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Indications and Dosage
Subcutaneous
Stimulation of follicular development Adult: In combination with follitropin alfa in patient with severe LH and FSH deficiency: 75 units daily until adequate follicular development is achieved. Max: 14 days. Max cycle duration: 5 weeks. Dose may be increased, reduced, or discontinued according to individual response (refer to detailed product guideline). Treatment is followed by HCG to induce ovulation.
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Contraindications
Primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, active, untreated tumours of the hypothalamus and pituitary gland; ovarian, uterine, or breast cancer, abnormal uterine bleeding, ovarian enlargement or cysts of unknown origin or unrelated to polycystic ovarian disease, sexual organ malformation, fibroid tumours of the uterus. Pregnancy and lactation.
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Special Precautions
Patient with porphyria or a family history of porphyria, polycystic ovarian syndrome, risk factors, recent or on-going thromboembolic disease, history of tubal disease.
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Adverse Reactions
Significant: Reproductive system neoplasms, ovarian hyperstimulation syndrome, ovarian enlargement, ovarian torsion, thromboembolism, acute porphyria attack, miscarriage, abortion, ectopic pregnancy, multiple births, congenital malformations, thromboembolic events.
Gastrointestinal disorders: Abdominal pain or discomfort, constipation, diarrhoea, flatulence, nausea, vomiting. General disorders and administration site conditions: Fatigue, malaise, pain, erythema, haematoma, swelling, irritation at the injection site. Nervous system disorders: Headache. Reproductive system and breast disorders: Ovarian cyst, ovarian disorder, breast pain, pelvic pain. |
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Monitoring Parameters
Evaluate LH and FSH levels prior to initiation of therapy. Monitor follicular maturation with serum oestradiol level and vaginal ultrasound regularly. Monitor signs and symptoms of ovarian hyperstimulation syndrome.
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Action
Description: Lutropin alfa is a recombinant human luteinising hormone (LH). It binds to and stimulates ovarian theca and granulosa cells, to secrete androgens necessary to produce oestradiol which is needed for follicle stimulating hormone induced-follicular development.
Pharmacokinetics: Absorption: Bioavailability: Approx 60%. Time to peak plasma concentration: 9 hours. Distribution: Volume of distribution: 10-14 L. Excretion: Via urine (<5%, as unchanged drug). Elimination half-life: 21 hours. |
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Storage
Store below 25°C. Protect from light.
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MIMS Class
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ATC Classification
G03GA07 - lutropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
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References
Anon. Lutropin Alfa. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/05/2018. Anon. Lutropin Alfa. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/05/2018. Buckingham R (ed). Lutropin Alfa. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/05/2018. Healthcare Logistics. Luveris 75 IU Powder for Injection data sheet 03 January 2013. Medsafe. http://www.medsafe.govt.nz/. Accessed 02/05/2018. Joint Formulary Committee. Lutropin Alfa. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/05/2018.
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