SubcutaneousStimulation of follicular developmentAdult: In combination with FSH preparation (usually follitropin alfa) in women with severe LH and FSH deficiency: 75 international units daily for 7-14 days or until adequate follicular development is achieved. If there is no proper response, the dose of the FSH inj may be increased at 7- or 14-day intervals until optimal response is obtained. Duration of stimulation in any one cycle may be extended up to 5 weeks. Once an optimal response is achieved, hCG must be given 24-48 hours after the last dose of lutropin alfa and FSH inj. Treatment should be individualised based on response (evaluated by follicle size measurement through ultrasound and estrogen response). Treatment interruption or discontinuation may be required according to patient response (refer to detailed product guidelines).
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Reconstitute the vial with the sterile water for inj provided prior to administration. Gently swirl; do not shake. May be mixed and co-administered with follitropin alfa as a single inj; in this case, reconstitute the lutropin alfa 1st, then use it to reconstitute the follitropin alfa powder. Refer to detailed product guidelines for further instructions.
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Ovarian, uterine, or breast cancer; active or untreated tumours of the hypothalamus or pituitary gland; uncontrolled thyroid or adrenal dysfunction; ovarian enlargement or cyst (of unknown origin and unrelated to polycystic ovarian disease); abnormal gynaecological bleeding of undetermined origin; primary ovarian failure, sexual organ malformations or fibroid tumours of the uterus that are incompatible with pregnancy. Pregnancy and lactation.
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Patient with or a family history of porphyria; history of tubal disease, risk factors for developing ovarian hyperstimulation syndrome (OHSS) (e.g. PCOS, numerous developing ovarian follicles or oocytes retrieved in assisted reproductive technology [ART] cycles); thromboembolic disease or risk factors for thromboembolic events (e.g. personal or family history, thrombophilia, severe obesity [BMI >30 kg/m2]). Renal and hepatic impairment.
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Significant: OHSS, ovarian and other reproductive system neoplasms (benign and malignant), ovarian enlargement, ovarian torsion, pregnancy loss (by miscarriage or abortion), ectopic pregnancy, multiple pregnancies, congenital malformations; thromboembolic events, increased risk of acute porphyria attack.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, flatulence, abdominal pain or discomfort.
General disorders and administration site conditions: Fatigue, injection site reactions (e.g. pain, erythema, swelling, irritation, haematoma).
Immune system disorders: Rarely, hypersensitivity reactions, including anaphylactic reaction and shock.
Investigations: Increased serum cholesterol, ALT, and AST.
Nervous system disorders: Headache.
Reproductive system and breast disorders: Ovarian cyst, breast pain, pelvic pain, dysmenorrhoea.
Respiratory, thoracic and mediastinal disorders: URTI.
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Perform a thorough gynaecologic and endocrinologic examination and confirm LH levels (<1.2 international units/L) prior to starting therapy. Confirm pregnancy status in females of childbearing potential before treatment initiation. Evaluate for hypothyroidism, hyperprolactinaemia and adrenocortical deficiency then provide appropriate treatment. Monitor serum estradiol levels and follicular maturation by transvaginal ultrasound to determine adequate ovarian response and hCG timing. Assess for signs and symptoms of OHSS for at least 2 weeks following hCG administration.
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Description:
Mechanism of Action: Lutropin alfa is a recombinant human luteinising hormone (LH). It binds to and stimulates the ovarian theca cells to secrete androgens, which will be utilised as substrate by the granulosa cell aromatase enzyme to produce estradiol needed for follicle stimulating hormone induced follicular development.
Pharmacokinetics:
Absorption: Bioavailability: 56%. Time to peak plasma concentration: 9 hours.
Excretion: Via urine (<5% as unchanged drug). Terminal elimination half-life: 8-21 hours.
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Store below 30°C. Protect from light.
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G03GA07 - lutropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
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Anon. Lutropin Alfa. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 30/08/2023. Buckingham R (ed). Luteinising Hormone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/08/2023. Joint Formulary Committee. Lutropin Alfa. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/08/2023. Luveris 75 IU Powder and Solvent for Solution for Injection (Merck Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 30/08/2023. Luveris 75 IU Powder and Solvent for Solution for Injection (Merck Serono Ltd). MHRA. https://products.mhra.gov.uk. Accessed 30/08/2023. Merck Healthcare Pty Ltd. Luveris 75 IU Powder for Injection data sheet 9 March 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 30/08/2023.
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