Оргалутран

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Оргалутран

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Medically reviewed

Rosario Oropesa

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 Оргалутран

Property Description
Active ingredient Ganirelix
Form Solution for injection (pre-filled syringe)
Pharmacological class GnRH Antagonist
General purpose Controlled hormonal suppression
Origin Synthetic decapeptide analogue

The medicinal product Оргалутран (Orgalutran) is a key synthetic, prescription medicine primarily utilized in assisted reproductive technologies (ART). The drug is classified as a Gonadotropin-Releasing Hormone (GnRH) Antagonist, with the single active ingredient being Ganirelix. It is structurally synthesized to mimic the natural GnRH but acts to immediately block its effects.

Defining Оргалутран: Class and Core Substance

The active ingredient, Ganirelix, is a synthetic decapeptide analogue, meaning it is a chemically created compound designed to interact with specific receptors in the pituitary gland. Ganirelix provides immediate, reversible suppression of gonadotropin secretion. This direct, competitive antagonism mechanism is clinically recognized as a rapid method for achieving hormonal control. This is important because it means the medication is fast-acting and its effects can be quickly managed by the treating clinician.

The Pharmaceutical Form and Composition

Оргалутран is supplied as a sterile aqueous solution provided in a ready-to-use pre-filled syringe for subcutaneous injection. This specific format is a key differentiating factor, enabling straightforward administration essential in complex fertility protocols. The composition contains Ganirelix acetate dissolved in an aqueous base, with the inclusion of excipients such as mannitol. The liquid form is purposefully formulated to ensure the prompt inhibitory action required for time-sensitive procedures.

General Purpose and Mechanism Principle

The fundamental purpose of Оргалутран is to gain precise control over the timing of a woman's reproductive cycle during fertility treatment. By competitively blocking the GnRH receptors, the drug stops the release of Luteinizing Hormone (LH), thereby preventing the body's natural trigger for spontaneous ovulation. Ganirelix is effective in preventing premature LH surges in women undergoing ovarian stimulation. The general therapeutic scenario involves its use to ensure the optimal maturation of ovarian follicles and control the timing for procedures such as egg retrieval.

Regulatory References

  1. European Medicines Agency
  2. [EMA - Orgalutran Product Information]
  3. [FDA - Ganirelix Acetate Labeling]
  4. [NIH - StatPearls Ganirelix]

What side effects are possible with Оргалутран?

Possible Side Effects and Safety Information

The safety profile of Ganirelix (Orgalutran) is classified according to regulatory standards, detailing adverse reactions by their officially documented frequency and the affected physiological system. This information is derived from authoritative governmental sources such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) labeling.

Documented Adverse Reactions

The most frequently observed adverse events are related to the injection process, classified as Very Common (ge 1/10). These include local skin reactions at the injection site, such as redness, swelling, and itching, which generally resolve within four hours after administration.

Adverse reactions classified as Uncommon (ge 1/1,000 to < 1/100) include systemic effects such as headache, nausea, and a general feeling of malaise. These effects are grouped within Nervous system disorders and Gastrointestinal disorders, respectively, in regulatory documentation.

Serious Adverse Reactions and Safety Constraints

Serious hypersensitivity reactions are documented, including manifestations such as angioedema, urticaria, and the possibility of anaphylaxis (anaphylactic shock). These events are classified as Very Rare (< 1/10,000) and have been reported as early as with the first dose. The overall treatment context of controlled ovarian stimulation also carries the documented risks of Ovarian Hyperstimulation Syndrome (OHSS) and ectopic pregnancy.

The medicine is formally contraindicated in specific patient populations. This includes individuals with a known hypersensitivity to Ganirelix, any GnRH analogue, or any excipients. Furthermore, due to a lack of clinical experience, use is not advised in women with severe renal or hepatic impairment, or those who are pregnant or breast-feeding.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents regarding an overdose of Orgalutran (Ganirelix) emphasize the required immediate action and management approach, as no data on acute toxicity in humans are available.

Documented Overdose Presentations The primary documented manifestation of an overdose is a prolonged duration of the drug's pharmacological action. Studies involving single subcutaneous doses up to 12 mg did not result in systemic adverse reactions in humans. Potential severe effects, specifically hypotension (low blood pressure) and bradycardia (slow heart rate), have been observed only in acute toxicity studies in animals following very high intravenous doses.

Immediate Emergency Actions If an overdose is suspected, urgent medical attention must be sought immediately. The regulatory guidance mandates contacting a doctor or hospital emergency department or a regional poison control centre.

