Inbrija

What Is Inbrija?

Inbrija (levodopa inhalation powder) is an aromatic amino acid indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa.

What Are Side Effects of Inbrija?

Common side effects of Inbrija include:

• cough,
• nausea,
• upper respiratory tract infection, and
• discolored mucus

Dosage for Inbrija

The dose of Inbrija is oral inhalation of the contents of two Inbrija capsules (84 mg) as needed for OFF symptoms, up to 5 times daily.

What Drugs, Substances, or Supplements Interact with Inbrija?

Inbrija may interact with monoamine oxidase inhibitors (MAOIs), dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide), isoniazid, and iron salts or multivitamins containing iron salts. Tell your doctor all medications and supplements you use.

Inbrija During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Inbrija; it may harm a fetus. Inbrija passes into breast milk and may interfere with lactation. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Inbrija.

Additional Information

Our Inbrija (levodopa inhalation powder), for Oral Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Inbrija Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using levodopa inhalation and call your doctor or seek emergency medical attention if you have a wheezing, chest tightness, or trouble breathing after inhaling this medicine.

Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly (even after feeling alert);
• nausea, sweating, and a light-headed feeling (like you might pass out);
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• confusion, paranoia, hallucinations (seeing or hearing things that are not real);
• unusual thoughts or behavior;
• trouble sleeping, or increased dreaming;
• agitation, aggression; or
• increased sexual urges, unusual urges to gamble, or other intense urges.

Some people using this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. This side effect has occurred up to 1 year after the start of treatment with levodopa inhalation. Tell your doctor if you have any problems with daytime drowsiness.

Common side effects may include:

• cough;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• nausea; or
• sweat, urine, or saliva that appears dark in color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Inbrija (Levodopa Inhalation Powder)

 

Inbrija Professional Information

SIDE EFFECTS

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]
• Withdrawal-Emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]
• Hallucinations/Psychosis [see WARNINGS AND PRECAUTIONS]
• Impulse Control/Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
• Dyskinesia [see WARNINGS AND PRECAUTIONS]
• Bronchospasm in Patients with Lung Disease [see WARNINGS AND PRECAUTIONS]
• Glaucoma [see WARNINGS AND PRECAUTIONS]

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]. 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
Headache	2	0
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
Psychiatric disorders
Insomnia	2	1
Vascular disorders
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.

Read the entire FDA prescribing information for Inbrija (Levodopa Inhalation Powder)