Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
FERTINEX vs BRAVELLE
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Follitropin beta, a recombinant form of human follicle-stimulating hormone (FSH), binds to the FSH receptor on ovarian granulosa cells and testicular Sertoli cells, stimulating follicular development and maturation in women and spermatogenesis in men.
Bravelle (urofollitropin) is a purified preparation of follicle-stimulating hormone (FSH) that stimulates ovarian follicular growth and maturation by binding to FSH receptors on granulosa cells, increasing c AMP production and promoting follicular development.
Ovulation induction in anovulatory women with polycystic ovary syndrome (PCOS) who have failed to respond to clomiphene citrate,Controlled ovarian hyperstimulation for assisted reproductive technologies (ART) such as in vitro fertilization (IVF),Hypogonadotropic hypogonadism in men
Ovulation induction in anovulatory women with polycystic ovary syndrome (PCOS),Controlled ovarian hyperstimulation for assisted reproductive technologies (ART) such as in vitro fertilization (IVF)
For ovulation induction: 75-150 IU subcutaneously or intramuscularly once daily for 7-12 days; for spermatogenesis: 75-150 IU subcutaneously or intramuscularly 3 times per week.
For ovulation induction: 150 IU subcutaneously or intramuscularly once daily for 5 days, starting on day 3 or 5 of menstrual cycle. For controlled ovarian hyperstimulation: 150-225 IU subcutaneously or intramuscularly once daily for 5-7 days, then adjust based on response.
Terminal elimination half-life is approximately 24-36 hours in patients with normal renal function, supporting once-daily dosing.
Terminal elimination half-life approximately 5-6 hours in healthy adults. Extended in renal impairment (up to 24 hours with Cr Cl <30 m L/min).
Metabolized primarily via the liver and kidneys; exact enzymes not fully characterized, but involves hepatic degradation and renal excretion.
Primarily metabolized in the liver via renal excretion; metabolic pathways not fully characterized.
Primarily renal excretion of unchanged drug (80-90% of administered dose), with the remainder excreted as metabolites in urine and feces.
Primarily renal: 95% of administered dose excreted unchanged in urine within 24 hours. Biliary/fecal: 5% eliminated via feces.
Approximately 60-70% bound to plasma proteins, primarily albumin.
Approximately 10-20% bound to plasma proteins (albumin and α-1 acid glycoprotein).
Vd is approximately 0.3-0.5 L/kg, indicating distribution mainly into extracellular fluid.
Approximately 0.3-0.5 L/kg. Distributing primarily in extracellular fluid; does not extensively penetrate tissues.
Subcutaneous: ~70% relative to intravenous; intramuscular: ~90% relative to intravenous.
Subcutaneous: 90-95% bioavailable relative to intramuscular route. Oral: not clinically used due to enzymatic degradation.
No specific dosing guidelines; use with caution in severe renal impairment (Cr Cl <30 m L/min) due to limited data; consider reduced dose or extended interval.
No specific guidelines exist for GFR-based dose modifications; use with caution in severe renal impairment (Cr Cl <30 m L/min) and monitor for adverse effects.
No specific dosing guidelines; use with caution in severe hepatic impairment (Child-Pugh class C) due to limited data; consider reduced dose.
No specific guidelines exist for Child-Pugh based modifications; use with caution in severe hepatic impairment and monitor for adverse effects.
For delayed puberty (males): 75-150 IU subcutaneously or intramuscularly 3 times per week; adjust based on testosterone response. For cryptorchidism: 1000-1500 IU subcutaneously or intramuscularly 2-3 times per week for 4-6 weeks; not weight-based but age-adjusted.
Not indicated for use in pediatric patients; safety and efficacy not established.
Elderly patients are not typically candidates for FERTINEX; no specific dose adjustments recommended due to lack of use; monitor for comorbidities and potential hypersensitivity.
Not indicated for use in geriatric patients; safety and efficacy not established.
FERTINEX should only be used by physicians with expertise in infertility treatment. Ovarian hyperstimulation syndrome (OHSS) may occur, which can be severe and result in ovarian enlargement, pelvic pain, ascites, pleural effusion, and thromboembolic events. Multiple gestation increases the risk of adverse maternal and perinatal outcomes.
Bravelle should only be used by physicians who are experienced in infertility treatment and can manage potential serious adverse events, including ovarian hyperstimulation syndrome (OHSS) and multiple gestations.
Risk of ovarian hyperstimulation syndrome (OHSS), which may be severe and require hospitalization,Increased risk of multiple gestation (twins, triplets, etc.),Ovarian torsion reported,Potential for ovarian enlargement and cyst formation,Thromboembolic events, especially in patients with risk factors,Should not be used in patients with primary ovarian failure, uncontrolled thyroid/adrenal dysfunction, or sex hormone-dependent tumors
Ovarian enlargement and ovarian hyperstimulation syndrome (OHSS) – can lead to serious complications; discontinue treatment if OHSS is suspected.,Multiple gestations – increased risk of multiple births.,Ovarian torsion – report sudden abdominal pain.,Pulmonary and vascular complications – thromboembolic events; discontinue if suspected.,Ectopic pregnancy and spontaneous abortion – higher rates in ART patients.,Neoplasms – risk of ovarian neoplasms with repeated use.
