Advertisements

Androcur Depot

Quick links to important sections

Androcur 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 Androcur Depot

What is Androcur Depot?

Androcur Depot is an injectable form of hormonal medication containing the active substance cyproterone acetate. It belongs to a class of drugs known as anti-androgens. Unlike the oral tablet version, the depot formulation is designed for intramuscular injection, allowing for a slow and sustained release of the medication into the bloodstream over an extended period.

Mechanism of Action

Cyproterone acetate works by blocking the effects of androgens, which are male sex hormones such as testosterone. It achieves this through a dual action:

  • Receptor Blockade: It competes with androgens at the receptor sites in target tissues, preventing the hormones from exerting their biological effects.
  • Hormone Suppression: It acts on the central nervous system to reduce the production of hormones that signal the testes to produce testosterone, leading to a significant decrease in serum testosterone levels.

Therapeutic Use

In clinical practice, Androcur Depot is primarily utilized in the management of conditions where the suppression of androgen activity is required. This most commonly includes the palliative treatment of advanced prostate cancer, where reducing testosterone levels can help slow the progression of the disease and alleviate associated symptoms.

In certain jurisdictions and clinical contexts, it may also be used for the reduction of sexual drive in cases of sexual deviations in men, where other forms of treatment are considered inappropriate or ineffective.

Advertisements

What side effects are possible with Androcur Depot ?

Possible Side Effects and Safety Information

The safety profile of Androcur Depot (cyproterone acetate injection) is documented by regulatory authorities, with adverse reactions categorized by frequency and the body system affected. The most Very Common (ge 1/10) effects are hormonal, including decreased libido, erectile dysfunction, and a reversible inhibition of spermatogenesis (reduced sperm production) in men.

Common (ge 1/100) reactions include depressive moods, restlessness, changes in body weight, hot flushes, and fatigue. In the reproductive system, gynaecomastia (breast swelling) is a common occurrence in men.


Serious Adverse Reactions

Official labeling describes several serious safety concerns. Direct hepatic toxicity (jaundice, hepatitis, or hepatic failure) is a known risk, particularly at high doses, and cases of fatal hepatic failure have been reported. Rare reports of benign and malignant liver tumours have also been documented.

Meningioma (a benign brain tumor) is a documented risk, primarily associated with long-term use and high cumulative doses of cyproterone acetate. The medication is generally restricted in individuals with severe, pre-existing hepatic impairment or a history of meningioma.

Safety notes also emphasize that certain effects are linked to duration; for example, the risk of meningioma increases with extended exposure. Patients with diabetes mellitus require strict supervision, as treatment may alter their need for insulin or anti-diabetic agents.

Advertisements

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents for Androcur Depot focus primarily on the required emergency response and management constraints rather than describing a specific acute symptom profile following a single, massive overdose of the drug.

Element Regulatory Finding
Documented Manifestations No specific set of acute symptoms is formally documented for single-event overdose.
Emergency Risk A serious, officially documented risk is pulmonary microembolism of oily solutions, an event specific to the Depot injection, which may manifest as cough, dyspnoea (shortness of breath), and chest pain.
Management Measures Treatment, if required, should be symptomatic and supportive. Management for microembolism may include the administration of oxygen.
Antidote Status No specific antidote is known for Cyproterone acetate.
Population Notes No population-specific overdose severity or special considerations are explicitly documented.

Seeking Urgent Medical Help

Immediate medical attention must be sought for any suspected overdose or if severe injection-related symptoms, such as sudden cough, difficulty breathing, or chest pain, occur. The regulatory guidance for Cyproterone acetate overdose confirms that no specific antidote is known. Because of this constraint, all necessary clinical care is mandated to be strictly symptomatic and supportive treatment. This focus confirms the requirement for professional medical monitoring until the patient is clinically stable.

Advertisements

Therapeutic Uses of Androcur Depot

What Androcur Depot Treats: Main Uses and Benefits

Androcur Depot, containing cyproterone acetate, functions as an anti-androgen, supporting the management of conditions linked to male sex hormones (androgens) in both men and women. This treatment focuses on addressing certain clinical scenarios where managing androgen activity is a key therapeutic goal.

In men, this medication is indicated as a component of palliative care for prostate carcinoma (prostate cancer). This includes managing hot flashes in patients receiving other treatments or for addressing certain temporary symptoms associated with starting other hormone treatments. The medication may also be considered for supporting the management of libido in adult men with severe hypersexuality or sexual deviation when other therapeutic options are not suitable.

In women, the medication is utilized to manage severe signs of androgenisation, including severe forms of hirsutism (excessive hair growth), moderate-to-severe androgen-dependent alopecia (scalp hair loss), and severe forms of acne and/or seborrhoea (oily skin).


