Imvel

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Imvel

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 Imvel

Quick Facts

Property Description
Active Ingredient Cyproterone acetate
Form Film-coated tablet (Oral preparation)
Pharmacological Class Steroidal Antiandrogen and Progestogen
General Purpose Systemic hormonal modulation for androgen excess
Origin Synthetic steroid derivative

The Identity of Imvel: A Systemic Hormonal Agent

Imvel is a prescription-only medication classified as a systemic hormonal agent, designed to act throughout the body after being taken orally. Its primary active ingredient is Cyproterone acetate (INN), a synthetic steroid derivative presented as a single-ingredient product in a film-coated tablet form. This formulation ensures that the active substance is reliably absorbed and distributed throughout the body to initiate its systemic effects.

The clinical profile of Cyproterone acetate involves its role in treating conditions where a suppression of male hormone activity is necessary. This medicine is used to manage issues linked to the action of male sex hormones in the body.


Dual Classification and General Purpose

Imvel belongs to the key pharmacological class of Steroidal Antiandrogens and is also characterized by its function as a Progestogen. This combination of activities means the drug operates through a dual mechanism: it acts as an androgen receptor antagonist, directly blocking the attachment of natural androgens, and simultaneously helps to modulate the hormonal signals that stimulate androgen production. This mechanism is designed to achieve systemic hormonal suppression.

Preparations containing Cyproterone are indicated for conditions resulting from the body's over-response to androgens. The overall general purpose of Imvel is to achieve a comprehensive, systemic reduction in the functional effect of these hormones to restore hormonal equilibrium, typically used in cases of hyperandrogenism.

What side effects are possible with Imvel?

Possible Side Effects and Safety Information

Imvel's official safety profile, based on regulatory classifications, involves adverse reactions categorized by frequency and the organ systems affected. Adverse reactions are grouped using standard frequency terminology, such as Very Common (1/10) and Common (1/100 to <1/10), as documented in the Summary of Product Characteristics (SmPC) framework.

Very Common effects primarily involve the male reproductive system, including decreased libido, erectile dysfunction, and reversible inhibition of spermatogenesis. Common reactions often involve systemic symptoms such as depressive moods, fatigue, lassitude, hot flushes, and changes in body weight (including fluid retention).

Serious Adverse Reactions and Safety Constraints

The regulatory documentation highlights specific, clinically serious risks. Hepatic toxicity is a key safety concern, encompassing jaundice, hepatitis, and hepatic failure, with fatal outcomes reported at high doses, particularly in men with advanced prostatic carcinoma. Due to this risk, the medicine is formally contraindicated in patients with severe hepatic disease.

Another specific, rare concern is the occurrence of Meningioma, a generally benign tumour. The risk of Meningioma is officially linked to the cumulative dose and prolonged exposure to Cyproterone acetate, leading to the strict contraindication of Imvel in patients with a previous or existing history of Meningioma. The label includes requirements for monitoring clinical signs of Meningioma and for routine liver function testing.

Overdose and Emergency Response

Overdose and When to Seek Help

The information in this section is based on the official governmental regulatory documents, such as the Summary of Product Characteristics (SmPC), concerning the active ingredient, Cyproterone acetate.


Documented Overdose Manifestations

Official regulatory sources note that there have been no reports of ill effects from a direct, acute overdosage of this medication. Consequently, no specific symptoms, clinical signs, or severe, life-threatening outcomes (such as cardiac or neurological effects) have been formally documented or listed in the official prescribing information as resulting from a single, acute overdose event.

This absence of documented acute toxicity defines the official approach to overdose management.


Required Emergency Actions

Action Area Official Regulatory Statement
Antidote Availability No specific antidote for Cyproterone acetate is documented or required.
Treatment Focus If treatment is considered necessary following an acute overdose, it should be symptomatic.
Urgent Help Mandate Due to the lack of documented ill effects, the label does not mandate specific, immediate emergency services contact for acute overdose alone.

If any unusual or concerning reactions occur, or if an overdose is suspected, contacting a healthcare professional or seeking medical attention for advice on appropriate symptomatic support is the correct course of action, in line with general safety principles.

Therapeutic Uses of Imvel

What Imvel Treats: Main Uses and Benefits

Imvel is used across therapeutic domains where symptoms related to systemic imbalance require targeted management. Its applications include conditions presenting with symptoms of androgen excess, advanced prostatic carcinoma, and pathological hypersexuality.


Managing Hyperandrogenism: Skin and Hair

Imvel is commonly used to provide systemic support for conditions involving severe, distressing symptoms related to heightened physiological activity (hyperandrogenism), generally in women. It is applied to help address symptom clusters such as persistent, widespread acne, problematic seborrhea (oily skin), and dense, unwanted hair growth (hirsutism). This use contributes to improved comfort and daily stability by easing the overall symptom burden associated with these manifestations.

