Follitrope

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Medically reviewed

Marina Burgos

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 Follitrope

Quick Facts about Follitrope (Urofollitropin)

Property Description
Active Ingredient Urofollitropin (Follicle-Stimulating Hormone, FSH)
Form Lyophilized powder for solution (for injection)
Pharmacological Class Gonadotropins
Common Use Hormonal stimulation of the ovarian follicle
Origin Biological origin (derived from urine)

What Type of Medicine is Follitrope (Urofollitropin)?

Follitrope is a highly purified, prescription-only medicine that functions as an exogenous hormone replacement therapy. The drug is defined by its active component, Urofollitropin, and is classified within the gonadotropins pharmacological class, belonging to the broader category of Pituitary and hypothalamic hormones and analogues. The use of gonadotropins like Urofollitropin is recognized for controlled stimulation regimens. Its primary distinction is its targeted focus as a source of FSH, a hormone central to reproductive endocrine processes.

Composition, Origin, and Pharmaceutical Form

The active ingredient, Urofollitropin, is notable for its biological origin, as it is isolated and highly purified from the urine of postmenopausal women. This purification process ensures the Follitrope product is predominantly FSH, containing minimal or negligible Luteinizing Hormone (LH) activity. The medication is prepared as a sterile lyophilized powder for solution, and use involves mixing it with an aqueous solvent before parenteral administration via injection.

What is the General Purpose of Urofollitropin?

The general purpose of Urofollitropin is to provide the necessary hormonal supplementation to stimulate the growth and maturation of the ovarian follicles (folliculogenesis). This specific physiological action is intended for facilitating ovulation induction in women with certain anovulatory conditions. Ultimately, Follitrope is employed to support ovarian preparation required for achieving pregnancy, including use within the protocols of assisted reproductive technology (ART).

Regulatory References

  1. NICE Guideline on Fertility Problems: Assessment and Treatment (CG156)

What side effects are possible with Follitrope?

Possible Side Effects and Safety Information

The safety profile of Follitrope (Urofollitropin) is defined by officially documented adverse reactions classified by their frequency and the physiological systems affected, based on government regulatory labeling. Injection site reactions (such as pain, swelling, or bruising) are the most frequent finding, categorized as Very Common.

Frequency-Classified Adverse Reactions

Frequency Classification Examples of Documented Reactions
Very Common (1/10) Injection site reactions (pain, swelling, bruising)
Common (1/100 to < 1/10) Headache, Abdominal pain/discomfort, Nausea, Ovarian Cysts, Ovarian Hyperstimulation Syndrome (OHSS) (mild to moderate)
Rare (1/10,000 to < 1/1,000) Thromboembolic events

Serious Safety Considerations

Ovarian Hyperstimulation Syndrome (OHSS) is the most significant safety concern associated with gonadotropins, with the severe form classified as a serious adverse reaction in regulatory documents. This syndrome may involve fluid accumulation and large ovarian cysts. Thromboembolic events, the formation of blood clots in the arteries or veins, are documented as Rare, and are often associated with severe OHSS. Ovarian torsion has also been reported in patients treated with gonadotropins.

Other Documented Safety Patterns

The onset of clinically significant OHSS is typically documented as occurring within the first two weeks following the completion of treatment. The regulatory label documents an increased potential for multiple pregnancies and ectopic pregnancy in women with a history of tubal disease. Furthermore, the development of anti-FSH antibodies is a specific safety characteristic noted in men treated for hypogonadotropic hypogonadism, reflecting a population-specific safety consideration.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdosing on Follitrope (follitropin alfa) may lead to Ovarian Hyperstimulation, a condition that can progress to Ovarian Hyperstimulation Syndrome (OHSS). While acute toxicity data are limited, the main clinical concern is the resulting OHSS, which can range from mild to potentially life-threatening in rare cases.

