Rekovelle

Rekovelle

Manufacturer:

Ferring

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Follitropin delta
Indications/Uses
Controlled ovarian stimulation for multiple follicles development in women undergoing assisted reproductive technologies (eg, in vitro fertilisation or intracytoplasmic sperm injection cycle).
Dosage/Direction for Use
SC Individualised dosage. Women w/ anti-Müllerian hormone (AMH) <15 pmol/L 12 mcg daily, irrespective of body wt. Women w/ AMH ≥15 pmol/L Decrease daily dose from 0.19 to 0.10 mcg/kg by increasing AMH conc. Round off the dose to the nearest 0.33 mcg to match the dosing scale on the inj pen. Max: 12 mcg/day for the 1st treatment. Initiate dosing, 2 or 3 days after menstrual bleeding started, & continue until adequate follicular development has been achieved. Inj a single dose of 250 mcg recombinant hCG or 5,000 IU hCG as soon as ≥3 follicles ≥17 mm are observed. Consider GnRH agonist instead of hCG in patients w/ excessive ovarian response at risk of ovarian hyperstimulation syndrome (OHSS). Subsequent treatment cycle: Maintain & modify daily dose according to patient's ovarian response in previous cycle. Patients who developed OHSS or were at risk of OHSS in a previous cycle Lower daily dose used from previous cycle where OHSS or risk of OHSS occurred by 33%, for subsequent treatment cycles. Max: 24 mcg daily.
Contraindications
Hypersensitivity. Hypothalamus or pituitary gland tumours. Ovarian enlargement or cyst not due to polycystic ovarian syndrome. Gynaecological haemorrhages of unknown aetiology. Ovarian, uterine or mammary carcinoma. Not to be used when an effective response cannot be obtained (eg, primary ovarian failure, sexual organ malformations & uterus fibroid tumours incompatible w/ pregnancy). Pregnancy & lactation.
Special Precautions
Triggering of final follicular maturation should not be performed in patients w/ excessive ovarian response of >35 follicles w/ ≥12 mm diameter. Monitor ovarian response w/ ultrasound alone, or in combination w/ measurement of serum estradiol levels, on a regular basis. Prior to treatment, assess couple's infertility as appropriate & evaluate putative contraindications for pregnancy; particularly, evaluate patients for hypothyroidism & hyperprolactinemia. Patients undergoing follicular growth stimulation may experience ovarian enlargement & may be at risk of developing OHSS. Women w/ recent or ongoing thromboembolic disease or generally recognised risk factors for thromboembolic events (eg, personal or family history, severe obesity or thrombophilia). Ovarian torsion. Potential risk of multiple pregnancy; increased risk of adverse maternal & perinatal outcomes. Higher incidence of pregnancy loss by miscarriage or abortion in patients undergoing controlled ovarian stimulation for ART. Risk of ectopic pregnancy in women w/ tubal disease history. Ovarian & other reproductive system neoplasms, both benign & malignant, in women who have undergone multiple infertility treatment regimens. Congenital malformation. Polycystic ovarian syndrome patients w/ anovulatory disorders. Contains <1 mmol Na (23 mg)/dose. Hepatic & renal impairment. Childn. Elderly >65 yr.
Adverse Reactions
Headache; nausea; OHSS, pelvic & adnexa uteri pain, pelvic discomfort; fatigue.
ATC Classification
G03GA10 - follitropin delta ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Form
Rekovelle 36 mcg/1.08 mL soln for inj
Packing/Price
1's
Form
Rekovelle 72 mcg/2.16 mL soln for inj
Packing/Price
1's
Form
Rekovelle 12 mcg/0.36 mL soln for inj
Packing/Price
1's
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