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INBRIJA™
(levodopa) Inhalation Powder
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 powder of 42 mg levodopa active ingredient with 1,2- dipalmitoyl-sn-glycero-3-phosphocholine (DPPC) and sodium chloride.
The active component of INBRIJA is levodopa, an aromatic amino acid. Its chemical name is (2S)-2-amino-3-(3,4-dihydroxyphenyl) propanoic acid and its structural formula is:
 |
Levodopa has a molecular weight of 197.19 g/mol and molecular formula C9H11NO4. Levodopa is a white to slightly off-white powder and is readily soluble in formic acid, slightly soluble in water, and practically insoluble in ethanol and diethyl ether; it dissolves in dilute hydrochloric acid.
The INBRIJA inhaler is a plastic device with a blue body, blue cap, and white mouthpiece used for inhaling INBRIJA powder.
The INBRIJA inhaler is breath-actuated by the patient. Under standardized in vitro testing conditions, the INBRIJA inhaler delivered 36.1 mg of levodopa (emitted dose) for the 42 mg capsule from the mouthpiece. No significant difference in emitted dose was observed when varying the flow rate and volume from 20 liters per minute/1L up to 90 li ters per minute/2L. Peak inspiratory flow rates (PIFR) achievable through the INBRIJA inhaler were evaluated in 24 adult patients with mild to moderate Parkinson’s disease. The mean PIFR was 64 L/min (range 39–98 L/min) for patients in the ON state and 57 L/min (range 29–98 L/min) in the OFF state.
INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa.
INBRIJA capsules are for oral inhalation only and should be used only with the INBRIJA inhaler.
INBRIJA capsules are for oral inhalation only and should be used only with the INBRIJA inhaler. INBRIJA capsules must not be swallowed as the intended effect will not be obtained. INBRIJA capsules should be stored in their blister package and only removed immediately before use [see HOW SUPPLIED/Storage And Handling].
INBRIJA should be taken when symptoms of an OFF period start to return.
The recommended dosage of INBRIJA is oral inhalation of the contents of two 42 mg capsules (84 mg) as needed, up to 5 times a day. The maximum dose per OFF period is 84 mg, and the maximum daily dosage is 420 mg. INBRIJA has been shown to be effective only in combination with carbidopa/levodopa [see INDICATIONS AND USAGE].
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, and “A42” printed on one side.
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 60 INBRIJA capsules (15 blister cards containing 4 capsules each) and 1 INBRIJA inhaler: NDC 10144-342-60
Carton containing 92 INBRIJA capsules (23 blister cards containing 4 capsules each) and 1 INBRIJA inhaler: NDC 10144-342-92
INBRIJA inhaler consists of a blue cap, blue handle with “INBRIJA” imprinted on it, and white mouthpiece covering the capsule chamber.
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 before use. INBRIJA capsules should not be stored inside the INBRIJA inhaler.
INBRIJA capsules should be used only with the INBRIJA inhaler.
The INBRIJA inhaler should not be used to administer any other medicines.
Manufactured by: Acorda Therapeutics, Inc., 420 Saw Mill River Road, Ardsley, NY 10502 USA. Revised: Dec 2018
The following serious adverse reactions are discussed below and elsewhere in the labeling:
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 drug and may not reflect the rates observed in clinical practice.
Table 1 lists the adverse reactions that occurred in at least 2% of patients with Parkinson's disease who were treated with INBRIJA 84 mg and higher than placebo for OFF periods in Study 1 [see Clinical Studies]. Study 1 was a double-blind, placebo-controlled study, in which 114 patients received INBRIJA 84 mg (two 42 mg capsules) for an average of 2 doses per day, to a maximum of 5 times a day, and 112 patients received placebo. INBRIJA-treated patients were 45-82 years of age (mean 63.5 years of age) and were predominantly male (72%) and white (94%). All patients were also treated with oral carbidopa/levodopa. The most common adverse reactions (≥ 5% and higher than placebo) in Study 1 were cough, nausea, upper respiratory tract infection, and sputum discolored.
