients with hepatic impairment. No dose adjustments based on hepatic impairment are required since amikacin is not hepatically metabolized [see Clinical Pharmacology ...

8.7. Renal Impairment

ARIKAYCE has not been studied in patients with renal impairment. Given the low systemic exposure to amikacin following administration of ARIKAYCE, clinically relevant accumulation of amikacin is unlikely ...

10. Overdosage

Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function ...

11. Description

The active ingredient in ARIKAYCE (amikacin liposome inhalation suspension) is amikacin sulfate USP, an aminoglycoside antibacterial. Its chemical name is D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6) ...

12.1. Mechanism of Action

ARIKAYCE is an antibacterial drug [see Microbiology (12.4)].

12.2. Pharmacodynamics

ARIKAYCE exposure-response relationships and the time course of pharmacodynamic response are unknown.

12.3. Pharmacokinetics

Sputum Concentrations Following once daily inhalation of 590 mg ARIKAYCE in Mycobacterium avium complex (MAC) patients, sputum concentrations at 1 to 4 hours post-inhalation were 1720, 884, and ...

12.4. Microbiology

Mechanism of Action Amikacin is a polycationic, semisynthetic, bactericidal aminoglycoside. Amikacin enters the bacterial cell by binding to negatively charged components of the bacterial cell wall disrupting ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year inhalation carcinogenicity study, rats were exposed to ARIKAYCE for 15-25, 50-70, or 155-170 minutes per day for 96-104 weeks. These provided approximate inhaled doses of 5, 15, and 45 mg/kg/day. ...

13.2. Animal Toxicology and/or Pharmacology

To provide information about chronic dosing of ARIKAYCE to another animal species, a 9-month inhalation toxicology study was conducted in dogs. Foamy alveolar macrophages associated with clearance of the ...

14. Clinical Studies

Trial 1 (NCT#02344004) was an open-label, randomized (2:1), multi-center trial in patients with refractory Mycobacterium avium complex (MAC) lung disease as confirmed by at least 2 sputum culture ...

16.1. How Supplied

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 ...

16.2. Storage and Handling

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 ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Patient Instructions for Use). Important Instructions for Administration of ARIKAYCE Instruct patients to read the ...