Clinical Manifestations and Required Actions

Overdose Presentation Key Clinical Symptoms
Ovarian Hyperstimulation Ovarian enlargement, abdominal pain, nausea, vomiting, weight gain. Severe cases involve large ovarian cysts, ascites, and difficulty breathing.
Serious Allergic Reaction Rash, itching, swelling of the face, mouth, or throat, and trouble breathing.

If you suspect an overdose or experience signs of ovarian hyperstimulation, you must discontinue Follitrope administration. The subsequent administration of Human Chorionic Gonadotropin (hCG) must be withheld, as this can worsen or trigger OHSS.

When Immediate Medical Attention Is Required

Call your doctor right away or seek immediate medical attention if you experience:

  • Severe symptoms of OHSS, such as intense pain in the lower stomach area, severe nausea, vomiting, sudden weight gain, or trouble breathing.
  • Signs of a serious allergic reaction (anaphylaxis), as these are life-threatening and require emergency care.

Therapeutic Uses of Follitrope

What Follitrope treats: main uses and benefits

Follitrope, which contains the active substance follitropin alfa, is commonly used across therapeutic domains that involve specific distressing symptoms linked to functional infertility. Its main uses are centered on addressing conditions that affect reproductive functional stability.

In clinical scenarios, Follitrope may assist with supporting ovulation induction in women with oligo-anovulatory infertility, as well as supporting the preparatory processes required for assisted reproductive technologies (ART), and assisting with the symptomatic management of hypogonadotropic hypogonadism in men. The benefit to the patient is that it helps address symptom clusters that interfere with daily comfort. The overall therapeutic goal plays a role in managing conditions characterized by periods of heightened symptoms, which provides support that helps ease the overall symptom burden.

“Follitropin alfa is relevant for easing symptoms linked to functional infertility and is applied in addressing specific categories of conditions.”

Quick Fact: Relief for Symptoms that Interfere with Daily Functioning
Follitrope is considered relevant in scenarios where additional management of discomfort is required to assist with maintaining functional stability related to reproductive processes.

Eligibility and Restrictions for Use

Population Eligibility and Contraindications

Follitrope is officially authorized for use in adult women (18 and older) requiring hormonal stimulation and adult men (18 and older) for the treatment of hypogonadotrophic hypogonadism. However, its use is subject to strict regulatory constraints and exclusions.

Contraindicated Populations

The medicine is strictly contraindicated in individuals with several conditions, including Primary Gonadal Failure (indicated by high FSH levels), Tumors of the Pituitary Gland or Hypothalamus, Sex Hormone Dependent Tumors, and Abnormal Uterine Bleeding of Undetermined Origin. Hypersensitivity to the active substance or any excipients also prohibits use.

Restricted and Use-Not-Established Groups

Use during pregnancy is absolutely contraindicated. Before beginning treatment, patients must be evaluated for, and have appropriately treated, underlying endocrine deficiencies, including hypothyroidism and hyperprolactinemia. Safety and efficacy have not been established in several populations, including pediatric and geriatric patients, or those with known renal or hepatic impairment. For nursing mothers, the regulatory status requires a decision to discontinue nursing or discontinue the drug due to unknown excretion.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Follitrope (Urofollitropin) establishes a limited scope of documented interaction information, primarily focused on co-administered hormonal agents used within assisted reproductive protocols. Government prescribing information explicitly notes that no formal drug/drug interaction studies have been conducted in humans to evaluate the full pharmacokinetic potential of Follitrope, meaning data on metabolic (e.g., CYP enzyme) or transporter-mediated interactions is not available.

Documented Interaction Patterns

Category Officially Documented Statement
Pharmacokinetic Data No formal studies conducted; no documentation of exposure-altering or metabolic effects.
Permissible Co-use Co-administration with Menotropins is noted as permissible within fertility regimens.
Timing Restriction Administration of Human Chorionic Gonadotropin (hCG) must be withheld if monitoring indicates an elevated risk of Ovarian Hyperstimulation Syndrome (OHSS) on the final day of Follitrope treatment.
Food/Substance No specific interactions with food, alcohol, or herbal products are documented in regulatory prescribing information.

