XYREM Oral solution (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Jazz Pharmaceuticals, Inc.
Λέξεις κλειδιά
68727-100
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BOXED WARNING SECTION
<b>WARNING: CENTRAL NERVOUS SYSTEM DEPRESSIONand ABUSE AND MISUSE</b> <b><u>Central Nervous System Depression</u></b> <b>Xyrem (sodium oxybate) is a CNS depressant. In clinical trials at recommended doses, ...
1. Indications and Usage
Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
2. Dosage and Administration
2.1 Adult Dosing Information The recommended starting dosage is 4.5 grams (g) per night administered orally, divided into two doses: 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later (see Table 1). ...
3. Dosage Forms and Strengths
Xyrem is a clear to slightly opalescent oral solution, in a concentration of 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate).
4. Contraindications
Xyrem is contraindicated for use in: combination with sedative hypnotics <em>[see Warnings and Precautions (5.1)]</em>. combination with alcohol <em>[see Warnings and Precautions (5.1)]</em>. patients ...
5. Warnings and Precautions
5.1 Central Nervous System Depression Xyrem is a central nervous system (CNS) depressant. In adult clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred ...
6. Adverse Reactions
The following clinically significant adverse reactions appear in other sections of the labeling: CNS depression <em>[see Warnings and Precautions (5.1)]</em> Abuse and Misuse <em>[see Warnings and Precautions ...
6.1. 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 ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Xyrem. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to ...
7. Drug Interactions
7.1 Alcohol, Sedative Hypnotics, and CNS Depressants Xyrem is contraindicated for use in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects ...
8.1. Pregnancy
Risk Summary There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. Oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 ...
8.2. Lactation
Risk Summary GHB is excreted in human milk after oral administration of sodium oxybate. There is insufficient information on the risk to a breastfed infant, and there is insufficient information on milk ...
8.4. Pediatric Use
The safety and effectiveness of Xyrem in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients (7 years of age and older) with narcolepsy have been established in a double-blind, ...
8.5. Geriatric Use
Clinical studies of Xyrem in patients with narcolepsy did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects. In controlled ...
8.6. Hepatic Impairment
Because of an increase in exposure to Xyrem, the starting dose should be reduced by half in patients with hepatic impairment <em>[see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]</em> ...
9.1. Controlled Substance
Xyrem is a Schedule III controlled substance under the Federal Controlled Substances Act. Non-medical use of Xyrem could lead to penalties assessed under the higher Schedule I controls.
9.2. Abuse
Xyrem (sodium oxybate), the sodium salt of GHB, produces dose-dependent central nervous system effects, including hypnotic and positive subjective reinforcing effects. The onset of effect is rapid, enhancing ...
9.3. Dependence
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant ...
10. Overdosage
10.1 Human Experience Information regarding overdose with Xyrem is derived largely from reports in the medical literature that describe symptoms and signs in individuals who have ingested GHB illicitly. ...
11. Description
Sodium oxybate, a CNS depressant, is the active ingredient in Xyrem. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C<sub>4</sub>H<sub>7</sub>NaO<sub>3</sub> ...
12.1. Mechanism of Action
Xyrem is a CNS depressant. The mechanism of action of Xyrem in the treatment of narcolepsy is unknown. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous compound and metabolite ...
12.3. Pharmacokinetics
Pharmacokinetics of GHB are nonlinear and are similar following single or repeat dosing of Xyrem. Absorption Following oral administration of Xyrem, GHB is absorbed rapidly across the clinical dose range, ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Administration of sodium oxybate to rats at oral doses of up to 1,000 mg/kg/day for 83 (males) or 104 (females) weeks resulted in no increase in tumors. Plasma exposure (AUC) at the highest ...
14. Clinical Studies
The efficacy of Xyrem for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy has been established in the following adequate and well-controlled ...
16.1. How Supplied
Xyrem is a clear to slightly opalescent oral solution. Each prescription includes one bottle of Xyrem with attached press in bottle adaptor, an oral measuring device (plastic syringe), and a Medication ...
16.2. Storage and Handling
<b>Keep out of reach of children.</b> Xyrem should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). Dispense in tight containers. Solutions ...
17. Patient Counseling Information
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Central Nervous System Depression Inform patients and/or caregivers that Xyrem ...