Pregnancy,Lactation,Primary ovarian failure (elevated FSH levels),Uncontrolled thyroid or adrenal dysfunction,Sex hormone-dependent tumors (e.g., breast, ovarian, uterine),Hypersensitivity to follitropin beta or any component of the formulation
Hypersensitivity to urofollitropin or any component,High levels of FSH indicating primary ovarian failure,Uncontrolled thyroid or adrenal dysfunction,Known or suspected pregnancy,Ovarian cyst or enlargement of undetermined origin,Abnormal uterine bleeding of undetermined origin,Sex hormone-dependent tumors (e.g., breast, uterus, ovary)
No specific food interactions. Maintain a balanced diet rich in folic acid (400-800 mcg/day) to reduce risk of neural tube defects. Avoid excessive alcohol and caffeine.
No known food interactions. Maintain normal diet and hydration. Avoid alcohol as it may exacerbate side effects like nausea.
Fertinex (urofollitropin) is associated with a Category X risk in pregnancy. Administration during pregnancy may cause fetal harm, including congenital malformations (neural tube defects, limb defects) and spontaneous abortion. Use is contraindicated in pregnant women.
Pregnancy Category X. Urofollitropin is contraindicated in pregnant women due to risk of fetal harm. First trimester: Ovarian hyperstimulation syndrome (OHSS) and multiple gestations. Second and third trimesters: No direct fetal effects reported, but risks associated with multiple gestation (preterm birth, low birth weight). Maternal OHSS may lead to thromboembolism.
Safety during breastfeeding has not been established. Excretion in human milk is unknown; no M/P ratio available. Due to potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment.
Urofollitropin is not indicated for use during lactation. No data on excretion in human milk, M/P ratio not established. Use during breastfeeding is contraindicated due to potential for adverse effects on infant hormone levels.
No dose adjustments are indicated as Fertinex is contraindicated in pregnancy. Use should be discontinued if pregnancy is confirmed.
No dose adjustment applicable as therapy is discontinued upon confirmed pregnancy. No pharmacokinetic data during pregnancy; drug is not used after conception due to contraindication.
FERTINEX (urofollitropin) is a purified FSH product used for ovulation induction. Monitor ovarian response via serum estradiol levels and transvaginal ultrasound to assess follicle size and number. Adjust dose based on response to minimize OHSS risk. Administer IM or SC after reconstitution. Use caution in patients at risk for thromboembolism.
BRAVELLE (urofollitropin) is a purified FSH product used for controlled ovarian hyperstimulation. Administer subcutaneously; rotate injection sites. Monitor estradiol levels and follicle growth via ultrasound. Risk of ovarian hyperstimulation syndrome (OHSS); consider using Gn RH antagonist protocols to reduce risk. Do not administer if patient has high baseline FSH levels (>15 IU/L) indicating poor ovarian reserve.
FERTINEX is a hormone injection given under the skin or into a muscle to help you ovulate.,You will need training on how to inject the medication and dispose of needles safely.,Common side effects include headache, bloating, and injection site reactions.,Seek immediate medical attention if you experience severe pelvic pain, sudden weight gain, or shortness of breath.,Avoid alcohol and limit caffeine intake during treatment.,Report any signs of ovarian hyperstimulation syndrome (OHSS) such as nausea, vomiting, or decreased urination.
Teach proper injection technique and site rotation (abdomen, thigh).,Report immediately if severe pelvic pain, nausea, vomiting, or rapid weight gain occurs (OHSS signs).,Avoid intercourse until instructed to prevent multiple pregnancy.,Inform of multiple pregnancy risk (especially twins).,Store vials in refrigerator (2-8°C) and protect from light.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about FERTINEX vs BRAVELLE, answered by our medical review team.
FERTINEX is a Gonadotropin that works by Follitropin beta, a recombinant form of human follicle-stimulating hormone (FSH), binds to the FSH receptor on ovarian granulosa cells and testicular Sertoli cells, stimulating follicular development and maturation in women and spermatogenesis in men.. BRAVELLE is a Gonadotropin that works by Bravelle (urofollitropin) is a purified preparation of follicle-stimulating hormone (FSH) that stimulates ovarian follicular growth and maturation by binding to FSH receptors on granulosa cells, increasing c AMP production and promoting follicular development.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between FERTINEX and BRAVELLE depend on the specific clinical indication. These are both Gonadotropin agents and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of FERTINEX is: For ovulation induction: 75-150 IU subcutaneously or intramuscularly once daily for 7-12 days; for spermatogenesis: 75-150 IU subcutaneously or intramuscularly 3 times per week.. The standard adult dose of BRAVELLE is: For ovulation induction: 150 IU subcutaneously or intramuscularly once daily for 5 days, starting on day 3 or 5 of menstrual cycle. For controlled ovarian hyperstimulation: 150-225 IU subcutaneously or intramuscularly once daily for 5-7 days, then adjust based on response.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between FERTINEX and BRAVELLE in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. FERTINEX is classified as Category C. Fertinex (urofollitropin) is associated with a Category X risk in pregnancy. Administration during pregnancy may cause fetal harm, including congenital malformations (neural tube d. BRAVELLE is classified as Category C. Pregnancy Category X. Urofollitropin is contraindicated in pregnant women due to risk of fetal harm. First trimester: Ovarian hyperstimulation syndrome (OHSS) and multiple gestatio. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.