Recagon

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Recagon

What is Recagon?

Recagon is a medicinal product that contains the active substance follitropin beta. It is a laboratory-produced version of the natural human follicle-stimulating hormone (FSH). FSH is a hormone produced by the pituitary gland that plays a fundamental role in human reproduction and fertility.

Mechanism of Action

In the human body, FSH is responsible for the growth and development of follicles in the ovaries of women and the production of sperm in the testes of men. Recagon works by mimicking the effects of this naturally occurring hormone.

Because it is produced using recombinant DNA technology, the substance is biologically similar to the FSH made by the body, allowing it to interact with the same biological receptors to stimulate reproductive processes.

Clinical Applications

Recagon is primarily used in the management of fertility-related conditions. Its use is generally categorized into the following areas:

  • Female Fertility: It is used to stimulate the development of follicles in the ovaries. This is often necessary for women who do not ovulate or for those undergoing assisted reproductive technologies, such as in vitro fertilization (IVF), where the goal is to produce multiple follicles for egg collection.
  • Male Fertility: It may be used to promote the production of sperm in men who have a hormone deficiency that leads to a low sperm count.

Composition

Recagon consists of follitropin beta and is formulated as a solution for injection. The recombinant technology used to create the hormone ensures a high degree of purity and consistency in the biological activity of each dose.

What side effects are possible with Recagon?

Possible Side Effects and Safety Information

The safety profile for Recagon (Follitropin Beta) is officially defined by government regulatory documents, which categorize adverse reactions by frequency and the body system affected. These classifications distinguish between common, expected effects and rare, clinically significant events. The information presented here is based strictly on the regulatory labeling, not on clinical advice or instruction.


Documented Adverse Reactions

Adverse reactions are classified into System-Organ Classes (SOCs). Common effects, reported in clinical trials, often include headache, injection site reactions (such as pain or swelling), pelvic discomfort, and gastrointestinal symptoms like nausea and abdominal pain.

System-Organ Class Common Adverse Reactions
Reproductive System & Breast Ovarian cyst, Pelvic pain, Gynecomastia (men)
Nervous System Headache
Gastrointestinal Disorders Abdominal discomfort, Nausea, Abdominal pain
General Disorders Injection site reaction, Fatigue

Serious Safety Considerations

The regulatory profile highlights several serious adverse reactions. The most significant is Ovarian Hyperstimulation Syndrome (OHSS), a potentially serious condition. OHSS severity may be more pronounced if pregnancy occurs and typically peaks seven to ten days following the ovulation-inducing injection. Other rare but serious complications documented in regulatory warnings include thromboembolic events (blood clots, such as pulmonary embolism or deep venous thrombosis) and ovarian torsion (twisting of the ovary).

Population-Specific Notes: Use is contraindicated in pregnant women. Women with pre-existing risk factors for blood clots, such as severe obesity, have an officially increased risk of thromboembolic events.

Safety Restrictions: The medicine is restricted and should not be used in individuals with prior hypersensitivity, primary gonadal failure, tumors of the reproductive organs or pituitary/hypothalamus, or uncontrolled non-gonadal endocrinopathies.

Overdose and Emergency Response

The regulatory documentation for Follitropin Beta (Recagon) defines overdose primarily by the risk of Ovarian Hyperstimulation Syndrome (OHSS) in women undergoing controlled ovarian stimulation. Overdose may result from the administration of an excessively high dose and is explicitly linked to the potential for multiple gestations.

Manifestations of severe OHSS are officially documented to include acute abdominal pain, rapid weight gain, vomiting, decreased urine output (oliguria), and difficulty breathing (dyspnoea). The official labeling classifies severe OHSS as a potentially life-threatening condition and notes the associated risk of venous or arterial thromboembolism (blood clot formation).

Regulators strictly mandate that individuals seek immediate medical attention and contact a poison control center if an overdose is suspected or if severe OHSS symptoms develop. Treatment for overdose is limited to symptomatic and supportive treatment, as the authorized prescribing information states that no specific antidote is known. For severe cases, consideration should be given to hospitalization and continuous monitoring, which reflects the urgency defined in the official regulatory profile.

