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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Gonal-f Rff Redi-ject
Generic Name
Follitropin
Active Ingredient
FollitropinCategory
Gonadotropin [EPC]
Variants
3
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 900 [iU]/1.5mL | INJECTION, SOLUTION | SUBCUTANEOUS | 44087-1117 |
| 450 [iU]/.75mL | INJECTION, SOLUTION | SUBCUTANEOUS | 44087-1116 |
| 300 [iU]/.5mL | INJECTION, SOLUTION | SUBCUTANEOUS |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Gonal-f Rff Redi-ject, you must consult a qualified healthcare professional.
Detailed information about Gonal-f Rff Redi-ject
Follitropin is a recombinant form of Follicle-Stimulating Hormone (FSH) used in assisted reproductive technology to stimulate follicular development in women and spermatogenesis in men.
Dosage for Follitropin is highly individualized and must be adjusted based on the patient's ovarian response (monitored via serum estradiol levels and vaginal ultrasound). There is no 'standard' dose that applies to all patients.
Follitropin is generally not approved for pediatric use. Its safety and efficacy in children have not been established. In rare clinical scenarios involving delayed puberty due to hypogonadotropic hypogonadism, a pediatric endocrinologist may prescribe it off-label, but this is not standard practice.
The pharmacokinetics of Follitropin in patients with kidney disease have not been extensively studied. Because a portion of the drug is excreted renally, caution is advised, though dose adjustments are rarely standardized for this population.
As Follitropin is a glycoprotein and not primarily metabolized by the liver's CYP450 system, hepatic impairment is not expected to significantly alter its clearance. However, clinical data in this population are limited.
Follitropin is not indicated for use in postmenopausal women or elderly men. There is no clinical reason for use in this demographic.
Follitropin is administered via subcutaneous (under the skin) or intramuscular (into the muscle) injection. Subcutaneous injection in the abdomen or upper thigh is the most common method for self-administration.
If you miss a dose, contact your healthcare provider or fertility clinic immediately. Do not double the dose to catch up. Missing a dose can disrupt the delicate hormonal balance required for follicular development and may result in the cancellation of a treatment cycle.
Acute overdose of Follitropin is unlikely to cause life-threatening toxicity. However, the primary risk of excessive dosing is Ovarian Hyperstimulation Syndrome (OHSS) or multiple gestations (twins, triplets, or more). Signs of an 'overdose' in the context of fertility treatment often manifest as severe abdominal pain, rapid weight gain, and extreme bloating. If you suspect you have injected too much, notify your doctor immediately.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose without medical guidance, as even small changes can significantly impact the safety and success of the treatment.
Side effects of Follitropin are often related to the hormonal changes it induces. Common experiences include:
Follitropin is a potent hormonal medication that must only be used under the supervision of a physician experienced in fertility disorders. Before starting treatment, a thorough gynecologic and endocrinologic evaluation must be performed. This includes ruling out primary ovarian failure (where the ovaries cannot produce eggs regardless of stimulation) and primary testicular failure in men.
There are no FDA black box warnings for Follitropin. However, the risk of Ovarian Hyperstimulation Syndrome (OHSS) is the most critical safety concern and is treated with the same level of clinical gravity as a boxed warning.
As a protein-based medication, Follitropin can cause hypersensitivity reactions. While rare, symptoms can include skin rash, hives, swelling of the face or throat, and difficulty breathing. Patients with a known allergy to FSH preparations or any of the excipients (such as sucrose or sodium phosphate) should not use this medication.
There are no specific drugs that are absolutely contraindicated for use with Follitropin in the sense of a toxic chemical reaction. However, using Follitropin with other fertility drugs outside of a strictly controlled protocol is dangerous.
When used sequentially or in combination with clomiphene, the ovarian response may be exaggerated. While sometimes used together in 'minimal stimulation' protocols, this requires expert monitoring to prevent OHSS.
These medications are frequently used alongside Follitropin to prevent premature ovulation. While this is a standard clinical combination, these drugs alter the body's response to Follitropin. A higher dose of Follitropin may be required to overcome the pituitary suppression caused by GnRH agonists.
Follitropin must NEVER be used in the following circumstances:
Follitropin is classified as Pregnancy Category X (under older FDA systems) or carries a warning that it should not be used during pregnancy. While it is used to achieve pregnancy, it must be discontinued as soon as pregnancy is confirmed. There is no evidence that Follitropin causes specific birth defects in humans when used for ovulation induction; however, in animal studies, high doses have shown embryotoxicity. The primary risk of using Follitropin during early pregnancy is the exacerbation of OHSS and the increased risk of multiple gestations.
