lutropin alfa (Discontinued)

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Brand and Other Names:Luveris

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Discontinued from United States market May 2012

powder for injection

  • 82.5 International Units/vial
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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

Not applicable

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Adverse 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
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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

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Pregnancy & 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.

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Pharmacology

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

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