INBRIJA Inhalation powder, capsule (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Acorda Therapeutics, Inc.

Λέξεις κλειδιά

10144-342

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1. Indications and Usage

INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinsons disease treated with carbidopa/levodopa.

2. Dosage and Administration

INBRIJA capsules are for oral inhalation only and should be used only with the INBRIJA inhaler. 2.1 Important Administration Instructions INBRIJA capsules are for oral inhalation only and should be used ...

3. Dosage Forms and Strengths

INBRIJA (levodopa inhalation powder) consists of INBRIJA capsules and the INBRIJA inhaler. INBRIJA capsules contain 42 mg dry powder formulation of levodopa in a white capsule with two black color bands, ...

4. Contraindications

INBRIJA is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or who have recently (within 2 weeks) taken a nonselective ...

5. Warnings and Precautions

5.1 Falling Asleep During Activities of Daily Living and Somnolence Patients treated with levodopa, the active ingredient in INBRIJA, have reported falling asleep while engaged in activities of daily living, ...

6. Adverse Reactions

The following serious adverse reactions are discussed below and elsewhere in the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see 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 reaction has been identified during post approval use of INBRIJA. Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Monoamine Oxidase (MAO) Inhibitors The use of nonselective MAO inhibitors with INBRIJA is contraindicated [see Contraindications (4)]. Discontinue use of any nonselective MAO inhibitors at ...

8.1. Pregnancy

Risk Summary There are no adequate data on the developmental risk associated with the use of INBRIJA in pregnant women. In animal studies, carbidopa/levodopa has been shown to be developmentally toxic ...

8.2. Lactation

Risk Summary The prolactin-lowering action of dopamine suggests that levodopa may interfere with lactation, although there are limited data on the effects of levodopa on milk production in lactating women. ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

Of the Parkinsons disease patients in Study 1 who took INBRIJA 84 mg, 49% (n=56) were 65 years of age and older and 51% (n=58) were under 65 years of age. Of these patients, the following age-related differences ...

10. Overdosage

Based on the limited available information, the acute symptoms of carbidopa/levodopa overdosage can be expected to arise from dopaminergic overstimulation. Using more than one dose (84 mg) to treat the ...

11. Description

INBRIJA consists of a dry powder formulation of levodopa for oral inhalation with the INBRIJA inhaler. The inhalation powder is packaged in white hypromellose capsules. Each capsule contains a spray-dried ...

12.1. Mechanism of Action

Levodopa, the metabolic precursor of dopamine, crosses the blood-brain barrier and presumably is converted to dopamine in the brain. This is thought to be the mechanism whereby levodopa relieves symptoms ...

12.2. Pharmacodynamics

There are no relevant data on the pharmacodynamic effects of INBRIJA.

12.3. Pharmacokinetics

In the presence of carbidopa, the pharmacokinetics of levodopa are dose-proportional in healthy subjects taking up to 84 mg of INBRIJA. In the presence of carbidopa, the terminal elimination half-life ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In rats, oral administration of carbidopa/levodopa for two years resulted in no evidence of carcinogenicity. Mutagenesis Studies to assess the potential mutagenic or clastogenic effects ...

14. Clinical Studies

The efficacy and safety of INBRIJA for the treatment of OFF episodes in patients with Parkinsons disease treated with oral carbidopa/levodopa was evaluated in a 12-week, randomized, placebo-controlled, ...

16.1. How Supplied

INBRIJA 42 mg contains foil blister strips of INBRIJA (levodopa inhalation powder) white capsules with two black bands on the body and A42 in black on the cap, and one INBRIJA inhaler. Carton containing ...

16.2. Storage and Handling

Store in a dry place between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). INBRIJA capsules should always be stored in the blister packaging and only removed immediately ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Instructions for Administering INBRIJA It is important for patients to understand how ...