Orphan drug: Lutrepulse®: Induction of ovulation in females with hypothalamic amenorrhea

1% to 10%: Local: Pain at injection site

<1%: Flushing, lightheadedness, headache, rash, nausea, abdominal discomfort

Decreased levels/effect: Oral contraceptives, digoxin, phenothiazines, dopamine antagonists

Increased levels/effect: Androgens, estrogens, progestins, glucocorticoids, spironolactone, levodopa

Factrel®: Prepare immediately prior to use; after reconstitution, store at room temperature and use within 1 day; discard unused portion

Lutrepulse®: Store at room temperature; reconstitute with diluent immediately prior to use and transfer to plastic reservoir. The solution will supply 90 minute pulsatile doses for 7 consecutive days (Lutrepulse® pump).

Onset of action: Peak effect: Maximal LH release: ~20 minutes

Duration: 3-5 hours

Half-life elimination: 4 minutes

Diagnostic test: Children >12 years and Female Adults: I.V., SubQ hydrochloride salt: 100 mcg administered in women during early phase of menstrual cycle (day 1-7)

Primary hypothalamic amenorrhea: Female Adults: Acetate: I.V.: 5 mcg every 90 minutes via Lutrepulse® pump kit at treatment intervals of 21 days (pump will pulsate every 90 minutes for 7 days)

Factrel®: Dilute in 3 mL of normal saline; administer I.V. push over 30 seconds

Lutrepulse®: A presterilized reservoir bag with the infusion catheter set supplied with the kit should be filled with the reconstituted solution and administered I.V. using the Lutrepulse® pump. Set the pump to deliver 25-50 mL of solution, based upon the dose, over a pulse period of 1 minute and at a pulse frequency of 90 minutes.

Pescovitz OH, Comite F, Hench K, et al, "The NIH Experience With Precocious Puberty: Diagnostic Subgroups and Response to Short-Term Luteinizing Hormone-Releasing Hormone Analogue Therapy,"J Pediatr, 1986, 108(1):47-54.