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Inbrija

LEVODOPA

Manufacturer: Merz Pharmaceuticals, LLC, a subsidiary of Merz Therapeutics GmbH

Score: 141.0

Quick Summary

Inbrija (levodopa) is an inhalation powder approved for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa. It works by crossing the blood-brain barrier and being converted to dopamine in the brain, relieving symptoms of Parkinson's disease. The recommended dosage is the contents of two 42 mg capsules (84 mg) as needed, up to 5 times a day. Inbrija is contraindicated in patients taking nonselective monoamine oxidase (MAO) inhibitors and has warnings for falling asleep during activities, withdrawal-emergent hyperpyrexia, hallucinations, impulse control, dyskinesia, and bronchospasm. Special considerations are needed for use in pregnancy, pediatric, and geriatric populations.

Key Clinical Findings and Indications

  • Intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa
  • Works by crossing the blood-brain barrier and being converted to dopamine in the brain

Important Safety Information

Warning

Contraindicated in patients taking nonselective monoamine oxidase (MAO) inhibitors

Contraindications

  • Nonselective monoamine oxidase (MAO) inhibitors
  • Hypertension can occur if these drugs are used concurrently

Adverse Reactions

  • Falling asleep during activities of daily living and somnolence
  • Withdrawal-emergent hyperpyrexia and confusion
  • Hallucinations/psychosis
  • Impulse control/compulsive behaviors
  • Dyskinesia
  • Bronchospasm in patients with lung disease

Dosing Recommendations

General Guidance

The maximum dose per OFF period is 84 mg, and the maximum recommended daily dosage of Inbrija is 420 mg

OFF episodes in Parkinson's disease

Adult Dose

84 mg (two 42 mg capsules) as needed, up to 5 times a day

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • No adequate data on the developmental risk associated with the use of Inbrija in pregnant women
  • Carbidopa/levodopa has been shown to be developmentally toxic in animal studies

Nursing Mothers

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established

Geriatric Use

  • Of the Parkinson's disease patients in Study 1 who took Inbrija 84 mg, 49% were 65 years of age and older
  • Age-related differences in adverse reactions were reported in patients 65 years of age and older vs. in patients under 65 years of age

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