Questions and answers about INBRIJA^®

OFF episodes can affect even those patients on optimized baseline therapy and create significant disruption in their daily activity. Motor fluctuations can make functioning difficult in the workplace setting and create embarrassing moments in public—leading to progressive social withdrawal. On-demand therapy may help address these symptoms when they happen. Learn more about the impact of OFF on your patients.

The levodopa therapeutic window narrows as Parkinson’s disease progresses, increasingly resulting in motor fluctuations despite therapeutic efforts. These OFF episodes occur in about 50% of patients by 5 years of disease progression, and greater than 90% of patients by 10 years.^6,7

The variability of GI tract absorption in treatment with oral CD/LD can result in slowed absorption of levodopa. There are several potential factors involved, including: gastroparesis from PD; high-protein meals; and small intestine bacterial overgrowth (SIBO).^2,4,25 Learn more about why inhaled absorption matters.

INBRIJA is the only inhaled levodopa that can be used to treat OFF episodes right when they happen. And INBRIJA can be used anytime, anywhere.* INBRIJA provides rapid relief starting in as early as 10 minutes. In a pivotal study, INBRIJA delivered, post dose^1,21:

• Rapid onset of action in as few as 10 minutes¹
• Significant improvement in motor functions within 30 minutes (P=0.09; primary study endpoint)¹
• Sustained effect over 60 minutes¹

Significantly more patients returned to an ON state and sustained that ON through 60 minutes post dose when taking INBRIJA 84 mg compared with placebo (58% vs 36%; P=0.003).¹ See the data.

ADVERSE REACTIONS

The most common adverse reactions (≥5% and higher than placebo) were cough (15% vs 2%), upper respiratory tract infection (6% vs 3%), nausea (5% vs 3%), and sputum discolored (5% vs 0%).¹

*Treatment with INBRIJA may cause drowsiness, sleepiness, and sudden sleep attacks while engaging in activities of daily living; avoid driving and operating heavy machinery while taking this medication.²¹

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.²¹

Patients should be advised that inhalation of INBRIJA can lead to coughing or a sensation of choking at the time of administration.²¹

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 who 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.¹

Two percent of patients taking INBRIJA 84 mg discontinued treatment because of cough.¹

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).²¹

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. Click the link to find some Helpful Hints 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 with 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.

Due to the nature of the delivery system, inhalation of INBRIJA can lead to coughing at the time of administration. To help your patients understand and adapt quickly to using an INBRIJA inhaler, share these administration tips.

Advise them to:

• Stand or sit up straight and look straight ahead while breathing in
• Breathe in slowly and gently until their lungs feel full. They should hear or feel the capsule whirl
• Take more than one breath per capsule if they need
• Try not to cough, though it is common when breathing in
• Take sips of water before and after breaths

Nurse Educators are available via phone and video calls to reinforce training with patients. Patients can call them at 1-833-INBRIJA (1-833-462-7452).

The Full Prescribing Information (PI) 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 time of day or number of hours since the most recent dose of CD/LD.²¹

A safety study assessed use of INBRIJA at the same time as oral CD/LD for morning OFF periods in 36 patients.²⁴

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.²⁴

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 they start to feel their Parkinson’s symptoms return.¹

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 (PI). 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 1 day
• No more than 1 dose (2 capsules) should be taken per OFF period

Nurse Educators are available via phone and video calls to reinforce training with patients. Patients can call them at 1-833-INBRIJA (1-833-462-7452).

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.