Table 1: Adverse Reactions at an Incidence ≥2%
and More Frequent with INBRIJA than with Placebo in Study 1
| Adverse Reactions | INBRIJA 84 mg N=114% |
Placebo N=112% |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 15 | 2 |
| Sputum discolored | 5 | 0 |
| Nasal discharge discoloration | 2 | 0 |
| Oropharyngeal pain | 2 | 0 |
| Gastrointestinal disorders | ||
| Nausea | 5 | 3 |
| Vomiting | 3 | 0 |
| Infections and infestations | ||
| Upper respiratory tract infection | 6 | 3 |
| Nasopharyngitis | 3 | 2 |
| Bronchitis/pneumonia | 2 | 0 |
| Nervous system disorders | ||
| Dyskinesia | 4 | 1 |
| Injury, poisoning and procedural complications | ||
| Fall | 3 | 2 |
| Laceration | 2 | 0 |
| Skin abrasion | 2 | 0 |
| General disorders and administration site conditions | ||
| Chest discomfort | 2 | 0 |
| Investigations | ||
| Blood bilirubin increased | 2 | 0 |
| Red blood cell count decreased | 2 | 0 |
| Musculoskeletal and connective tissue disorders | ||
| Pain in extremity | 2 | 1 |
| Nervous system disorders | ||
| Headache | 2 | 0 |
| Psychiatric disorders | ||
| Insomnia | 2 | 1 |
| Vascular disorders | ||
| Orthostatic hypotension/blood pressure decreased | 2 | 0 |
In Study 1, 6 of 114 patients (5%) in the INBRIJA 84 mg group and 3 of 112 patients (3%) in the placebo group discontinued because of adverse reactions. The most common of these adverse reactions was cough, which lead to discontinuation in 2% of patients in the INBRIJA 84 mg group and none in the placebo group.
The use of nonselective MAO inhibitors with INBRIJA is contraindicated [see CONTRAINDICATIONS]. Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating INBRIJA.
The use of selective MAO-B inhibitors with INBRIJA may be associated with orthostatic hypotension. Monitor patients who are taking these drugs concurrently.
Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce the effectiveness of levodopa. Monitor patients for worsening Parkinson's symptoms.
Iron salts or multivitamins containing iron salts can form chelates with levodopa and consequently reduce the bioavailability of levodopa.
Included as part of the PRECAUTIONS section.
Patients treated with levodopa, the active ingredient in INBRIJA, have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence, some reported no warning signs (sleep attack) and believed that they were alert immediately prior to the event. Some of these events have been reported more than 1 year after the initiation of treatment.
Prescribers should reassess patients for drowsiness or sleepiness. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.
Before initiating treatment with INBRIJA, advise patients about the potential to develop drowsiness and ask about factors that may increase the risk for somnolence with INBRIJA such as the concomitant use of sedating medications and the presence of sleep disorders. Consider discontinuing INBRIJA in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.).
If treatment with INBRIJA continues, patients should be advised not to drive and to avoid other activities that might result in harm if the patients become somnolent. There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.
A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy.
In placebo-controlled trials [see Clinical Studies], hallucinations were reported in less than 2% of patients treated with INBRIJA. Hallucinations may be responsive to reducing levodopa therapy. Hallucinations may be accompanied by confusion, insomnia, and excessive dreaming. Abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium.
Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should ordinarily not be treated with INBRIJA. In addition, medications that antagonize the effects of dopamine used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of INBRIJA [see DRUG INTERACTIONS].
Patients treated with INBRIJA can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued.
Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with INBRIJA. Consider stopping the medication if a patient develops such urges while taking INBRIJA.
INBRIJA may cause or exacerbate dyskinesias. If troublesome dyskinesias occur, prescribers may need to consider stopping treatment with INBRIJA and/or adjusting the patient's daily medications for the treatment of Parkinson's disease. In Study 1, 4% patients treated with INBRIJA 84 mg reported dyskinesia, compared with 1% for patients on placebo [see ADVERSE REACTIONS].
