Lutropin Alfa

Class: Gonadotropins and Antigonadotropins
Molecular Formula: C₄₃₇H₆₈₂N₁₂₂O₁₃₄S₁₃
CAS Number: 152923-57-4
Brands: Luveris

Medically reviewed by Drugs.com on Aug 23, 2021. Written by ASHP.

Introduction

Gonad-stimulating hormone; a biosynthetic (recombinant DNA origin) form of naturally occurring human LH.

Uses for Lutropin Alfa

Female Infertility

Used in conjunction with recombinant FSH (follitropin alfa) to stimulate follicular development in anovulatory, infertile women with hypothalamic or pituitary insufficiency (hypogonadotropic hypogonadism) and profound LH deficiency (LH <1.2 international units [IU]/L).

Lutropin Alfa Dosage and Administration

General

• Should be prescribed by clinicians experienced in infertility treatment.

• Prior to initiating therapy with lutropin alfa, perform a thorough gynecologic and endocrinologic evaluation; assess pelvic anatomy and rule out early pregnancy. Determine that serum LH concentrations are <1.2 IU/L, FSH concentrations <5 IU/L, and a negative progestin challenge test (i.e., a lack of withdrawal bleeding with progesterone administration). Perform a thorough diagnostic evaluation in patients who demonstrate abnormal uterine bleeding and other signs of endometrial abnormalities. Evaluate partner’s infertility.

• Administer lutropin alfa in conjunction with recombinant follitropin alfa daily until follicular maturation (as determined by serum estradiol concentrations and ovary ultrasound examinations) occurs.

• When ultrasound assessment and serum estradiol concentrations show sufficient follicular maturation, discontinue lutropin alfa and follitropin alfa; administer hCG 1 day after the last dose of lutropin alfa and follitropin alfa to complete final follicular maturation and induce ovulation.

• Do not administer hCG if the ovaries show an excessive response to treatment with gonadotropins because of an increased risk of ovarian hyperstimulation syndrome. (See Ovarian Hyperstimulation Syndrome under Cautions.)

• Encourage couple to have daily sexual intercourse beginning the day prior to administration of hCG, until ovulation occurs (as determined by a rise in basal body temperature, an increase in serum progesterone, and menstruation following a shift in basal body temperature). (See Adequate Patient Evaluation and Monitoring under Cautions.)

• Safety and efficacy of concomitant administration of lutropin alfa and other recombinant or urinary human follicle-stimulating hormone (FSH) preparations unknown.

Administration

Sub-Q Administration

Administer by sub-Q injection, generally into the abdomen; may be self-administered by patient.

Administer lutropin alfa and follitropin alfa as separate injections.

Reconstitution

Reconstitute vial containing 82.5 units of lutropin alfa sterile lyophilized powder with 1 mL of sterile water for injection (provided by manufacturer).

Gently swirl vial until lyophilized powder dissolves; do not shake. Following reconstitution, total extrac...