Management and Treatment In the event of overdose, Orgalutran treatment should be temporarily discontinued. The formal regulatory guidance dictates that treatment should be symptomatic and supportive. No specific antidote is described in the official prescribing information. The medicine is contraindicated in patients with moderate or severe renal or hepatic impairment, a precaution noted due to a lack of clinical experience in these populations.

Therapeutic Uses of Оргалутран

What Orgalutran Treats: Main Uses and Benefits

Orgalutran is generally used as part of fertility treatment protocols, such as In Vitro Fertilization (IVF). It is applied to help manage controlled ovarian stimulation (COH), which involves the process of stimulating the ovaries.

Its core indication is for managing the risk of unwanted hormonal surges during the stimulation phase. Orgalutran is considered relevant for use in clinical settings that involve temporary physiological imbalance related to the reproductive cycle, such as when symptoms of premature luteinizing hormone (LH) activity appear suddenly or unexpectedly. This medicine is applied to help manage the risk of premature ovulation and contributes to improved cycle synchronization for planned egg retrieval.


Supporting Stability and Synchronization

This medicine is applied across domains where additional symptomatic support is needed to support the reproductive system's functional stability. It is relevant for easing symptoms related to systemic imbalance and supports general well-being during symptomatic phases. It supports the synchronization of follicle development, assisting the specialist in planning the egg retrieval.

Quick Fact: Symptomatic Support for Hormonal Fluctuation

Regulatory References

  1. European Medicines Agency product information

Eligibility and Restrictions for Use

The regulatory profile for Orgalutran (Ganirelix) strictly defines population eligibility based on reproductive status, organ function, and physiological condition.

Eligibility

Use is officially documented for women undergoing Controlled Ovarian Hyperstimulation (COH) as part of Assisted Reproductive Technologies (ART) to prevent premature Luteinizing Hormone (LH) surges.


Contraindications (Must Not Use)

The medicine is strictly contraindicated for several populations, including:

  • Women with a known or suspected pregnancy or who are breast-feeding/lactating.
  • Patients with moderate or severe impairment of renal function or hepatic function.
  • Individuals with known hypersensitivity to Ganirelix or any other Gonadotrophin-releasing hormone (GnRH) analogue.

Population Restrictions

Regulatory information outlines further limitations:

  • Age: There is no relevant use documented for the paediatric population, and no data is available for use in the elderly.
  • Body Weight: Safety and efficacy have not been established in women weighing less than 50 kg or more than 90 kg.
  • Allergic Conditions: Use is not advised for women with severe allergic conditions due to lack of clinical experience.

What should I know about interactions with other medicines?

Interactions with other medicines and products for Оргалутран are primarily defined by mandated administrative requirements and specific restrictions related to co-administered hormonal agents.

Interaction-Related Restrictions

The use of Orgalutran is formally contraindicated in patients with moderate or severe renal or hepatic impairment. This restriction is documented in regulatory labeling due to a specific lack of clinical experience and safety data in these particular patient populations, as they were excluded from the initial clinical study protocols.

Co-Administration Requirements

The pharmacodynamic action of Ganirelix, which involves the suppression of pituitary gonadotropins, mandates that the dosage of co-administered exogenous gonadotropins (such as FSH) may require necessary adjustment.

  • Administration Timing: When co-administered with FSH, the two preparations should be given at approximately the same time, but they must not be mixed and require the use of different injection sites.
  • HCG Timing Constraint: The time interval between the final injection of Orgalutran and the Human Chorionic Gonadotropin (hCG) trigger injection must not exceed 30 hours.

Metabolic Interaction Status

Official regulatory documents state that formal in vivo or in vitro drug-drug interaction studies to assess metabolic or transporter effects (e.g., CYP enzymes) have not been conducted. No specific interactions with food, alcohol, or herbal products are explicitly documented.

Mechanism of Action

GnRH Receptor Antagonism

Orgalutran (ganirelix) works by competitively blocking the Gonadotropin-Releasing Hormone (GnRH) receptors located on the pituitary gland's gonadotroph cells. The synthetic decapeptide engages the receptor, thereby suppressing the natural signaling pathway that leads to hormone release. This targeted blockade prevents the binding of endogenous GnRH, halting the associated intracellular signaling cascade at an early molecular step.


⬇️ Suppression of Pituitary Gonadotropins

The effective GnRH receptor antagonism in the pituitary gland results in a rapid and reversible suppression of the secretion of pituitary luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This modifies the status of the GnRH signaling pathway within the hypothalamic-pituitary-gonadal axis. The suppression of LH secretion typically displays a greater magnitude than the suppression of FSH secretion, establishing an altered endocrine state.


