XYREM- sodium oxybate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM OXYBATE (UNII: 7G33012534) (4-HYDROXYBUTANOIC ACID - UNII:30IW36W5B2)

Available from:

Jazz Pharmaceuticals, Inc.

INN (International Name):

SODIUM OXYBATE

Composition:

SODIUM OXYBATE 0.5 g in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Xyrem is contraindicated for use in: 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 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Labor or D

Product summary:

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 Guide. The pharmacy provides two empty containers with child-resistant caps with each Xyrem shipment. Each amber bottle contains Xyrem oral solution at a concentration of 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate) and has a child-resistant cap. One 180 mL bottle                                               NDC 68727-100-01 Keep out of reach of children. 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 prepared following dilution should be consumed within 24 hours. Xyrem is a Schedule III drug under the Controlled Substances Act. Xyrem should be handled according to state and federal regulations. It is safe to dispose of Xyrem down the sanitary sewer.

Authorization status:

New Drug Application

Patient Information leaflet

XYREM- SODIUM OXYBATE SOLUTION
Jazz Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
XYREM® (ZĪE-rem)
(sodium oxybate)
oral solution, CIII
Read this Medication Guide carefully before you start or your child
starts taking XYREM and each time
you get or your child gets a refill. There may be new information.
This information does not take the
place of talking to your doctor about your or your child’s medical
condition or treatment.
What is the most important information I should know about XYREM?
•
XYREM is a central nervous system (CNS) depressant. Taking XYREM with
other CNS
depressants such as medicines used to make you or your child fall
asleep, including opioid
analgesics, benzodiazepines, sedating antidepressants, antipsychotics,
sedating anti-epileptic
medicines, general anesthetics, muscle relaxants, alcohol, or street
drugs, may cause serious
medical problems, including:
o
trouble breathing (respiratory depression)
o
low blood pressure (hypotension)
o
changes in alertness (drowsiness)
o
fainting (syncope)
o
death
Ask your doctor if you are not sure if you are, or your child is,
taking a medicine listed above.
•
XYREM is a federal controlled substance (CIII). The active ingredient
of XYREM is a form of
gamma-hydroxybutyrate (GHB) that is also a federal controlled
substance (CI). Abuse of illegal
GHB, either alone or with other CNS depressants may cause serious
medical problems, including:
o
seizure
o
trouble breathing (respiratory depression)
o
changes in alertness (drowsiness)
o
coma
o
death
Call your doctor right away if you have or your child has any of these
serious side effects.
•
Anyone who takes XYREM should not do anything that requires them to be
fully awake or is
dangerous, including driving a car, using heavy machinery, or flying
an airplane, for at least 6
hours after taking XYREM. Those activities should not be done until
you know how XYREM
affects you or your child.
•
Keep XYREM in a safe place to prevent abuse and misuse. Selling or
giving away XYREM may
harm others, and is again

Summary of Product characteristics

XYREM- SODIUM OXYBATE SOLUTION
JAZZ PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XYREM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XYREM.
XYREM (SODIUM OXYBATE) ORAL SOLUTION, CIII
INITIAL U.S. APPROVAL: 2002
WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND ABUSE AND MISUSE.
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CENTRAL NERVOUS SYSTEM DEPRESSION
•
ABUSE AND MISUSE
•
XYREM IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE XYWAV
AND XYREM
REMS (5.3)
INDICATIONS AND USAGE
Xyrem 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 AND ADMINISTRATION
Dosage for Adult Patients
•
•
•
TOTAL NIGHTLY DOSE
TAKE AT BEDTIME
TAKE 2.5 TO 4 HOURS LATER
4.5 g per night
2.25 g
2.25 g
6 g per night
3 g
3 g
7.5 g per night
3.75 g
3.75 g
9 g per night
4.5 g
4.5 g
Dosage for Pediatric Patients (7 years of Age and Older)
•
Important Administration Information
•
•
•
Patients with Hepatic Impairment
®
XYREM IS A CNS DEPRESSANT, AND RESPIRATORY DEPRESSION CAN OCCUR WITH
XYREM USE
(5.1, 5.4)
XYREM IS THE SODIUM SALT OF GAMMA-HYDROXYBUTYRATE (GHB). ABUSE OR
MISUSE OF
ILLICIT GHB IS ASSOCIATED WITH CNS ADVERSE REACTIONS, INCLUDING
SEIZURE, RESPIRATORY
DEPRESSION, DECREASED CONSCIOUSNESS, COMA, AND DEATH (5.2, 9.2)
Initiate dosage at 4.5 g per night orally, divided into two doses
(2.1).
Titrate to effect in increments of 1.5 g per night at weekly intervals
(0.75 g at bedtime and 0.75 g
taken 2.5 to 4 hours later) (2.1).
Recommended dosage range: 6 g to 9 g per night orally (2.1).
The recommended starting dosage, titration regimen, and maximum total
nightly dosage are based
on body weight (2.2).
Prepare both doses prior to bedtime; dilute each dose with
approximately ¼ cup of water in
pharmacy-provided containers (2.3).
Allow 2 hours after eating before