Advertisements

Lentaron Depot

Quick links to important sections

Lentaron Depot

Advertisements
Advertisements

Treatment option:

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.

Advertisements

Overview of Lentaron Depot

Property Description
Active ingredient Formestane (C19H26O3)
Form Depot preparation (Oily solution for injection)
Pharmacological class Steroid Aromatase Inhibitor (ATC L02BG02)
General Purpose Reduction of circulating estrogen levels
Origin Synthetic steroid compound

What Type of Medicine is Lentaron Depot?

Lentaron Depot is a prescription-only medicine that functions as a targeted hormonal agent. Its active compound, Formestane, is a synthetic steroid substance derived from an androgen precursor. The drug is categorized within the Steroid Aromatase Inhibitor pharmacological class, identified by the classification L02BG02. This classification describes its precise mechanism of interference with the body’s natural estrogen production pathways.

Understanding Lentaron Depot's Unique Formulation

The medicine is supplied as a specialized depot preparation—an oily solution for injection delivered via intramuscular injection. This specific formulation is designed to be a controlled-release system. This mechanism allows the Formestane to be absorbed slowly and consistently from the injection site over an extended period. The design aims to maintain steady therapeutic concentrations and reduce the administrative burden when compared to conventional, daily oral medications.

What is the Primary Action of Formestane?

The primary action of Formestane is the potent, irreversible inhibition of the aromatase enzyme. This enzyme is the biological catalyst responsible for the final conversion of androgens into estrogen in peripheral tissues. As a suicide inhibitor, Formestane permanently binds to the enzyme's active site. The general purpose of this sustained aromatase enzyme inhibition is the significant and continuous reduction of circulating estrogen levels, which is a requirement for modifying the internal hormonal environment in certain hormone-sensitive contexts.

Advertisements

What side effects are possible with Lentaron Depot?

Possible side effects and safety information

This section outlines the officially documented adverse effects and regulatory safety constraints for Formestane (Lentaron Depot), strictly based on government regulatory documentation. The adverse reactions are primarily attributable to the pharmacological effect of estrogen deprivation.


Documented Adverse Reactions and General Safety

Official summaries indicate that Formestane is generally well-tolerated. Comprehensive frequency data (such as 'Very Common' or 'Common') are not available in accessible regulatory summaries for this specific formulation. Adverse events rarely necessitate the cessation of therapy.

Key Adverse Reactions (System-Organ Classes):

  • Vascular Disorders: Commonly include hot flashes (also known as hot flushes), which result from the systemic reduction of estrogen.
  • General Disorders and Administration Site Conditions: Local reactions such as pain or inflammation at the intramuscular injection site are expected with the depot formulation.

Serious Safety Concerns: The most significant long-term safety concern documented for this pharmacological class is the reduction in bone mineral density (BMD). Extended estrogen suppression may increase the risk of osteoporosis and bone fracture.


Safety Restrictions and Contraindications

Official labeling defines strict prohibitions based on the drug's mechanism as a potent hormonal agent:

  • Hypersensitivity: The medicine is contraindicated in patients with a known allergy or hypersensitivity to the active substance or any of its excipients.
  • Pre-menopausal Women: Lentaron Depot is strictly contraindicated for use in women with pre-menopausal endocrine status.
  • Pregnancy and Lactation: Due to the risk of reproductive toxicity (H360 classification), the medication is contraindicated during pregnancy and lactation, as it may damage fertility or the unborn child.
Advertisements

Overdose and Emergency Response

Overdose and When to Seek Help

This section summarizes the official regulatory information regarding overdosage with Lentaron Depot (Formestane), based strictly on the prescribing information provided by government health authorities.


Official Overdose Profile

Domain Regulatory Information
Documented Manifestations No specific clinical signs, symptoms, or laboratory findings resulting from an acute Formestane overdose are formally documented in available public regulatory summaries.
Life-Threatening Risk The single dose of Formestane that could result in life-threatening symptoms in humans is officially stated as not known in regulatory documents.
Antidote Availability No specific antidote is known to exist for the management of Formestane overdosage.

Emergency Response Statements

Seeking Urgent Medical Attention

Regulatory guidance mandates that patients or caregivers must seek immediate medical attention for any suspected overdosage or if any unusual symptoms occur following administration. Urgent medical help is required in all circumstances of suspected overexposure.

Required Management

The required management of overdosage is strictly defined as symptomatic and supportive treatment. This general supportive care must include the frequent monitoring of vital signs and close observation of the patient in a controlled setting.