Modulated LH Secretion and Surge Inhibition

This downstream gonadotropin suppression results in the stabilization of LH levels and prevents the large, rapid increase in endogenous LH (the LH surge) that is otherwise characteristic of the reproductive cycle. By limiting the impact of excessive mediator activity, the drug engages mechanisms that regulate this physiological process, thereby influencing the temporal progression of subsequent follicular maturation and maintaining LH secretion at a reduced baseline level.

Dosage and Administration Information

Administration Guidelines for Orgalutran (Ganirelix)

Orgalutran is administered by subcutaneous injection (just under the skin) once daily, as part of a regimen prescribed by a fertility specialist. The product is a ready-to-use solution in a pre-filled syringe, and it should not be used if the solution is not clear or contains particles.

Administration Detail Guideline Description
Dosing 0.25 mg (contents of one pre-filled syringe) once daily.
Start Date Typically starts on Day 5 or Day 6 of Follicle-Stimulating Hormone (FSH) administration.
Route/Site Subcutaneous injection, preferably in the upper leg or abdomen. Injection site must be varied daily.
Timing Administer at approximately the same time as the FSH product, but at a different injection site; the two preparations must not be mixed.

Procedural Steps

  1. Preparation: Wash hands thoroughly. Swab the chosen injection site with disinfectant and allow it to air-dry completely.
  2. Injection: Pinch a large fold of skin. Insert the needle at the base of the pinched-up skin at an angle between 45° and 90° to the skin surface.
  3. Check Position: Gently draw back the plunger. If blood appears in the syringe, the needle is improperly placed; the syringe must be discarded, and a new one used at a different site.
  4. Completion: If no blood appears, depress the plunger slowly and steadily to inject the entire dose. Pull the needle out quickly and apply pressure to the site. The syringe is for single use and must be disposed of in a sharps container.

Missed Dose and Duration

If a dose is forgotten, administer it as soon as possible and contact your doctor for advice. Do not inject a double dose. The time between two Orgalutran injections, including the final dose before the Human Chorionic Gonadotropin (hCG) trigger, must not exceed 30 hours to prevent premature ovulation. Treatment continues until the day hCG is administered.

Recent Clinical Evidence

Overview of Clinical Research

Оргалутран (ganirelix) is an injectable gonadotropin-releasing hormone (GnRH) antagonist used to prevent premature surges of luteinizing hormone (LH) in women undergoing controlled ovarian hyperstimulation (COH) as part of assisted reproduction techniques (ART).

Clinical research, including randomized controlled trials, primarily assesses the drug's safety and effectiveness when used in conjunction with follicle-stimulating hormone (FSH) for COH. Trials compare ganirelix-based protocols (GnRH antagonist) to older regimens (GnRH agonist) protocols.


Key Study Findings

Measured Outcome Ganirelix-Based Protocol Findings (General)
Prevention of Premature LH Surge Highly effective; rates of premature LH surge were observed to be less than 1% across major clinical trials.
Ovarian Hyperstimulation Syndrome (OHSS) The incidence and severity of OHSS are typically reported as lower in GnRH antagonist protocols (like ganirelix) compared to GnRH agonist protocols.
Duration of Treatment GnRH antagonist protocols are generally associated with a shorter duration of treatment and may require a lower total dose of gonadotropins compared to GnRH agonist protocols.
Congenital Malformations Studies monitoring infants born after COH using ganirelix report the incidence of congenital malformations to be comparable to that reported after COH using GnRH agonists.
Fertility Outcomes Multiple large trials report the number of retrieved oocytes and pregnancy rates (ongoing or clinical) per cycle attempt were generally comparable between ganirelix-based antagonist protocols and GnRH agonist protocols, though some studies observed slightly lower figures for the antagonist group.

Safety Profile Summary

Reported adverse events frequently cited across clinical trials include injection site reactions (redness, swelling, or pain), which are typically mild to moderate and temporary. Other less frequent events included headache and nausea. Serious adverse events, such as severe OHSS or hypersensitivity reactions, are reported infrequently.

Frequently Asked Questions (FAQ)

Common questions about Оргалутран (FAQ)

Q: How quickly does Оргалутран start to work after the first use?

Official product information indicates that the medicine is absorbed very rapidly after subcutaneous injection. Maximum blood concentrations of the active ingredient are typically reached in about one hour after administration. This rapid onset aligns with the required hormonal suppression for the treatment protocol.

Q: Is it normal to feel tired while using Оргалутран?

