Xywav PI

Question 1

Black Box Label

Answer 1

1. Central Nervous System Depressant
2. Active Moiety of Xywav is GHB and is associated with CNS adverse reactions including seizure, respiratory depression, decreased consciousness, coma, and death

Question 2

Xywav Indication and Usage

Answer 2

Central nervous system depressant indicated for the treatment of:
1. Cataplexy or EDS in patients 7 years of age and older w/Narcolepsy
2. IH in adults

Question 3

Dosage for Adult Patients w/Narcolepsy

Answer 3

• 4.5 g/night divided into 2 doses
• Titrate up to 1.5g/night/week
• The recommended dose is 6g to 9g per night divided into 2 doses
• Dosses may be divided equally or unequally
  -The first dose is taken at bedtime; the second dose is taken 2.5 to 4 hours later

Question 4

Dosage for Pediatric Patients w/Narcolepsy (+7 years)

Answer 4

• Based on body weight

<20KG= insufficient info

20-30 KG = 1g; .5g; 3g (twice nightly)

30-45 KG = 1.5g; .5g; 3.75g (twice nightly)

45KG+=2.25g; .75g; 4.5g (twice nightly)

Question 5

Dosage for IH Adult Patients

Answer 5

Xywav can be administered as a twice or once-nightly regimen

Twice nightly: starting dose of 4.5g/night divided into 2 doses. Can titrate up to 1.5g/night/week. Max dose of 9g

Once nightly: starting dose of 3g/night as one dose. Can titrate in increments of 1.5g/night/week. Max dose of 6g

Question 6

Administrative Information

Answer 6

1. Administer Xywav at least 2 hours after eating
2. Prepare Xywav before bedtime, dilute with approx. 1/4 cup of water
3. Take Xywav while in bed and lie down after dosing

Question 7

Patients Transitioning From Xyrem to Xywav

Answer 7

Initiate the same dose regimen as Xyrem. Titrate as needed based on efficacy and tolerability

Question 8

Administration Info For Hepatic Impairment

Answer 8

Recommended starting dose is 1/2 of the original dosage per night divided into 2 doses

Question 9

Dosage Forms and Strengths

Answer 9

Oral Solution: .5g/ml total salts (equivalent to .413 g/ml of oxybate)

Question 10

Contraindications

Answer 10

1. In combination with sedative-hypnotics or alcohol
2. Succinic semialdehyde dehydrogenase deficiency (SSDD)

Question 11

Warning and Precautions

Answer 11

1. CNS Depression - use caution when considering the concurrent use of Xywav with other CNS Depressants
2. Caution patients against hazardous activities requiring mental alertness within the first 6 hours
3. Depression and Suicidality - monitor patients
4. Confusion/Anxiety - monitor patients
5. Parasomnias - evaluate episodes of sleepwalking

Question 12

Adult Adverse Reactions (Narcolepsy and IH)

Answer 12

Nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor

Question 13

Pediatric Adverse Reactions

Answer 13

enuresis, weight decrease, sleepwalking

Question 14

Drug Interactions

Answer 14

Concomitant use with Divalproex Sodium: an initial reduction in XYWAV dose of at least 20% is recommended

Question 15

Use in Specific Populations

Answer 15

1. Pregnancy - based on animal data, may cause fetal harm
2. Geriatric Patients - monitor for impaired motor and/or cognitive function when taking xywav