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GENITO URINARY SYSTEM AND SEX HORMONES › SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM › GONADOTROPINS AND OTHER OVULATION STIMULANTS › Gonadotropins
follitropin delta
G03GA10
Forms & Strengths
- Solution for injection: 12 mcg/0.36 mL in a pre-filled pen
- Solution for injection: 36 mcg/1.08 mL in a pre-filled pen
- Solution for injection: 72 mcg/2.16 mL in a pre-filled pen
Adult Dosing
- Controlled ovarian stimulation: Dosing is individualized based on the patient's anti-Müllerian hormone (AMH) level and body weight
- Starting dose: Fixed daily dose of 0.11 to 0.19 mcg/kg based on AMH (up to a maximum initial dose of 12 mcg)
- Dose remains fixed throughout the stimulation period (no dose adjustments for follicular response)
Pediatric Dosing
- Not indicated for pediatric use
Indications
- Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technology (ART) such as in vitro fertilization (IVF)
Mechanism of Action
- Recombinant human follicle-stimulating hormone (rFSH) produced by a human cell line (PER.C6)
- Binds to FSH receptors on granulosa cells of the ovary
- Stimulates follicular growth, proliferation, and estrogen production, promoting multiple follicular development
Contraindications
- Hypersensitivity to follitropin delta or any excipients
- High baseline levels of FSH indicating primary ovarian failure
- Presence of unmanaged thyroid or adrenal dysfunction
- Tumors of the hypothalamus, pituitary gland, ovary, breast, or uterus
- Ovarian enlargement or cyst not due to polycystic ovary syndrome
- Gynaecological bleedings of unknown etiology
- Pregnancy or lactation
Adverse Reactions
- Ovarian hyperstimulation syndrome (OHSS)
- Pelvic pain
- Headache
- Fatigue
- Nausea
- Pelvic discomfort
- Mood changes
Drug Interactions
- No formal drug-drug interaction studies have been performed
- Concomitant use with other ovulation-inducing agents (e.g., hCG, clomiphene citrate) may potentiate follicular response and increase OHSS risk
Curated Content: Needs Vetting Before Put to Clinical Use