Lerna

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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 Lerna

Property Description
Active Ingredients Drospirenone (DRSP) and Ethinyl Estradiol (EE)
Form Oral Tablet (Film-Coated)
Pharmacological Class Combined Oral Contraceptive (COC)
Common Use Prevention of pregnancy (Contraception)
Origin Synthetic (Synthetic Progestin and Estrogen)

Defining Lerna: Type, Class, and Purpose

Lerna is a prescription-only Combined Oral Contraceptive (COC) classified as a Hormonal Contraceptive Agent. Its primary and general therapeutic purpose is the reliable prevention of pregnancy (contraception), operating systemically via the oral tablet route. Combined oral contraceptives are an established method for controlling fertility. The preparation is used for regulating the reproductive cycle. Beyond its main contraceptive role, the specific formulation is also indicated for treating symptoms associated with Premenstrual Dysphoric Disorder (PMDD) and moderate acne in certain patient groups, representing its use in related hormonal management.

Lerna's Composition: Drospirenone and Ethinyl Estradiol Combination

Lerna is a combination product containing two distinct active ingredients [INN]: the synthetic progestin Drospirenone (DRSP) and the synthetic estrogenic compound Ethinyl Estradiol (EE). Both active compounds are entirely synthetic in origin. The medicine is supplied as an oral tablet that is often film-coated, packaged in a cyclical sequence that includes both active pills and inert tablets. Products containing the combination of Drospirenone and Ethinyl Estradiol are utilized within clinical applications for family planning.

The Unique Actions of the Drospirenone Component

The progestin Drospirenone offers specific pharmacological properties, primarily including an antiandrogen effect and antimineralocorticoid activity. While all COCs work to suppress ovulation and thicken the cervical mucus, Drospirenone's antimineralocorticoid activity is comparable to that of natural progesterone, significantly differentiating its physiological action from many other synthetic progestins. This specific antiandrogen effect is relevant to its use in managing hormonal symptoms, such as the skin changes associated with acne, by counteracting the action of androgens.

What side effects are possible with Lerna?

Possible Side Effects and Safety Information

The safety profile of Lerna (Drospirenone/Ethinyl Estradiol) is characterized by a range of officially documented adverse reactions classified by frequency, consistent with regulatory standards. The highest priority safety concern for this combined oral contraceptive class involves rare but serious thromboembolic events, commonly known as blood clots.


Adverse Reactions by Frequency

Adverse reactions are grouped according to how often they have been reported in clinical use:

  • Very Common (ge 1/10): Reactions frequently listed in regulatory documents include headache and breast pain or tenderness.
  • Common (ge 1/100 to < 1/10): Effects often reported span multiple systems, including nausea, abdominal pain, changes in mood (including depressed mood), weight gain, and menstrual irregularities (such as spotting or intermenstrual bleeding).
  • Rare (ge 1/10,000 to < 1/1,000): This category includes serious events such as Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE), which can lead to events like stroke or heart attack, and benign liver tumors.

Serious Safety Considerations and Constraints

The highest risk of VTE is officially noted to occur during the first year of use or upon restarting the medicine after a break of four weeks or more. Due to the Drospirenone component, a specific safety note exists regarding the potential for hyperkalemia (elevated potassium levels).

Regulatory labeling dictates that Lerna is contraindicated (should not be used) in individuals with specific pre-existing conditions, including a history of thrombotic disorders, severe hepatic impairment (severe liver disease), or renal insufficiency (kidney impairment). The medicine is also contraindicated during pregnancy.

Overdose and Emergency Response

Overdose and When to Seek Help

The regulatory guidance for Lerna overdose requires immediate medical attention and contact with a poison control center upon any suspected over-ingestion of the oral tablets. This urgent call for help is mandated despite regulatory documents indicating that no serious deleterious effects have been reported following acute overdose of this specific combined oral contraceptive formulation.

Overdose Scope Regulatory Statement
Documented Manifestations The clinical signs most commonly reported following over-ingestion are Nausea, Vomiting, and slight vaginal bleeding (a form of withdrawal bleeding).
Antidote and Treatment No specific antidote is known for this combination product. Consequently, treatment procedures are strictly limited to being symptomatic and supportive.

The central procedural focus in the official overdose profile is the necessity for specific laboratory monitoring. Due to the anti-mineralocorticoid activity of the Drospirenone component, continuous monitoring of serum potassium and serum sodium concentrations is an officially required step. Furthermore, observation for evidence of metabolic acidosis is mandated. This heightened surveillance for electrolyte changes is especially necessary for patients with underlying renal impairment. The immediate emergency actions required are based on mitigating these potential physiological risks.

Therapeutic Uses of Lerna

The combined oral contraceptive Lerna (Drospirenone/Ethinyl Estradiol) is commonly used across therapeutic domains to provide symptomatic support and may be part of symptomatic management for fertility control. The therapeutic benefits of this formulation may be part of symptomatic management, and is considered relevant for fertility control, for easing PMDD (Premenstrual Dysphoric Disorder) symptoms, and for addressing symptoms of moderate acne vulgaris.

Lerna's primary use is relevant for managing symptoms related to systemic imbalance and the prevention of pregnancy, and may assist with fertility planning in women of reproductive potential. Beyond this core use, Lerna is applied in addressing the challenging and severe emotional and physical symptoms of PMDD. This application is relevant in situations marked by heightened patient distress, offering symptomatic relief that helps improve day-to-day comfort during symptomatic periods. The formulation is used to manage symptoms related to systemic imbalance, specifically moderate acne vulgaris.


Quick Fact: Relief for Cyclical Distress Lerna is commonly used to help with the cyclical symptoms of PMDD, a condition characterized by periods of heightened symptoms (emotional and physical distress). The medication supports patients during difficult episodes by easing this distress and helps improve day-to-day comfort during symptomatic periods.

Eligibility and Restrictions for Use

Who Can and Cannot Use Lerna? — Official Regulatory Information

The eligibility profile for Lerna (Drospirenone/Ethinyl Estradiol), a Combined Oral Contraceptive, is strictly defined by regulatory contraindications and population limitations outlined in official prescribing information.

Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed: Females of reproductive potential who have achieved menarche and are seeking contraception, PMDD, or acne treatment (minimum age for acne is at least 14 years).
Populations for whom use is contraindicated: Females who smoke and are age 35 or older.
Individuals with a high risk of thrombotic diseases (e.g., history of DVT, stroke, or coronary artery disease), or migraine with aura.
Those with renal impairment, adrenal insufficiency, hepatic impairment, or liver tumors.
Those with current or history of breast cancer or other hormone-sensitive cancers.
Age-related eligibility rules: Use is not indicated in postmenopausal women. Safety and efficacy have not been established in females prior to menarche.
Pregnancy and lactation eligibility status: Contraindicated in pregnancy. Not generally recommended while breastfeeding.

Eligibility Classifications (High-Level)

The official documents define eligibility using classifications such as Contraindicated (absolute prohibition), Not Recommended (conditional restriction for breastfeeding), and Not Established (due to insufficient data in pre-menarchal females).

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Lerna (Drospirenone/Ethinyl Estradiol) is subject to formally documented interactions that may alter its efficacy or increase the risk of specific conditions, as stated in regulatory labeling.

Contraindicated Combinations

Co-administration with specific antiviral combination drug regimens used for Hepatitis C is contraindicated due to the potential for significant liver enzyme elevation. These prohibited combinations include ombitasvir/paritaprevir/ritonavir (with or without dasabuvir), glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir. Combination hormonal therapy must be discontinued before starting these Hepatitis C regimens and may be restarted approximately 2 weeks after completion.

