Inbrija
These highlights do not include all the information needed to use INBRIJA safely and effectively. See full prescribing information for INBRIJA. INBRIJA (levodopa inhalation powder), for oral inhalation use Initial U.S. Approval: 1970
a906f8e1-6e1c-480a-8276-c01bc65dd3be
HUMAN PRESCRIPTION DRUG LABEL
Jan 19, 2023
Acorda Therapeutics, Inc.
DUNS: 963845136
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levodopa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
Drug Labeling Information
WARNINGS AND PRECAUTIONS SECTION
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, 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.
5.2 Withdrawal-Emergent Hyperpyrexia and Confusion
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.
5.3 Hallucinations/Psychosis
In placebo-controlled trials [see Clinical Studies (14)], 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 (7.2)].
5.4 Impulse Control/Compulsive Behaviors
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.
5.5 Dyskinesia
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% of patients treated with INBRIJA 84 mg reported dyskinesia, compared with 1% for patients on placebo [see Adverse Reactions (6.1)] .
5.6 Bronchospasm in Patients with Lung Disease
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 FEV 1; 4 of these subjects also had a reduction in FEV 1 following administration of placebo. Subjects with a reduction in FEV 1 remained asymptomatic and did not require rescue treatment.
5.7 Glaucoma
INBRIJA may cause increased intraocular pressure in patients with glaucoma. Monitor patients for increased intraocular pressure during therapy with INBRIJA.
5.8 Laboratory Test Abnormalities
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.
- May cause falling asleep during activities of daily living ( 5.1)
- Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion ( 5.2)
- Hallucinations/exacerbation of psychosis may occur. Patients with a major psychotic disorder should not be treated with INBRIJA ( 5.3, 7.2)
- Impulse Control Disorders: consider dose reduction or stopping INBRIJA ( 5.4)
- May cause or exacerbate dyskinesia: adjustment of levodopa therapy may be considered, including stopping INBRIJA ( 5.5)
- Not recommended in patients with asthma, COPD, or other chronic underlying lung disease ( 5.6)
ADVERSE REACTIONS SECTION
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)]
- Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.2)]
- Hallucinations/Psychosis [see Warnings and Precautions (5.3)]
- Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.4)]
- Dyskinesia [see Warnings and Precautions (5.5)]
- Bronchospasm in Patients with Lung Disease [see Warnings and Precautions (5.6)]
- Glaucoma [see Warnings and Precautions (5.7)]
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 drug and may not reflect the rates observed in clinical practice.
Adverse Reactions in Study 1
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 (14)]. 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 % |
|---|---|---|
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Respiratory, thoracic and mediastinal disorders | ||
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Cough |
15 |
2 |
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Sputum discolored |
5 |
0 |
|
Nasal discharge discoloration |
2 |
0 |
|
Oropharyngeal pain |
2 |
0 |
|
Gastrointestinal disorders | ||
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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 | ||
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Dyskinesia |
4 |
1 |
|
Headache |
2 |
0 |
|
Injury, poisoning and procedural complications | ||
|
Fall |
3 |
2 |
|
Laceration |
2 |
0 |
|
Skin abrasion |
2 |
0 |
|
General disorders and administration site conditions | ||
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Chest discomfort |
2 |
0 |
|
Investigations | ||
|
Blood bilirubin increased |
2 |
0 |
|
Red blood cell count decreased |
2 |
0 |
|
Musculoskeletal and connective tissue disorders | ||
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Pain in extremity |
2 |
1 |
|
Psychiatric disorders | ||
|
Insomnia |
2 |
1 |
|
Vascular disorders | ||
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Orthostatic hypotension/blood pressure decreased |
2 |
0 |
Adverse Reactions Leading to Discontinuation in Study 1
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.
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 to reliably estimate their frequency or establish a causal relationship to drug exposure: sensation of choking immediately following administration.
The most common adverse reactions (incidence ≥ 5% and higher than placebo) were cough, nausea, upper respiratory tract infection, and sputum discolored ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Acorda Therapeutics, Inc. at 1-800-367-5109 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS SECTION
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 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.
7.2 Dopamine D2 Receptor Antagonists and Isoniazid
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.