Because of the risk of bronchospasm, use of INBRIJA in patients with asthma, COPD, or other chronic underlying lung disease is not recommended.
In a double-blind, placebo-controlled, crossover clinical study, 25 otherwise healthy subjects with mild or moderate asthma on a stable regimen of asthma medication received placebo or INBRIJA 84 mg every 4 hours for a total of three doses. Cough was the most frequent adverse reaction, reported by 60% of subjects following administration of INBRIJA and 0% following administration of placebo. Following administration of INBRIJA, 10 subjects (40%) had temporary reductions from baseline (between 15% and 59%) for FEV1; 4 of these subjects also had a reduction in FEV1 following administration of placebo. Subjects with a reduction in FEV1 remained asymptomatic and did not require rescue treatment.
INBRIJA may cause increased intraocular pressure in patients with glaucoma. Monitor patients for increased intraocular pressure during therapy with INBRIJA.
Abnormalities in laboratory tests may include elevations of liver function tests such as alkaline phosphatase, AST, ALT, lactic dehydrogenase (LDH), and bilirubin. Abnormalities in blood urea nitrogen (BUN), hemolytic anemia and positive direct antibody test have also been reported.
Patients taking levodopa or carbidopa-levodopa may have increased levels of catecholamines and their metabolites in plasma and urine giving false positive results suggesting the diagnosis of pheochromocytoma in patients on levodopa and carbidopa-levodopa.
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
It is important for patients to understand how to correctly administer INBRIJA. It is recommended that patients be instructed in the proper administration of INBRIJA prior to use [see DOSAGE AND ADMINISTRATION].
Patients should be counseled to take a dose of INBRIJA when the return of their Parkinson's symptoms (OFF periods) first occur [see DOSAGE AND ADMINISTRATION].
Instruct patients to read the Instructions for Use before using INBRIJA. Remind patients that INBRIJA capsules should only be administered via the INBRIJA inhaler and the INBRIJA inhaler should not be used for administering other medications. Remind patients that the contents of INBRIJA capsules are for oral inhalation only and must not be swallowed. Instruct patients to keep INBRIJA capsules in their sealed blister packaging and to remove each INBRIJA capsule immediately before using [see DOSAGE AND ADMINISTRATION].
Remind patients they need to orally inhale the contents of two capsules to take a full dose. They should not take more than 5 doses of INBRIJA in one day. Instruct patients they should not take more than one dose (2 capsules) per OFF period [see DOSAGE AND ADMINISTRATION].
Ask patients to report whether they develop asthma, COPD, or other chronic lung diseases, since INBRIJA is not recommended in patients with these conditions [see WARNINGS AND PRECAUTIONS].
Inhalation of INBRIJA can lead to coughing at the time of administration [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Patients should be advised that dark color may appear in bodily fluids (saliva, sputum, urine, or sweat) when using INBRIJA [see ADVERSE REACTIONS].
Advise patients that certain side effects such as sleepiness and dizziness may affect some patients' ability to drive and operate machinery safely. Advise patients of the possible additive sedative effects when taking other CNS depressants in combination with INBRIJA [see WARNINGS AND PRECAUTIONS].
Inform patients of the potential for experiencing Impulse Control Disorder: patients may experience intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, that are generally used for the treatment of Parkinson's disease [see WARNINGS AND PRECAUTIONS].
Instruct patients to notify their healthcare provider if abnormal involuntary movements appear or get worse during treatment with INBRIJA [see WARNINGS AND PRECAUTIONS].
Advise patients that while they are on levodopa therapy, including INBRIJA, that they may develop orthostatic hypotension with or without symptoms such as dizziness, nausea, syncope, and sweating [see ADVERSE REACTIONS]. Advise patients to rise slowly after sitting or lying down, especially if they have been doing so for a prolonged period.
Inform patients that iron salts or multivitamins containing iron salts can reduce the bioavailability of levodopa [see DRUG INTERACTIONS].