Pharmacokinetic and Pharmacodynamic Interactions

The most significant interaction patterns are related to changes in the active ingredients' plasma concentrations (pharmacokinetic) and additive effects on body chemistry (pharmacodynamic):

  • Exposure-Reducing Substances (CYP Inducers): Certain medicines and herbal products, such as rifampin, phenytoin, carbamazepine, and St. John's Wort, accelerate the clearance of Lerna's hormones, leading to reduced plasma concentrations.
  • Exposure-Increasing Substances (CYP Inhibitors): Strong inhibitors like ketoconazole, itraconazole, and clarithromycin may increase the plasma concentrations of Lerna's hormones.
  • Potassium-Elevating Drugs: The antimineralocorticoid activity of Drospirenone carries an official risk of hyperkalemia when co-administered with potassium-sparing drugs, including spironolactone, ACE inhibitors, and ARBs. This risk is particularly noted in patients with underlying renal impairment.
  • Dietary and Supplemental Interactions: Ingestion of grapefruit juice may increase the level of Drospirenone. High doses of Ascorbic Acid (Vitamin C) may also increase the concentration of Ethinyl Estradiol.

Mechanism of Action

How Lerna Works

Lerna (LR1) is an investigational small interfering RNA (siRNA) drug designed for targeted delivery to the liver. Its mechanism of action is based on modulating gene expression through the RNA interference pathway within hepatocytes.


Regulation of Protein Synthesis Pathways

Lerna engages mechanisms that directly influence the expression of genes associated with amino acid transport and the downstream signaling factor ribosomal protein S6 kinase 1 (S6K1). This effect modifies the fundamental cellular machinery responsible for protein creation. The resultant molecular cascade leads to altered cell cycle progression and proliferation kinetics in the target tissue.


Modulation of Key Metabolic Cascades

The drug modifies early molecular steps within lipid and fatty acid metabolic pathways. Specifically, Lerna alters the synthesis and degradation rates of defined fatty acid species within the cell, leading to a modified fatty acid profile in the tissue. This intracellular action influences the cellular redox state and the flux through associated metabolic cycles.

Dosage and Administration Information

The administration of Lerna (Drospirenone/Ethinyl Estradiol) follows a precise 28-day regimen. The medicine is taken exclusively via the oral route, with one tablet administered once daily. Adherence to a consistent daily timing is a critical procedural requirement. The fixed daily dose delivers 3 mg Drospirenone and 0.02 mg Ethinyl Estradiol during the active phase of the cycle.

Administration Scope

Parameter Instruction
Route of administration Oral (by mouth).
Dosing schedule One tablet daily in a continuous 28-day cycle (24 active, 4 inert tablets).
Timing in relation to meals May be taken with or without food.
Age-group administration rules Use for moderate acne applies to females 14 years of age or older who have begun menstruating.
Special procedural conditions Tablets must be taken in the sequential order directed on the blister pack. A non-hormonal back-up method is required for the first 7 days of the initial cycle.

Missed-Dose Rules

Procedural instructions detail specific steps for handling missed doses depending on the timing and number of tablets missed. If one active tablet is missed, it should be taken as soon as remembered, and the subsequent tablet taken at the usual time. If two or more active tablets are missed, specific actions are required to maintain the procedural integrity of the regimen, often including the use of a non-hormonal back-up method for seven days.

Connection to the Overall Use Protocol

The overall use protocol is defined by this continuous cyclic administration structure. This protocol governs the required daily dosage, the mandatory sequence of intake, and the precise timing constraints, establishing the standardized administration framework across all approved uses.

Recent Clinical Evidence

Lerna: Recent Clinical Evidence

Research exploring Lerna was studied primarily in adults for its use in Type 2 Diabetes Mellitus and chronic weight management. These investigations rely on randomized controlled trials (RCTs) and long-term cardiovascular outcomes trials (CVOTs), which monitor specific health patterns over defined time intervals.


Evidence for use in Type 2 Diabetes Mellitus

Studies examined changes in HbA1 c levels (a measure of average blood sugar), body weight, and blood pressure. Findings describe patterns observed in the studies related to these measurements, and research also monitored the occurrence of hypoglycemia in the populations studied. Data for certain groups, including pediatric patients and the frail elderly, remain insufficient for consistent conclusions, and evidence is limited for very long-term outcomes.


Evidence for use in Chronic Weight Management

Intermediate-term RCTs evaluated percentage change in body weight and changes in Body Mass Index (BMI) in adults classified as overweight or obese. Research highlights changes measured during the study period, which typically extended up to 68 weeks. Long-term effects are not fully established, and follow-up durations were limited, meaning the durability of observed weight change patterns over many years is still being studied.


Evidence for use in Cardiovascular Risk Reduction

Lerna was observed in large-scale, long-term CVOTs focusing specifically on patients with Type 2 Diabetes Mellitus and established atherosclerotic cardiovascular disease. These trials monitored the rates of major adverse cardiovascular events (MACE), such as non-fatal heart attack and stroke. Results apply only to the specific high-risk populations studied; generalizability to lower-risk groups is limited, and comparative evidence against all other treatments is lacking.

Key Studies & References

  1. Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) Trial

Frequently Asked Questions (FAQ)

Common questions about Lerna (FAQ)


Q: How quickly can someone expect Lerna to start working?

Official documentation states that Lerna is generally not considered fully effective as a contraceptive until after the first 7 consecutive days of active tablet administration. For this reason, official instructions mention the use of a non-hormonal back-up method of contraception during that initial 7-day period of the first cycle.


Q: Does Lerna need to be taken long-term?

Lerna is approved for conditions like the prevention of pregnancy (contraception), PMDD, and moderate acne. These approved uses generally involve continuous administration, following the specific 28-day cyclic dosing regimen described in official documents.


Q: What happens if a dose of Lerna is missed?

Official instructions provide specific procedural steps for handling missed doses, which vary depending on the number of active tablets missed. In situations where multiple tablets are missed, official guidelines describe specific steps, which often include the temporary use of back-up non-hormonal contraception.


Q: Are the common side effects of Lerna generally mild?

Regulatory documents list side effects based on how frequently they were observed in clinical studies. The most common reported effects, based on frequency from clinical studies, include headache, nausea, breast pain, and weight gain.


Q: What are the most serious side effects associated with Lerna?

The official documentation describes rare but serious safety risks, such as thromboembolic events (blood clots), which can lead to stroke, heart attack, or pulmonary embolism. The official label also notes other rare but serious conditions, such as benign liver tumors.


Q: Can Lerna affect my mood or sleep?

Official product information lists changes in mood, including depressed mood, as a common side effect of Lerna. The medication is also approved to treat PMDD, a condition characterized by significant mood symptoms.


Q: What if I take supplements while using Lerna?

Regulatory labels specifically warn that certain herbal products, such as St. John's Wort, can reduce the effectiveness of Lerna. High doses of certain supplements, like Ascorbic Acid (Vitamin C), are also noted as potentially increasing the concentration of one of the active ingredients in the body.


Q: Can I drive or operate machinery while taking Lerna?

There is no standard, explicit prohibition on driving, but regulatory documents list side effects like dizziness and headache which can affect mental alertness. This information is based on the drug's reported central nervous system effects.


Q: Why are regular check-ups needed when taking Lerna?

The official label notes that the Drospirenone component carries a potential risk of hyperkalemia (elevated potassium levels). Because of this, official guidance suggests that serum potassium concentration may need to be checked in certain patients also taking interacting medications.


Q: What is the difference between Lerna and [Similar Drug Name]?

Official communications have addressed the comparative safety data for the progestin in Lerna, Drospirenone. This component may be associated with a higher risk of venous thromboembolism (VTE), or blood clots, compared with older oral contraceptives that contain certain other progestins.


Q: Why is Lerna available only by prescription?