7.3 Iron Salts
Iron salts or multivitamins containing iron salts can form chelates with levodopa and consequently reduce the bioavailability of levodopa.
- Monitor patients on MAO-B inhibitors for orthostatic hypotension ( 7.1)
- Dopamine D2 antagonists, isoniazid, and iron salts: May reduce the effectiveness of INBRIJA ( 7.2, 7.3)
DOSAGE & ADMINISTRATION SECTION
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 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 (16.2)] .
2.2 Recommended Dosage
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 (1)].
- For oral inhalation only. DO NOT swallow INBRIJA capsules. Only use INBRIJA capsules with the INBRIJA inhaler ( 2.1)
- Inhale the contents of two INBRIJA capsules (84 mg) as needed for OFF symptoms, up to 5 times daily ( 2.2)
- The maximum dose per OFF period is 84 mg, and the maximum recommended daily dosage of INBRIJA is 420 mg ( 2.2)
USE IN SPECIFIC POPULATIONS SECTION
8 USE IN SPECIFIC POPULATIONS
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 (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.
Data
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.
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.
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.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
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%.
Pregnancy: Based on animal data, may cause fetal harm ( 8.1)
CLINICAL PHARMACOLOGY SECTION
12 CLINICAL PHARMACOLOGY
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 of Parkinson's disease.
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 (t 1/2) of levodopa following a single administration of INBRIJA 84 mg was 2.3 hours.
Absorption
After a single dose of INBRIJA 84 mg (two 42 mg capsules), the median T max 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 C max of levodopa from INBRIJA is approximately 50% of that following immediate-release oral tablets.
Distribution
Apparent volume of distribution (Vz/F) was 168 L for INBRIJA 84 mg.
Metabolism and Elimination
Levodopa is extensively metabolized, and the two major metabolic pathways are decarboxylation by dopa decarboxylase and O-methylation by catechol-O- methyltransferase (COMT).
Specific Populations
Geriatric Population
Clinical studies specifically designed to analyze the effects of age on the pharmacokinetics of levodopa were not conducted with INBRIJA.
Male and Female Patients
After a single dose administration of INBRIJA 84 mg, the body-weight adjusted C max and AUC 0-24 were similar between women and men. No adjustment in dosage is required based on sex.
Hepatic/ Renal Impairment
INBRIJA has not been studied in patients with hepatic or renal impairment.
Smokers
In a pharmacokinetic study following a single administration of INBRIJA 84 mg dose in the presence of carbidopa, levodopa exposure (AUC and C max) in smokers (N=25) and non-smokers (N=31) were similar.
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
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 of levodopa have not been conducted.
Impairment of Fertility
In reproduction studies in rats, oral administration of carbidopa/levodopa resulted in no effects on fertility.
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
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 4 INBRIJA capsules (1 blister card containing 4 capsules) and 1 INBRIJA inhaler: NDC 10144-342-04
- Carton containing 12 INBRIJA capsules (3 blister cards containing 4 capsules each) and 1 INBRIJA inhaler: NDC 10144-342-12
- 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.
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 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.
INFORMATION FOR PATIENTS SECTION
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 to correctly administer INBRIJA. It is recommended that patients be instructed in the proper administration of INBRIJA prior to use [see Dosage and Administration (2.1)] .
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 (2.2)] .
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 (2.1)] .
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 (2.2)] .
Lung Disease
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 (5.6)] .
Cough/Sensation of Choking
Inhalation of INBRIJA can lead to coughing or a sensation of choking at the time of administration [see Warnings and Precautions (5.6), and Adverse Reactions (6.1, 6.2)] .
Discoloration of Body Fluids
Patients should be advised that dark color may appear in bodily fluids (saliva, sputum, urine, or sweat) when using INBRIJA [see Adverse Reactions (6.1)] .
Falling Asleep
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 (5.1)] .
Impulse Control Disorder
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 (5.4)] .
Dyskinesia
Instruct patients to notify their healthcare provider if abnormal involuntary movements appear or get worse during treatment with INBRIJA [see Warnings and Precautions (5.5)] .