The drug’s interaction profile is thus defined by administrative rules tied to the pharmacodynamic response observed during controlled ovarian stimulation rather than by documented pharmacokinetic interactions with unrelated medicinal products.

Mechanism of Action

Follitrope Mechanism of Action: How it Works at a Biological Level

Follitrope works as a direct agonist on the Follicle-Stimulating Hormone Receptor ( FSHR), a G protein-coupled receptor located primarily on ovarian granulosa cells and testicular Sertoli cells. This binding action mimics the body's natural Follicle-Stimulating Hormone ( FSH), initiating the downstream signaling cascade.

Upon receptor activation, Follitrope triggers the G s protein pathway, leading to the rapid conversion of ATP to the second messenger cyclic AMP ( cAMP). The resulting cAMP activation in turn activates Protein Kinase A ( PKA), which regulates specific enzymes and transcription factors, thereby translating the external hormonal message into an internal biochemical command.

This cascade drives the proliferation of granulosa cells and stimulates enzymes, such as aromatase, which increases local estrogen production in females. This physiological effect promotes ovarian follicle growth. In males, this mechanism promotes Sertoli cell function necessary for spermatogenesis.

Dosage and Administration Information

How to use Follitrope

Follitrope is a highly specialized medicine administered through parenteral injection (typically subcutaneous or, in some contexts, intramuscular) and is not taken orally. When the medicine is supplied as a lyophilized powder, it requires reconstitution with a solvent immediately prior to injection, and the resulting solution must be clear and colorless. The correct use of Follitrope is structured into distinct treatment cycles and demands professional guidance.


Standardized Usage Protocol

Administration involves a once-daily injection over a fixed period. Dosing is highly individualized based on the patient’s clinical response, as determined by frequent clinical monitoring. For initial treatment cycles, the starting daily dose is typically set between 75 IU and 150 IU of Follitropin.

Dose changes are implemented cautiously and are restricted in frequency; adjustments, which are usually small (e.g., 37.5 IU to 75 IU), generally do not occur more often than every 7 to 14 days during the stimulation phase. The total duration of stimulation often does not exceed 10 to 12 days.


Procedural Requirements

The first dose of Follitrope is typically administered under the direct supervision of a physician experienced in fertility management. Treatment requires continuous monitoring via frequent assessments to determine the appropriate continuation or modification of the daily dose. An official treatment course is concluded not by stopping Follitrope, but by administering a single dose of human chorionic gonadotropin (hCG) to complete the final protocol. If a dose is missed, patients are instructed to contact their physician immediately due to the highly time-sensitive nature of the regimen.

Recent Clinical Evidence

Follitrope: Recent Clinical Evidence

Evidence for Ovulation Induction and Assisted Reproductive Technology (ART)

Urofollitropin, the active component in Follitrope, has been studied in Randomized Controlled Trials (RCTs) to evaluate its use in women with anovulatory infertility, including those with Polycystic Ovary Syndrome (PCOS). These studies typically compare Urofollitropin against other hormone treatments, measuring outcomes like ovulation rate and clinical pregnancy rate. The evidence for this indication is largely based on comparative studies, with follow-up durations typically short-term for pregnancy outcomes.

For use in ART procedures like IVF and ICSI, Urofollitropin has been evaluated through a wide range of studies, including numerous RCTs and Meta-analyses. Research in this context examined protocols for controlled ovarian stimulation. The studies monitored key endpoints such as the number of retrieved oocytes (eggs) and a major outcome measure, the live birth rate (LBR). Studies reported measurements of reproductive outcomes that were monitored in both Urofollitropin and other FSH groups.