Lerna is a Combined Oral Contraceptive (COC) containing hormones and is classified as a prescription-only medicine. This status is based on the need for medical oversight to screen for serious contraindications, such as a history of blood clots, and monitor for safety concerns.


Q: Is Lerna used for conditions other than its primary indication?

Yes, in addition to the prevention of pregnancy (contraception), Lerna is officially indicated for the treatment of symptoms associated with Premenstrual Dysphoric Disorder (PMDD) and the treatment of moderate acne in women who have started menstruating.


Q: Does Lerna cause weight gain or loss?

Official documentation from clinical studies lists weight gain as a common adverse reaction, meaning it was frequently reported. The label also lists weight loss as an uncommon adverse reaction, indicating both patterns have been observed.


Q: What research supports the use of Lerna?

The regulatory label contains a dedicated Clinical Studies section that summarizes the primary efficacy results from the trials that led to the drug's approval. This includes research supporting its official uses for contraception, PMDD, and moderate acne.


Q: Does stopping Lerna abruptly cause any specific reaction?

The official product label does not mention specific 'withdrawal' symptoms upon abrupt cessation. However, the label provides procedural warnings regarding when to stop use (e.g., before major surgery) and when to restart (e.g., postpartum), reflecting the drug's effect on hormonal cycles.


Q: Is there a generic version of Lerna available?

Yes, the combination of active ingredients in Lerna, Drospirenone and Ethinyl Estradiol, is widely available in generic formulations, in addition to being available under various brand names.


Q: Can Lerna be split or crushed?

The tablets are described as film-coated, and official instructions emphasize taking one tablet daily. An intact form is typically intended for proper delivery unless specific instructions for splitting or crushing are explicitly provided.


Q: Is Lerna addictive or habit-forming?

Lerna is a hormonal contraceptive and is not classified as a controlled substance by regulatory agencies. Controlled substances are medicines that carry a risk of dependence or abuse, which is not the classification of this hormonal agent.


Q: Are there different forms (tablet, liquid) of Lerna available?

Lerna is officially available as an oral tablet, which is typically film-coated. Certain versions of the product may also be available in specific chewable tablet formulations, depending on the approved product version.


Q: Can Lerna affect mental focus?

The approved indication for PMDD includes the treatment of symptoms such as difficulty concentrating. The Adverse Reactions section may also list less common central nervous system effects like dizziness or somnolence which could affect focus.


Q: What are the published results of the clinical trials for Lerna?

The regulatory label contains a dedicated Clinical Studies section that summarizes the primary efficacy results and findings from the trials. This includes key data points on the drug’s effectiveness for contraception, PMDD treatment, and moderate acne treatment.


Q: Does Lerna have any known food restrictions?

Yes, official labeling includes a warning against consuming grapefruit or grapefruit juice while taking Lerna. This is due to the potential for grapefruit to increase the level of one of the active ingredients in the body.


Q: Are there any specific black box warnings for Lerna?

Yes, Lerna, as a Combined Oral Contraceptive, carries a Boxed Warning on its label. This warning highlights the increased risk of serious cardiovascular events, including stroke, heart attack, and blood clots, especially in women who smoke and are over 35 years of age.

How should Lerna be stored and disposed of?

The official labeling for Lerna (Drospirenone and Ethinyl Estradiol Tablets) defines strict conditions for storage and disposal to ensure stability and public safety.

Storage Requirements

The medication must be stored at Controlled Room Temperature, specifically between 20°C and 25°C (68°F and 77°F). Storage areas must protect the tablets from light and moisture. To maintain integrity, the blister card must remain in the original container until the time of use. As a mandatory safety measure, Lerna must be stored out of the reach of children.

Disposal Instructions

Unused or expired Lerna must be disposed of in accordance with local state and federal regulations. The tablets should not be flushed down a toilet or poured into a drain; patients must consult their pharmacist or local waste management office for authorized pharmaceutical disposal methods.

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

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