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
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 Acorda 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
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 Acorda's cash pay program at a discounted price.
INBRIJA is available only through a limited network of specialty pharmacies.