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Rekovelle

Rekovelle

Manufacturer:

Ferring

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Follitropin δ
Indications/Uses
Controlled ovarian stimulation for multiple follicles development in women undergoing assisted reproductive technologies eg, in vitro fertilisation or intracytoplasmic sperm inj cycle.
Dosage/Direction for Use
SC Individualized dosage. Women w/ anti-Müllerian hormone (AMH) <15 pmol/L 12 mcg daily, ≥15 pmol/L Decrease dose from 0.19 to 0.1 mcg/kg by increasing AMH conc, may be rounded off to nearest 0.33 mcg to match dosing scale on inj pen. Max: 12 mcg daily for 1st treatment cycle. Initiate 2 or 3 days after menstruation & continue until adequate follicular development has been achieved. Patient who developed ovarian hyperstimulation syndrome (OHSS) or at risk of OHSS in previous cycle Max: 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. Not to be administered in primary ovarian failure; sexual organ malformations or uterine fibroid tumours incompatible w/ pregnancy.
Special Precautions
OHSS; ovarian torsion; benign & malignant ovarian & other reproductive system neoplasms. Personal or family history of thromboembolic events, severe obesity (BMI >30 kg/m2) or thrombophilia. Anovulatory patients w/ polycystic ovarian syndrome. Monitor ovarian response w/ ultrasound alone or in combination w/ measurement of serum estradiol levels regularly. Assess couple's infertility, hypothyroidism & hyperprolactinemia prior to treatment. Evaluate medical conditions contraindicating pregnancy prior to treatment. Multiple pregnancy; pregnancy loss. Increased risk of ectopic pregnancy & congenital malformations. Not indicated during pregnancy & lactation.
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 12 mcg/0.36 mL
Packing/Price
1's
Form
Rekovelle soln for inj 36 mcg/1.08 mL
Packing/Price
1's
Form
Rekovelle soln for inj 72 mcg/2.16 mL
Packing/Price
1's
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