Lafamme

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Lafamme

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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 Lafamme

What is Lafamme? Foundational Identity and Classification

Property Description
Active ingredients Dienogest, Estradiol Valerate
Form Oral Tablet (Film-coated)
Pharmacological class Combined Sex-Hormonal Preparation / Combined Oral Contraceptive (COC)
Common use Contraception, heavy menstrual bleeding (menorrhagia)
Origin Synthetic Hormones (Steroid)

What Type of Medicine is Lafamme and Its Purpose?

Lafamme is defined as a Combined Sex-Hormonal Preparation, a classification that places it among oral medicines containing a blend of both estrogen and progestogen for systemic effect. Its primary identity is that of a Combined Oral Contraceptive (COC), designated as a prescription-only medication in the form of oral tablets. The medication has a general dual therapeutic purpose: serving as contraception and providing targeted treatment for heavy menstrual bleeding (menorrhagia) in appropriate patients. This specific combination allows for a multiphasic dosing regimen in certain formulations, a distinctive feature compared to many traditional monophasic COCs.

Lafamme’s Composition: The Combination of Estradiol and Dienogest

The medication's action is rooted in its two active ingredients: Estradiol Valerate and Dienogest. Estradiol Valerate is the estrogen component, functioning as a precursor that the body converts into 17β-estradiol, the human endogenous estrogen. Dienogest is the progestogen component, structurally recognized as a 19-nortestosterone derivative. This component is characterized by a profile that includes high binding to the progesterone receptor and antiandrogenic properties. This combination of synthetic hormones provides a targeted hormonal regulation profile.

How Does Lafamme Generally Achieve Its Effect?

The core mechanism principle involves the systemic regulation of the hormonal cycle through the introduction of these hormones, fundamentally resulting in the inhibition of ovulation. Furthermore, the potent progestogenic activity of Dienogest specifically acts upon the lining of the womb (endometrium), modifying it to contribute to the general benefit of reducing excessive menstrual flow. This makes Lafamme relevant in a typical use scenario where a woman seeks both reliable contraception and relief from heavy periods.

What side effects are possible with Lafamme?

Possible Side Effects and Safety Information

The following information summarizes the high-level safety patterns and adverse effects of this combined hormonal preparation, as documented in official government regulatory labeling. The description is strictly neutral and medically grounded.


Officially Classified Common Adverse Reactions

Based on clinical trial data, common adverse reactions (reported in ge 2% of patients) are noted across several physiological systems. These effects are often more frequently observed during the initial months of treatment. Common reactions officially listed include Headache (including Migraines), Breast pain, various Menstrual disorders (e.g., irregular bleeding), Nausea/Vomiting, Acne, Mood changes (including depressed mood), and Increased body weight.


Serious Vascular and Thromboembolic Safety Risks

The use of this medication is associated with a regulatory risk for serious cardiovascular events, notably Venous Thromboembolism (VTE), which includes Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), as well as Stroke and Myocardial Infarction. The risk of VTE is highest during the first year of use or when restarting after a break of four weeks or more. This risk is significantly amplified for women over 35 years of age who smoke.


Safety Constraints and Special Populations

Official labeling defines specific safety constraints. The medication is contraindicated in women with uncontrolled hypertension, vascular disease, or migraines with aura. Use is restricted in the postpartum period (not before four weeks in non-breastfeeding women) and is contraindicated in cases of severe hepatic impairment. Safety and efficacy are not established for women with a BMI greater than 30 kg/m^2.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Lafamme, a combined sex-hormonal preparation, outlines the specific clinical manifestations expected following an acute overdose. Overdose is generally classified as not likely to result in serious adverse effects, consistent with regulatory findings for this class of medicine.

Documented Clinical Manifestations

Symptoms primarily affect the gastrointestinal system, including nausea and vomiting. A common reported sign is vaginal bleeding, often described as withdrawal bleeding, which may occur a few days after the exposure.

Mandatory Emergency Actions

It is officially mandated that an individual seek immediate medical attention following any suspected overdose. Emergency services or a certified Poison Help line should be contacted for urgent guidance. This action is required even when symptoms appear mild.

Management and Supportive Measures

No specific antidote is known for this overdose. Treatment, if necessary, is strictly symptomatic and supportive. This approach involves monitoring vital signs, blood and urine testing, and may require hospital observation. In extreme cases, regulatory information mentions the potential use of interventions such as activated charcoal and intravenous fluids to manage the overdose situation.

