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Questions and answers
about INBRIJA

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Efficacy of INBRIJA

INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with CD/LD. INBRIJA has been shown to be effective only in combination with CD/LD.

Safety Profile of INBRIJA

Please see additional Important Safety Information below.

Patients should be advised that inhalation of INBRIJA can lead to coughing or a sensation of choking at the time of administration.

During the 12-week pivotal trial, cough was reported in 15% of the 114 patients on INBRIJA 84 mg compared with 2% of the 112 patients in the placebo group. Of the 17 patients that reported cough in the 84 mg treatment arm, 11 patients and 6 patients reported cough as mild or moderate, respectively; no severe cough was reported. Of these 17 patients, 14 patients reported cough within the first 30 days of treatment.11 Two percent of patients taking INBRIJA 84 mg discontinued treatment because of cough.

Of the patients who reported cough in this study, cough was more common (25% vs 5%) in patients 65 years or older (n=56) than patients younger than 65 (n=58).

Please click here for additional information on this clinical trial.

Before your patients use INBRIJA or if they experience a cough, remind them that using INBRIJA may take some practice. Keep the following Helpful Hints in mind to address cough.

The use of INBRIJA in patients with asthma, COPD, or other chronic underlying lung disease is not recommended because of the risk of bronchospasm.

In a double-blind, placebo-controlled crossover study, 25 otherwise healthy subjects with mild/moderate asthma on a stable regimen of asthma medication experienced more cough with INBRIJA (60%) vs placebo (0%). Ten subjects (40%) had temporary reductions from baseline (15%-59%) in FEV1 with INBRIJA compared to 4 subjects (16%) with placebo.

Ask patients to report whether they develop asthma, COPD, or other chronic lung diseases, since INBRIJA is not recommended in patients with these conditions.

The Full Prescribing Information (FPI) states that INBRIJA should be taken when symptoms of an OFF period start to return, as needed, as an 84 mg dose; no more than 1 dose per OFF period and up to a maximum of 5 doses per day. The morning OFF is a type of OFF period. Use of INBRIJA is not limited to any specific times of day or number of hours since the most recent dose of CD/LD.

A safety study assessed use of INBRIJA at the same time as oral CD/LD for morning OFF periods in 36 patients.17

Based on the results of this study, an amendment to the 1-year extension study SPAN-PD was made and allowed use of INBRIJA for early-morning OFF, which was excluded in the phase 3 pivotal trial.17

Use of INBRIJA

It is important for patients to understand how to correctly use INBRIJA prior to use. Patients should be counseled to take an 84 mg dose of INBRIJA when the return of their Parkinson's symptoms (OFF periods) first occur.

Remind patients that using INBRIJA may take some getting used to. Tips for getting started and taking INBRIJA can be found in the Helpful Hints Brochure.

Detailed directions on how to use INBRIJA can be found in the Instructions For Use section of the Full Prescribing Information. A demonstration video for patients is also available on INBRIJA.com, from your Merz representative, and in INBRIJA Start Kits provided to new patients.

In addition to in-office instruction, advise patients to read the Instructions For Use before using INBRIJA. It is important to remind patients of the following instructions:

  • INBRIJA capsules should only be administered via the INBRIJA inhaler and the INBRIJA inhaler should not be used for administering other medications
  • The contents of INBRIJA capsules are for oral inhalation only and must not be swallowed
  • INBRIJA capsules are to be kept in their sealed blister packaging and each INBRIJA capsule is to be removed immediately before using
  • Two capsules must be orally inhaled in order to take a full dose
  • No more than 5 doses of INBRIJA should be taken in one day
  • No more than one dose (2 capsules) should be taken per OFF period

In 2 clinical trials, 99.8% (628 of 629) of patients demonstrated the ability to self-administer INBRIJA while in an OFF period after instruction.11

Support for Using INBRIJA

There are 2 options for prescribing INBRIJA, either via an electronic prescription or via a Prescription Request Form. For instructions on how to prescribe INBRIJA, click here. Your INBRIJA representative can also assist you with information on how to prescribe.

The Patient Assistance Program (PAP) is available to help patients, if eligible, gain access to INBRIJA at no cost to them. The INBRIJA Co-pay Assistance program may help commercially insured (non-government funded) patients lower their out-of-pocket costs. In addition, eligible patients may purchase INBRIJA directly through Merz’s cash pay program at a discounted price.