Advertisements

Therapeutic Uses of Lentaron Depot

What Lentaron Depot Treats: Main Uses and Benefits

Lentaron Depot (Formestane) is used in situations involving certain distressing symptoms related to specific types of malignancy. As a targeted therapy, its core function is relevant for easing symptoms related to systemic imbalance associated with the condition.

Addressing Symptom Patterns Linked to Systemic Discomfort

The primary therapeutic application is applied in addressing conditions marked by systemic or localized discomfort associated with specific malignant conditions. The treatment is relevant for easing symptoms that interfere with daily functioning and may assist with reducing the overall symptom burden. The treatment is commonly used to help with managing the progression of the disease. This therapeutic approach contributes to easing the overall symptom load by addressing symptoms related to systemic imbalance associated with the condition.

The treatment is commonly used to help with managing conditions characterized by periods of heightened symptoms related to the malignant process, including recurrent or episodic manifestations. Applying this approach helps provide a valuable therapeutic option in challenging clinical scenarios, supporting the patient during difficult episodes and supporting general well-being during symptomatic phases.

Quick Fact: Supportive Management for Systemic Imbalance
This medication is relevant for easing symptoms linked to organ-specific functional stress associated with the condition. It supports patients during episodes of heightened physiological activity and helps maintain a sense of stability when symptoms are more noticeable.

Regulatory References

  1. National Cancer Institute Drug Dictionary
Advertisements

Eligibility and Restrictions for Use

Eligibility Scope

Field Official Regulatory Statement
Populations for whom use is allowed Postmenopausal women with Estrogen-receptor positive advanced breast cancer.
Populations for whom use is not recommended Premenopausal women (Use is not indicated).
Populations for whom use is contraindicated Pregnant women; women who are breastfeeding; patients with a known hypersensitivity to Formestane or any excipients.
Age-related eligibility rules Approved for use in the Adult and Older Adult demographic; Use is not established or indicated in Pediatric and Adolescent populations.
Condition-specific eligibility rules Renal/Hepatic Impairment: No explicit restrictions are documented in publicly available regulatory summaries.
Pregnancy and lactation eligibility status Contraindicated in both pregnancy and lactation due to reproductive risk.

Eligibility Classifications (High-Level)

Field Regulatory Classification
Eligibility severity classification Contraindicated (Reproductive risk and hypersensitivity).
Eligibility-context constraints Use is dependent on the diagnosis of Estrogen-receptor positive malignancy and postmenopausal status.

Connection to the overall eligibility profile

The official regulatory documents strictly define the eligible user population for Lentaron Depot based on the patient's hormonal status and specific disease state. Use is explicitly contraindicated in all populations with reproductive potential, including pregnant women and those who are breastfeeding, due to documented risk. The medicine is permitted only for postmenopausal women diagnosed with Estrogen-receptor positive malignancy; its use is not established in children or adolescents.

Advertisements

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes officially documented interaction patterns for Lentaron Depot (Formestane) based strictly on authoritative government regulatory information. The focus remains on classification of interaction types and documented outcomes.

Documented Pharmacodynamic Restriction

Co-administration with estrogen-containing medicinal products is restricted. Formestane is classified as an irreversible aromatase inhibitor, and its primary therapeutic objective is the significant and continuous reduction of circulating estrogen levels. The simultaneous use of any medication containing systemic estrogen would directly counteract this core pharmacological effect, resulting in a pharmacodynamic antagonism that neutralizes the treatment’s intended action.

Metabolic and Timing Constraints

Interaction Type Regulatory Status
Pharmacokinetic (CYP-mediated) Official regulatory documentation does not explicitly list specific enzyme-based interactions or exposure modifications (AUC/Cmax changes) for Formestane.
Transporter-Based No specific interactions involving drug transporters (e.g., P-gp) are formally documented in regulatory text.
Mandatory Timing Rules No requirements for mandatory timing separation between the administration of Lentaron Depot and other medicines are officially established.
Food, Alcohol, or Herbal Products Official regulatory labels do not specify clinically significant interactions with food, alcohol, or herbal supplements.

The official interaction profile is primarily defined by the prohibition of co-use with estrogen-containing substances. Specific, restrictive requirements concerning metabolic pathways or administration timing are not documented in the regulatory text.

Advertisements

Mechanism of Action

️ How Lentaron Depot Works: Mechanism of Action

Lentaron Depot acts through a highly specific and irreversible biochemical process to modulate the body's hormonal environment.