Therapeutic Uses of Lafamme

What Lafamme Treats: Main Uses and Benefits

The primary therapeutic applications of this medication address two distinct but related gynecological domains. The medication is commonly used when patients present with symptoms that create noticeable physiological strain and require sustained symptomatic support. Established therapeutic uses include effective pregnancy prevention and the symptomatic management of heavy menstrual bleeding (Menorrhagia).

Lafamme is applied across domains where additional symptomatic support is needed, and is relevant in clinical contexts that involve sustained support for reproductive health and recurrent excessive menstrual flow. This dual approach assists patients who are coping with their reproductive planning while managing symptoms that interfere with daily functioning.

“This use supports general comfort during symptomatic phases and may assist with easing associated menstrual discomfort.”

This use is relevant for managing the symptoms of heavy bleeding, and generally contributes to easing the overall burden of distressing manifestations. Beyond its core indications, the use of this medication generally assists with predictable and regular menstrual cycles.


Quick Fact: Relief for Heavy Bleeding The medication is applied in conditions marked by heightened symptoms of menstrual flow and assists with maintaining a sense of stability during episodes of heightened discomfort by contributing to a reduction in blood volume.

Eligibility and Restrictions for Use

Lafamme is officially indicated for women of reproductive potential for whom contraception or treatment of heavy menstrual bleeding is appropriate. Regulatory documents strictly define certain populations for whom use is prohibited.

Population Eligibility Status (Regulatory Wording)
Thrombotic Risk Contraindicated in current or history of venous or arterial thromboembolic events (e.g., DVT, stroke).
Cancer & Liver Health Contraindicated in breast cancer or other hormone-sensitive cancers, and in active liver disease or severe hepatic impairment.
Pregnancy/Lactation Contraindicated in pregnancy or suspected pregnancy. Not recommended during breastfeeding.
Age Contraindicated before menarche. Not indicated for postmenopausal women.
Vascular Health Contraindicated in migraine with focal neurological symptoms (aura), and in women over age 35 who smoke.

Use is also contraindicated in cases of undiagnosed abnormal uterine bleeding or known hypersensitivity to the components. The medication is not indicated for pre-pubertal children or postmenopausal women. The label advises that the medicine should be discontinued at least four weeks before and two weeks after major surgery due to the risk of thromboembolism. Efficacy has not been evaluated in women with a BMI over 30 kg/m^2.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines officially documented interaction patterns for Lafamme (Dienogest/Estradiol Valerate) based on government regulatory labeling.

Classification Examples of Interacting Substances Official Interaction Outcome
Contraindicated Combinations HCV regimens (e.g., Ombitasvir/Paritaprevir/Ritonavir pm Dasabuvir, Glecaprevir/Pibrentasvir) Risk of Hepatic Transaminase Elevations (ALT increases)
Enzyme Inducers Phenytoin, Carbamazepine, Rifampicin, St. John’s Wort Decreased plasma concentrations of active hormones
Enzyme Inhibitors Azole antifungals (e.g., Ketoconazole), Macrolide antibiotics (e.g., Erythromycin) Increased plasma concentrations of active hormones

The primary documented interactions are pharmacokinetic, resulting from co-administered medicines that alter the metabolic breakdown of the hormonal components, mainly through CYP3A4 enzyme induction or inhibition. Enzyme-inducing substances may reduce the exposure to Estradiol and Dienogest, while inhibitors may increase their exposure. Furthermore, the use of Combined Oral Contraceptives can affect the metabolism of other co-administered drugs, such as potentially increasing the concentrations of Ciclosporin or decreasing the concentration of Lamotrigine. These label-based restrictions establish mandatory prohibitions, such as those against specific HCV regimens, to avoid documented interaction-related risks.

Mechanism of Action

Lafamme is a fixed-dose combination containing estradiol valerate and dienogest.

Estradiol valerate functions as a prodrug that is rapidly hydrolyzed in vivo to 17β-estradiol. Estradiol acts as an agonist at the nuclear Estrogen Receptor (ER), including the ERalpha and ERbeta subtypes, which are present in numerous tissues including the uterus, bone, and central nervous system. Upon binding, the receptor-ligand complex translocates to the nucleus and binds to specific DNA sequences, modulating the transcription of target genes, which affects protein synthesis and cellular function in responsive tissues.

Dienogest is a progestogen that acts as an agonist with a high degree of selectivity for the Progesterone Receptor (PR). Its binding and activation of the PR primarily impact the uterus, where it exerts a progestagenic effect on the endometrium, promoting a reduction in proliferation and inducing decidualization. Dienogest also acts as an antagonist at the Androgen Receptor (AR).