It is not known whether Follitropin is excreted in human milk. Because FSH is a large protein molecule, it is unlikely to be absorbed by the infant's digestive tract in significant amounts. However, FSH can suppress lactation by altering the prolactin balance. Breastfeeding is generally not recommended while undergoing fertility treatments with Follitropin, as the hormonal environment required for stimulation is not compatible with nursing.
Follitropin is not approved for use in children. Its use is restricted to adults of reproductive age. In very rare cases, it may be used by pediatric endocrinologists to treat hypogonadotropic hypogonadism in male adolescents to induce puberty, but this is an off-label use with limited safety data in this age group.
Follitropin is a recombinant human Follicle-Stimulating Hormone (r-hFSH). It is a glycoprotein consisting of two non-covalently linked subunits: an alpha subunit (common to LH, TSH, and hCG) and a beta subunit that provides biological specificity.
Upon administration, Follitropin binds to the FSH receptor (FSHR) on the surface of granulosa cells (females) or Sertoli cells (males). This binding activates the Gs protein, which stimulates adenylate cyclase to produce cAMP. Increased cAMP activates Protein Kinase A (PKA), leading to the transcription of genes involved in steroidogenesis (specifically aromatase) and cell proliferation. In women, this results in follicular growth and estradiol production. In men, it promotes the maturation of sperm cells within the seminiferous tubules.
The primary pharmacodynamic effect is the dose-dependent increase in serum estradiol and the growth of ovarian follicles. In men, the effect is measured by an increase in Inhibin B and, eventually, sperm count. There is a lag time between administration and the observable effect; follicular growth is usually not visible on ultrasound until after 4 to 5 days of continuous stimulation.
Common questions about Gonal-f Rff Redi-ject
Follitropin is primarily used to treat infertility by providing the body with extra Follicle-Stimulating Hormone (FSH). In women, it is used to stimulate the ovaries to produce one or more mature follicles, which is essential for ovulation induction or complex procedures like In Vitro Fertilization (IVF). In men, it is used to treat certain types of low sperm count caused by hormonal deficiencies. By mimicking the body's natural signals, Follitropin helps the reproductive organs function more effectively. It is only used when the ovaries or testes are capable of responding to hormonal stimulation.
The most common side effects include injection site reactions like redness or bruising, headaches, and abdominal bloating. Many women also report breast tenderness and mild nausea as their estrogen levels rise during treatment. Mood swings or irritability, similar to what one might feel before a menstrual period, are also frequently reported. Most of these side effects are mild and resolve once the medication is stopped or the body adjusts. However, any severe abdominal pain or rapid weight gain should be reported to a doctor immediately.
There is no known direct drug interaction between Follitropin and alcohol, but most doctors advise against drinking during fertility treatments. Alcohol can interfere with hormonal balance and may dehydrate the body, which is particularly risky if you are at risk for Ovarian Hyperstimulation Syndrome (OHSS). Furthermore, some studies suggest that even moderate alcohol consumption can reduce the success rates of IVF and ovulation induction. To give your treatment the best chance of success, it is generally recommended to avoid alcohol entirely. Always follow the specific lifestyle advice provided by your fertility clinic.
Follitropin is not safe for use once pregnancy has been established. Its purpose is to help you conceive, but once a pregnancy is confirmed via a blood test or ultrasound, the medication must be discontinued. While there is no evidence that Follitropin causes birth defects if taken very early in pregnancy, continuing the drug could cause the ovaries to become dangerously overstimulated. If you suspect you are pregnant while still on a cycle of Follitropin, contact your healthcare provider immediately. Your doctor will perform a pregnancy test before starting any new cycle of the drug.
The effects of Follitropin are not immediate and require several days of consistent use. In women, it typically takes 7 to 14 days of daily injections for follicles to reach a mature size (usually 18mm or larger). Your doctor will monitor this progress every few days using ultrasound and blood tests. In men, the process is much slower because the production of new sperm takes about 70 to 90 days. Consequently, men may need to take Follitropin for 3 to 6 months before an improvement in sperm count is seen in a semen analysis.
Yes, Follitropin can be stopped suddenly without causing physical withdrawal symptoms or 'crashing.' However, doing so will stop the growth of any developing follicles, which usually means the fertility cycle will fail. You should never stop the medication without consulting your fertility specialist, as the timing of the last dose is critical for the success of procedures like egg retrieval. If you are experiencing side effects that make you want to stop, call your doctor to discuss a dose adjustment or alternative treatment plan.
