ASUMATE

Quick links to important sections

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 ASUMATE

Quick Facts

Property Description
Active Ingredients Ethinyl Estradiol, Levonorgestrel
Form Oral Tablet (Combination Pill)
Pharmacological Class Combination Hormonal Contraceptive (CHC)
Common Use Prevention of Pregnancy (Contraception)
Origin Synthetic (Steroidal Hormones)

What Type of Medicine is ASUMATE and What is its Primary Classification?

ASUMATE is an oral tablet categorized pharmacologically as a Combination Hormonal Contraceptive (CHC), representing a standard composition widely employed in reproductive medicine. This classification places the drug within the Estrogen and Progestin Combinations, a class of therapeutic agents designed for systemic hormonal regulation. ASUMATE, like similar low-dose formulations such as Alesse or Aviane, is a prescription-only medication intended specifically for postmenarchal females. This formulation is clinically recognized for its role as a low-dose hormonal contraceptive, differentiating it from products that utilize single hormone components.

Composition and Origin: The Synthetic Hormonal Components

The active ingredients in ASUMATE are the synthetic hormones Ethinyl Estradiol and Levonorgestrel. Ethinyl Estradiol is a synthesized Estrogen derivative, while Levonorgestrel is a widely researched Progestin component, confirming the entire preparation's synthetic origin. This drug is delivered as an Oral Tablet via the oral route. The combination of these synthetic steroidal hormones is supported by pharmacological studies confirming the efficacy of this particular composition for achieving reproductive control.

General Purpose and Utility for Postmenarchal Females

The single, established therapeutic purpose of ASUMATE is the effective prevention of pregnancy, serving as a reliable method of Contraception. The utility of this Combination Hormonal Contraceptive is to provide females of reproductive potential with a consistent and systemic method of birth control. This general benefit is achieved by employing the combined hormonal action of Ethinyl Estradiol and Levonorgestrel to create a hormonal environment unfavorable for conception.

Regulatory References

  1. MedlinePlus Drug Information

What side effects are possible with ASUMATE?

Possible Side Effects and Safety Information

The safety profile for ASUMATE, containing Ethinyl Estradiol and Levonorgestrel, is classified by government regulatory documents into frequency and physiological system categories.

Officially Classified Adverse Reactions

Adverse reactions are formally categorized to reflect the estimated incidence, based on regulatory data:

Classification Examples of Reactions Estimated Incidence
Very Common Headache, irregular uterine bleeding, nausea, breast pain ge 1/10
Common Mood changes, migraine, weight gain, abdominal pain ge 1/100 to < 1/10
Uncommon Hypertension, chloasma, changes in libido ge 1/1,000 to < 1/100

Serious Documented Safety Concerns

The most clinically significant adverse reactions documented in official labeling relate to vascular risks. These include the risk of Venous Thromboembolism (VTE), such as Deep Vein Thrombosis and Pulmonary Embolism, and Arterial Thromboembolism (ATE), encompassing stroke and myocardial infarction. Other rare but serious documented events include hepatic tumors (liver tumors).

Population and Time-Related Safety Patterns

The official safety information includes specific constraints for certain populations and duration of use. The risk of VTE is documented to be highest during the first year a patient uses any combined hormonal contraceptive. Furthermore, use is strictly restricted for smokers over 35 years of age due to a significantly increased risk of serious cardiovascular events. Unscheduled bleeding is officially noted as common and expected during the first three cycles of treatment.

High-Level Restrictions

The regulatory profile specifies high-level constraints, including being contraindicated for individuals with a history of thrombotic events, active liver disease, or known hormone-sensitive malignancies like breast cancer.

Overdose and Emergency Response

Overdose and When to Seek Help

This information is derived from official government regulatory documents detailing the acute overdose profile for Combination Hormonal Contraceptives (Ethinyl Estradiol and Levonorgestrel).


Official Regulatory Statement Focus

Element Regulatory Statement
Documented Manifestations Nausea, vomiting, and withdrawal bleeding (vaginal bleeding).
Severe Outcomes Acute ingestion is generally associated with no serious sequelae or life-threatening adverse effects.
Management Symptomatic and supportive treatment is the primary procedure; no specific antidote is known.

Required Emergency Actions

The regulatory mandate is to seek immediate medical attention for suspected or confirmed overdose, regardless of the expected severity. Urgent consultation with emergency services is required following any over-ingestion. While acute overdose is documented as non-life-threatening, the need for clinical observation and supportive care must be determined by a healthcare professional.

Population-Specific Note

Withdrawal bleeding is a documented physiological effect that is expected to occur in females, including those who have not yet reached menarche (premenarchal females), following acute overdose.

