Version May 2024
Note: Follow current clinical practice to reduce the risk of ovarian hyperstimulation syndrome (OHSS); if OHSS occurs, initiate appropriate treatment and discontinue gonadotropin therapy (Ref).
Infertility, ovulation induction: SUBQ: 75 units daily until adequate follicular development is noted (maximum daily dose: 75 units/day); maximum duration of treatment: 14 days, unless signs of imminent follicular development are present. Duration of stimulation may be extended in any one cycle up to 5 weeks (treatment should be individualized based on response to prior cycle). Administer concomitantly with follitropin alfa. Administer hCG one day after the last dose of lutropin alfa and follitropin alfa.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Headache (3% to 19%), pain (≤13%)
Endocrine & metabolic: Ovarian cyst (3% to 27%)
Gastrointestinal: Flatulence (≤16%), abdominal pain (7% to 15%)
Genitourinary: Dysmenorrhea (18%), mastalgia (7% to 18%)
1% to 10%:
Central nervous system: Fatigue (3% to 9%)
Endocrine & metabolic: Ovarian hyperstimulation (≤9%), ovarian disease (3% to 6%), increased serum cholesterol (4%)
Gastrointestinal: Nausea (3% to 9%), constipation (4% to 7%), diarrhea (≤6%)
Hepatic: Increased serum ALT (4%), increased serum AST (4%)
Local: Injection site reaction (≤7%)
Respiratory: Upper respiratory tract infection (≤3%)
<1%, postmarketing, and/or case reports: Accidental injury, acne vulgaris, anaphylaxis, anxiety, back pain, breast hypertrophy, conjunctivitis, cough, dental caries, depression, dizziness, drowsiness, dyspnea, dysuria, ectopic pregnancy, edema, endometrium disease, enlargement of abdomen, fever, flu-like symptoms, genital edema, hemorrhage (in pregnancy), herpes simplex infection, hyperkinesia, hypersensitivity reaction, infection, insomnia, Klebsiella species, leg cramps, leg pain, leukorrhea, malaise, nail disease, nervousness, ovarian hyperstimulation syndrome, ovary enlargement, pelvic congestion syndrome, pelvic pain, pharyngitis, porphyria, premenstrual syndrome, rhinitis, shock, skeletal pain, skin rash, spontaneous abortion, thromboembolism, urination disorder (change in frequency), uterine disease, uterine spasm, vaginal hemorrhage, vaginitis, vasodilation, vomiting, vulvovaginal candidiasis, weakness, xeroderma
Hypersensitivity to lutropin alfa or any component of the formulation; primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; active, untreated tumors of the hypothalamus and pituitary gland; ovarian, uterine, or breast cancer; abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement unrelated to polycystic ovarian disease and of undetermined origin; malformations of sexual organs incompatible with pregnancy; fibroid tumors of the uterus incompatible with pregnancy; pregnancy; breastfeeding
Concerns related to adverse effects:
• Ectopic pregnancy: Risk for ectopic pregnancy may be increased in patients with tubal abnormalities.
• Ovarian enlargement: Mild or moderate uncomplicated ovarian enlargement may be accompanied by abdominal distention or abdominal pain in patients treated with gonadotropins. This generally regresses without treatment within 2 to 3 weeks.
• Ovarian hyperstimulation syndrome: Ovarian hyperstimulation syndrome (OHSS) is a rare exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Mild/moderate signs/symptoms of OHSS may include abdominal distention/discomfort, diarrhea, nausea, and mild/moderate enlargement of ovaries/ovarian cysts; severe signs/symptoms of OHSS may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, hydrothorax, nausea/vomiting (intractable), pleural effusion, rapid weight gain, venous thrombosis, and large ovarian cysts. Decreased CrCl, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012).
• Thromboembolism: In association with and separate from OHSS, thromboembolic events have been reported. Risk may be increased in patients with thromboembolic disease or risk factors for thromboembolic events.
Disease-related concerns:
• Porphyria: Gonadotropins may increase the risk of an acute porphyric attack in patients with porphyria or a family history of porphyria; discontinuation of therapy may be necessary with onset or worsening of condition.
Other warnings/precautions:
• Appropriate use: To minimize risks, use only at the lowest effective dose.
• Experienced physician: These medications should only be used by physicians who are thoroughly familiar with infertility problems and their management.
• Multiple births: Multiple births may result from use; advise patients of the potential risk of multiple births before starting the treatment. Discontinuation of therapy is recommended if there is a high risk for multiple pregnancies. Consider discontinuing or converting to assisted reproductive technology if >2 follicles are mature prior to triggering ovulation.
Not available in the US
May be product dependent
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Subcutaneous:
Luveris: 75 units (1 ea)
SUBQ: Administer in the stomach or thigh; rotate injection sites. Do not shake solution; allow any bubbles to settle prior to administration. Contents of lutropin alfa vial may be mixed in the same syringe with follitropin alfa. Refer to manufacturer labeling for instructions on how to use lutropin alfa prefilled syringe.
Note: Not approved in the United States.
Infertility, ovulation induction: Stimulation of follicular development in patients with hypogonadotropic hypogonadism who have profound luteinizing hormone deficiency (<1.2 units/L); to be used in combination with follitropin alfa.
Limitations of use: Safety and efficacy have not been established for patients <16 and >60 years of age.
None known.
There are no known significant interactions.
Possible contraindications to pregnancy should be evaluated prior to use. Lutropin alfa is contraindicated for use in patients who have medical conditions which are incompatible with a normal pregnancy. The rate of positive pregnancy tests and clinical pregnancies were increased in patients with hypogonadotropic hypogonadism administered lutropin alfa plus follitropin alfa, compared to patients receiving follitropin alfa and placebo (Dhillon 2008).
Use is contraindicated in patients who are pregnant.
Ectopic pregnancy, miscarriage, spontaneous abortion, and multiple births have been reported. The incidence of congenital abnormality may be slightly higher after assisted reproductive techniques than with spontaneous conception; higher incidence may be related to parenteral characteristics (maternal age, sperm characteristics).
It is not known if lutropin alfa is present in breast milk.
Use is contraindicated in patients who are breastfeeding.
Prior to initiation of therapy, a thorough gynecologic and endocrinologic evaluation must be performed; pregnancy should be ruled out. Confirm that luteinizing hormone <1.2 units/L.
Monitor serum estradiol levels as well as follicular growth by transvaginal ultrasound to determine adequate ovarian response and timing of human chorionic gonadotropin (hCG) administration.
Monitor for signs and symptoms of ovarian hyperstimulation syndrome (OHSS) for at least 2 weeks following hCG administration. Initial symptoms of moderate to severe OHSS may include a sensation of bloating, abdominal pain, rapid weight gain, and decreased urine output (Shmorgun 2017).
Ovarian hyperstimulation syndrome: Monitoring of hospitalized patients should include serum albumin, degree of ascites, cardiorespiratory status, electrolytes, fluid balance, hematocrit, hemoglobin, hydration status, serum creatinine, urine output, urine-specific gravity, signs of thromboembolism, vital signs, weight (daily or as necessary), and liver enzymes (weekly) (Shmorgun 2017).
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.
Distribution: Vdss: 10 to 14 L
Bioavailability: 56%
Half-life elimination: Terminal: 21 hours
Time to peak, serum: 9 hours
Excretion: Urine (<5% unchanged)
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