Hypotension and Syncope
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 (6.1)] . Advise patients to rise slowly after sitting or lying down, especially if they have been doing so for a prolonged period.
Iron Salts
Inform patients that iron salts or multivitamins containing iron salts can reduce the bioavailability of levodopa [see Drug Interactions (7.3)].
Pregnancy and Breastfeeding
Instruct patients to notify their physicians if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations (8.1)] .
Instruct patients to notify their physicians if they intend to breastfeed or are breastfeeding an infant [see Use in Specific Populations (8.2)] .
SPL PATIENT PACKAGE INSERT SECTION
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This Patient Information has been approved by the U.S. Food and Drug Administration |
Issued: 12/2022 | |
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PATIENT INFORMATION INBRIJA**®** (in-BRIH-jah) (levodopa inhalation powder) for oral inhalation use | ||
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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. | ||
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Do not use INBRIJA if you:
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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-the-counter 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. | ||
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How should I use INBRIJA? *See thestep-by-step Instructions for Use that come with your INBRIJA prescription.
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What should I avoid while using INBRIJA? *Do not drive, operate machinery, or do other activities until you know how INBRIJA affects you. INBRIJA can cause sleepiness and falling asleep suddenly as late as 1 year after you start treatment. | ||
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What are the possible side effects of INBRIJA? ** INBRIJA can cause serious side effects including:** *falling asleep during normal daily activities. INBRIJA may cause you to fall asleep while you are doing normal daily activities such as driving a car, doing physical tasks, using hazardous machinery, talking with other people, or eating. * You could fall asleep without being drowsy or without warning. If you become drowsy while using INBRIJA, you should not drive or do activities where you need to be alert for your safety or the safety of others. * Your chances of falling asleep while doing normal activities while using INBRIJA are greater if you take other medicines that cause drowsiness. Tell your healthcare provider if you take medicines that can make you sleepy such as sleep medicines, antidepressants, or antipsychotics. *withdrawal-emergent hyperpyrexia and confusion. INBRIJA may cause a problem that can happen in people who suddenly lower their dose, stop using, or change their dose of INBRIJA. Symptoms may include: | ||
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*low blood pressure. People on INBRIJA may also develop low blood pressure (hypotension) that can happen without or with the following symptoms: | ||
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Get up slowly after sitting or lying down, especially if you have been sitting or lying down for a long time. Tell your healthcare provider if you have any of these symptoms. | ||
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*hallucinations and other psychosis. INBRIJA can cause or worsen psychotic symptoms including: * hallucinations (seeing or hearing things that are not real) * confusion, disorientation, or disorganized thinking * trouble sleeping (insomnia) * dreaming a lot * being overly suspicious or feeling people want to harm you (paranoid ideation) * believing things that are not real (delusional beliefs) * acting aggressive * feeling agitated or restless If you have hallucinations or any of these changes, talk with your healthcare provider. *unusual urges. Some people using medicines like INBRIJA for Parkinson's have had unusual urges such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges, talk to your healthcare provider. *uncontrolled, sudden body movements (dyskinesia). INBRIJA may cause or worsen movements you cannot control in your face, tongue, or other body parts. Tell your healthcare provider if this happens. Your treatment with INBRIJA may need to be stopped or your other medicines for Parkinson's may need to be changed. *bronchospasm. People with lung disease such as asthma, COPD, or other lung diseases have a risk of wheezing or difficulty breathing (bronchospasm) after inhaling INBRIJA. If you have these symptoms, stop taking INBRIJA and call your healthcare provider or go to the nearest hospital emergency room right away. *increased eye pressure. INBRIJA may cause increased intraocular pressure in people with glaucoma. Your healthcare provider should check your eyes while you are using INBRIJA. *changes in certain lab values. INBRIJA may cause changes in certain lab tests, including liver tests. The most common side effects of INBRIJA include:
Other side effects of INBRIJA:
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. | ||
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How should I store INBRIJA?
Keep INBRIJA and all medicines out of the reach of children. | ||
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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. | ||
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What are the ingredients in INBRIJA? ** Active ingredient:** levodopa Inactive ingredients: 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC), sodium chloride. For more information, go to www.INBRIJA.com, or call 1-800-367-5109. |