- Approval Id
- 16831bb17c63d5fa
- Drug Name
- LUVERIS FOR INJECTION 75 IU/VIAL (REVISED FORMULA)
- Product Name
- LUVERIS FOR INJECTION 75 IU/VIAL (REVISED FORMULA)
- Approval Number
- SIN12507P
- Approval Date
- 2004-01-30
- Registrant
- MERCK PTE. LTD.
- Licence Holder
- MERCK PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>Posology and method of administration</strong></p>
<p>Treatment with Luveris® should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.</p>
<p>Self-administration of Luveris® should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.</p>
<p>In LH and FSH deficient women, the objective of Luveris® therapy in association with FSH is to promote follicular development followed by final maturation after the administration of human chorionic gonadotrophin (hCG). Luveris® should be given as a course of daily injections simultaneously with FSH. If the patients is amenorrhoeic and has low endogenous oestrogen secretion, treatment can commence at any time.</p>
<p>All clinical experience to date with Luveris® in this indication has been gained with concomitant administration of follitropin alfa.</p>
<p>Luveris® is intended for subcutaneous administration. The injection site should be alternated daily. The powder should be reconstituted, immediately prior to use, with the solvent provided.</p>
<p>A recommended regimen commences at 75 international units of lutropin alfa (ie. one vial of Luveris®) daily with 75–150 international units FSH. Treatment should be tailored to the individual patient’s response as assessed by measuring (i) follicle size by ultrasound and (ii) oestrogen response.</p>
<p>In clinical trials, Luveris has been shown to increase ovarian sensitivity to follitropin alfa. If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7 to 14 day intervals and preferably by 37.5 international units to 75 international units increments. It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.</p>
<p>When an optimal response is obtained, a single injection of 5,000 international units to 10,000 international units hCG should be administered 24 to 48 hours after the last Luveris® and FSH injections. The patient is recommended to have coitus on the day of, and on the day following, hCG administration.</p>
<p>Alternatively, intrauterine insemination (IUI) or another medically assisted reproduction procedure may be performed based on the physician’s judgement of the clinical case.</p>
<p>Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.</p>
<p>If an excessive response is obtained, treatment should be stopped and hCG withheld. Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>Therapeutic indications</strong></p>
<p>Luveris® in association with a follicle stimulating hormone (FSH) preparation is Indicated for the stimulation of follicular development in women with severe LH and FSH deficiency. (<em>See clinical efficacy section</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Luveris® is contraindicated in patients with:</p>
<ul>
<li><p>hypersensitivity to gonadotrophins or to any of the excipients.</p></li>
<li><p>ovarian, uterine, or mammary carcinoma;</p></li>
<li><p>active, untreated tumours of the hypothalamus and pituitary gland;</p></li>
<li><p>ovarian enlargement or cyst not due to polycystic ovarian disease;</p></li>
<li><p>gynaecological haemorrhages of unknown origin</p></li>
</ul>
<p>Luveris must not be used when a condition exists which would make a normal pregnancy impossible, such as:</p>
<ul>
<li><p>primary ovarian failure</p></li>
<li><p>malformations of sexual organs incompatible with pregnancy</p></li>
<li><p>fibroid tumours of the uterus incompatible with pregnancy</p></li>
</ul>
- Atc Code
- G03GA07
- Atc Item Name
- lutropin alfa
- Pharma Manufacturer Name
- MERCK PTE. LTD.
- Company Detail Path
- /organization/merck-pte-ltd