Therapeutic Uses of Recagon

Quick Facts

  • Female Infertility: Used to support the development of follicles in women with anovulatory infertility.
  • Assisted Reproduction: Indicated for controlled ovarian hyperstimulation as part of medically assisted reproduction programs, such as in vitro fertilization (IVF).
  • Male Hypogonadism: Used to address deficient spermatogenesis in adult men who have hypogonadotropic hypogonadism.

Recagon is a prescribed medication used in fertility and reproductive care. The treatment's primary applications are centered on supporting ovarian and testicular function in specific patient populations.

For women, the medication is indicated to promote the growth and development of ovarian follicles, which may be beneficial in cases of anovulatory infertility when prior clomiphene citrate treatment has not resulted in a therapeutic response. It is also used to encourage the development of multiple follicles when undergoing procedures related to assisted reproductive technologies (ART).

For men, Recagon is an option used in the management of hypogonadotropic hypogonadism, aiming to stimulate spermatogenesis. Treatment with this medication may help improve the potential for conception by addressing these underlying conditions. Individual outcomes may vary, and the use of Recagon should always be determined and monitored by a qualified healthcare professional.

Eligibility and Restrictions for Use

Recagon (follitropin beta) is a prescription medicine whose use is strictly governed by regulatory eligibility rules. The medicine is indicated exclusively for adult females and adult males seeking to address certain hormonal causes of infertility.

Who Cannot Use Recagon (Contraindications)

Official labeling contraindicates use in patients with the following conditions:

Category Exclusion Criteria
Primary Gonadal Failure High FSH levels indicating primary ovarian or testicular failure.
Hormone-Dependent Tumors Tumors of the hypothalamus, pituitary gland, ovary, breast, uterus, or testis.
Pathological Conditions Undiagnosed vaginal bleeding; ovarian cysts/enlargement not due to PCOS; certain uterine malformations.
Other Prior hypersensitivity to follitropin beta, excipients, or traces of streptomycin/neomycin.

Limitations on Use

Use is also contraindicated during pregnancy and is not recommended for nursing mothers. Safety and efficacy have not been established in pediatric or geriatric patient populations. Furthermore, the pharmacokinetics have not been determined in patients with renal or hepatic impairment, indicating limited data for these specific groups in official documents.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Recagon (Follitropin Beta) details interaction constraints primarily concerning other reproductive hormones and administration procedures. Formal pharmacokinetic interaction studies (e.g., involving CYP enzymes or transporters) have not been conducted; therefore, no exposure-altering effects of co-administered medicines are officially established. No clinically relevant interactions with food, alcohol, or herbal products are documented in the official regulatory sources.

Two main interaction patterns are noted: pharmacodynamic influence and mandatory administration restrictions. Prior administration of Gonadotropin-Releasing Hormone (GnRH) agents—which are used for pituitary desensitization—influences the ovarian response to Follitropin Beta. This pharmacodynamic effect means a higher starting dose of Follitropin Beta is typically required to achieve adequate follicular development. Additionally, co-administration with Clomiphene may enhance the overall ovarian follicular response.

Strict administration constraints are mandated in regulatory labels. Follitropin Beta must not be physically mixed with any other medicines in the same cartridge, vial, or syringe, which is a crucial restriction. Furthermore, a timing-based safety restriction involves Human Chorionic Gonadotropin (hCG): the administration of hCG must be withheld if monitoring suggests an increased risk of Ovarian Hyperstimulation Syndrome (OHSS) on the last day of Follitropin Beta therapy.

Mechanism of Action

How Recagon Works: Pharmacodynamics


Hormone Receptor Agonism

Recagon (Follitropin alfa or beta) functions as a recombinant Follicle-Stimulating Hormone (r-hFSH) agonist, achieving highly specific binding to the FSH receptor. This receptor is primarily expressed on the surface of granulosa cells within the ovary and Sertoli cells within the testis. This binding event serves as the molecular trigger, initiating the primary signaling sequence required for the regulation of gamete development.


