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Calcium, Magnesium, Potassium, And Sodium Oxybates

Also known as: Xywav

Route: Oral

Check Calcium, Magnesium, Potassium, And Sodium Oxybates Interactions →

3 interactions on record⛔ Black Box Warning

Calcium, Magnesium, Potassium, And Sodium Oxybates has 3 known drug interactions based on U.S. FDA drug labeling data. Of these, 2 are contraindicated combinations that should be avoided entirely. 1 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Alcohol, Sedative-Hypnotics, Divalproex Sodium. Patients taking Calcium, Magnesium, Potassium, And Sodium Oxybates should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Contraindicated: 2
Major: 1

Contraindicated (2)

Calcium, Magnesium, Potassium, And Sodium Oxybates + Alcohol— XYWAV is contraindicated for use in combination with alcohol due to potentiation of CNS-depressant effects.
Calcium, Magnesium, Potassium, And Sodium Oxybates + Sedative-Hypnotics— XYWAV is contraindicated for use in combination with sedative hypnotics due to potentiation of CNS-depressant effects.

Major (1)

Calcium, Magnesium, Potassium, And Sodium Oxybates + Divalproex Sodium— Concomitant use increases systemic exposure to GHB, causing greater impairment on tests of attention and working memory.…

Calcium, Magnesium, Potassium, And Sodium Oxybates + Alcohol⛔Contraindicated

XYWAV is contraindicated for use in combination with alcohol due to potentiation of CNS-depressant effects.

Calcium, Magnesium, Potassium, And Sodium Oxybates + Sedative-Hypnotics⛔Contraindicated

XYWAV is contraindicated for use in combination with sedative hypnotics due to potentiation of CNS-depressant effects.

Calcium, Magnesium, Potassium, And Sodium Oxybates + Divalproex Sodium⚠️Major

Concomitant use increases systemic exposure to GHB, causing greater impairment on tests of attention and working memory. Initial XYWAV dose reduction of at least 20% is recommended.

⛔ FDA Black Box Warning

WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. • Central Nervous System Depression XYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses [see Warnings and Precautions ( 5.1 , 5.4 )]. Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving central nervous system stimulants [see Clinical Studies ( 14.1 , 14.2 , 14.3 )]. • Abuse and Misuse The active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death [see Warnings and Precautions ( 5.2 )]. Because of the risks of CNS depression and abuse and misuse, XYWAV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS [see Warnings and Precautions ( 5.3 )]. WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. See full prescribing information for complete boxed warning. Central Nervous System Depression • XYWAV is a CNS depressant, and respiratory depression can occur with XYWAV use ( 5.1 , 5.4 ) Abuse and Misuse • The active moiety of XYWAV is oxybate or 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 ) XYWAV is available only through a restricted program called the XYWAV and XYREM REMS ( 5.3 )

Contraindications

4 CONTRAINDICATIONS XYWAV is contraindicated for use in: • combination with sedative hypnotics [see Warnings and Precautions ( 5.1 )] . • combination with alcohol [see Warnings and Precautions ( 5.1 , 5.2 )] . • patients with succinic semialdehyde dehydrogenase deficiency [see Clinical Pharmacology ( 12.3 )] . • In combination with sedative hypnotics or alcohol ( 4 ) • Succinic semialdehyde dehydrogenase deficiency ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of XYWAV or sodium oxybate in pregnant women. Oral administration of sodium oxybate to pregnant rats (0, 150, 350, or 1,000 mg/kg/day) or rabbits (0, 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 Delivery XYWAV has not been studied in labor or delivery. In obstetric anesthesia using an injectable formulation of sodium oxybate, newborns had stable cardiovascular and respiratory measures but were very sleepy, causing a slight decrease in Apgar scores. There was a fall in the rate of uterine contractions 20 minutes after injection. Placental transfer is rapid, and gamma-hydroxybutyrate (GHB) has been detected in newborns at delivery after intravenous administration of GHB to mothers. Subsequent effects of sodium oxybate on later growth, development, and maturation in humans are unknown. Data Animal Data Oral administration of sodium oxybate to pregnant rats (0, 150, 350, or 1,000 mg/kg/day) or rabbits (0, 300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity. The highest doses of sodium oxybate tested in rats and rabbits were approximately 1 and 3 times, respectively, the maximum recommended human dose (MRHD) of 9 g per night on a body surface area (mg/m 2 ) basis. Additionally, oral administration of sodium oxybate (0, 150, 350, or 1,000 mg/kg/day) to

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.