Resources
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For your practice
Review the access and educational materials below to better support your practice.
Explore ELEVATE-PD Phase 4 interim results
Interim results (n=111) from an ongoing open- label Phase 4 clinical trial are consistent with FDA-approved labeling and showed that patients who switched to CREXONT from other oral LD therapies* experienced 3.3 more hours of “Good On” time per day† at 6 weeks1
CREXONT in the Evolving PD Landscape
In this program, movement disorder specialists and Parkinson’s disease experts Drs. Sanaz Attaripour Isfahani, Alberto Espay, and Michael Soileau discuss the evolution of Parkinson’s treatment and the role of CREXONT, a formulation designed to optimize oral levodopa absorption and support patient care.
Letter of Appeal
Access Tip Sheet
See useful suggestions for writing a Letter of Medical Necessity, Letter of Appeal, or Letter of Medical Exception.
Letter of Medical Necessity
Letter of Medical Exception
When CREXONT is nonformulary with your patient’s insurance, download this sample Letter of Medical Exception to request coverage based on their clinical needs.
Dosing and educational resources
See the dosing and online resources below.
The Expert Institute for Parkinson's Disease
CD/LD=carbidopa/levodopa; IR=immediate-release; PD=Parkinson’s disease.
For your patients
Share these materials with your patients to help them learn about CREXONT.
Considering CREXONT Brochure
Newsletter: THRIVE
Tell your patients about the THRIVE newsletters, which cover topics for people living with PD and their care partners.
*Other oral LD therapies included IR CD/LD (with or without a bedtime dose of CR CD/LD), IR CD/LD plus a COMT inhibitor, or RYTARY® (carbidopa and levodopa) extended-release capsules.1 †“Good On” time was defined as “On” time without troublesome dyskinesia. The mean difference from baseline was 3.3 more hours of “Good On” time per day. 1,2 1. Data on file. Amneal Pharmaceuticals LLC. 2. 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.
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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
- Evaluate vitamin B6 levels before and during treatment with carbidopa/levodopa therapies.
- 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
- Treatment with carbidopa/levodopa, including CREXONT, may contribute to reduced vitamin B6 levels. Seizures associated with vitamin B6 deficiency have been reported. Seizures were refractory to traditional anti-seizure medications and were only resolved after vitamin B6 administration. Supplement with vitamin B6 as necessary
- Other symptoms of vitamin B6 deficiency may occur, including depression, confusion, cheilosis, glossitis, dermatitis, anemia, and/or neuropathy. Supplement with vitamin B6 as necessary
- 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 Global Patient Safety at 1‑877‑835‑5472, or 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.