Irreversible Inactivation of the Aromatase Enzyme

The core mechanism involves the active ingredient, Formestane, acting as a steroid suicide inhibitor that permanently binds to and deactivates the Aromatase enzyme (CYP19A1). This enzyme is the biological target responsible for the final conversion of androgen precursors into estrogens (estradiol and estrone) in peripheral tissues. The mechanism is dependent on enzyme turnover, meaning the blockade persists until the body synthesizes a new supply of functional Aromatase molecules.


Sustained Modulation of Estrogen Biosynthesis

By continuously destroying the Aromatase enzyme pool, the drug significantly interrupts the Estrogen Biosynthesis Pathway. This blockade leads to a systemic reduction in the concentrations of circulating estrogens. This specific alteration of the hormonal supply is a primary physiological effect, altering systemic endocrine homeostasis.

Advertisements

Dosage and Administration Information

The administration of Lentaron Depot (Formestane) follows a specific procedural structure dictated by its depot formulation and the pharmacokinetic properties of the active compound. The medicine is strictly for parenteral use administered via deep intramuscular (IM) injection. This exclusive route is a mandatory constraint because Formestane exhibits poor bioavailability when administered orally, meaning it cannot be taken by mouth.

Official Administration Guidelines

The usage protocol is built around a standardized, recurring schedule:

Administration Scope Details
Route of Administration Intramuscular (IM) injection exclusively.
Dosing Schedule Maintenance Dose: 250 mg per injection. Initial treatment regimens may use a higher dose up to 500 mg per injection.
Frequency Pattern Bi-weekly (fortnightly) administration.
Preparation Requirements The product, often supplied as a powder, requires reconstitution into an oily solution immediately prior to use.
Special Constraint Must be administered via IM route due to poor oral absorption.

Connection to the Overall Use Protocol

The official instructions establish a controlled bi-weekly cycle of administration, which is central to the drug's usage. This schedule is dependent on the specialized depot preparation, which is engineered to release the active compound continuously from the injection site over the entire 14-day interval. The specific route and frequency are therefore required to maintain the necessary therapeutic pattern.

Advertisements

Recent Clinical Evidence

Lentaron Depot: Recent Clinical Evidence

The research for Lentaron Depot (Formestane) primarily consists of randomized controlled trials (RCTs) and comparative studies. The overall body of evidence was evaluated through the study of clinical outcomes and biological markers in a defined patient group.

Evidence for Use in Advanced Hormone-Sensitive Malignancy

The main research involved multicenter randomized controlled trials in adult postmenopausal women with advanced, hormone receptor-positive cancer. The studies explored the approach in both initial (first-line) and subsequent (second-line) settings after prior hormonal treatment. Researchers monitored key clinical metrics, including Objective Response Rate (a measure of tumor changes), Time to Disease Progression (a metric for the length of time before a change in disease activity is noted), and Overall Survival (a key research endpoint). Studies consistently examined circulating estrogen levels as a biological measure, reporting changes observed often within the first few weeks of starting treatment.

Comparing Lentaron Depot to Other Treatments

Several Phase III comparative studies were conducted against standard hormonal therapies, such as tamoxifen and megestrol acetate. Studies that evaluated Lentaron Depot versus tamoxifen reported comparable measurements for objective antitumor response and patient survival. However, some trials tracking time to disease progression reported that the duration was longer in the tamoxifen comparator arm. In subsequent settings, outcomes were generally comparable to those reported for megestrol acetate.

Limitations and Research Uncertainty

The research base consists of trials completed some time ago. This means the comparative evidence is lacking against the most current treatments available today. Later research explored differences in the maximum degree of estrogen change when comparing Lentaron Depot to newer generations of aromatase inhibitors; the long-term clinical importance of this difference remains uncertain. The evidence applies only to the populations studied (adult postmenopausal women) and provides limited insight into how the outcomes were measured or observed in other special groups.

Key Studies & References

  1. Formestane - National Cancer Institute Drug Dictionary
Advertisements

Frequently Asked Questions (FAQ)

Common questions about Lentaron Depot (FAQ)


Q: What is the typical time frame before the effects of Lentaron Depot are observed?

A: Studies and official information indicate that the primary biological effect of Lentaron Depot is the significant reduction of circulating estrogen levels. Changes in these levels have been observed often within the first few weeks after beginning treatment. The time frame for clinical observation is described as varying among patients.


Q: How long does the drug stay in the body after the last injection?

