Lumryz
sodium oxybate · KIT · Avadel CNS Pharmaceuticals, LLC
Lumryz is a kit containing sodium oxybate. Manufactured by Avadel CNS Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Lumryz
- Generic Name
- sodium oxybate
- NDC Code (Product)
13551-005- Manufacturer
- Avadel CNS Pharmaceuticals, LLC
- Dosage Form
- KIT
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- NDA214755
- Marketing Start
- 10/07/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. LUMRYZ is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dosing for Adults: • Initiate dosage at 4.5 g once per night orally ( 2.1 ). • Titrate to effect in increments of 1.5 g per night at weekly intervals ( 2.1 ). • Recommended dosage range: 6 g to 9 g once per night orally ( 2.1 ). Dosing for Pediatric Patients (7 Years of Age and Older): • The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight ( 2.2 ) • Pediatric patients 7 years and older weighing at least 45 kg : The recommended starting dosage is 4.5 g once per night. Increase the dosage by 1.5 g per night at weekly intervals to the maximum recommended dosage of 9 g once per night orally. The dosage may be gradually titrated based on efficacy and tolerability ( 2.2 ). • Pediatric patients 7 years and older weighing less than 45 kg : Because the recommended starting dosage cannot be achieved with the available strengths of LUMRYZ, use another sodium oxybate product to initiate treatment ( 2.2 ). Important Administration Information • Prepare the dose of LUMRYZ prior to bedtime; suspend dose in approximately ⅓ cup of water (with or without calorie-free drink mix or flavored water enhancer) in the mixi…
Contraindications
4 CONTRAINDICATIONS LUMRYZ is contraindicated for use in: ● combination with sedative hypnotics [see Warnings and Precautions (5.1) ] ● combination with alcohol [see Warnings and Precautions (5.1) ] ● patients with succinic semialdehyde dehydrogenase deficiency [see Clinical Pharmacology (12.3) ] • In combination with sedative hypnotics or alcohol ( 4 ). • Succinic semialdehyde dehydrogenase deficiency ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS 7.1 Alcohol, Sedative Hypnotics, and CNS Depressants LUMRYZ is contraindicated for use in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of LUMRYZ [see Warnings and Precautions (5.1) ] . In addition to coadministration of LUMRYZ and alcohol being contraindicated because of respiratory depression, consumption of alcohol while taking LUMRYZ may also result in a more rapid release of the dose of sodium oxybate [see Clinical Pharmacology (12.3) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions appear in other sections of the labeling: ● CNS Depression [see Warnings and Precautions (5.1) ] ● Abuse and Misuse [see Warnings and Precautions (5.2) ] ● Respiratory Depression and Sleep-Disordered Breathing [see Warnings and Precautions (5.4) ] ● Depression and Suicidality [see Warnings and Precautions (5.5) ] ● Other Behavioral or Psychiatric Adverse Reactions [see Warnings and Precautions (5.6) ] ● Parasomnias [see Warnings and Precautions (5.7) ] ● Use in Patients Sensitive to High Sodium Intake [see Warnings and Precautions (5.8) ] Most common adverse reactions in adults (incidence ≥ 5% and greater than placebo) reported for any dose of LUMRYZ were nausea, dizziness, enuresis, headache, and vomiting ( 6.1 ). Most common adverse reactions for pediatric patients (≥ 5%) in a study with immediate-release sodium oxybate were nausea, enuresis, vomiting, headache, weight decreased, decreased appetite, dizziness, and sleepwalking ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Avadel CNS Pharmaceuticals, LLC at 1-888-828-2335 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Exper…
Frequently Asked Questions
What is Lumryz used for?
Lumryz contains sodium oxybate. It is a kit taken as directed. Consult your doctor for specific uses.
Is Lumryz a controlled substance?
Yes, Lumryz is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Lumryz?
The generic name for Lumryz is sodium oxybate. There are 5 other brand versions of sodium oxybate.
What is the NDC code for Lumryz ?
The NDC (National Drug Code) for Lumryz is 13551-005, listed by Avadel CNS Pharmaceuticals, LLC.