Gonadal Pathway Modulation

In the ovaries, the agonistic action initiates intracellular signaling cascades that drive the proliferation and maturation of ovarian follicles. This modifies the early molecular steps crucial for follicular development and subsequent steroidogenesis (estrogen synthesis), resulting in the physiological adjustment necessary for oocyte release.


Spermatogenesis Influence

Within the testes, Recagon engages mechanisms that stimulate Sertoli cells, a key step in regulating the process of spermatogenesis (sperm production). This action also supports the downstream hormonal signaling that governs the production of male sex hormones, such as testosterone, influencing the hormonal balance of the targeted system.

Dosage and Administration Information

How to Use Recagon

Recagon is administered as a subcutaneous injection (just under the skin). The procedure for use is individualized based on patient response.

Administration Protocol

Procedural Element Instruction
Route of Administration Subcutaneous injection. The very first injection must be given by a health professional.
Dosing Schedule The doctor determines and may adjust the individual daily dose as treatment progresses, as ovarian response varies significantly between patients. This dose is maintained for a specific duration until an adequate response is obtained.
Preparation The solution for injection in cartridges is developed for use exclusively with the Puregon Pen.
Frequency Typically administered daily, or as instructed by the doctor, until the treatment cycle is complete.
Injection Site Administered into the stomach or thigh.
Missed Dose If an injection is forgotten, the patient must contact their doctor or nurse immediately for advice. Do not double the dose on any day.

Step Sequence

  1. The initial injection is performed by a qualified health professional to ensure correct technique.
  2. Subsequent injections are administered subcutaneously using the Puregon Pen device.
  3. Follow the individual dose and duration instructions provided by the prescribing physician.
  4. Continue use until the doctor tells you to stop treatment, which is typically after the final maturation phase.

The method of administration is parenteral and is performed with a designated delivery device. Due to the high inter-individual variation in response, the central procedural component is the daily, physician-adjusted dosing based on continuous clinical monitoring. This structured protocol ensures the medication usage adheres to the established treatment plan.

Recent Clinical Evidence

Recagon: Recent Clinical Evidence


Recagon for Conditions Characterized by Episodic Manifestations

Recagon was studied for conditions characterized by fluctuating or episodic manifestations. The research was evaluated in exploring how symptoms change over time and applied in contexts involving fluctuating or unstable symptoms. The evidence describes studies evaluating short-term or episodic symptom patterns, including outcomes related to physical discomfort.

Findings describe patterns observed in the studies. Research highlights changes measured during the study period, and data show patterns related to how symptoms evolved in the observed populations. In this context, data show patterns related to patient-reported outcomes describing perceived discomfort. These findings help contextualize short-term symptom patterns.

However, research is ongoing, and certainty remains low for the overall evidence. While studies monitored the use of Recagon over defined time intervals, follow-up durations were limited. Long-term effects are not fully established, and evidence is limited for how these short-term patterns translate over longer periods.


Recagon for Outcomes Related to Daily Functioning

Studies explored outcomes reflecting daily functioning or activity level, used in research for conditions marked by functional limitations. This research examined settings with varying symptom burdens, including studies conducted during periods of increased symptom activity. Research examined outcomes related to systemic or functional imbalance.

Findings describe patterns observed in the studies. Studies explored how Recagon was associated with daily-life functioning measured during the research. Evidence contributes to understanding how patients reported their experience when the product was studied for this indication. The findings indicate soft, non-causal patterns related to daily functioning.


Limitations and Gaps in the Current Evidence Landscape

Comparative evidence, which involves studies directly comparing Recagon to other established approaches, is lacking. Furthermore, data for certain groups of patients remain insufficient to draw confident conclusions. The evidence quality varies across studies, and certainty remains low in some areas. Research provides context but not individual predictions regarding how a person may respond to the use of Recagon.

Frequently Asked Questions (FAQ)

Common questions about Recagon (FAQ)

Q: How quickly does Recagon start working after the first dose?

Studies on how the medicine moves through the body show that the active ingredient typically reaches its highest concentration in the bloodstream roughly 8 to 20 hours after a single injection. While the active substance is detectable soon after dosing, the full effect on follicle growth is part of the overall treatment cycle.

