Aromatic Amino Acid

Crexont

Approved 7 Aug 2024OralCapsule, extended release

The FDA lists this product in 4 strengths and forms.

Indications

CREXONT is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults. CREXONT is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.

( 1 )

Contraindications

CREXONT is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently [see Drug Interactions (7.1) ] . Nonselective MAO inhibitors (4)

Warnings and precautions

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 ) Cardiovascular Events: Monitor patients with a history of cardiovascular disease. ( 5.3 ) Hallucinations/Psychosis may occur. ( 5.4 ) Impulse Control Disorders: Consider dose reduction or stopping CREXONT if occurs. ( 5.5 ) May cause or exacerbate dyskinesia: Consider dose reduction.

( 5.6 )

5.1Falling Asleep During Activities of Daily Living and Somnolence

Patients treated with levodopa, a component of CREXONT, 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 while on levodopa, some perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event (sleep attack).

Some of these events have been reported more than 1 year after initiation of treatment. Falling asleep while engaged in activities of daily living usually occurs in patients experiencing preexisting somnolence, although patients may not give such a history. For this reason, prescribers should reassess for drowsiness or sleepiness in CREXONT-treated patients, especially since some of the events occur well after the start of treatment.

Indications

( 1 )

Warnings and precautions

( 5.6 )

5.1Falling Asleep During Activities of Daily Living and Somnolence

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) ] Cardiovascular Ischemic Events [see Warnings and Precautions (5.3) ] Hallucinations/Psychosis [see Warnings and Precautions (5.4) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.5) ] Dyskinesia [see Warnings and Precautions (5.6) ] Vitamin B6 Deficiency and Seizures [see Warnings and Precautions (5.7) ] P eptic Ulcer Disease [see Warnings and Precautions (5.8) ] Glaucoma [see Warnings and Precautions (5.9) ] The most common adverse reactions (incidence ≥ 3% and greater than immediate-release CD-LD) are nausea and anxiety.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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. The safety population consisted of 589 patients with Parkinson’s disease who received CREXONT for up to 76 weeks and had an average duration of exposure of 35 weeks.

Study 1 in patients with Parkinson’s Disease consisted of a dose adjustment period of immediate-release carbidopa-levodopa treatment prior to a 4-week dose conversion period to CREXONT, which was then followed by a 13-week, double-blind, randomized period comparing CREXONT to immediate-release carbidopa-levodopa [see Clinical Studies (14) ]. In Study 1 , the most common adverse reactions (in at least 3% of patients treated with CREXONT and more frequently than with immediate-release carbidopa-levodopa) that occurred during the double-blind maintenance period were nausea and anxiety.

Table 2 lists adverse reactions occurring in at least 2% of CREXONT-treated patients while converting from immediate-release carbidopa-levodopa and at a higher rate than immediate-release carbidopa-levodopa in the double-blind maintenance period. Table 2. Adverse Reactions that Occurred in at Least 2% of Patients with Parkinson’s Disease who Received CREXONT and at a Higher Rate than Patients who Received Immediate-Release Carbidopa-Levodopa (Study 1) Adverse Reaction Dose Conversion Period Double-Blind Period CREXONT CREXONT Immediate-Release Carbidopa-Levodopa (N=589) % (N=256) % (N= 250) % Nausea 5 4 1 Anxiety 2 3 0 Dizziness 3 2 1 Dyskinesia 7 2

0.4 Constipation 2 2

0.4 Headache 2 1 0 Vomiting 2 1 0 Insomnia 2 1

0.4Adverse Reactions Leading to Discontinuation In Study 1, 6%

of patients discontinued treatment because of adverse reactions during conversion to CREXONT. During the double-blind treatment period of Study 1, 5% of patients taking CREXONT and 1% of patients taking immediate-release carbidopa-levodopa discontinued treatment because of adverse events. The common adverse reactions leading to drug discontinuation during dose conversion were dyskinesia, dizziness, and nausea.

Crexont

Indications

Contraindications

Warnings and precautions

5.1Falling Asleep During Activities of Daily Living and Somnolence

Two medicines in one question?

Crexont

Indications

Contraindications

Warnings and precautions

5.1Falling Asleep During Activities of Daily Living and Somnolence

Two medicines in one question?

5.2Withdrawal-Emergent Hyperpyrexia and Confusion

5.3Cardiovascular Ischemic Events

5.4Hallucinations/Psychosis

5.5Impulse Control/Compulsive Behaviors

5.6Dyskinesia

5.7Vitamin B6 Deficiency and Seizures Treatment

5.8Peptic Ulcer Disease Treatment with

5.9Glaucoma

Interactions

7.1Monoamine Oxidase (MAO) Inhibitors Nonselective MAO Inhibitors

7.2Dopamine D2 Receptor Antagonists and Isoniazid Dopamine

7.3Iron Salts

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

0.4Adverse Reactions Leading to Discontinuation In Study 1, 6%

Composition

Strengths and forms

Official product information

At a glance