Amikacin Liposome Inhalation

Amikacin Liposome Inhalation is a prescription medication used to treat Mycobacterium Avium Complex (MAC) lung disease as part of a combination antibacterial drug regimen in adults who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy.

• Amikacin Liposome Inhalation is available under the following different brand names: Arikayce 

Common side effects of Amikacin Liposome Inhalation include:

• Difficulty speaking,
• Cough,
• Bronchospasm,
• Coughing up blood,
• Damage to the inner ear,
• Upper airway irritation,
• Musculoskeletal pain,
• Fatigue,
• Weakness,
• Worsening of underlying lung disease,
• Diarrhea, and
• Nausea

Serious side effects of Amikacin Liposome Inhalation include:

• Cough
• Coughing or spitting up blood
• Difficulty breathing
• Dizziness
• Feeling of fullness in the ears
• Fever
• Loss of balance
• Loss of hearing
• Noisy breathing
• Ringing or buzzing in the ears
• Sore throat
• Tightness in the chest
• Trouble hearing
• Upper airway irritation
• Voice changes

Rare side effects of Amikacin Liposome Inhalation include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Liposome suspension for oral inhalation

• 590 mg/8.4 mL; single-use vial (623 mg/8.4 mL amikacin sulfate equivalent)

Mycobacterium Avium Complex Lung Disease

Adult dosage

• 590 mg/8.4 mL inhaled orally once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Amikacin Liposome Inhalation has severe interactions with no other drugs.
• Amikacin Liposome Inhalation has serious interactions with no other drugs.
• Amikacin Liposome Inhalation has moderate interactions with the following drugs
  • abobotulinumtoxinA
  • prabotulinumtoxinA
  • sodium sulfate/? magnesium sulfate/potassium chloride
  • sodium sulfate/potassium sulfate/magnesium sulfate
  • voclosporin
• Amikacin Liposome Inhalation has minor interactions with the following drug:
  • entecavir

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to any aminoglycoside

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Amikacin Liposome Inhalation?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Amikacin Liposome Inhalation?”

Cautions

• Hypersensitivity pneumonitis (. g, allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction) reported; if hypersensitivity pneumonitis occurs, discontinue the drug and manage as medically appropriate
• Hemoptysis reported; if hemoptysis occurs, manage as medically appropriate
• Bronchospasm (. g, asthma, bronchial hyperreactivity, bronchospasm, dyspnea, exertional dyspnea, prolonged expiration, throat tightness, wheezing) reported; if bronchospasm occurs, treat as medically appropriate
• Exacerbations of underlying pulmonary disease (. g, chronic obstructive pulmonary disease, infective exacerbation of the chronic obstructive pulmonary disease, infective exacerbation of bronchiectasis) reported in clinical trials; if exacerbations of the underlying pulmonary disease occur, treat as medically appropriate
• Ototoxicity (. g, deafness, dizziness, presyncope, tinnitus, vertigo) reported in clinical trials; closely monitor patients with known or suspected auditory or vestibular dysfunction; if ototoxicity occurs, manage as medically appropriate, including potentially discontinuing treatment
• Nephrotoxicity observed during clinical trials in patients with MAC lung disease; nephrotoxicity has been associated with the aminoglycosides; closely monitor patients with known or suspected renal dysfunction
• Patients with neuromuscular disorders were not enrolled in clinical trials; closely monitor patients with known or suspected neuromuscular disorders (. g, myasthenia gravis) since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions
• Fetal harm may occur when administered to a pregnant woman (see Pregnancy)
• Drug interactions overview
  • Avoid the use of medications associated with neurotoxicity, nephrotoxicity, and ototoxicity
  • Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue; avoid use with ethacrynic acid, furosemide, urea, or IV mannitol

Pregnancy and Lactation

• There are no data on 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 of amikacin following oral inhalation is expected to be low, systemic exposure to aminoglycoside antibacterial drugs, including inhaled amikacin, may be associated with total, irreversible, bilateral congenital deafness when administered to pregnant women
• Advise pregnant women of the potential risk to a fetus.
• Lactation
  • There is no information regarding the presence of inhaled amikacin in human milk, its effects on the breastfed infant, or its effects on milk production
  • Although limited published data on other routes of administration indicate that amikacin is present in human milk, systemic absorption following inhaled administration is expected to be low
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child or from the underlying maternal condition