Dosing and uses of Luveris (lutropin alfa)
Adult dosage forms and strengths
Discontinued from United States market May 2012
powder for injection
- 82.5 International Units/vial
Follicle Stimulation
75 International Units SC concomitantly with 75-150 International Units GONAL-f (as 2 separate injections) until follicular development; not to exceed 14 days unless signs of imminent follicular development
Administration
See mfr package insert for injection procedure
Give HCG one day after last dose of Luveris/Gonal-f
Monitor
Ovarian response (ovarian ultrasound, serum estradiol)
Other Indications & Uses
Stimulation of follicular development (in conjunction with follitropin) in hypogonadotropic hypogonadal women with profound LH deficiency who do not have primary ovarian failure
Pediatric dosage forms and strengths
Not applicable
Luveris (lutropin alfa) adverse (side) effects
>10%
Headache
1-10%
Fatigue
Pain
Breast pain
Dysmenorrhea
Abdominal pain
Constipation
Diarrhea
Flatulence
Inj site reaction
URI
Frequency not defined
Serious
- Arterial thrombosis
- Cyst of ovary
- Hypertrophy of ovary
- Ovarian hyperstimulation syndrome
Warnings
Contraindications
Hypersensitivity to LH
Primary ovarian failure
Uncontrolled thyroid or adrenal dysfunction
Uncontrolled organic intracranial cyst, eg, pituitary tumor
Abnl idiopathic uterine bleeding
Idiopathic ovarian cyst or enlargement
Sex-hormone-dependent ovarian or reproductive tract tumors
Pregnancy
Cautions
Pts should have
- Serum LH< 1.2 IU/L; serum FSH <5 IU/L
- Negative progestin challenge test
Should be carefully evaluated with regards to fertility potential, pelvic anatomy & the possibility of endometrial abnormalities
Risk of ovarian hyperstimulation syndrome (OHSS)
Possibility of multiple births
Should be administered only by a physician well-versed in infertility medicine
Luveris has not been evaluated with any other follitropin preparation besides Gonal-f
Pregnancy and lactation
Pregnancy category: X
Lactation: use caution
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 Luveris (lutropin alfa)
Peak Plasma Time: 4-16 hr
Bioavailability: 33-79%
Total Body Clearance: 2-3 L/hr
Half-Life, Distribution: 11 hr
Half-Life, Elimination: 18 hr
Metabolism: N/A
Excretion: <5% unchanged in urine
Mechanism of action
Recombinant human luteinizing hormone
