Abbreviated Prescribing Information of REKOVELLE
Indication:
Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Dosage & Administration:
First cycle: Individual daily dose based on women’s recent serum anti-Mullerian hormone (AMH) concentration (in pmol/L) (within the last 12 months) and body weight. For AMH <15 pmol/L, daily dose is 12 mcg irrespective of body weight. For AMH ≥15 pmol/L, daily dose decreases from 0.19 to 0.10 mcg/kg (with increasing AMH concentration). Dose rounded to nearest 0.33 mcg. Max. daily dose: 12 mcg. Subsequent cycles: Adequate ovarian response in previous cycle with no Ovarian Hyperstimulation Syndrome (OHSS): Same dose. Hypo-response: Increase dose by 25% or 50%. Hyper-response: Decrease dose by 20% or 33%. OHSS developed or risk of OHSS: Decrease dose by 33%. Max. daily dose: 24 mcg.
Clinical trial data suggest that a daily dose of 10.0 micrograms REKOVELLE provides, for the majority of patients, an ovarian response close to that obtained with 150 IU/day follitropin alfa.
Contraindications:
Hypersensitivity to the active substance or any of the excipients; Tumours of the hypothalamus or pituitary gland; Ovarian enlargement or ovarian cyst not due to Polycystic Ovarian Syndrome; Gynaecological haemorrhages of unknown etiology; Ovarian, uterine or mammary carcinoma; Pregnancy and lactation; When an effective response cannot be obtained, such as primary ovarian failure, malformations of sexual organs incompatible with pregnancy, fibroid tumours of the uterus.
Warnings and Precautions:
Physicians should be thoroughly familiar with infertility and their management before use; Monitor ovarian response with ultrasound or in combination with measurement of serum estradiol levels on regular basis; Interpatient variability in response; Infertility of couple to be assessed and putative contraindications for pregnancy to be evaluated before treatment initiation, including hypothyroidism and hyperprolactinemia; Ovarian enlargement; Careful monitoring of follicular development, and consider administering GnRH agonist instead of hCG to trigger final follicular maturation to reduce risk of OHSS for GnRH antagonist cycles; Withhold hCG, advise to refrain from coitus and use barrier contraception for at least 4 days in OHSS cases; Follow patients for at least 2 weeks after trigger of final follicular maturation; Women with recent or ongoing thromboembolic disease; Women with recognised risk factors for thromboembolic events; Ovarian torsion; Multiple pregnancy; Pregnancy loss; Risk of ectopic pregnancy in women with history of tubal disease; Reproductive system neoplasms; Slightly higher prevalence of congenital malformations.
Undesirable Effects:
Common (≥1/100 to <1/10): Headache, pelvic discomfort, OHSS, pelvic pain, nausea, adnexa uteri pain, fatigue.
Full Prescribing Information available upon request.