Safety
CREXONT safety profile
CREXONT demonstrated a well-tolerated safety profile in a head-to-head study vs optimized IR CD/LD1,2
Adverse reactions occurring in at least 2% of patients treated with CREXONT® (carbidopa and levodopa) extended-release capsules while converting from IR CD/LD and at a higher rate than IR CD/LD in the double-blind maintenance period1,2:
| Dose conversion period | Double-blind period | ||
| ADVERSE REACTION | CREXONT(n=589) | CREXONT (n=256) | IR CD/LD (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% | 0.4% |
- During the 4-week dose conversion period to CREXONT, 6% of patients discontinued treatment due to adverse reactions2
- Common adverse reactions leading to drug discontinuation during the dose conversion period were dyskinesia, dizziness, and nausea2
CD/LD=carbidopa/levodopa; IR=immediate-release.
Discover flexible dosing for your patients
IMPORTANT SAFETY INFORMATION
Indications and Usage
CREXONT® (carbidopa and levodopa) extended-release capsules for oral use 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.Dosage and Administration
- Levodopa-naïve patients: Starting dose is 35 mg carbidopa/140 mg levodopa taken orally twice daily for the first three days; thereafter, dosage may be increased gradually as needed
- For patients converting to CREXONT from immediate-release carbidopa/levodopa, dosages are not substitutable on a 1:1 basis. See full prescribing information Section 2.2 for instructions
- For patients converting from Rytary® (carbidopa and levodopa) extended-release capsules, initiate CREXONT on an approximately 1:1 mg basis using the levodopa component for conversion
- CREXONT may be taken up to four times daily. The maximum recommended daily dosage is 525 mg carbidopa/2100 mg levodopa
- CREXONT may be taken with or without food. Capsules should not be chewed, divided or crushed
- CREXONT should not be taken with alcohol
Contraindications
Nonselective MAO inhibitors.Warnings and Precautions
- CREXONT may cause falling asleep during activities of daily living, somnolence or dizziness. Patients should avoid activities that require alertness such as driving and operating machinery until they know how CREXONT affects them
- It is important to avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal symptoms such as high fever or confusion. Patients who are discontinuing CREXONT should taper off with healthcare provider guidance
- Consider dose reductions or stopping CREXONT in patients with hallucinations or impulse control disorders (e.g., gambling, sexual urges, or uncontrolled spending)
- Consider dose reduction in patients with dyskinesia
- Patients with a major psychotic disorder should not be treated with CREXONT
- Monitor patients with a history of cardiovascular disease for cardiac function
- Monitor patients with a history of peptic ulcer for upper GI hemorrhage
- Monitor patients with glaucoma for increased intraocular pressure
Adverse Reactions
The most common adverse reactions (incidence ≥ 3% and greater than immediate-release CD/LD) are nausea and anxiety.Drug Interactions
Iron salts and dopamine D2 antagonists, including metoclopramide, may reduce the effectiveness of CREXONT.Use in Specific Populations
Pregnancy: Based on animal data, CREXONT may cause fetal harm. There are no adequate data on the developmental risk associated with the use of CREXONT in pregnant women.Breastfeeding: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CREXONT.
Geriatric patients: There were no differences in safety outcomes between patients less than 65 years of age, 65-75 years of age, or 75 years and older.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals, LLC at 1‑877‑835‑5472 or the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for CREXONT.
Content is for guidance only. Please use clinical judgment when prescribing CREXONT. Dosage is individualized for each patient.
References: 1. Hauser RA, Espay AJ, Ellenbogen AL, et al. IPX203 vs immediate-release carbidopa-levodopa for the treatment of motor fluctuations in Parkinson disease: the RISE-PD randomized clinical trial. JAMA Neurol. 2023;80(10):1062-1069. 2. CREXONT [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2024.