Evidence for Spermatogenesis Induction and Study Limitations

The research base for Urofollitropin in men is characterized by a different study design approach. It was studied for stimulating sperm production in men diagnosed with the rare hormonal deficiency known as hypogonadotropic hypogonadism. The evidence includes small cohort studies and long-term open-label clinical studies that tracked the establishment of sperm production. Certainty of findings remains low due to the modest sample sizes and non-comparative design of this research.

Overall, the clinical research is noted for its reliance on comparative evidence rather than non-active control data in all major trials. For all indications, data are still emerging, and there is limited information for long-term outcomes that track patients for many years beyond their immediate fertility treatment.

Frequently Asked Questions (FAQ)

Common questions about Follitrope (FAQ)


Q: Is Follitrope the same as other 'Follitropin' drugs?

Follitrope contains Urofollitropin, a form of Follicle-Stimulating Hormone (FSH) that is highly purified from human urine. While it provides the same essential FSH activity, this origin distinguishes it from other follitropin products, such as recombinant FSH, which are produced synthetically in a lab. All these medications are designed to provide hormonal stimulation for reproductive processes.


Q: What is the difference between Follitrope and Menopur?

The key difference relates to the hormone composition. Follitrope primarily provides Follicle-Stimulating Hormone (FSH) activity, containing minimal or negligible Luteinizing Hormone (LH) activity. Medicines like Menopur (Menotropins) are defined as containing both FSH and LH activity. Both types of medication are utilized in fertility treatment protocols.


Q: Are there any common food or drink interactions with Follitrope?

Official regulatory documents do not document specific interactions between Follitrope and food, beverages, or alcohol. Information in the regulatory documents suggests patients generally do not need specific dietary restrictions related to Follitrope.


Q: Does Follitrope affect blood pressure?

High blood pressure (hypertension) has been reported in clinical studies as a common adverse event associated with the use of Urofollitropin. This information is reviewed by healthcare providers in the context of a patient's overall health history.


Q: Is it normal to have mild bruising at the injection site?

Yes, injection site reactions, which can include pain, swelling, and bruising, are officially documented as Very Common findings in patients using Follitrope. This means they are expected to affect many patients during the course of treatment.


Q: Does Follitrope cause weight gain or fluid retention?

Weight gain and fluid retention are documented as possible adverse events associated with Follitrope use. Fluid accumulation is also known to be a component of severe Ovarian Hyperstimulation Syndrome (OHSS), a more serious safety consideration.


Q: Are there different forms of Follitrope, like a pen or a vial?

Follitrope is supplied as a lyophilized powder in a vial for solution for injection. This powder must be mixed with a provided solvent (diluent) immediately prior to use. It is not currently supplied in a ready-to-use pen device.


Q: Is Follitrope considered safe for long-term use?

Clinical treatment protocols for Follitrope are defined by short-term cycles. Official clinical research documents note that there is limited information available regarding long-term patient outcomes that extend for many years beyond the immediate fertility treatment.


Q: What happens if a dose of Follitrope is missed?

The official protocol advises that if a dose is missed, the patient should not attempt to double the next dose. Instead, the patient should contact their physician immediately for guidance on how to proceed, as is recommended in the official protocol.


Q: Does Follitrope affect mood or cause emotional changes?

Emotional changes, including emotional lability and depression, have been reported as adverse events in clinical studies associated with this type of medication. Any changes in mood should be brought to the attention of a healthcare professional.


Q: Does Follitrope interact with common over-the-counter pain relievers?

No formal drug-drug interaction studies have been conducted to evaluate the full potential for interactions with other medications, including common over-the-counter pain relievers. Therefore, there is no official documentation regarding these specific interactions.


Q: What happens if a person notices a severe side effect from Follitrope?

The regulatory documents categorize certain risks, such as severe Ovarian Hyperstimulation Syndrome (OHSS), as serious safety considerations. Regulatory documents indicate that patients should seek medical attention immediately if they develop symptoms suggestive of a severe reaction.


