GONAL-F RFF REDI-JECT
Clinical safety rating
cautionComprehensive clinical and safety monograph for GONAL-F RFF REDI-JECT (GONAL-F RFF REDI-JECT).
Comprehensive clinical and safety monograph for GONAL-F RFF REDI-JECT (GONAL-F RFF REDI-JECT).
Ovulation induction in anovulatory womenControlled ovarian hyperstimulation for assisted reproductive technologies (ART)Spermatogenesis induction in hypogonadotropic hypogonadism (with hCG)
GONAL-F (follitropin alfa) is a recombinant human follicle-stimulating hormone (FSH) that binds to FSH receptors on ovarian follicles, stimulating follicular growth, maturation, and estrogen production.
| Metabolism | Primarily metabolized in the liver via peptide hydrolysis, with renal excretion of metabolites. |
| Excretion | Renal: approximately 70-80% of the dose; fecal: <20% |
| Half-life | Terminal elimination half-life: approximately 24 hours; clinically, steady-state is achieved within 3-5 days of daily dosing. |
| Protein binding | Approximately 30-40% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Approximately 8-10 L/kg, indicating extensive distribution into extracellular fluid. |
| Bioavailability | Subcutaneous: approximately 70-80%. |
| Onset of Action | Subcutaneous: follicular growth is typically observed after 5-7 days of daily administration. |
| Duration of Action | Subcutaneous: the effect on follicular development persists for the duration of treatment; the half-life of 24 hours supports daily dosing. |
| Molecular Weight | 17000 |
Subcutaneous injection. Initial dose 75-225 IU once daily for 7-14 days, titrated based on ovarian response. Maximum daily dose 450 IU.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. Not studied in severe renal impairment (CrCl <30 mL/min) or dialysis; use with caution. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C); use with caution. |
| Pediatric use | Not indicated for use in pediatric patients. Safety and effectiveness not established. |
| Geriatric use | Not indicated for use in geriatric patients. Safety and effectiveness not established. |
| 1st trimester | Contraindicated. FSH can cause ovarian hyperstimulation and is not indicated during pregnancy. |
| 2nd trimester | Contraindicated. No indication for use during pregnancy. |
| 3rd trimester | Contraindicated. No indication for use during pregnancy. |
Clinical note
Comprehensive clinical and safety monograph for GONAL-F RFF REDI-JECT (GONAL-F RFF REDI-JECT).
| Placental transfer | Minimal to no placental transfer due to large molecular weight and protein structure. |
| Breastfeeding | Excretion into human milk is unknown. Due to high molecular weight and protein nature, oral absorption is unlikely. However, caution is advised as no data are available. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | FDA Pregnancy Category X. Contraindicated in pregnancy. No fetal risk data in first trimester due to lack of exposure; however, follicular stimulation may induce ovarian hyperstimulation syndrome and multiple gestations. Second and third trimester: no indicated use; potential for harm based on animal studies. |
| Fetal Monitoring | Monitor ovarian response via ultrasound and serum estradiol levels; assess for ovarian hyperstimulation syndrome. In pregnancy, monitor for multiple gestations and ectopic pregnancy. No fetal monitoring required for GONAL-F itself as it is discontinued before conception. |
| Fertility Effects | Induces follicular growth and maturation in anovulatory women and controlled ovarian stimulation for assisted reproductive technology. May cause multiple follicular development leading to multiple pregnancies. Ovarian hyperstimulation syndrome is a risk. Does not impair fertility; used to treat infertility. |
■ FDA Black Box Warning
GONAL-F should only be used by physicians thoroughly familiar with infertility problems and their management. Use may lead to ovarian hyperstimulation syndrome (OHSS) and multiple gestations.
| Serious Effects |
Hypersensitivity to FSH or any excipientHigh levels of FSH indicating primary gonadal failureOvarian, breast, uterine, or pituitary tumorsPregnancyNonsexual causes of infertility (e.g., thyroid, adrenal)
| Precautions | Ovarian Hyperstimulation Syndrome (OHSS): risk of severe OHSS with pulmonary and vascular complications, Ovarian torsion and rupture, Multiple gestation and birth defects, Thromboembolic events, Ectopic pregnancy, Ovarian neoplasms, Respiratory distress syndrome in offspring |
| Food/Dietary | No known food interactions. No dietary restrictions required. However, grapefruit juice may increase estrogen levels and should be avoided during treatment. Maintain adequate hydration. |
| Clinical Pearls | GONAL-F RFF REDI-JECT contains recombinant human follicle-stimulating hormone (follitropin alfa). It is used for ovulation induction and controlled ovarian hyperstimulation. Administer subcutaneously, rotating injection sites. Monitor ovarian response via ultrasound and estradiol levels to avoid ovarian hyperstimulation syndrome (OHSS). Dose adjustments based on patient response; individualize therapy. Can be used in combination with GnRH agonists or antagonists. |
| Patient Advice | Rotate injection sites (abdomen, thigh, upper arm) to reduce lipodystrophy. · Do not shake the Redi-Ject device; store in refrigerator (2-8°C) before first use, then at room temperature for up to 28 days. · Report severe pelvic pain, nausea, or rapid weight gain (possible OHSS). · Avoid alcohol and grapefruit juice as they may affect hormone levels. |
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