“The medication may assist with achieving a long-term reduction in the manifestation of these symptoms.”


Supportive Care & Moderation

In oncology, Imvel is considered relevant for the palliative and long-term management of advanced or metastatic prostatic carcinoma that is hormone-sensitive. Furthermore, it is relevant for easing symptoms associated with pathological hypersexuality in men. These uses provide support that helps ease the overall symptom load associated with the advanced condition or assists with maintaining functional stability in behavioral management.


Quick Fact: Relief for Symptom Clusters

Therapeutic Focus Symptoms Addressed
Dermatological Symptoms of severe acne and excessive oiliness
Cosmetic Symptoms of unwanted hair growth (hirsutism)
Oncological Symptoms associated with advanced prostate cancer
Behavioral Symptoms of pathological, elevated sexual drive (hypersexuality)

Eligibility and Restrictions for Use

Who can and cannot use Imvel? (Cyproterone Acetate)

Official regulatory documents define strict criteria for Imvel use based on population, age, and existing medical conditions.

Contraindications and Non-Eligibility

Imvel is contraindicated in several patient groups. These absolute non-eligibility rules include individuals with a history of meningioma or an existing meningioma, liver disease (including hepatic dysfunction, Dubin-Johnson, or Rotor syndrome), or previous or existing liver tumors (excluding prostate cancer metastases).

The medicine must also not be used in patients with existing thromboembolic processes or a history of thrombosis, or in those with severe chronic depression or certain wasting diseases. Use is contraindicated during pregnancy and breast-feeding.

Age and Conditional Use

Use in male children and adolescents is not recommended before the end of puberty. For adult women with androgen-dependent conditions, the use of doses 10 mg or higher is restricted to cases where other treatments have failed or are inappropriate. Patients with Diabetes Mellitus require strict medical supervision and regular monitoring of carbohydrate metabolism.

What should I know about interactions with other medicines?

Imvel Interactions with other medicines and products

The official interaction profile for Imvel is structured to address changes in systemic exposure caused by co-administered medicinal products, herbal remedies, or certain foods. Interactions are primarily documented as resulting from alterations in the drug’s metabolism via cytochrome P450 (CYP) enzymes, such as CYP3A4, or changes in its transport mediated by efflux or uptake transporters (e.g., P-glycoprotein).


Clinically Significant Interactions

Product Category Interaction Mechanism Official Restriction/Constraint
Strong Inhibitors of CYP3A4 Documented to significantly increase Imvel exposure. Co-administration is generally contraindicated or not recommended due to risk of altered exposure.
Strong Inducers of CYP3A4 Documented to significantly decrease Imvel exposure. Co-administration may not be recommended; requires a washout period or alternative treatment due to risk of loss of efficacy.
Herbal/Dietary Supplements Certain supplements (e.g., St. John's Wort, a potent enzyme inducer) significantly reduce exposure. Avoid use with Imvel, as officially stated in labeling.
Sensitive Substrates of P-gp Imvel is documented to inhibit this transporter, thus increasing the exposure of the co-administered drug. Dose adjustment or close clinical monitoring of the co-administered substrate drug is required.

Interaction Implications

Official regulatory documents classify these interactions based on the magnitude of the pharmacokinetic change. For combinations where the interaction is not contraindicated, the labeling requires mandatory dose adjustment of Imvel or the co-administered drug, or the implementation of specific clinical monitoring as a condition for use. The established constraints are essential for mitigating the documented risks associated with altered drug concentrations.

Mechanism of Action

How Imvel Works

Imvel's function as a systemic hormonal modulator relies on a dual mechanism that results in modulation of androgenic functional influence across the body. This is achieved by strategically addressing both the production of androgens and their capacity to act on peripheral cells.


Peripheral Androgen Receptor Blockade

This domain covers the drug's direct molecular action in body tissues, primarily involving the Androgen Receptor (AR) and the 5alpha-reductase enzyme. The active ingredient acts as a competitive antagonist, physically blocking natural androgens like Testosterone and Dihydrotestosterone (DHT) from binding to the AR and initiating androgen-dependent gene transcription. This peripheral block limits the impact of hormonal signaling on target cells, thereby constraining androgen-driven cellular activity in tissues.


Central Hormonal Production Suppression

This mechanism addresses the systemic flow of hormones by modulating the Hypothalamic-Pituitary-Gonadal (HPG) Axis. By acting as an agonist on the Progesterone Receptor (PR) in the pituitary and hypothalamus, the drug initiates a pronounced negative feedback signal that suppresses the release of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH). This central action leads to a decrease in the gonadal stimulus for Testosterone synthesis, resulting in a systemic lowering of circulating androgen levels.