While tiredness is not listed among the most common adverse effects, safety data reports the general feeling of malaise in some users. Official documents classify malaise, a sense of being generally unwell, as an uncommon side effect. The reporting of persistent tiredness would be consistent with the general adverse event safety data.

Q: Is there any risk of long-term side effects from using Оргалутран in an IVF cycle?

According to the FDA regulatory label, long-term toxicity studies to specifically evaluate the risk of cancer development (carcinogenesis) have not been performed with the medicine. This approach to testing aligns with the short, non-chronic use of the drug in assisted reproduction protocols. The primary safety data focuses on outcomes observed during and immediately following treatment.

Q: Is the medication intended for multiple cycles of treatment, or just a single cycle?

Studies and official documents indicate that the medicine has been shown to be safe and effective for use in women undergoing multiple treatment cycles for assisted reproduction. The use in subsequent cycles depends on the patient's overall treatment plan and clinical guidance.

Q: Can Оргалутран be used in men for any medical purpose?

Official regulatory indications state that this medicine is solely intended for the prevention of premature LH surges in women undergoing controlled ovarian hyperstimulation. There is no data or approved indication provided in regulatory documents for its use in male patients.

Q: Does Оргалутран affect the body after the treatment cycle is complete?

The effect of the medicine is reversible once treatment is completed. Official pharmacokinetics data indicates that the suppression of pituitary Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) levels is typically fully recovered within 48 hours of the last administration. This indicates that the drug’s hormonal suppression is quickly reversed after treatment cessation.

Q: Are there specific instructions for travel that apply to keeping Оргалутран effective?

Official guidance relates to the storage requirements necessary to maintain the medicine's effectiveness. It specifies that the product must be stored at a stable room temperature, generally between 15 C and 30 C (59 F and 86 F). The product should be kept in its original outer carton to protect it from light and must not be frozen.

Q: Is it normal to feel a burning sensation when the injection is administered?

Local skin reactions at the injection site are the most frequently reported adverse effects, classified as Very Common in official documents. These reactions include pain, redness, swelling, and itching. Discomforts such as a burning sensation may be related to the documented pain and irritation, which is typically mild and temporary.

Q: What steps are outlined in official documents if too much Оргалутран is used?

Official regulatory documents state that an overdose in humans may lead to a prolonged duration of the drug's action. Regulatory documents state that the treatment should be temporarily discontinued. Furthermore, in cases of suspected overdose, patients are directed to contact a poison control center for specialized guidance.

Q: Does the drug have any known effect on blood pressure or heart rate?

Official acute toxicity studies in animals observed effects on blood pressure (hypotension) and heart rate (bradycardia). However, official documents note that these effects were only observed after the medicine was administered intravenously, which is not the approved subcutaneous route of use.

Q: How long does the effect of Оргалутран last in the body?

The duration of the drug's presence and activity in the body is described by its elimination half-life. Official pharmacokinetics data states that the half-life (the time required for half the dose to be cleared from the body) is approximately 16.2 hours.

Q: Why is the drug given at a specific time of day?

The administration of the medicine at approximately the same time each day helps to maintain hormone suppression. Official documents emphasize that the interval between any two injections must not exceed 30 hours to prevent a premature LH surge from occurring.

Q: Are there guidelines for managing common mild side effects like injection site pain?

Official regulatory documents describe local injection site reactions, such as pain or redness, as generally mild to moderate and temporary. They typically resolve naturally within a few hours after administration. No specific guidelines for the medical management of these mild, self-limiting reactions are provided in the official labeling.

Q: What are the restrictions on donating blood while using Оргалутран?

Regulatory guidance restricts individuals from donating blood while they are undergoing current fertility treatment. This is related to the underlying condition and the process of assisted reproductive technology itself, rather than the medicine alone.

How should Оргалутран be stored and disposed of?

How to Store and Dispose of Orgalutran

Orgalutran (ganirelix acetate injection) must be stored according to official regulatory requirements to maintain its stability and integrity.


Storage Requirements

Condition Requirement
Temperature Store at room temperature between 15 C and 30 C (59 F to 86 F).
Protection Keep the medicine in the original outer carton to protect it from light. Do not freeze.
Stability Use the pre-filled syringe only if the solution is clear, colorless, and free of particles. Do not use after the expiry date.
Safety Keep Orgalutran out of the sight and reach of children.

Disposal Instructions

Orgalutran is for single use only. Used syringes and needles must be placed into a designated sharps disposal container.

Regulatory instructions require that the medicine is not disposed of via household waste or wastewater. Any unused product or waste material must be disposed of in accordance with local regulatory requirements to ensure environmental protection.

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

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