Q: Does Recagon interact with vitamins or supplements?

Official regulatory documents indicate that formal studies that measure how the active ingredient interacts with co-administered medicines (including vitamins or supplements) have not been conducted. Regulatory sources do not currently establish any specific warnings concerning the co-administration of vitamins or supplements.

Q: What should I do if I miss a dose of Recagon?

Official administration guidelines state that forgetting an injection requires contacting a doctor or nurse for advice on how to proceed. It is explicitly directed in the product information that you should not double the dose on any day.

Q: Does Recagon interact with common pain relievers like ibuprofen?

The official product information states that formal pharmacokinetic interaction studies have not been completed. Therefore, no changes in exposure related to common pain relievers are officially established in the regulatory labels.

Q: Can I take Recagon with my high blood pressure medication?

Regulatory information indicates that formal studies on drug-to-drug interactions have not been completed. Official labels do not document specific warnings or established changes in exposure related to co-administering the medicine with other prescription drugs.

Q: How does Recagon's safety profile compare to similar drugs?

Official summaries of the clinical research note that comparative evidence—which involves studies that directly contrast Recagon’s outcomes or safety profile with other established treatment approaches—is currently lacking in the evidence landscape.

Q: Are there any warnings about using Recagon during breastfeeding?

Regulatory documents state that the medicine is not intended for use by nursing mothers.

Q: Can Recagon cause changes in weight?

While minor changes in weight are not listed as a common side effect, official safety information documents that rapid weight gain is a symptom associated with the potentially serious condition called Ovarian Hyperstimulation Syndrome (OHSS).

Q: Is Recagon safe to take if I have liver problems?

Official regulatory documents explicitly state that the safety, effectiveness, and pharmacokinetics—the way the body handles the drug—have not been established in patients with hepatic (liver) impairment. There are limited official data regarding the medicine’s use in this specific patient group.

Q: How does Recagon compare to a placebo in clinical trials?

Clinical trials for the active ingredient often compare its effectiveness to other established fertility treatments, such as urinary-derived FSH, rather than specifically to a placebo (an inactive substance).

Q: Do I need to change my diet while taking Recagon?

Official regulatory documents do not document any clinically relevant interactions with food or alcohol. This means no specific dietary restrictions or changes are mandated by the drug’s label.

Q: Is there a maximum time I can take Recagon for?

Official dosing guidelines describe treatment in cycles, generally not exceeding about 14 days per cycle for women undergoing controlled ovarian stimulation. For men being treated for deficient sperm production, the therapy may be continued for 18 months or longer to see an effect.

Q: Does Recagon cause mood swings or changes in personality?

Common adverse reaction listings in official documents include nervous system effects such as headache, but mood swings or personality changes are not listed as common or serious side effects reported in the clinical trials.

Q: How long does Recagon stay in your system?

Pharmacokinetic data from official sources indicate that the half-life of the active ingredient is approximately 33 to 44 hours after a single dose. The half-life is the time it takes for half of the drug's substance to be eliminated from the body.

Q: Does Recagon interact with caffeine or energy drinks?

Official regulatory information states there are no clinically relevant interactions documented with food, alcohol, or herbal products. Official labels do not document specific warnings against common beverages like caffeine.

Q: Is it normal to feel tired when starting Recagon?

Fatigue (feeling tired) is listed in regulatory safety information as a common adverse reaction that was reported in clinical studies of the medicine.

Q: Can men and women use Recagon for the same conditions?

No, the medicine is officially indicated for different conditions. In women, it is used for infertility due to specific ovulatory issues or controlled ovarian stimulation. In men, it is used for deficient spermatogenesis (sperm production) due to specific hormonal imbalances.

Q: Are there any specific foods that interact with Recagon?

Official regulatory information states that no clinically relevant interactions with food are documented. This means that there are no official instructions regarding avoiding specific foods while using the medicine.

Q: Does taking Recagon affect fertility or planning a pregnancy?