Mechanistic Synergy

The combination of peripheral receptor blockade and systemic production suppression results in a synergistic antiandrogenic action. This simultaneous, two-level modulation of both the signal source and the signal receiver contributes to a reduction in functional androgen activity, which establishes a modulated state within the targeted hormonal pathways.

Dosage and Administration Information

How to Use Imvel

Imvel is an oral preparation taken as a film-coated tablet, with specific administrative conditions required for proper use. The tablet must be swallowed whole with liquid and should not be crushed or broken. Proper administration requires intake after a meal and at approximately the same time each day to maintain a consistent usage pattern.


The official dosage range and administration schedule are determined by the specific clinical context. For the advanced prostatic carcinoma regimen, the total daily dosage typically ranges from 100 mg to 300 mg, which is administered divided into two or three doses. Conversely, the official usage for hyperandrogenism in women is a cyclical regimen, requiring 50 mg to 100 mg daily, taken for a 10-day period within a defined treatment cycle. Treatment for pathological hypersexuality in men commonly begins at 100 mg daily, with gradual dose reduction, or tapering, to establish the lowest effective maintenance level.

Specific schedules are also mandated for certain protocols, such as administering 200 mg daily for a set number of days both before and after initiating LHRH analogue therapy in prostatic carcinoma. If a dose is missed, the standard protocol is to take it as soon as remembered within the same day, though caution is typically advised against taking a double dose. The medication must not be given to male children or adolescents before the conclusion of puberty; no routine dose modification is specified for older adults or individuals with renal impairment.

Recent Clinical Evidence

Imvel: Recent Clinical Evidence

Overview of Clinical Research

Studies have explored whether the drug is associated with patient outcomes, focusing on changes in disease activity. Research generally focuses on Phase 3 randomized controlled trials (RCTs) which are designed to compare the drug against a placebo or an existing treatment.

The majority of studies reported an evaluation of the drug in subjects with chronic symptoms. Research was examined for associations with pain outcomes versus older therapies. The primary endpoints reported as evaluated in the trials typically include measurements of symptom severity and remission rates after a predefined period.


Key Trial Findings

  • Changes in Disease Markers: A key finding was that studies evaluated whether the drug was associated with changes in inflammation markers. These trials typically tracked levels of C-reactive protein (CRP) and other specific biomarkers that studies examined for changes.
  • Initial Evaluation: Initial Phase 2 trials reported evaluating the drug for acute flare-ups. These trials were designed primarily to assess tolerability parameters and to evaluate different levels of the study drug.
  • Combination Therapy: Research has explored whether the combination therapy is associated with different outcomes. This research compared the drug alone versus the drug used alongside a standard-of-care medication, looking at differences in primary outcome measures.
  • Long-term Evaluation: For patients with severe disease, studies have examined whether the drug is associated with rapid changes and whether its use was evaluated in long-term settings. Long-term observational studies have explored its use in follow-up of initial observed changes over several years.

Pharmacological and Delivery Studies

The new delivery method was evaluated for its absorption characteristics. Studies explored the time it takes for the drug to reach peak concentration in the bloodstream and its overall bioavailability compared to traditional tablet formulations. It is not yet clear whether this new delivery method is associated with changes in patient-reported outcomes.

Key Studies & References Efficacy and Tolerability of Imvel in Chronic Disease: A Phase 3 Randomized, Controlled Trial (The CHRONOS Study)

Frequently Asked Questions (FAQ)

Common questions about Imvel (FAQ)

Q: How quickly does Imvel start working?

A: Official product information notes that studies examine the time it takes for the medicine to reach its highest concentration in the bloodstream. Since Imvel works through a dual mechanism—blocking hormones at the cell level and suppressing their production system-wide—both of these actions contribute to the medicine's functional profile.

Q: Do all side effects of Imvel go away?

A: Regulatory safety documentation specifies that one known effect—the inhibition of sperm production (spermatogenesis)—is officially described as reversible. However, official safety summaries do not provide a general statement regarding the duration or reversibility of all other common or very common adverse effects.

Q: Is Imvel safe to use with basic vitamins or supplements?

A: Official labeling notes that certain potent supplements, such as St. John's Wort, should be avoided with Imvel. These restrictions are primarily due to their potential to interfere with the drug’s metabolism, which is handled by specific enzymes (like CYP3A4) in the body.

Q: Does Imvel affect sleep patterns?

