Usual Adult Dose for Mycobacterium avium-intracellulare - Treatment

590 mg inhaled via Lamira (TM) nebulizer once a day

Comments:

• Patients using bronchodilators should use the bronchodilator prior to using this drug.
• Pretreatment with short-acting beta-2 agonists should be considered in patients with specific patient populations (e.g., asthma, bronchospasm, chronic obstructive pulmonary disease, hyperactive airway disease).

Use: Patients 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

Renal Dose Adjustments

Frequent monitoring recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

US BOXED WARNINGS:
RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS:

• This drug 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.

NARROW THERAPEUTIC INDEX:

• This drug should be considered a narrow therapeutic index (NTI) drug as small differences in dose or blood concentrations may lead to serious therapeutic failures or adverse drug reactions.

Recommendations:

• Generic substitution should be done cautiously, if at all, as current bioequivalence standards are generally insufficient for NTI drugs.
• Additional and/or more frequent monitoring should be done to ensure receipt of an effective dose while avoiding unnecessary toxicities.

CONTRAINDICATIONS:

• Hypersensitivity to any of the aminoglycosides

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This formulation is for oral use only.
• This drug should be reserved for patients with limited to no alternative treatment options and should be used in patients with nonrefractory MAC disease.
• Patients who need bronchodilator treatment concurrently should take this drug last.
• The solution should be brought to room temperature for at least 45 minutes prior to administration.

Storage requirements:

• Refrigerate at 2 to 8 C; do not freeze.
• Vials may be stored at room temperature (up to 25C) for up to 4 weeks, but any unused vials should be discarded at the end of 4 weeks.
• Nebulizer components (e.g., handset, aerosol head) should be properly cleaned and disinfected prior to the first use and then after each use.

Reconstitution/preparation techniques:

• Nebulizer preparation instructions: The manufacturer product information should be consulted.
• Vials should be shaken for 10 to 15 seconds until the content are uniform, then the contents should be poured into the nebulizer.

General:

• LIMITATION OF USE: Limited safety and efficacy data of this formulation are available; treatment is recommended for a limited and specific patient population.

Monitoring:

• Other: Auditory function monitoring in patients at risk of auditory or vestibular dysfunction
• Renal: Renal function monitoring in patients with renal dysfunction
• Respiratory: Sputum culture conversion

Patient advice:

• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
• Inform patients that this drug may cause dizziness and/or vertigo, and they should avoid driving or operating machinery if these side effects occur.
• Patients should be told to report any unusual or severe side effects, including signs/symptoms of nephrotoxicity, neuromuscular blockade, and ototoxicity.
• Patients should be directed to take the full course of treatment, even if they feel better. If a daily dose is missed, the next dose should be taken on the next day.

Frequently asked questions

• What type of drug is Arikayce?