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Rekovelle

Rekovelle

Manufacturer:

Ferring

Distributor:

Zuellig Pharma

Marketer:

Ferring
Concise Prescribing Info
Contents
Follitropin delta
Indications/Uses
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.
Contraindications
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.
Presentation/Packing
Form
Rekovelle soln for inj 72 mcg/2.16 mL
Packing/Price
((+ 9 inj needles)) 1's
Form
Rekovelle soln for inj 36 mcg/1.08 mL
Packing/Price
((+ 6 inj needles)) 1's
Form
Rekovelle soln for inj 12 mcg/0.36 mL
Packing/Price
((+ 3 inj needles)) 1's
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