The medicine's official purpose is to address certain hormonal causes of infertility, which is the underlying cause for difficulty in planning or achieving pregnancy. It works by stimulating the processes needed for egg or sperm production.

Q: Why is Recagon prescribed for this specific condition?

Recagon's active component is a man-made version of Follicle-Stimulating Hormone (FSH). It is prescribed to replace or supplement natural FSH activity to help correct hormonal deficiencies that cause infertility in eligible patients.

Q: Can people with kidney problems use Recagon?

Official regulatory documents indicate that the safety, effectiveness, and pharmacokinetics—how the drug is processed by the body—have not been established in patients with renal (kidney) impairment. There are limited official data regarding the medicine’s use in this patient population.

Q: What is the experience of other patients taking Recagon?

The official documents describe patient experience through study results. For women, outcomes assessed included the number of eggs recovered and ongoing pregnancy rates. The safety profile is detailed by documenting all common and serious adverse reactions reported in clinical trials.

Q: Is Recagon known to cause hair loss?

Hair loss has been noted in post-marketing reports for the active substance but is not considered a common or frequent side effect documented during clinical trials. It is classified as an event with a frequency that is not defined.

Q: What are the limitations of the research on Recagon?

Official evidence summaries note that key limitations include a lack of long-term follow-up data to assess effects over many years, insufficient comparative evidence against other treatment options, and variable evidence quality across different studies.

Q: Can Recagon be taken on an empty stomach?

The regulatory documents specify that the medicine is given by subcutaneous injection, meaning it is administered under the skin. Unlike oral medicines, the official instructions for this injection do not include any directions relating to food intake.

Q: Do I need regular blood tests while on Recagon?

Yes, official treatment protocols state that ovarian response must be closely monitored throughout the process. This continuous clinical monitoring is mandated using tools like ultrasonography and measurement of hormone levels in the blood.

Q: Can Recagon be used alongside herbal remedies?

Official regulatory information states that no clinically relevant interactions with herbal products are documented, indicating that there are no specific warnings against using herbal remedies present in the drug label.

Q: What happens if Recagon does not work for me?

Regulatory guidelines acknowledge that individual patient response varies. If a patient does not respond after a specific duration, official protocols allow for the possibility of adjusting the treatment dose or continuing the therapy for a longer period. Primary gonadal failure is an official contraindication, where the therapy is known to be ineffective.

Q: Is there a risk of dependence or addiction with Recagon?

Official safety documents explicitly state that there have been no reports of abuse or dependence associated with the active substance (follitropin beta).

Q: Why do some people say Recagon didn't work for them?

Official documents indicate that individual patient response varies significantly. Furthermore, a non-response may occur in patients with primary gonadal failure, a condition where the therapy is known to be ineffective, which is listed as an official contraindication.

Q: Does Recagon affect sleep patterns?

Official adverse reaction listings do not include sleep disturbances or insomnia among the common or serious effects documented during the clinical trials.

Q: What is the expected timeline for seeing the full benefit of Recagon?

For women, the process of follicular development typically takes between 7 to 14 days per treatment cycle. For men, achieving deficient sperm production may require treatment to be continued for at least 3 to 4 months, and potentially up to 18 months or longer.

Q: Can Recagon be taken with alcohol?

Official regulatory information states that no clinically relevant interactions with alcohol are documented in the product label.

How should Recagon be stored and disposed of?

Storage Conditions and Stability

Recagon (Follitropin Beta) must be stored in a refrigerator, strictly maintaining a temperature between 2°C and 8°C (36°F and 46°F) before its first use. It is critical to not freeze the medicine at any time. The cartridge must be kept in its original outer carton to provide protection from light, as stated in the official labeling.

Once the cartridge is first pierced, the medicine may be stored for a maximum of 28 days. During this post-opening period, it may be stored at room temperature, up to 25°C (77°F). Official labeling requires that Recagon be kept out of the sight and reach of children.

Disposal of Waste

Any unused or expired product must be discarded in accordance with local regulatory requirements, often by returning it to a pharmacist or clinic. Used needles and syringes must be disposed of immediately in a specialized, hard, puncture-proof sharps container, and should not be placed in household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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