Follitropin delta

UNITS: REKOVELLE is dosed in MICROGRAMS, not IU — the SPC states 'The dosing regimen is specific for REKOVELLE and the microgram dose cannot be applied to other gonadotropins.' DOSING TABLE (SPC §4.2 Table 1, AMH in pmol/L, micrograms/kg per day unless stated): below 15 = fixed 12 micrograms; 15-16 = 0.19; 17 = 0.18; 18 = 0.17; 19-20 = 0.16; 21-22 = 0.15; 23-24 = 0.14; 25-27 = 0.13; 28-32 = 0.12; 33-39 = 0.11; 40 or above = 0.10 micrograms/kg. Round the calculated dose to the nearest 0.33 micrograms to match the dosing scale on the injection pen. AMH must be from a recent determination (within the last 12 months) measured by ELECSYS AMH Plus (Roche), ACCESS AMH Advanced (Beckman Coulter) or LUMIPULSE G AMH (Fujirebio); express AMH in pmol/L rounded to the nearest integer (ng/mL x 7.14 = pmol/L). Measure body weight without shoes and overcoat just prior to the start of stimulation. START OF TREATMENT: with a GnRH antagonist protocol, initiate on day 2 or 3 after the start of menstrual bleeding; with GnRH agonist down-regulation, initiate approximately 2 weeks after the start of agonist treatment (a longer stimulation and higher total dose may be needed). Continue until adequate follicular development (3 or more follicles of 17 mm or more), on average by the ninth or tenth day (range 5 to 20 days). TRIGGER: a single injection of 250 micrograms recombinant hCG or 5,000 IU hCG. If there is excessive follicular development (25 or more follicles of 12 mm or more), stop REKOVELLE and do NOT trigger final follicular maturation with hCG. SUBSEQUENT CYCLES: maintain the same daily dose if the previous response was adequate without OHSS; increase by 25% or 50% for ovarian hypo-response; decrease by 20% or 33% for ovarian hyper-response; use a dose 33% lower if the patient developed OHSS or was at risk of OHSS in the previous cycle. Potential high responders (AMH above 35 pmol/L) have not been studied in a GnRH agonist down-regulation protocol. Anovulatory patients with polycystic ovarian syndrome have not been studied. The first injection should be performed under direct medical supervision; self-administration only by patients who are well motivated, adequately trained and with access to expert advice. There is no relevant use in the paediatric or elderly populations.