A: Lentaron Depot is prepared as a specialized depot system designed to release the active ingredient (Formestane) slowly and continuously. This controlled-release mechanism allows the medicine to be absorbed from the injection site over the entire bi-weekly (fortnightly) dosing interval, designed to achieve sustained concentrations.


Q: Can Lentaron Depot be taken by patients who have liver problems?

A: Publicly available regulatory summaries do not contain explicit restrictions for the use of Lentaron Depot in patients who have liver or kidney impairment. A healthcare professional is best suited to provide specific guidance regarding these conditions.


Q: What if I experience unusual bruising at the injection site?

A: Local reactions, such as pain or inflammation at the site of the intramuscular injection, are an expected possibility with the depot formulation. Any specific unusual or persistent reaction is best reviewed by a healthcare professional.


Q: What are the different types of patient monitoring recommended during treatment with Lentaron Depot?

A: Due to the medicine's mechanism of significantly reducing estrogen, a documented long-term safety concern is the reduction of bone mineral density (BMD). Therefore, monitoring for the risk of bone health issues, such as osteoporosis and fracture, is documented in official guidelines.


Q: What are the common reasons a doctor might stop Lentaron Depot treatment?

A: Treatment is strictly contraindicated (prohibited) for certain populations, such as pre-menopausal women or those with a known hypersensitivity to the drug. Additionally, official documents indicate treatment may be discontinued if monitoring shows key clinical metrics, such as disease progression, have occurred.


Q: Can Lentaron Depot be used by men?

A: Official regulatory documents clearly define the allowed patient population for Lentaron Depot as postmenopausal women with estrogen-receptor positive advanced breast cancer. Use of the medicine is not established or indicated for men.


Q: Can Lentaron Depot affect fertility in women after treatment is stopped?

A: Due to its mechanism as a potent hormonal agent, the medication carries a documented risk of reproductive toxicity or damage to fertility. Official documents do not explicitly guarantee or describe the timeline for the return of fertility after the cessation of treatment.


Q: Does Lentaron Depot have known interactions with common over-the-counter pain relievers?

A: Official regulatory text does not explicitly document specific enzyme-based or transporter-based interactions for Formestane. Official labels also do not specify clinically significant interactions with food, alcohol, or herbal supplements, but co-administration of any medicine is typically reviewed by a healthcare professional.


Q: Is Lentaron Depot a controlled substance?

A: Lentaron Depot is classified in regulatory documents as a prescription-only medicine. It functions as a targeted hormonal agent within the steroid aromatase inhibitor pharmacological class.


Q: Can people who are allergic to certain dyes or preservatives use Lentaron Depot?

A: The medication is strictly contraindicated (prohibited) for patients with a known allergy or hypersensitivity. This contraindication applies to the active substance (Formestane) and to any of its excipients (non-active ingredients like dyes or preservatives).


Q: Are there specific symptoms that warrant immediate contact with a healthcare provider while using Lentaron Depot?

A: The medicine is strictly contraindicated for patients with a known hypersensitivity to the drug or its components. Any indication of a serious allergic reaction or severe, unexpected adverse effect is a matter for immediate review by a healthcare professional.


Q: How does Lentaron Depot interact with blood thinners or anti-clotting medications?

A: Official regulatory text does not explicitly document specific metabolic interactions with Formestane. However, co-administration of any medication, including blood thinners, is a clinical matter best reviewed and monitored by a healthcare professional.


Q: What are the different strengths or versions of Lentaron Depot available?

A: Official guidelines describe the standard maintenance dose as 250 mg per injection. Initial treatment regimens, administered by a healthcare professional, have been noted to potentially use a dose up to 500 mg per injection.

Advertisements

How should Lentaron Depot be stored and disposed of?

How to Store and Dispose of Lentaron Depot?

The storage of Lentaron Depot (formestane oily solution for injection) must comply strictly with official regulatory guidelines to maintain its stability.

Storage Requirements

Condition Requirement (Official Labeling)
Temperature Store in a refrigerator between 2^circmathrmC and 8^circmathrmC (36^circmathrmF and 46^circmathrmF).
Environment Must be protected from light and stored in the original container.
Prohibition The product must not be frozen.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

All unused, expired medicine, or waste materials from Lentaron Depot must be disposed of in accordance with local regulatory requirements for pharmaceutical waste. Medicine should not be discarded via household waste or wastewater.

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

Available in countries:

Equivalent of Lentaron Depot found in:

A-Z Index: