Lunar

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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 Lunar

Quick Facts

Property Description
Active ingredient Cyproterone Acetate, Ethinyl Estradiol
Form Oral Tablet
Pharmacological class Combined Antiandrogen-Estrogen
General purpose Management of androgen-dependent conditions
Origin Synthetic Steroid Combination

What is Lunar: Definition and Classification

Lunar is a prescription-only synthetic steroid combination classified primarily as a Combined Antiandrogen-Estrogen preparation. This medication is a combination product delivered in the oral tablet form, designed for systemic hormonal intervention via the oral route of administration.

Active Components and Differentiation

The composition of Lunar consists of two synthetic steroid compounds: Cyproterone Acetate (CPA) and Ethinyl Estradiol (EE). Cyproterone Acetate functions as a potent progestogen that also exhibits strong antiandrogenic activity, a key differentiating factor compared to many standard combined oral contraceptives (COCs). This antiandrogenic property is essential for the medication's therapeutic focus. The dual components are manufactured to provide precise, controlled therapeutic properties.

General Purpose and Mechanism Summary

The general purpose of Lunar is the management of androgen-dependent dermatological conditions, such as severe acne, seborrhea, and mild hirsutism in women of reproductive age. By systematically countering the physiological impact of androgens, the hormones that drive these conditions, the therapy aims to regulate the biological factors affecting the skin and hair. As a result of its composition, the medication inherently provides a strong and reliable contraceptive effect.

What side effects are possible with Lunar?

Adverse Reaction Scope

The official safety information for Lunar (Cyproterone Acetate/Ethinyl Estradiol) is structured to communicate the documented risks and frequency of adverse reactions, as classified by government regulatory authorities.

Category Description
Key adverse reaction categories Thromboembolic events (Venous and Arterial), Liver Tumors (benign and malignant), and Meningioma (a rare non-cancerous brain tumor associated with the cyproterone component).
Frequency classification Common (ge 1%): Nausea, abdominal pain, headache, depressed mood, breast pain, and weight changes. Rare (le 0.1%): Thromboembolic events, hypersensitivity reactions.
System-organ classes involved Vascular Disorders, Hepatobiliary Disorders, Nervous System, Gastrointestinal Disorders, Psychiatric Disorders, and Reproductive System disorders.
Serious adverse reactions Venous Thromboembolism (VTE), Arterial Thromboembolism (ATE) (e.g., stroke), Hepatic Adenoma/Carcinoma, and Meningioma.
Population-specific safety considerations Contraindicated in individuals with a history of severe hepatic disease, liver tumors, meningioma, or severe diabetes mellitus with vascular changes.
Dose- or exposure-related patterns The risk of VTE is highest during the first year of use. The risk of Meningioma is associated with prolonged exposure (several years).
Safety-related restrictions or limitations Should not be used solely for the purpose of contraception; Contraindicated for use with any other hormonal contraceptive.

Safety Classifications (High-Level)

Category Description
Regulatory frequency framework used Based on standard regulatory definitions where Common ge 1/100 and Rare le 1/10,000.
Regulatory basis Primarily based on Summary of Product Characteristics (SmPC) documents and North American Product Monographs.
Context-of-use safety notes Unscheduled bleeding or spotting may occur, particularly during the initial three months of use, noted as the adjustment period.

Resulting safety structure

Regulatory safety summary:

  • The primary, officially documented serious adverse reactions involve the risk of thromboembolic events (VTE/ATE) and rare neoplasms (liver tumors, meningioma).
  • Adverse reactions such as headache, nausea, and depressed mood are classified in regulatory documents as Common side effects.
  • Use is strictly contraindicated by regulatory labels in patients with a history of meningioma or pre-existing severe conditions like hepatic disease or uncontrolled vascular risk factors.
  • The maximum risk of VTE is officially documented as occurring during the first year of treatment.

Connection to the overall safety profile

The official regulatory documents structure the safety profile around the increased risk of thromboembolic events and specific neoplastic risks, requiring a thorough assessment against the documented contraindications before use. Frequency classification lists the expected reactions, while duration-related notes define how the risk level changes during the course of treatment, particularly emphasizing the higher VTE risk at initiation.

Overdose and Emergency Response

Lunar Overdose and when to seek help

The official regulatory documentation for Lunar (Cyproterone Acetate/Ethinyl Estradiol) describes the clinical profile of acute overdose based on expected hormonal and gastrointestinal effects.

Overdose Scope

Property Official Regulatory Statement
Documented Manifestations Nausea, vomiting, and withdrawal bleeding (expected in females).
Physiological Systems Affected Gastrointestinal system and reproductive system.
Antidote Status No specific antidote is known for this combination product.

Management and Emergency Action

Classification Official Regulatory Statement
Severity Classification Overdose is generally characterized by mild, non-life-threatening effects.
Emergency Response Further treatment should be symptomatic and supportive.
Seeking Urgent Help Seek medical attention for professional assessment following any suspected overdose.

The regulatory framework establishes that the acute overdose presentation is typically non-severe, characterized by transient gastrointestinal and hormonal manifestations. Since the regulatory label explicitly confirms the absence of a specific antidote, the mandated management procedure is restricted to supportive care. Patients are officially instructed to seek professional evaluation for assessment and symptomatic treatment. No specific monitoring requirements or population-based considerations are documented in the overdose section of the official prescribing information.

Therapeutic Uses of Lunar

What Lunar treats: Main Uses and Benefits

The therapeutic focus of Lunar is the management of challenging symptoms associated with systemic imbalance in women of reproductive age, generally providing supportive relief for conditions where symptoms are related to systemic imbalance. Its primary use is for conditions related to androgen sensitivity where supportive symptom management is appropriate.

This medication is commonly used to help manage chronic conditions characterized by periods of heightened symptoms, such as persistent acne, excessive skin oiliness (seborrhea), and unwanted hair growth (hirsutism). Applied in scenarios where additional management of discomfort is required, Lunar is used for managing these symptom clusters, which may contribute to improved comfort during symptomatic periods.

“The formulation is used in areas where short-term symptom management is appropriate for symptoms related to inflammatory or irritative states.”


Quick Fact: Relief for Androgen-Driven Symptoms

The formulation is applied across domains involving hormonal regulation, offering a practical benefit as a form of oral contraception. Additionally, it is used for managing symptoms related to systemic imbalance, which may contribute to improved comfort during periods of heightened symptoms for women whose symptoms might otherwise be disruptive.

Eligibility and Restrictions for Use

Eligibility Scope

The medicine is approved for use exclusively in women of reproductive age for the management of specific androgen-dependent conditions, such as severe acne or hirsutism. It must only be used after alternative treatments, such as topical therapy or systemic antibiotics, have failed.

Classification Population Restriction
Contraindicated Individuals with a personal or family history of thromboembolic events (e.g., blood clots, stroke, heart attack) or known hereditary clotting disorders; individuals with severe liver disease (until function is normal); history of liver tumors or meningioma; and individuals with migraine with focal neurological symptoms.
Not Eligible Men; women who are pregnant or breastfeeding; women over 35 years of age who smoke; women taking other hormonal contraceptives.
Restricted Use Not recommended before menarche (onset of menstruation) and not established in older adults. Use requires temporary discontinuation at least four weeks before major surgery or during periods of prolonged immobilization. Patients with certain conditions, such as controlled hypertension or diabetes, require strict monitoring.

Connection to the overall eligibility profile

Regulatory documents define eligibility through a framework of absolute contraindications based on vascular, hepatic, and neoplastic risk factors. Eligibility is strictly limited to a defined patient demographic (women of reproductive age with specific therapeutic need), with explicit non-eligibility for high-risk groups and physiological states like pregnancy, as detailed in the official product labeling.

What should I know about interactions with other medicines?

Lunar Interactions with other medicines and products

It is essential to inform your healthcare provider of all prescription, over-the-counter, and herbal supplements you are taking, as Lunar can interact with various medications. These interactions may alter the effectiveness of Lunar or the other drugs, or increase the risk of adverse effects.