Quick Fact: Used in the management of Androgen-Related Skin and Hair Conditions


Advertisements

Eligibility and Restrictions for Use

Androcur Depot is strictly permitted only for adult males within its two labeled indications. Official regulatory documents define eligibility through a rigorous set of absolute prohibitions and conditional restrictions, primarily driven by underlying health status.

Contraindicated Populations (Absolute Prohibition)

The medicine must not be used in patients presenting with serious pre-existing conditions. These include specific liver diseases (such as Dubin-Johnson or Rotor syndrome), reduced liver function, or the presence or history of a meningioma (a benign brain tumour). Use is also contraindicated in most forms of wasting diseases, and for the sexual deviation indication, it is prohibited in cases of severe chronic depression or existing thromboembolic processes (blood clots).

Age and Comorbidity Restrictions

  • Pediatric Use: The injection is not recommended for male children and adolescents below 18 years of age and is prohibited before the conclusion of puberty due to potential effects on growth and endocrine function.
  • Conditional Use: Regulators require a careful risk:benefit evaluation for eligible adult males with conditions like severe diabetes with vascular changes or a history of thromboembolic processes or sickle-cell anaemia.
  • Pregnancy: The medicine is contraindicated if pregnancy is possible, as its use is not indicated for women.
Advertisements

What should I know about interactions with other medicines?

Androcur Depot (cyproterone acetate) is metabolized by the enzyme CYP3A4, and its interaction profile is largely defined by this pathway. Co-administration with strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir) is expected to inhibit the drug's metabolism, which would lead to increased levels of the active substance in the body. Conversely, concomitant use with CYP3A4 inducers (such as rifampicin, phenytoin, and St John's Wort) may reduce the concentration of the drug by accelerating its metabolism.

Caution is advised when Androcur Depot is used concurrently with certain HMGCoA reductase inhibitors (Statins), particularly those primarily metabolized by CYP3A4. This combination may increase the risk of statin-associated muscle adverse effects, including myopathy and rhabdomyolysis.

The medication can also alter blood sugar levels, requiring close monitoring and potential adjustment of antidiabetic agents for patients with diabetes. Finally, for the indication of reducing sex drive in sexual deviations, the effect of Androcur Depot may be diminished by the disinhibitory influence of alcohol; patients receiving treatment for this condition are recommended to avoid alcohol use.

Advertisements

Mechanism of Action

How Androcur Depot Works

Direct Blockade of Cellular Androgen Receptors

The medication engages in peripheral mechanistic activity by acting as an antagonist that directly binds to the Androgen Receptors ( AR) on cells in target tissues. By occupying these receptor sites, the drug prevents natural male sex hormones from initiating their binding, which alters the downstream signaling cascade initiated by androgens.

Suppression of Central Hormone Production

A separate, central mechanistic domain involves the drug's effect on the Hypothalamic-Pituitary-Gonadal (HPG) axis. By mimicking the activity of progesterone in the pituitary gland, the drug suppresses the release of Luteinizing Hormone ( LH), which causes a decrease in the synthesis and secretion of circulating male sex hormones.

Overall Physiological Consequence

The combined effect of blocking the receptor at the cellular level and reducing the supply of hormones from the source establishes an overall reduction in androgenic signaling. The combination of receptor blockade and production suppression acts to reduce both the availability of androgens and the capacity of cells to respond to them.

Advertisements

Dosage and Administration Information

How to Use Androcur Depot: Official Administration Guidelines

Androcur Depot is a 300 mg/3 mL oily solution designed exclusively for deep intramuscular (IM) injection, requiring the dose to be administered very slowly. The administration route is strictly intramuscular; special care must be taken to avoid intravasal injection (injection into a blood vessel) during the procedure.


Labeled Dosing Schedule

The dosage and frequency are determined by the specific condition being managed, but consistently use the 300 mg strength.

Clinical Context Labeled Dose and Frequency
Advanced Prostatic Carcinoma (Without Orchiectomy) 300 mg once weekly.
Advanced Prostatic Carcinoma (After Orchiectomy) 300 mg once every two weeks.
Sexual Deviations/Hypersexuality Typically 300 mg every 10 to 21 days. (Up to 600 mg in two separate injections may be used.)

Administration Protocol and Duration Rules

Treatment duration is typically protracted. For prostate carcinoma, the dosage must not be reduced nor the treatment interrupted following clinical improvement. In the context of sexual deviations, the dosage may be gradually reduced by increasing the time interval between injections once a satisfactory result is achieved, often alongside psychotherapeutic measures.

Androcur Depot is not recommended for use in males below 18 years of age due to concerns regarding its potential influence on longitudinal growth before the conclusion of puberty. If an injection appointment is missed, the patient must contact the doctor immediately to reschedule the administration.

Advertisements

Recent Clinical Evidence

Androcur Depot: Recent Clinical Evidence

This overview describes the landscape of clinical research and the types of studies conducted to evaluate Androcur Depot (cyproterone acetate injection). The summary focuses on what outcomes were measured and where research gaps exist, based on findings described in regulatory and peer-reviewed scientific literature.


