Zuellig Pharma


Concise Prescribing Info
Follitropin delta
Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies eg, in vitro fertilisation or intracytoplasmic sperm inj cycle.
Dosage/Direction for Use
SC Individualized dosage. Administer preferably in the abdominal wall. Initiate treatment on day 2 or 3 after start of menstrual bleeding & continue until adequate follicular development (≥3 follicles ≥17 mm) which on average is on day 9 (range 5-20 days). 1st treatment cycle: Woman's serum anti-Müllerian hormone ≥40 pmol/L 0.1 mcg/kg daily, 33-39 pmol/L 0.11 mcg/kg daily, 28-32 pmol/L 0.12 mcg/kg daily, 25-27 pmol/L 0.13 mcg/kg daily, 23-24 pmol/L 0.14 mcg/kg daily, 21-22 pmol/L 0.15 mcg/kg daily, 19-20 pmol/L 0.16 mcg/kg daily, 18 pmol/L 0.17 mcg/kg daily, 17 pmol/L 0.18 mcg/kg daily, 15-16 pmol/L 0.19 mcg/kg daily, <15 pmol/L 12 mcg daily. Round off the dose to the nearest 0.33 mcg to match the dosing scale on the inj pen. Max dose of 1st cycle: 12 mcg daily. Subsequent treatment cycles: Maintain daily dose or modify according to the patient's ovarian response in the previous cycle. Max dose: 24 mcg daily.
Hypersensitivity. Hypothalamic or pituitary gland tumours; ovarian enlargement or cyst not due to polycystic ovarian syndrome. Gynaecological haemorrhages of unknown aetiology. Ovarian, uterine or mammary carcinoma. Primary ovarian failure. Malformations of sexual organs & fibroid tumours of the uterus incompatible w/ pregnancy.
Special Precautions
Monitor ovarian response w/ ultrasound alone, or in combination w/ measurement of serum estradiol levels regularly. Assess couple's infertility before starting treatment. Evaluate for hypothyroidism & hyperprolactinemia. Not recommended to use results other than from ELECSYS AMH Plus immunoassay from Roche for dose determination. Risk of ovarian enlargement & ovarian hyperstimulation syndrome (OHSS). Carefully & frequently monitor follicular development to reduce risk of OHSS; follow for at least 2 wk after triggering of final follicular maturation. Withhold hCG in OHSS & advise patient to refrain from coitus or to use barrier contraceptive methods for at least 4 days. May have increased risk of venous or arterial thromboembolic events during or following treatment w/ gonadotropins in women w/ thromboembolic disease, risk factors for thromboembolic events eg, personal or family history, severe obesity (BMI >30 kg/m2) or thrombophilia; pregnancy, OHSS; reproductive system neoplasms in infertile women; potential risk of multiple births before starting treatment; ectopic pregnancy in women w/ tubal disease history. Ovarian torsion; miscarriage or abortion; congenital malformations. Moderate/severe renal or hepatic impairment. Not indicated during pregnancy & breastfeeding.
Adverse Reactions
Headache; nausea; OHSS, pelvic pain & discomfort, adnexa uteri pain; fatigue.
ATC Classification
G03GA10 - follitropin delta ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Rekovelle soln for inj 72 mcg/2.16 mL
((+ 9 inj needles)) 1's
Rekovelle soln for inj 36 mcg/1.08 mL
((+ 6 inj needles)) 1's
Rekovelle soln for inj 12 mcg/0.36 mL
((+ 3 inj needles)) 1's
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