Interactions often occur because one drug affects how the body absorbs, metabolizes, or eliminates another. Key categories of interacting substances include:


Potential Drug-Drug Interactions

Type of Interacting Agent Potential Effect Recommendation
Strong CYP450 Inducers (e.g., rifampin, phenytoin, carbamazepine) May decrease Lunar concentration, potentially reducing efficacy. Dosage adjustments or alternative therapy may be necessary.
Strong CYP450 Inhibitors (e.g., ketoconazole, protease inhibitors) May increase Lunar concentration, potentially increasing side effects. Close monitoring and possible dose reduction of Lunar.
Other Medications Lunar may alter the effects of certain drugs, such as oral contraceptives (by possibly affecting their hormone levels) and immunosuppressants. Monitor hormone levels or drug concentrations and adjust dosages as directed.

Food and Other Interactions

Grapefruit and grapefruit juice should be avoided, as they can inhibit the metabolism of Lunar, leading to higher levels in the blood and an increased chance of side effects. It is generally recommended to take Lunar without regard to food, but patients should follow specific instructions provided by their physician or pharmacist. Never start, stop, or change the dosage of any medication without consulting your healthcare professional.

Mechanism of Action

How Lunar Works

Lunar operates through a dual-level antiandrogenic mechanism involving the central endocrine system and peripheral target cell signaling. The combination of Cyproterone Acetate (CPA) and Ethinyl Estradiol (EE) ensures a regulated reduction in androgen activity.


Central Suppression and Androgen Supply Control

This domain covers the drug's influence on the Hypothalamic-Pituitary-Ovarian (HPO) axis and the liver. EE and CPA cooperate to suppress the pituitary hormones LH and FSH, reducing the ovarian production of androgens. Additionally, EE stimulates the liver to produce SHBG, a protein that binds and sequesters circulating androgens. This combined action initiates a systemic reduction in the overall supply of free, bioavailable androgens.


Peripheral Receptor Antagonism

This domain covers the local action of Cyproterone Acetate (CPA) in peripheral tissues. CPA functions as a competitive antagonist at the Androgen Receptor (AR), blocking potent androgens (like DHT) from initiating their action in target cells (e.g., sebaceous glands and hair follicles). This direct blockade stops the androgen-driven gene expression that controls local physiological activity, which limits the downstream effects of androgen signaling.

Dosage and Administration Information

Lunar is an oral prescription medication consisting of a combined 2 mg Cyproterone Acetate and 35 micrograms Ethinyl Estradiol tablet. Administration is strictly via the oral route, with the fundamental regimen defined by a standardized 28-day cycle.

The standard dosing schedule requires one active tablet to be taken daily for 21 consecutive days, followed immediately by a 7-day tablet-free interval. This sequence is repeated, and a new treatment pack must always be started after the 7-day break. To maintain consistent therapeutic levels, the tablet must be ingested at about the same time every day, though consumption is allowed with or without food.

Regarding the course of treatment, use is generally continued for several months. Following the complete resolution of the condition being managed, the medication should be continued for an additional 3 to 4 treatment cycles before discontinuation. The use of Lunar is limited to women of reproductive age.

A critical administration constraint is the absolute requirement that Lunar must not be taken simultaneously with any other form of hormonal contraceptive, including patches or rings, to prevent over-dosing of the hormonal components. In the event a tablet is missed by less than 12 hours, the user should take the missed tablet immediately and continue the cycle as normal.

Recent Clinical Evidence

Lunar: Recent Clinical Evidence

Clinical Efficacy in Primary Indication

Research has explored the role of the study compound across the pivotal Phase 3 LUNAR clinical trial, focusing on its use in combination with standard systemic therapies for metastatic non-small cell lung cancer (NSCLC). This trial included patients who experienced disease progression during or after platinum-based therapy.

