Lutropin Alfa

Pronunciation

(LOO troe pin AL fa)

U.S. Brand Names

Luveris®

Synonyms

Recombinant Human Luteinizing Hormone; r-hLH

Generic Available

No

Use

Stimulation of follicular development in infertile hypogonadotropic hypogonadal (HH) women with profound luteinizing hormone (LH) deficiency; to be used in combination with follitropin alfa

Pregnancy Risk Factor

X

Pregnancy Implications

An increase in pre- and postimplantation loss was observed in animal studies. Lutropin alfa is contraindicated for use during pregnancy.

Lactation

Excretion in breast milk unknown/use caution

Contraindications

Hypersensitivity to lutropin alfa or any component of the formulation; primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; uncontrolled organic intracranial lesion; abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement of undetermined origin; sex hormone-dependant tumors of the reproductive tract and accessory organs; pregnancy

Warnings/Precautions

For use by infertility specialists. May cause ovarian hyperstimulation syndrome (OHSS); if severe, treatment should be discontinued and patient should be hospitalized. OHSS results in a rapid (<24 hours to 7 days) accumulation of fluid in the peritoneal cavity, thorax, and possibly the pericardium, which may become more severe if pregnancy occurs; monitor for ovarian enlargement. Patients should be advised of the potential risk for multiple births before beginning therapy. Safety and efficacy have not been established with hepatic or renal dysfunction. Not for use in children or postmenopausal women.

Adverse Reactions

1% to 10%:

Central nervous system: Headache (10%), fatigue (2% to 3%)

Endocrine & metabolic: Ovarian hyperstimulation (6%)

Gastrointestinal: Nausea (7%), constipation (2% to 3%), diarrhea (2% to 3%)

Adverse events reported with gonadotropin or menotropin therapy: Adnexal torsion, arterial thromboembolism, congenital abnormalities, ectopic pregnancy, hemoperitoneum, ovarian enlargement (mild-to-moderate), ovarian neoplasms (infrequent), postpartum fever, premature labor, pulmonary complications, spontaneous abortion, vascular complications

Overdosage/Toxicology

Multiple gestations and ovarian hyperstimulation may occur following overdose.

Stability

Store under refrigeration or at room temperature of 2°C to 25°C (36°F to 77°F). Protect from light. Reconstitute with SWFI; mix gently, do not shake. Use immediately after reconstitution.

Mechanism of Action

Lutropin alfa is a recombinant luteinizing hormone prepared using Chinese hamster cell ovaries. Administration leads to increased follicular estradiol secretion needed for follicle stimulating hormone induced follicular development.

Pharmacodynamics/Kinetics

Distribution: Vd: 10

Bioavailability: 56% ± 23%

Half-life elimination: Terminal: ~18 hours

Time to peak, serum: 4-16 hours

Excretion: Urine (<5% unchanged)

Dosage

SubQ: Adults: Female: Infertility: 75 int. units daily until adequate follicular development is noted; maximum duration of treatment: 14 days; to be used concomitantly with follitropin alfa

Administration

SubQ: Administer on the stomach, a few inches above or below the navel.

Monitoring Parameters

Prior to therapy: Baseline LH <1.2 int. units/L, FSH <5 int. units/L, negative progestin challenge test

During therapy: Signs and symptoms of OHSS, ovarian enlargement; follicular maturation (vaginal ultrasound, serum estradiol levels); ovulation (basal body temperature, serum progesterone, menstruation)

Patient Education

For subcutaneous injection only. Follow administration schedule as directed by prescriber. Do not alter dosage or miss dose. If dose missed, notify prescriber. You may experience headache, nausea (small, frequent meals, frequent oral care, sucking lozenges, or chewing gum may help), fatigue, constipation, or diarrhea. Report immediately abdominal pain/distension, persistent nausea. Pregnancy/breast-feeding precautions: Pregnancy must be excluded before starting medication. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause fatigue

Mental Health: Effects on Psychiatric Treatment

May cause GI side effects; concurrent use with SSRIs, lithium, or valproic acid may produce additive GI effects

Dosage Forms

Injection, powder for reconstitution: 75 int. units [contains sucrose; packaged with SWFI]

International Brand Names

Luveris® (AT, CH, CZ, DE, DK, ES, FI, FR, GB, IL, IT, NO, PL, PT, SE, SG, SI)