Therapeutic Uses of ASUMATE

What ASUMATE Treats: Main Uses and Benefits

ASUMATE is primarily used to help prevent pregnancy. In addition to its main use, the medication is applied across domains where additional symptomatic support is needed, primarily focusing on conditions involving episodic or fluctuating manifestations related to the menstrual cycle.

The treatment is generally relevant for easing groups of symptoms that may become intense or disruptive, particularly those related to systemic imbalance and heightened physiological activity. It is commonly used across conditions characterized by periods of heightened symptoms, including those that manifest as issues with menstrual cycle regularity or skin health.

When symptoms create noticeable physiological strain, ASUMATE provides symptomatic support that supports patients during difficult episodes and contributes to easing the overall symptom load. The medication may assist with maintaining functional stability by addressing these underlying symptomatic patterns.


Quick Fact

Used for Managing Symptoms that Interfere with Daily Functioning

Eligibility and Restrictions for Use

Who Can and Cannot Use ASUMATE?

The official regulatory profile for ASUMATE is strictly defined by contraindications based on vascular risk, cancer history, and specific comorbidities. The medicine is intended solely for postmenarchal females of reproductive potential for pregnancy prevention.

Populations for Whom Use is Contraindicated

Use is contraindicated in females over age 35 who smoke due to the significantly increased risk of serious cardiovascular events. The medicine must not be used by individuals with a current or history of thromboembolic disorders (such as DVT, PE, or stroke), coronary artery disease, or conditions that increase the risk of blood clots. Further prohibitions include liver tumors, severe cirrhosis, undiagnosed abnormal uterine bleeding, and hormone-sensitive cancers like breast cancer.

Condition-Based and Age Restrictions

ASUMATE is contraindicated in the presence of uncontrolled hypertension, diabetes with vascular disease, and migraine headaches with aura. Use is not indicated before menarche or in postmenopausal women. It is also contraindicated during known or suspected pregnancy and is generally not recommended while breastfeeding. A key restriction requires that the medicine be stopped 4 weeks before and 2 weeks after major surgery.

What should I know about interactions with other medicines?

ASUMATE, a regimen containing daclatasvir and asunaprevir, has documented drug interaction risks arising primarily from the daclatasvir component's metabolic profile. The drug is both a substrate of CYP3A4 and an inhibitor of drug transporters including P-glycoprotein (P-gp), OATP1B1/1B3, and BCRP.

Contraindicated and Restricted Combinations

Co-administration with strong CYP3A inducers is contraindicated, as these medicines can significantly lower the concentration of daclatasvir in the blood. This reduction may lead to a loss of the drug’s effectiveness and potentially cause viral resistance. Examples of strong CYP3A inducers include rifampin, carbamazepine, phenytoin, and the herbal product St. John's wort.

Special caution and patient monitoring are required for combinations involving amiodarone with daclatasvir and sofosbuvir, as this combination has been associated with reports of serious symptomatic bradycardia (very slow heart rate) and heart block.

Altered Exposure of Other Medicines

Due to the drug's role as a transporter inhibitor, it may increase the plasma concentrations of certain co-administered medicines that are substrates of P-gp or other transporters. Examples of medicines that may require monitoring or dose adjustment when taken with daclatasvir include dabigatran and rosuvastatin. Many commonly used drugs, such as oral contraceptives and certain acid-reducing agents like famotidine, have been studied and showed no clinically relevant change in daclatasvir exposure.

Mechanism of Action

How ASUMATE Works: Mechanism of Action

ASUMATE operates through a layered pharmacodynamic action by engaging hormone receptors to suppress central regulatory processes and establish peripheral mechanisms.

Central Suppression of the HPO Axis

The synthetic hormones, particularly Levonorgestrel, function as agonists at their respective steroid hormone receptors, creating sustained negative feedback on the Hypothalamic-Pituitary-Ovarian (HPO) axis. This centralized mechanism inhibits the release of FSH and LH, eliminating the necessary LH surge signal. The physiological consequence of this blockade is anovulation, which is the primary mechanistic effect of the drug.

Local Modulation of Reproductive Tissues

The progestin component also exerts an effect on receptors within the cervical canal and the endometrial lining of the uterus. This peripheral action leads to an increase in the viscosity of cervical mucus, physically impeding sperm migration. Concurrently, it causes structural modulation of the uterine lining, which alters its cellular receptivity. This dual local effect contributes to the overall effect profile by establishing secondary physiological mechanisms.

Dosage and Administration Information

How ASUMATE is Used

ASUMATE (Ethinyl Estradiol/Levonorgestrel) is administered through a strict, repeating 28-day cyclic regimen. This structure governs the oral route of administration and the required consistency of daily intake.