  • Primary Outcome Measure: Studies evaluated whether the compound, when added to physician's choice of an immune checkpoint inhibitor (ICI) or docetaxel, influenced overall survival compared to standard therapy alone. The primary analysis included all randomized participants.
  • Summary of Findings: The LUNAR trial met its primary endpoint. Researchers observed that the combination treatment resulted in a median overall survival of 13.2 months, compared to 9.9 months for patients treated with standard therapy alone. This difference was statistically significant. For the subgroup receiving the compound with ICI, the median overall survival was 18.5 months, compared to 10.8 months for ICI alone.

Research Characteristics and Context

Research examined the pharmacological characteristics of the study compound, which is a medical device that generates Tumor Treating Fields (TTFields). These fields are intended to disrupt cancer cell division.

  • Study Population Context: Study enrollment included a broad range of participants with Stage 4 NSCLC. The research protocol excluded individuals reporting severe kidney issues, and participants did not report a history of severe liver impairment.
  • Safety Profile: The compound was generally found to be well-tolerated. Device-related adverse events were primarily mild to moderate skin and subcutaneous tissue disorders, which were reported in the majority of patients receiving the combination treatment. The addition of the compound did not appear to increase systemic toxicities associated with the standard systemic therapies.

Key Studies & References

  1. Tumor Treating Field (TTFields) therapy with standard of care (SOC) in metastatic non-small cell lung cancer (mNSCLC) following platinum failure: Randomized, phase 3 LUNAR study (NCT02973789)
  2. Optune Lua for Non-Small Cell Lung Cancer (NSCLC) Physician Instructions for Use (IFU)

Frequently Asked Questions (FAQ)

Common questions about Lunar (FAQ)


Q: How is Lunar different from other medicines used for the same purpose?

A: Lunar is classified as a Combined Antiandrogen-Estrogen preparation. According to official product information, a key distinguishing factor is the presence of the Cyproterone Acetate component. This antiandrogenic property is essential for the medication's therapeutic focus, which differentiates it from many standard combined oral contraceptives (COCs).


Q: Can Lunar affect how birth control works?

A: Lunar inherently provides a strong and reliable contraceptive effect due to its hormonal composition. Because of this, the product must not be taken simultaneously with any other form of hormonal contraceptive (such as the pill, patch, or ring) to prevent over-dosing of the hormonal components.


Q: What should I know about taking Lunar with certain foods or supplements?

A: Regulatory documents advise that Grapefruit and grapefruit juice should be avoided while using this medication, as they can inhibit how the body breaks down the drug, potentially leading to higher drug levels. The medication is generally allowed to be taken with or without food.


Q: Is it common to feel tired when starting Lunar?

A: The official product literature for the Cyproterone Acetate component of Lunar lists feeling tired, or fatigue, as a common side effect. This indicates that it is an adverse reaction reported frequently in clinical settings.


Q: How long does it usually take for Lunar to start working?

A: Official documents indicate that the time to symptomatic relief for the condition being managed is typically at least three months. This reflects the period required to achieve the expected outcome on symptoms.


Q: What happens if I forget to take a dose of Lunar?

A: Instructions for missed doses are detailed in the official product information. This guidance must be followed to ensure the intended effects, particularly concerning contraceptive efficacy.


Q: Is Lunar safe for older adults to take?

A: The medication is primarily indicated for use in women of reproductive age for the management of specific conditions. Regulatory documents state that the use of Lunar is not established in older adults and is not indicated after menopause.


Q: Is Lunar safe to take if I have kidney problems?

A: Official product characteristics indicate that the product has not been specifically studied in patients with kidney problems. Therefore, specific safety data regarding kidney function are not available in the official product characteristics.


Q: Is Lunar safe to take if I have liver problems?

A: Lunar is contraindicated (not permitted for use) in women with severe hepatic disease (severe liver disease), as long as liver function values have not returned to normal. It is also contraindicated if there is a history of liver tumors.


Q: What should I watch out for regarding a potential allergic reaction to Lunar?

A: Hypersensitivity reactions are classified as a rare adverse reaction. Signs of a serious allergic reaction may include sudden swelling of the face and throat, difficulty breathing, or abdominal cramps.


Q: Can Lunar cause changes in weight?