Instruct patients to notify their physicians if they become pregnant or intend to become pregnant during therapy [see Use In Specific Populations].
Instruct patients to notify their physicians if they intend to breastfeed or are breastfeeding an infant [see Use In Specific Populations].
In rats, oral administration of carbidopa/levodopa for two years resulted in no evidence of carcinogenicity.
Studies to assess the potential mutagenic or clastogenic effects of levodopa have not been conducted.
In reproduction studies in rats, oral administration of carbidopa/levodopa resulted in no effects on fertility.
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 (including teratogenic effects) [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2- 4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Animal Data
When administered to pregnant rabbits throughout organogenesis, carbidopa/levodopa caused both visceral and skeletal malformations in rabbits. No teratogenic effects were observed when carbidopa/levodopa was administered to pregnant mice throughout organogenesis.
There was a decrease in the number of live pups delivered by rats receiving carbidopa/levodopa during organogenesis.
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. Levodopa has been detected in human milk. There are no adequate data on the effects of levodopa on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for INBRIJA and any potential adverse effects on the breastfed infant from INBRIJA or from the underlying maternal condition.
Safety and effectiveness in pediatric patients have not been established.
Of the Parkinson's 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 in adverse reactions were reported in patients 65 years of age and older vs. in patients under 65 years of age, respectively: cough 25% vs. 5%; upper respiratory tract infection 11% vs. 2%; nausea 7% vs. 3%; vomiting 4% vs. 2%; pain in the extremities 4% vs. 0%; and discolored nasal discharge 4% vs. 0%.
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 same OFF period may result in CNS disturbances, with an increasing risk for cardiovascular disturbance (e.g., hypotension, tachycardia) and increased risk for new or worsening psychiatric problems at higher doses.
Reports of rhabdomyolysis and transient renal insufficiency suggest that levodopa overdosage may give rise to systemic complications.
Monitor patients and provide supportive care. Patients should receive electrocardiographic monitoring for the development of arrhythmias; if needed, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs, increasing the risk of drug interactions (especially catechol-structured drugs) should be taken into consideration.
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 MAO inhibitor. Hypertension can occur if these drugs are used concurrently [see DRUG INTERACTIONS].
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 of Parkinson's disease.
There are no relevant data on the pharmacodynamic effects of INBRIJA.
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 (t½) of levodopa following a single administration of INBRIJA 84 mg was 2.3 hours.
After a single dose of INBRIJA 84 mg (two 42 mg capsules), the median Tmax for plasma levodopa was approximately 0.5 hours (range 0.17–2.00 hours). In fasted healthy volunteers the bioavailability of levodopa from INBRIJA was approximately 70% relative to immediate-release oral levodopa tablets. The dose-normalized Cmax of levodopa from INBRIJA is approximately 50% of that following immediate-release oral tablets.
Apparent volume of distribution (Vz/F) was 168 L for INBRIJA 84 mg.
Levodopa is extensively metabolized, and the two major metabolic pathways are decarboxylation by dopa decarboxylase and O-methylation by catechol-O-methyltransferase (COMT).
Clinical studies specifically designed to analyze the effects of age on the pharmacokinetics of levodopa were not conducted with INBRIJA.
After a single dose administration of INBRIJA 84 mg, the body-weight adjusted Cmax and AUC0- 24 were similar between women and men. No adjustment in dosage is required based on sex.
INBRIJA has not been studied in patients with hepatic or renal impairment.
In a pharmacokinetic study following a single administration of INBRIJA 84 mg dose in the presence of carbidopa, levodopa exposure (AUC and Cmax) in smokers (N=25) and non-smokers (N=31) were similar.
The efficacy and safety of INBRIJA for the treatment of OFF episodes in patients with Parkinson's disease treated with oral carbidopa/levodopa was evaluated in a 12-week, randomized, placebo-controlled, double-blind study (Study 1; NCT02240030).