The combined actions of the two components modulate the hypothalamic-pituitary-ovarian (HPO) axis, resulting in altered circulating levels of gonadotropins and endogenous ovarian steroid hormones. System-level physiological consequences include changes in bone turnover markers, lipid parameters, and endometrial morphology.

Dosage and Administration Information

How to Use Lafamme

Lafamme (Estradiol Valerate/Dienogest) is an oral tablet that is administered daily in a sequential regimen. The product is taken continuously in 28-day cycles, which utilize a quadriphasic dosing schedule where the strength of the two active ingredients changes over four distinct phases.

Administration Protocol

Treatment requires taking one tablet daily by mouth at the same time every day. Tablets must be consumed in the precise sequential order directed on the blister pack, as this structure is essential to the overall use protocol. A new 28-day pack is started immediately after the previous one is completed.

Cycle Days Estradiol Valerate (EV) Dienogest (DNG) Tablet Type
Days 1–2 3 mg 0 mg Active
Days 3–7 2 mg 2 mg Active
Days 8–24 2 mg 3 mg Active
Days 25–26 1 mg 0 mg Active
Days 27–28 0 mg 0 mg Inert

Specific Use Conditions

When initiating the medication, dosing is typically started on the first day of the menstrual cycle. A non-hormonal back-up method is required for the first 9 days of the initial treatment cycle. If a dose is skipped or delayed by more than 12 hours, a specific procedural protocol must be followed. Regarding specific populations, the same regimen is used for post-pubertal adolescents, and initiation is advised no earlier than four weeks postpartum for non-breastfeeding women. Efficacy has not been studied in women with a Body Mass Index (BMI) greater than 30 kg/m^2.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Lafamme

This section describes the structure of the available clinical research, outlining the types of studies that have been conducted for each approved use. It summarizes what researchers studied and what findings were described in a neutral way, without offering any clinical advice or interpretation of results. Study results reflect the specific conditions under which they were conducted and do not determine whether an individual will respond similarly.


Evidence Supporting Use for Contraception (Pregnancy Prevention)

Research exploring how symptoms change over time for the purpose of pregnancy prevention was primarily evaluated in large, multi-site Phase III clinical trials. These studies focused on healthy adult women of reproductive age who were seeking contraception. The studies largely utilized an open-label design.

  • Study Design: Trials utilized an open-label design and compared the medicine to other active contraceptives or involved no non-hormonal placebo comparator.
  • Outcomes Measured: The central measurement monitored was related to Pregnancy Rates, quantified using the Pearl Index (PI)—a calculation of the number of unintended pregnancies that occur per 100 women using the method for one year.

Studies report on the patterns observed in the studies that were included in the regulatory assessment for this class of medicine. Studies reported measurements of the Pearl Index across the different groups observed, with data collected over intermediate follow-up periods. These findings help contextualize how the medicine was observed in a controlled clinical setting, but research does not determine whether an individual will respond similarly in real-world use.

Research has explored that the core pivotal trials were of intermediate duration, typically covering about one year of use. Long-term effects are not fully established beyond this initial observation period, which limits insight into efficacy patterns or very rare events over many years. Furthermore, data are still emerging for specific groups, as the primary trials often excluded women with certain health conditions or higher body mass index (BMI ge 32 kg/m^2), meaning findings do not apply to these groups.


Evidence Supporting Use for High-Volume Menstrual Flow (Menorrhagia)

This indication was evaluated in short-term Randomized, Double-Blind, Placebo-Controlled Trials (RCTs). These studies were applied in research contexts involving women who were experiencing conditions characterized by high-volume menstrual flow. A double-blind, placebo-controlled design was utilized to examine symptomatic treatments.

  • Study Design: Trials used a double-blind, placebo-controlled design.
  • Outcomes Measured: Researchers examined and monitored volume measurements related to menstrual flow using a specific scientific method. They also examined outcomes related to systemic or functional imbalance, specifically looking at blood markers such as hemoglobin and ferritin levels.
  • Populations: Studies focused on women who met the entry criteria for high-volume menstrual flow but without any underlying structural causes of the uterus, such as fibroids or polyps.

Studies report on the patterns of changes measured during the study period when comparing the group that used the medicine to the group that used a placebo. The findings describe patterns observed in the studies regarding the measurements of menstrual flow volume and how outcomes related to blood markers evolved over the defined study interval. Reported outcomes were short-term and limited to a primary efficacy phase of approximately 90 days.