A: Official documents list weight changes as a Common (ge 1%) side effect associated with the use of this medication. This indicates that changes in body weight are an expected occurrence reported by a number of users.


Q: How long can a person typically stay on Lunar?

A: The course of treatment is not considered permanent. Official guidance specifies that following the complete resolution of the condition, the medication should be continued for an additional 3 to 4 treatment cycles before being discontinued. The treating physician should regularly check whether there is still a need for treatment.


Q: What is the risk of stopping Lunar suddenly?

A: Official information indicates that upon stopping the medication, androgenic effects that were previously suppressed will gradually return, which may lead to a resurgence of the original symptoms (such as acne or hair issues). It may also lead to changes in the re-establishment of the natural hormonal cycle.


Q: Can Lunar be taken with anxiety or depression medicines?

A: Lunar can interact with other medicines due to its influence on drug metabolism in the body. Certain classes of medicines, including some used for depression, may alter Lunar’s effectiveness or increase the risk of side effects. It is important to review all prescription medicines being taken with a healthcare provider.


Q: Are there any long-term effects of taking Lunar that research has shown?

A: Officially documented long-term risks include an increased risk of Venous Thromboembolism (VTE) (blood clots), which is noted as highest during the first year of use. The risk of the rare brain tumor Meningioma is also associated with prolonged exposure (several years) to the cyproterone component.


Q: Does Lunar affect blood pressure?

A: Official warnings note that clinically significant blood pressure increases have been reported during therapy with estrogen-containing products. Use in women with severe hypertension is a contraindication according to official labeling.


Q: Can Lunar be taken by people who have diabetes?

A: The use of Lunar is contraindicated (not permitted for use) in individuals with severe diabetes mellitus with vascular changes (damage to blood vessels). Diabetes mellitus is listed in official documents as a medical condition associated with adverse circulatory events.


Q: Is Lunar a 'maintenance' medicine?

A: Official administration instructions define the course of treatment as limited, rather than long-term maintenance. Guidance requires the medication to be continued for only 3 to 4 cycles after the original condition has fully resolved.


Q: Why is Lunar sometimes prescribed alongside other treatments?

A: Official prescribing guidelines state that for the management of acne, Lunar should only be used after other treatment methods have failed. This includes topical therapy or systemic antibiotic treatments, as outlined in the official prescribing guidelines.


Q: What kind of monitoring (like blood tests) might be needed while on Lunar?

A: Ongoing medical monitoring may be required during the course of treatment. Regulatory documents note that this can include checks of blood pressure, Liver Function Tests (LFTs), and blood sugar (HbA1c). Patients with certain pre-existing conditions require strict monitoring.


Q: Can Lunar affect vision?

A: Although rare, combined oral contraceptives have been associated with ocular complications. These can include visual disturbances and retinal vascular complications. Sudden disturbances of vision are listed in the official product literature as a serious event requiring medical evaluation.


Q: Are there different strengths or forms of Lunar available?

A: The standard regulated formulation contains 2 mg Cyproterone Acetate and 35 micrograms Ethinyl Estradiol. According to official regulatory documents, this is provided only in the form of an oral tablet.


Q: How quickly is Lunar removed from the body?

A: Pharmacological data from official sources indicates that the primary active component, Cyproterone Acetate (CPA), has an elimination half-life cited as being about 1.6 to 4.3 days for the oral form. The half-life describes the time it takes for half of the drug to be removed from the body.

How should Lunar be stored and disposed of?

The official labeling for Lunar (Cyproterone Acetate/Ethinyl Estradiol) tablets mandates specific conditions for storage and disposal to maintain stability and ensure safety.

Storage Requirements

The medication must be stored at Controlled Room Temperature, typically 20 C to 25 C, with the temperature not to exceed 30 C. The product must be kept out of the sight and reach of children. It is mandatory to store in the original blister pack and outer carton to protect from light and moisture. The product must not be frozen.

Disposal Instructions

Unused or expired Lunar tablets must not be disposed of via wastewater or as routine household waste. The official instruction requires returning the unused product to a pharmacist or following local requirements for the safe disposal of medicinal waste.

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

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