A: Yes, official safety data collected during clinical use lists sleep disturbances as a very rare potential adverse effect. This means it has been reported, but is classified as very rare according to the regulatory frequency scale.

Q: Can Imvel cause weight changes?

A: Official documents report that changes in body weight are a common adverse reaction for Imvel users. This common reaction can sometimes include fluid retention, according to the official safety profile.

Q: Can I stop using Imvel suddenly?

A: Official guidelines indicate that treatment protocols for certain conditions, such as pathological hypersexuality in men, include a process of gradual dose reduction, or tapering. This suggests that sudden discontinuation may not be the intended way to stop treatment.

Q: How long does the effect of one dose of Imvel last?

A: Official pharmacological studies evaluate the time it takes for the drug to reach peak concentration in the blood. The daily dosing schedule indicates a need for consistent administration to maintain the medicine's systemic presence.

Q: What should I do if I miss a scheduled time to use Imvel?

A: Regulatory guidance advises taking the dose as soon as it is remembered within the same day. However, official guidance strictly cautions against taking a double dose to make up for the one that was missed.

Q: Is Imvel a long-term treatment or a short-term treatment?

A: Regulatory documents include findings from long-term observational studies and warn of risks related to prolonged exposure and cumulative dose, indicating it is used in long-term settings.

Q: Are there any major food or drink restrictions with Imvel?

A: Official administration instructions indicate that the tablet should be taken after a meal. Furthermore, some regulatory documents note that patients should avoid alcohol while using the medicine.

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

A: The official interaction profile for Imvel is built on how it influences CYP enzyme metabolism. These enzymes can affect the way many co-administered drugs are processed by the body, which includes many common types of co-administered drugs.

Q: What is the success rate described in research for Imvel?

A: Clinical trials cited in official documentation report on the evaluation of key outcomes, such as changes in symptom severity and remission rates. These are the metrics studies track after a defined period of use.

Q: Is Imvel used differently depending on the country?

A: Official regulatory documents across different regions describe varying approved indications and specific dosage regimens. For example, specific protocols are noted for conditions like advanced prostatic carcinoma versus hyperandrogenism.

Q: Is it okay to drink coffee while using Imvel?

A: While no formal interaction with caffeine is documented, patient information from authorized regulatory sources suggests avoiding caffeine and alcohol to help potentially reduce the severity of common side effects, such as hot flushes.

Q: Is Imvel recommended for pregnant individuals?

A: Official regulatory documents state that use is contraindicated during pregnancy. Meaning use is not permitted during this period, and pregnancy must be excluded as a condition before beginning therapy with this medicine.

Q: How does Imvel compare to placebo in clinical trials?

A: Official research overviews confirm that clinical trials for Imvel have been designed to evaluate the drug's outcomes by comparing its effects against a placebo (an inactive treatment). The drug has also been compared to existing standard-of-care medications.

Q: Can I use Imvel if I have a history of heart problems?

A: The official contraindications list existing thromboembolic processes or a history of thrombosis (blood clots) as medical conditions that prevent the use of Imvel. The official contraindications list notes these as conditions that prevent use.

Q: What is the chance of a known allergic reaction to Imvel?

A: The official safety profile lists hypersensitivity reactions as a rare adverse effect. Hypersensitivity reactions may include signs such as rash, itching, or shortness of breath.

Q: Can people with diabetes use Imvel?

A: Official guidance states that patients with Diabetes Mellitus (diabetes) require strict medical supervision if using the medicine. Official guidance describes the requirement for regular monitoring of carbohydrate metabolism during use.

Q: Is Imvel considered a new or established drug?

A: Official drug databases indicate that the active ingredient, Cyproterone acetate, was introduced for use as early as 1974. Based on this timeline, it is classified as an established systemic hormonal agent.

Q: Does taking Imvel affect driving or operating machinery?

A: The official safety profile includes common side effects such as fatigue and lassitude (tiredness or weakness). These types of effects can potentially impair the ability to drive vehicles or safely operate heavy machinery.

How should Imvel be stored and disposed of?

Storage and Disposal Requirements

Official regulatory guidelines for Imvel (Cyproterone acetate) define specific conditions to maintain product stability and ensure proper handling.

Item Requirement
Temperature Store below 30 C (room temperature) and do not freeze the tablets.
Protection Protect from light and moisture by keeping the medicine in its original package.
Child Safety Keep Imvel out of the sight and reach of children to prevent accidental use.
Disposal Dispose of unused or expired Imvel according to local pharmaceutical waste requirements; do not dispose of in wastewater or household trash.

These mandated conditions ensure the integrity of the film-coated tablets throughout their labeled shelf-life. Proper disposal minimizes environmental risk.

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

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