Official Usage Guidelines

Instruction Entity Standard
Route of Administration The medication is taken orally as a tablet.
Dosing Schedule One tablet is taken once daily for 28 consecutive days, following a 21/7 cyclic pattern (21 days of active hormone tablets followed by 7 days of inactive/placebo tablets).
Timing & Consistency The tablet must be taken at the same time each day, and administration is performed without regard to meals.
Target Population Use is indicated exclusively for postmenarchal females of reproductive potential.

Procedural Protocol

Treatment initiation follows a specific protocol, such as the Day 1 Start (first day of the menstrual period) or the Sunday Start method. For continued use, the 28-day cycle must be repeated immediately after the preceding cycle is completed. There are precise procedural steps for handling missed active doses to guide the maintenance of the cycle. This entire framework—from initiation to the continuous repetition of the 28-day schedule—constitutes the established administration protocol.

Recent Clinical Evidence

Research evidence / Overview of studies for ASUMATE

Evidence for Use in Pregnancy Prevention (Contraception)

This section summarizes the core scientific research relating to the drug’s primary area of investigation, detailing the large-scale Randomized Controlled Trials (RCTs) and open-label effectiveness studies that were used to calculate the primary outcome measure (the Pearl Index) in healthy women of reproductive age.

The primary research for ASUMATE involves Randomized Controlled Trials (RCTs) and large, long-running observational studies. These are studies focusing on episodes where symptoms become more noticeable and studies explore patterns related to reproductive function. Researchers primarily measure how often unintended pregnancies occur in women using the medicine, an outcome tracked by the Pearl Index (PI). Studies also monitored biological markers, such as hormone levels, to observe patterns related to the suppression of ovulation.

Findings indicate that the research describes group patterns related to the suppression of ovulation in the women studied. Studies report how the rate of unintended pregnancies evolved in the observed populations, allowing researchers to calculate the PI under specific trial conditions. The evidence derives from settings with varying symptom burdens and reflects the use of a combined hormonal contraceptive, a class that was studied for this core purpose for decades.

Long-term effects are not fully established based only on the initial RCTs, as follow-up durations were limited (often up to one year) in the initial trials. Evidence related to outcomes in typical daily life remains uncertain because results apply only to the populations studied under the highly structured conditions of the research. Additionally, data for certain groups remain insufficient, especially regarding how the outcome measure may vary for women with higher Body Mass Index (BMI), meaning certainty remains low in these specific subgroups.


Evidence for Cycle-Related Outcomes and Bleeding Patterns

This part outlines studies that examined the effects of this combination on menstrual cycle predictability, including how researchers measured outcomes like dysmenorrhea (menstrual pain) and the frequency and characteristics of unscheduled bleeding and spotting during use.

Research has also explored outcomes related to systemic or functional imbalance, such as changes in the experience of physical discomfort during the menstrual cycle. Studies were used in research exploring how symptoms change over time and assessed patient-reported outcomes describing perceived discomfort, particularly in conditions characterized by fluctuating or episodic manifestations. The research focused on tracking cycle control, monitoring how women reported the frequency, duration, and incidence of unscheduled bleeding and spotting across different dosing regimens.

Studies reported patterns observed in the studies regarding how often women experienced bleeding outside of their expected time and how the intensity of menstrual pain (dysmenorrhea) evolved in the observed populations. Research highlights changes measured during the study period related to both cycle predictability and the reporting of physical symptoms. Studies monitored outcomes reflecting daily functioning or activity level in women who were experiencing symptoms linked to inflammatory or irritative states.

Evidence quality varies across studies, and many findings were mixed or highly dependent on how compliant women were with reporting their symptoms in daily diaries. Because many studies compared this medicine to other active hormonal pills, comparative evidence is lacking against a non-treatment group for these specific symptom changes. This means the research provides context but not individual predictions about short-term changes, and there is limited information for long-term outcomes regarding sustained changes in these cycle-related symptoms.


Long-Term Studies and Follow-Up Monitoring

This area addresses the data derived from studies that monitor use over extended periods, including the scope of long-term epidemiological surveillance used by regulatory bodies to track the safety profile of the combined hormonal contraceptive class over many years.

The hormone combination in ASUMATE has been studied in large-scale databases and observational cohorts spanning many years. This type of research, known as epidemiological surveillance, is applied in research contexts involving fluctuating or unstable symptoms and is applied in research to track outcomes that are too rare or take too long to appear in short-term clinical trials. These studies data show patterns related to long-term use across millions of women, contributing to the broader evidence landscape for this class of medicine.

Long-term effects are not fully established by the initial RCTs alone, as follow-up durations were limited in those studies. The available data on long-term outcomes primarily describe large-group patterns associated with outcomes that require long-term observation over many years of use. Findings describe group patterns, not personal outcomes, which are monitored continuously by regulatory agencies.