Evidence for Use in Advanced Prostate Carcinoma

Research exploring this primary indication was studied for adult men with advanced cancer, often through Randomized Controlled Trials (RCTs). Studies were designed to evaluate its use in androgen deprivation. The main outcomes monitored included outcomes related to patient survival and the time before the cancer showed signs of progression (measured by PSA). An important context is that this evidence is primarily derived from comparative studies against other hormonal treatments. While this evidence is primarily derived from randomized controlled trials, data for certain groups of patients starting different therapy sequences may be limited.


Evidence for Specialized Indications

For managing severe hypersexuality in men, research relies more on observational settings and clinical case series. Studies describe that assessing outcomes—such as sex drive suppression and changes in circulating testosterone—requires protracted observation, and there is a general lack of modern RCTs.

For severe androgenisation in women (hirsutism, acne), evidence was evaluated in women of reproductive age, often using RCTs that monitored severity scores (e.g., Ferriman-Gallwey score) and serum androgen levels. A major consideration is that data for the high-dose Depot injection as a monotherapy are limited, as much primary research utilized the oral combination formulation.


Long-Term Follow-up and Research Gaps

For prostate carcinoma, studies monitored outcomes for long-term follow-up periods spanning several years. For other indications, studies often monitored outcomes over intermediate-term durations (6 to 12 months). However, certainty remains low regarding the maintenance of changes beyond one year.

Broadly, while the evidence is extensive in some areas, sample sizes were modest and evidence quality varies across studies for specialized indications. Data for specific subgroups and comorbidities are often insufficient, and research provides context but not individual predictions.

Key Studies & References

  1. Cyproterone acetate: new advice to minimise risk of meningioma - Drug Safety Update (Regulatory Document)
Advertisements

Frequently Asked Questions (FAQ)

Common questions about Androcur Depot (FAQ)


Q: What is the main difference between Androcur Depot and the oral Androcur tablets?

Official product information describes Androcur Depot as a specific formulation intended for deep intramuscular injection. This differs from the oral tablets, which are formulated for daily use. The Depot is an oily solution designed to release the active ingredient (cyproterone acetate) slowly over a longer period, resulting in an administration schedule appropriate for a long-acting injection.


Q: What is pulmonary oil micro-embolism and how is it related to the injection technique?

Pulmonary Oil Micro-embolism (POME) is a serious, rare risk associated with oily injectable medicines like this one. It can occur if the solution accidentally enters a blood vessel (intravasal injection). Official regulatory warnings emphasize the importance of administering the injection very slowly and strictly intramuscularly by a healthcare professional to minimize this risk. Signs of this reaction may include sudden cough or chest pain.


Q: Does Androcur Depot affect my ability to drive or operate machinery safely?

Official safety information indicates that fatigue and general weakness (asthenia or lassitude) are common side effects, especially when treatment is first started. Since these effects can be marked, official product information indicates that special care and caution is required when operating machinery or driving vehicles.


Q: What kind of monitoring is required for liver function during treatment?

Because there is a known risk of liver toxicity, health authorities indicate that monitoring of liver function is necessary. This includes performing liver function tests (LFTs) before starting treatment and at regular intervals afterward. If test results show signs of severe liver toxicity, official guidance indicates that discontinuation of the medication may be necessary.


Q: Does Androcur Depot treatment affect bone density or increase the risk of osteoporosis?

Official information indicates that the anti-androgen effect of this therapy can lead to a reduction in bone strength. This potential loss of bone density increases the risk of developing osteoporosis (thinning of the bones). This is considered a side effect associated with the long-term suppression of androgens.


Q: Does Androcur Depot cause anemia or require monitoring of red blood cell count?

Anemia (low red blood cell count) has been observed as a reported adverse effect associated with this medication. Regulatory authorities state that regular blood assessments, known as hematological assessments, are necessary while undergoing treatment.


Q: Can I consume alcohol while undergoing treatment with Androcur Depot?

Regulatory guidance indicates that the use of alcohol during therapy may not be recommended. This is because official documents indicate that alcohol consumption may reduce the expected anti-androgen effect of the medication in some circumstances.

Advertisements

How should Androcur Depot be stored and disposed of?

How to Store and Dispose of Androcur Depot?

Androcur Depot (cyproterone acetate injection) must be stored according to specific regulatory requirements to maintain product stability.

Storage Requirements

Condition Requirement
Temperature Store below 30 C (Do not refrigerate or freeze).
Container Keep ampoules in the original outer carton to protect from light.
Stability Do not use the medicine after the expiry date printed on the packaging.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Unused or expired Androcur Depot must not be disposed of in household waste or flushed down the drain. For proper handling as pharmaceutical waste and to protect the environment, return the product to a pharmacy or a designated local medicine take-back program.

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

Available in countries:

Equivalent of Androcur Depot  found in:

A-Z Index: