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gonadorelin (Lutrepulse)

 

Classes: Gonadotropins

Dosing and uses of Lutrepulse (gonadorelin)

 

Adult dosage forms and strengths

lyophilized powder for injection

  • 0.8mg/vial

No Longer Available in the United States

5 mcg q90min SC/IV

 

Other Indications & Uses

Induction of ovulation in women with primary hypothalamic amenorrhea

 

Pediatric dosage forms and strengths

Not applicable

 

Lutrepulse (gonadorelin) adverse (side) effects

Frequency not defined

Inj site reaction

Ovarian hyperstimulation

Thrombophlebitis

 

Warnings

Contraindications

Hypersensitivity to gonadorelin

Ovarian cysts

Hormonally-dependent tumors

Any condition potentially exacerbated by pregnancy

 

Cautions

Monitor ovarian function

Possibility of multiple gestation

Should be administered only by physician familiar with reproductive medicine & pulsatile LHRH/GnRH delivery

 

Pregnancy and lactation

Pregnancy category: X

Lactation: not recommended

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Lutrepulse (gonadorelin)

Vd: 9-15 L

Half-Life, Initial: 2-10 min

Half-Life, Terminal: 10-40 min

Metabolism: to small peptides

Excretion: urine

 

Mechanism of action

Recombinant human LHRH (GnRH)

 

Administration

IV/SC Preparation

Reconstitute aseptically with 8 mL of diluent provided (NS) immediately prior to use

Shake for a few seconds

 

IV/SC Administration

Administer using a pulsatile pump

Set to deliver 25 or 50 mcL based upon dose selected, over a pulse period of 1 min & a pulse frequency of 90 min