Q: Does Follitrope interact with herbal supplements?

Official regulatory prescribing information does not document any specific interactions with herbal products. While formal interaction studies are limited, regulatory guidance requires providing the prescribing physician with a complete list of all products, including supplements.


Q: Are allergic reactions to Follitrope common?

While hypersensitivity (allergic reaction) to Follitrope or its components is a strict contraindication, the frequency of general allergic reactions is not typically classified as a Common or Very Common adverse event in regulatory documents.


Q: What restrictions are typically placed on physical activity while using Follitrope?

The regulatory label generally does not specify restrictions on routine physical activity. However, certain adverse events, such as severe abdominal discomfort related to potential OHSS, may necessitate limitations in physical activity.


Q: Are there different ways Follitrope is packaged?

Follitrope is packaged as a lyophilized powder (freeze-dried) and includes a separate diluent (solvent) vial. Both components are required for reconstitution before the solution can be prepared for injection.


Q: Can Follitrope be used if someone has thyroid issues?

Before starting Follitrope, underlying endocrine deficiencies, including hypothyroidism (underactive thyroid), must be evaluated and appropriately treated. The requirement for appropriate treatment of conditions like hypothyroidism is a precondition documented in regulatory guidance.


Q: What is the typical range of duration for a Follitrope treatment cycle?

The duration of the ovarian stimulation phase is highly individualized based on patient monitoring. However, the total duration for this phase is generally short, often not exceeding 10 to 12 days.


Q: Can women with Polycystic Ovary Syndrome (PCOS) use Follitrope?

Yes, Follitrope is indicated for ovulation induction in women with anovulatory infertility, and this includes patients with Polycystic Ovary Syndrome (PCOS). The use of the drug requires assessment and authorization from a healthcare provider.


Q: Can Follitrope be used in older patients?

The safety and efficacy of Follitrope have not been established in geriatric patients. The official authorization for use is limited to adults typically under the age of 65.


Q: Why is Follitrope sometimes mentioned alongside luteinizing hormone (LH)?

Follitrope provides Follicle-Stimulating Hormone (FSH), but it is often used in combination with another hormone, Human Chorionic Gonadotropin (hCG), to complete the final steps of the treatment protocol. While Follitrope itself contains negligible LH, other related hormones are necessary for the full reproductive process.


Q: Can Follitrope cause digestive issues or bloating?

Yes, regulatory documents list adverse reactions that include abdominal pain or discomfort, nausea, and bloating (or enlarged abdomen). These are classified as common findings in patients using this medication.


Q: What is the success rate described in general research about Follitrope?

Clinical studies cite several specific measures, such as the rates of ovulation, clinical pregnancy, and live births, as outcome data. Official documents do not summarize or promise a single 'success rate' figure, as individual outcomes vary greatly.


Q: What are the general rules regarding driving or operating machinery while using Follitrope?

Official regulatory documents state that Follitrope is expected to have no or negligible influence on a patient’s ability to drive or use machinery.


Q: Is there a link between Follitrope and an increased risk of twins or multiples?

Yes, the regulatory label documents an increased potential for multiple pregnancies in women treated with gonadotropins like Follitrope. This is a known risk related to hormonal stimulation.

How should Follitrope be stored and disposed of?

How to Store and Dispose of Follitrope?

Follitrope must be stored according to specific regulatory requirements to maintain its stability and effectiveness. Unopened product should be kept refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light by storing it in its original carton.

It is strictly required to not freeze the medication. Once the container is opened or the stopper is pierced (first use), the product has a limited in-use shelf life, typically up to 28 days at a temperature not exceeding 25°C (77°F). Any medicine remaining after this period must be discarded.

Keep Follitrope out of the sight and reach of children. Used or unused medicinal product and waste materials, such as needles, must be disposed of in accordance with local requirements and must not be placed in household waste or wastewater.

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

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