If you miss a dose of Follitropin, contact your fertility clinic as soon as possible for instructions. Do not inject a double dose to make up for the one you missed. Depending on where you are in your cycle, your doctor may tell you to take the missed dose immediately or wait until your next scheduled time. Consistency is vital for maintaining the steady hormone levels needed for follicle growth. Frequent missed doses can lead to a 'cancelled cycle,' meaning the treatment will have to be restarted from the beginning next month.
Follitropin can cause temporary weight gain, but this is usually due to fluid retention and ovarian enlargement rather than an increase in body fat. It is common to feel 'heavy' or bloated toward the end of a treatment cycle. However, rapid weight gain—such as more than 3 pounds in a single day—is a warning sign of Ovarian Hyperstimulation Syndrome (OHSS). This occurs when fluid leaks from the blood vessels into the abdomen. If you notice a sudden, significant increase in weight, you must notify your healthcare provider immediately for evaluation.
Follitropin is often taken as part of a 'cocktail' of other fertility drugs, including GnRH agonists like Lupron or antagonists like Ganirelix. While these combinations are safe under medical supervision, Follitropin can interact with other hormonal supplements. For example, herbal products like Vitex or St. John's Wort may interfere with the HPG axis and should be avoided. Always provide your doctor with a full list of all prescriptions, over-the-counter drugs, and vitamins you are taking. Most non-hormonal medications, like antibiotics or blood pressure drugs, do not interact with Follitropin.
Follitropin is a complex biologic medication, so it does not have 'generics' in the same way that simple drugs like aspirin do. Instead, it has 'biosimilars.' While there are different brands of recombinant FSH (like Gonal-f and Follistim), they are produced by different manufacturers and are not always considered interchangeable by pharmacists. In some regions, biosimilar versions of Follitropin alfa are available and may be more cost-effective. You should always use the specific brand and delivery device (pen or vial) that your doctor prescribed and trained you to use.
Other drugs with the same active ingredient (Follitropin)
> Warning: Stop taking Follitropin and call your doctor immediately if you experience any of the following symptoms, as they may indicate Ovarian Hyperstimulation Syndrome (OHSS):
There has been significant research into whether long-term or repeated use of Follitropin increases the risk of ovarian or breast cancer. According to large-scale epidemiological studies and the American Society for Reproductive Medicine (ASRM), there is currently no definitive evidence that gonadotropin use significantly increases the risk of these cancers. However, patients who undergo multiple cycles of ART should remain under regular gynecological surveillance.
In men, long-term use may lead to gynecomastia (enlargement of breast tissue) due to the peripheral conversion of increased testosterone into estrogen.
No FDA black box warnings currently exist for Follitropin. However, the product labeling contains extensive 'Warnings and Precautions' regarding Ovarian Hyperstimulation Syndrome (OHSS) and Multiple Births, which are the most significant clinical risks associated with the drug.
OHSS is a medical condition where the ovaries become overstimulated and leak fluid into the abdominal and chest cavities. While mild cases are common, severe OHSS can be life-threatening. It typically occurs after the administration of hCG (the 'trigger shot') following a Follitropin cycle. Your doctor will monitor you closely with ultrasounds and blood tests to minimize this risk.
Treatment with Follitropin increases the likelihood of multiple births (twins, triplets, or more). Multiple pregnancies carry higher risks for both the mother (gestational diabetes, preeclampsia) and the infants (premature birth, low birth weight). Your healthcare provider will discuss the strategy of 'low-dose' protocols or single embryo transfer (SET) to mitigate this risk.
Report any unusual symptoms to your healthcare provider immediately. Early detection of side effects is key to a safe and successful fertility journey.
OHSS is the most significant risk. It results in a dramatic increase in vascular permeability, leading to fluid accumulation in the peritoneal, pleural, and pericardial spaces. Severe cases can result in kidney failure, liver dysfunction, and respiratory distress. If your estradiol levels are excessively high or if ultrasound shows too many follicles, your doctor may 'coast' (withhold Follitropin) or cancel the hCG trigger shot to prevent OHSS.
Women with a personal or family history of blood clots (thrombophilia), obesity, or severe OHSS are at an increased risk for venous or arterial thromboembolism. This can lead to deep vein thrombosis (DVT), pulmonary embolism, or stroke. Notify your doctor if you have a history of clotting disorders.
