GONAL-F RFF REDI-JECT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for GONAL-F RFF REDI-JECT (GONAL-F RFF REDI-JECT).
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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for GONAL-F RFF REDI-JECT (GONAL-F RFF REDI-JECT).
| Breastfeeding | Not recommended during breastfeeding. Excretion in human milk unknown; M/P ratio not determined. May suppress lactation due to hormonal effects. |
| 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 |
■ 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 follitropin alfa or any excipient","High levels of FSH indicating primary ovarian failure","Uncontrolled thyroid or adrenal dysfunction","Sex hormone-dependent tumors (e.g., ovarian, breast, uterine)","Pregnancy","Ovarian cyst or enlargement of unknown origin"]
| 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"] |
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| 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. |