In Study 1, a total of 114 patients were treated with INBRIJA 84 mg (two 42 mg capsules), and 112 patients received placebo. Study medication could be administered up to five times a day. At baseline, patients had at least 2 hours per day of OFF time per day, and carbidopa/levodopa medication did not exceed 1600 mg levodopa per day. The mean UPDRS Part III scores at screening in the ON state were 14.9 for patients randomized to INBRIJA 84 mg and 16.1 for patients randomized to placebo. The UPDRS part III is designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability) in patients with Parkinson's disease.
The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III motor score from pre-dose OFF state to 30 minutes post-dose, measured at Week 12. The average use of INBRIJA 84 mg or placebo was approximately 2 doses per day. At Week 12, the reduction in UPDRS Part III motor score for INBRIJA 84 mg, compared to placebo at 30 minutes post-dose, were -9.8 and -5.9, respectively (See Table 2 and Figure 1). The proportion of patients who returned to an ON state and sustained that ON through 60 minutes post-dose was 58% for INBRIJA 84 mg and 36% for placebo (p=0.003).
Table 2: Mean Change in UPDRS Part III Motor Score at
30 minutes post-dose (INBRIJA 84 mg) for the Intent-to-Treat Population at Week
12a
| Treatment | Pre-dose (OFF) UPDRS Part III Motor Score (mean) | Post-dose UPDRS Part III Motor Score (mean) | Mean Change 30 minutes postdoseb, c | Difference from Placebo (95% confidence internal) | p-value |
| Placebo | 32.1 | 25.3 | -5.9 | — | — |
| INBRIJA 84 mg | 29.0 | 19.3 | -9.8 | -3.92 (-6.84, -1.00) | 0.009 |
| a Treatment group least-squares mean change is
a model-based population estimate; the pre-dose and post-dose means are
descriptive statistics. b Least-squares mean. c Negative numbers indicate improvement as compared with the baseline value. |
|||||
Figure 1: Least-squares Mean Change in UPDRS Part III
Motor Score After Administration of INBRIJA 84 mg vs. Placebo (at Week 12)
 |
The effect of INBRIJA on pulmonary function was evaluated in patients with Parkinson's disease treated with oral carbidopa/levodopa in a 12 month, randomized, controlled, openlabeled study (Study 2: NCT02352363). A total of 271 patients were treated with INBRIJA 84 mg (two 42 mg capsules), and 127 patients with Parkinson's disease in a control group were observed on their regular oral medication regimen for the treatment of Parkinson's disease. Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last 5 years were excluded [see WARNINGS AND PRECAUTIONS]. Pulmonary function was assessed by spirometry every 3 months in both groups. After 12 months, the average reduction in the forced expiratory volume in 1 second (FEV1) from baseline was the same in both groups (-0.1 L).
INBRIJA™
(in-BRIH-jah)
(levodopa inhalation powder) for oral inhalation use
What is INBRIJA?
INBRIJA is an inhaled prescription levodopa medicine used to treat the return of Parkinson's symptoms (known as OFF episodes) in people with Parkinson's disease who are treated with carbidopa-levodopa medicines. It does not replace the regular carbidopa-levodopa medicines.
It is not known if INBRIJA is safe or effective in children.
Do not use INBRIJA if you:
Before you use INBRIJA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements.
Using INBRIJA and certain other medicines may affect each other and cause serious side effects.
Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
How should I use INBRIJA?
What should I avoid while using INBRIJA?
What are the possible side effects of INBRIJA?
INBRIJA can cause serious side effects including:
The most common side effects of INBRIJA include:
These are not all the possible side effects with INBRIJA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store INBRIJA?
Keep INBRIJA and all medicines out of the reach of children.
General information about the safe and effective use of INBRIJA
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use INBRIJA for a condition for which it was not prescribed. Do not give INBRIJA to other people even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about INBRIJA that is written for health professionals.
What are the ingredients in INBRIJA?
Active ingredient: levodopa
Inactive ingredients: 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC), sodium chloride.
This Patient Information has been approved by the U.S. Food and Drug Administration