Enlarged ovaries are more prone to twisting on their vascular pedicle. This condition, known as ovarian torsion, causes sudden, severe pelvic pain and requires emergency surgery to save the ovary. Avoid strenuous physical activity and heavy lifting during and immediately after a Follitropin cycle.
Safety and efficacy are managed through rigorous monitoring:
Follitropin is not known to impair the ability to drive or operate heavy machinery. However, if you experience dizziness or severe abdominal discomfort, you should avoid these activities until you feel better.
While there is no direct chemical interaction between Follitropin and alcohol, most fertility specialists recommend avoiding alcohol during treatment. Alcohol can dehydrate the body and may negatively impact egg and sperm quality, potentially reducing the success rate of the fertility cycle.
Follitropin can be stopped abruptly without physical withdrawal symptoms. However, stopping the medication before the follicles are mature will result in the failure of the treatment cycle. If you are undergoing IVF, your doctor will provide a specific schedule for when to stop Follitropin and when to administer the 'trigger' injection.
> Important: Discuss all your medical conditions, including history of asthma, blood clots, or previous abdominal surgeries, with your healthcare provider before starting Follitropin.
Long-term use of high-dose corticosteroids may interfere with the hormonal axis, potentially reducing the effectiveness of Follitropin. The mechanism involves the suppression of the hypothalamic-pituitary-gonadal (HPG) axis.
There are no known food interactions with Follitropin. It can be administered regardless of the timing of meals. However, maintaining a balanced diet rich in antioxidants is often recommended by fertility clinics to support overall reproductive health.
While St. John's Wort primarily affects drugs metabolized by CYP3A4, its impact on the endocrine system is not fully understood. Some evidence suggests it may interfere with hormonal balance, so it is best avoided during fertility treatments.
Vitex is a popular herbal supplement for 'hormonal balance.' However, it can affect prolactin levels and the HPG axis, which may interfere with the precise dosing of Follitropin. Patients should discontinue Vitex before starting gonadotropin therapy.
Many patients take DHEA or Coenzyme Q10 to improve egg quality. While these generally do not interact negatively with Follitropin, you must inform your doctor, as DHEA can raise androgen levels, which may alter the ovarian response.
Follitropin will directly increase serum FSH levels. This is expected and is not a 'false' result. However, it can also cause transient elevations in liver function tests in rare cases of OHSS. If you are having blood work done for other reasons, ensure the lab and your other doctors know you are taking recombinant FSH.
For each major interaction, the primary concern is the pharmacodynamic effect—meaning how the drugs work together to either overstimulate or understimulate the reproductive system. The management strategy is always frequent monitoring via ultrasound and blood work.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including 'natural' fertility boosters, as they can significantly impact your treatment outcome.
Conditions requiring careful risk-benefit analysis include:
Patients who are sensitive to 'Menotropins' (human menopausal gonadotropins) may also be sensitive to Follitropin. Additionally, since some recombinant products are produced in CHO cells, patients with rare allergies to hamster proteins should discuss this with their doctor, although the purification process makes this risk extremely low.
> Important: Your healthcare provider will evaluate your complete medical history, including a pelvic exam and hormonal screening, before prescribing Follitropin.
Follitropin has no clinical indication in the geriatric population. It is not used in postmenopausal women, as their ovaries no longer respond to FSH stimulation.
Specific dosing guidelines for patients with renal impairment do not exist. However, because about 10% of the drug is cleared by the kidneys, patients with severe renal failure (GFR < 30 mL/min) should be monitored even more closely for signs of over-accumulation. Dialysis does not significantly clear Follitropin due to its large molecular weight.
No dosage adjustments are typically required for patients with mild to moderate hepatic impairment. In cases of severe liver disease, the body's ability to produce clotting factors and manage fluid balance is compromised, which significantly increases the danger of OHSS. Treatment in these patients is generally discouraged.
> Important: Special populations, particularly those with underlying chronic illnesses, require individualized medical assessment and potentially more frequent monitoring during fertility treatment.
| Parameter | Value |
|---|---|
| Bioavailability | 66% - 76% (Subcutaneous) |
| Protein Binding | Negligible |
| Half-life | 24 - 37 hours |
| Tmax | 7 - 16 hours |
| Metabolism | Biochemical degradation to peptides/amino acids |
| Excretion | Renal (10-15% unchanged), Fecal (Minimal) |
Follitropin is a Gonadotropin [EPC]. It is closely related to other fertility medications such as Luteinizing Hormone (LH), Human Menopausal Gonadotropin (hMG), and Human Chorionic Gonadotropin (hCG).