The existing studies provide limited direct comparative data against other forms of medical therapy, as the key trials used only a placebo comparator. Additionally, the research focused specifically on women without underlying uterine conditions, meaning data for those with structural issues are limited.

Frequently Asked Questions (FAQ)

Common questions about Lafamme (FAQ)

Q: How is Lafamme different from other medicines used for the same condition?

A: According to official product information, Lafamme is a combined oral contraceptive (COC) that is distinguished by its quadriphasic dosing schedule, meaning the dosage of the active ingredients changes across four phases during the 28-day cycle. Furthermore, studies indicate that the estrogen component (estradiol valerate) may have less pronounced effects on hemostatic parameters compared to COCs containing ethinylestradiol, as noted in studies.


Q: Is it true that Lafamme causes weight gain?

A: Official regulatory documents list Increased body weight as a common adverse reaction observed in clinical trials. This indicates that weight increase was reported in ge 2% of patients during clinical studies. This effect is often noted more frequently during the initial months of using the medication.


Q: Can Lafamme be taken with vitamins or herbal supplements?

A: Official documents require users to inform their healthcare provider about all vitamins, supplements, and herbal products they use. Regulatory labeling specifically names St. John’s Wort as a potent enzyme inducer that may reduce the concentration of the active hormones in the body. Other supplements may also alter the effectiveness of Lafamme, and official guidance emphasizes the need to inform a healthcare provider about all such products.


Q: Is it important to take Lafamme at the exact same time every day?

A: Yes, the administration protocol outlined in official labeling requires taking one tablet daily by mouth at the same time every day. Following this routine is essential for the effectiveness of the regimen. Specific missed-dose protocols are based on the time delay from the scheduled dose.


Q: Does Lafamme affect fertility in men or women?

A: As an oral contraceptive, the medicine works by preventing pregnancy through hormonal regulation. Official product information confirms that this contraceptive effect is intended to be reversible upon discontinuation. Regulatory documents do not define or warn about a long-term impairment of fertility associated with discontinuation.


Q: Are there any reports about Lafamme causing a change in mood?

A: Yes, official regulatory labeling classifies Mood changes (which includes depressed mood) as a common adverse reaction observed in clinical trials. If persistent or concerning changes in mood are experienced, medical guidance should be sought.


Q: Why do some people say they didn't feel any effect from Lafamme?

A: Official research evidence notes that efficacy has not been established or evaluated in women with a Body Mass Index (BMI) greater than 30 kg/m^2. The lack of study in this specific population is a limitation noted in the official research evidence.


Q: Can Lafamme be safely taken by someone with diabetes or high blood pressure?

A: Official safety constraints note that Lafamme is contraindicated in women with uncontrolled hypertension or hypertension with associated vascular disease. For women with prediabetes or diabetes, regulatory documents advise that they must be monitored while taking the medication due to the potential for changes in carbohydrate and lipid metabolism.


Q: What do official sources say about Lafamme's potential to cause headaches?

A: Regulatory documents explicitly list Headache (including Migraines) as an officially classified common adverse reaction observed in clinical trials. These types of effects are noted in ge 2% of patients in the studies.


Q: Can Lafamme be safely given to children?

A: Lafamme is contraindicated (prohibited) before menarche (the first menstrual period). Official product information states that the same adult regimen is typically used for post-pubertal adolescents, meaning it can be prescribed after puberty, but only as directed by a healthcare professional.


Q: Can Lafamme be used by adults over 65?

A: Lafamme is a combined oral contraceptive and is not indicated for postmenopausal women or generally for women over age 65. Its intended use is strictly limited to women of reproductive potential.


Q: Does Lafamme interact with alcohol?

A: Some interaction databases cite alcohol (Ethanol) as having a minor potential interaction with the dienogest component of the medication. Official guidance related to alcohol and this medication advises that consumption habits should be discussed with a healthcare provider.


Q: Is there any information on Lafamme's use during pregnancy or breastfeeding?

A: Yes, regulatory documents clearly state that Lafamme is contraindicated (prohibited) in cases of existing or suspected pregnancy. It is also not recommended during breastfeeding because the hormonal components may decrease the production of breast milk.


Q: Does Lafamme affect sleep or cause drowsiness?

A: Official labeling of common adverse effects does not specifically list drowsiness or significant sleep effects. However, some related central nervous system effects, such as Headache and Mood disturbances, are classified as common adverse reactions.


Q: If I am feeling better, is it safe to stop taking Lafamme?

A: Regulatory documents do not recommend abrupt discontinuation of use, particularly if stopping is related to surgical procedures or other risk factors. Discontinuation decisions require the evaluation of a healthcare professional.


Q: Are there any food or drinks that should be avoided while taking Lafamme?

A: Official interaction data indicates that Grapefruit or grapefruit juice should be avoided or limited. This is because it may increase the plasma concentrations of the hormonal components in the body.


Q: Does Lafamme lose its effectiveness over time?

A: Regulatory studies assessing the effectiveness of Lafamme typically cover a duration of up to one year. Within this observed period, the effectiveness (measured by the Pearl Index) is generally stable, indicating continued effectiveness over the studied duration.


Q: What is the official information regarding Lafamme and driving or operating machinery?

A: Official regulatory documents typically state that the medicine is unlikely to have any effect on the ability to drive or use machines. Possible adverse effects such as headache or dizziness should be considered by the user.


Q: Is it common for people to have a skin rash or allergic reaction to Lafamme?

A: Official documents list Acne and Chloasma (skin discoloration) as common skin-related adverse effects. A general skin rash and serious allergic reactions have been reported but are generally classified as less common or rare adverse reactions in official labeling.


Q: Does Lafamme affect blood tests or lab results?

A: Yes, official labeling notes that the use of combined hormonal contraceptives can interfere with the results of certain laboratory tests. This interference may include tests related to the biochemical parameters of liver, thyroid, adrenal, and renal function.


Q: Is Lafamme considered safe for people with a history of seizures?

A: While not listed as a direct contraindication, official warnings advise caution in patients with conditions that may be negatively affected by fluid accumulation, such as epilepsy. The exacerbation of epilepsy has been reported with the use of estrogen/progestin therapy.


Q: What is the official guidance on managing minor stomach upset from Lafamme?

A: Official documents list mild gastrointestinal issues like nausea as a common adverse reaction. Patient materials sometimes advise taking the tablet with or immediately after food to help reduce this kind of minor stomach upset.


Q: Do I need to carry an alert card while taking Lafamme?

A: In some regions, regulatory risk management plans (RMPs) require that a Patient Information Card be provided with the medicine. This card serves to address the serious risk of Venous Thromboembolism (VTE) and other vascular events associated with combined hormonal contraceptives.


Q: Are there any known issues with Lafamme and eye health or vision?

A: Official safety documents include warnings related to Retinal Vascular Thrombosis (a serious, rare vascular event that affects the eye). Additionally, intolerance to contact lenses has been reported as an adverse reaction in clinical experience.


Q: What should I do if a side effect does not go away after a few weeks?

A: Regulatory documents note that common adverse effects are often expected to subside after the initial months of use. Official guidelines indicate that if side effects are serious, persistent, or cause concern, medical advice is warranted.


Q: Is Lafamme only for severe cases of the condition it treats?

A: No. The medication is officially indicated for the treatment of heavy menstrual bleeding (menorrhagia) and for pregnancy prevention. Regulatory labeling does not define or limit its use to only 'severe' cases of the conditions it is approved to treat.


Q: What is the duration of action for a single dose of Lafamme?

A: Official pharmacokinetic data describes how the hormones are processed by the body. The half-life of the dienogest component is approximately 9 to 10 hours, and the estradiol component is approximately 12 to 20 hours after oral administration. Half-life refers to the time it takes for the concentration of a substance in the body to be reduced by half.


Q: Do official patient leaflets discuss long-term safety data for Lafamme?

A: Yes, regulatory documents and risk management plans address the need for continuous monitoring and outline the risks. They also confirm that the primary clinical trials typically covered approximately one year of use, which limits the insight into long-term effects over many years.

How should Lafamme be stored and disposed of?

How to Store and Dispose of Lafamme?

The storage and disposal of Lafamme (Estradiol Valerate and Dienogest) must adhere strictly to the conditions specified in official regulatory labeling to ensure product stability and safety.

Official Storage Requirements

The tablets require storage at Controlled Room Temperature, which is defined as 20 C to 25 C (68 F to 77 F), with permitted brief temperature excursions between 15 C and 30 C. It is mandatory to keep the medicine in its original container and blister packs to protect the synthetic hormones from moisture and light. The product should not be refrigerated or frozen.

Handling and Disposal Rules

It is required to keep this and all medicines out of the sight and reach of children. Unused or expired tablets must not be flushed down the toilet or placed in wastewater systems. Disposal should occur through an official medicine take-back program or by following local guidelines for discarding pharmaceuticals.

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

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