INBRIJA is available only through a limited network of specialty pharmacies.
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INBRIJA
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INBRIJA® Indication

INBRIJA is indicated for intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD) treated with carbidopa/levodopa.

Important Safety Information
  • INBRIJA is contraindicated in patients taking or who have recently taken (within 2 weeks) nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine) due to risk of hypertension. Discontinue use of nonselective MAO inhibitors at least 2 weeks prior to initiating INBRIJA.
  • Patients treated with levodopa, the active ingredient in INBRIJA, have reported falling asleep during activities of daily living, including operation of motor vehicles, which sometimes resulted in accidents. Many patients reported somnolence but some reported no warning signs (sleep attack). This may occur more than a year after initiating treatment. Reassess patients for drowsiness/sleepiness including occurrence during specific activities. Advise patients of potential for drowsiness and ask about factors that may increase this risk (e.g., sedating medications, sleep disorders).
    • Consider discontinuing INBRIJA in patients who report significant daytime sleepiness or falling asleep during activities that require active participation. If continuing INBRIJA, advise patients not to drive and to avoid activities that may result in harm. There is insufficient information that dose reduction will eliminate episodes of falling asleep during activities of daily living.
  • Neuroleptic malignant syndrome-like symptoms (e.g., elevated temperature, muscular rigidity, altered consciousness, autonomic instability) have been reported with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy.
  • Hallucinations (with or without confusion, insomnia, and excessive dreaming) may occur and may respond to reducing levodopa therapy. Abnormal thinking and behavior may present with paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium.
  • INBRIJA should ordinarily not be used in patients with major psychotic disorder due to risk of exacerbating psychosis. Dopamine antagonists used to treat psychosis may exacerbate symptoms of PD and may decrease INBRIJA efficacy.
  • Patients on medications that increase central dopaminergic tone such as INBRIJA can experience intense urges to gamble or spend money, increased sexual urges, binge eating, and/or other intense urges, and inability to control them. In some cases, these urges stopped with dose reduction or medication discontinuation. Since some patients may not recognize these behaviors as abnormal, ask patients or their caregivers about development of new or increased urges and consider stopping INBRIJA if this occurs.
  • INBRIJA may cause or exacerbate dyskinesias. If troublesome dyskinesias occur, consider stopping INBRIJA or adjusting other PD medications.
  • INBRIJA is not recommended in patients with asthma, COPD, or other chronic underlying lung disease because of the risk of bronchospasm.
  • Monitor patients with glaucoma for increased intraocular pressure.
  • Abnormalities in laboratory tests may include elevations of liver function tests (e.g., alkaline phosphatase, AST, ALT, lactic dehydrogenase, bilirubin), blood urea nitrogen, hemolytic anemia, and positive direct antibody test. Increased levels of catecholamines and their metabolites in plasma and urine may result in false-positive results suggesting pheochromocytoma.
  • The most common adverse reactions (≥ 5% and > placebo) were cough (15% vs 2%), upper respiratory tract infection (6% vs 3%), nausea (5% vs 3%), and sputum discolored (5% vs 0%).
  • Use of selective MAO-B inhibitors with INBRIJA may be associated with orthostatic hypotension. Monitor patients taking these drugs concurrently.
  • Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce levodopa efficacy; monitor for worsening symptoms.
  • Iron salts or multivitamins with iron salts may reduce levodopa bioavailability.
  • INBRIJA should be used during pregnancy/nursing only if potential benefit justifies potential risk. There are no adequate data on INBRIJA in pregnant women or breastfed infants. Animal data shows carbidopa/levodopa is developmentally toxic (including teratogenicity). Levodopa may affect milk production, interfering with lactation. Levodopa has been detected in human milk.
  • Safety and effectiveness in pediatric patients have not been established.
  • Geriatric patients (n=56) experienced more of the following adverse reactions than patients <65 (n=58): cough (25% vs 5%), upper respiratory tract infection (11% vs 2%), nausea (7% vs 3%), vomiting (4% vs 2%), pain in extremities (4% vs 0%), and discolored nasal discharge (4% vs 0%).

Please see the Full Prescribing Information.

IMPORTANT SAFETY INFORMATION

INBRIJA is contraindicated in patients taking or who have recently taken (within 2 weeks) nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine) due to risk of hypertension.

WARNINGS AND PRECAUTIONS

Patients treated with levodopa have reported falling asleep during activities of daily living, including operation of motor vehicles, which

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