Evidence in Specific Subgroups

This section will summarize what published research exists for women with particular characteristics, focusing on evidence related to Body Mass Index (BMI) differences and the study populations used in clinical trials, without giving specific clinical advice.

Research was evaluated in specific subgroups to explore if the findings describing group patterns remained consistent across different body types. Studies were observed in populations divided by their Body Mass Index (BMI). These studies examine potential differences in outcomes for women with a higher BMI.

Research has examined whether effectiveness measures vary for women with higher BMIs, but these findings are generally based on smaller sample sizes within the overall trial populations. Subgroup findings are uncertain due to the modest sample sizes, meaning the results apply only to the populations studied, and certainty remains low when trying to apply these patterns broadly. Data for certain groups remain insufficient, especially for those with specific comorbidities or varying health statuses outside of the healthy populations included in the primary trials.


Key Limitations and Areas of Research Uncertainty

This concluding part will synthesize the research constraints and acknowledged gaps, clarifying the difference between "perfect use" efficacy measured in trials and "typical use" effectiveness, and highlighting areas where more data is still needed or where findings remain heterogeneous.

A key limitation across much of the effectiveness research is the difference between the environment of a clinical trial and typical daily use. Studies report patterns related to use where women follow the instructions precisely ("perfect use"), but findings describe group patterns, not personal outcomes, and real-world outcomes may differ from those observed in trials.

Evidence quality varies across studies, especially for secondary outcomes like symptom relief, where outcomes rely heavily on patient-reported outcomes describing perceived discomfort and are therefore highly subjective. Follow-up durations were limited in many primary effectiveness studies, meaning the research provides context but not individual predictions about long-term maintenance or durability of effect. Additionally, comparative evidence is lacking for many outcomes against non-treatment groups, as trials often compare this pill to other active hormonal contraceptives. Long-term effects are not fully established outside of large, post-marketing observational cohorts.

Key Studies & References Oral Contraceptive Pills - StatPearls (Reference for typical/perfect use rates and non-contraceptive benefits like dysmenorrhea reduction)

Frequently Asked Questions (FAQ)

Common questions about ASUMATE (FAQ)


Q: How quickly does ASUMATE usually start working?

Official product information describes that the body requires at least 7 days to adjust and achieve the intended effect. Because of this, a backup contraceptive method is typically recommended during the first 7 days after starting the medicine for the first time. Effectiveness depends on consistent and correct daily use after this initial period.


Q: What is the difference between ASUMATE and other medicines for the same condition?

ASUMATE is classified as a combination hormonal contraceptive (CHC). Official product information suggests that the primary distinctions among products in this class are based on the specific dose of the synthetic hormones (Ethinyl Estradiol and Levonorgestrel) and the chosen regimen. Regulatory documents show that combination pills are available in various strengths and dosing schedules.


Q: Is it normal to feel tired after starting ASUMATE?

Unusual weakness or fatigue is not listed as a very common side effect in regulatory documents. However, this symptom is noted as a possible accompaniment to mood changes or depression, which are known common side effects. Any significant or persistent change should be discussed with a healthcare provider.


Q: Can ASUMATE cause problems with sleep?

Sleep problems are not noted as a primary side effect in the regulatory labeling. They are sometimes mentioned as a symptom that can accompany mood changes or depression, which is a common side effect for some users. This effect is generally attributed to the drug’s systemic action, as noted in official sources.


Q: Are there any common foods or drinks that should be avoided while taking ASUMATE?

While the official guidelines state the medicine can be taken without regard to meals, regulatory documents list categories of food and alcohol interactions. These interactions may have the potential to affect the drug's concentration in the body. The drug's patient information materials can provide more specific details regarding potential restrictions.


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

Studies and regulatory sources indicate that the drug's components may have potential interactions with certain common over-the-counter pain relievers. This includes medicines such as acetaminophen. It is important to review the official interaction section for a complete view of affected products.


Q: Is ASUMATE considered safe for long-term use?

The long-term safety of this class of medicine is continually monitored through large-scale, long-term epidemiological surveillance. However, official labeling lists specific, rare long-term risks, such as hepatic tumors and cardiovascular events. These specific risks are continually tracked by health authorities.


Q: How long do the effects of ASUMATE typically last?

The medication is designed to be taken once daily at the same time every 24 hours. The consistent 24-hour interval is necessary to ensure the maintenance of hormonal levels for intended use. This schedule is a critical part of the administration protocol.


Q: Is there a generic version of ASUMATE available yet?

Yes, the active ingredients in ASUMATE (Ethinyl Estradiol and Levonorgestrel) are commonly available in various generic tablet forms. These generic options are approved by regulatory agencies and are used in place of the brand-name product.


Q: Are there any known issues with taking ASUMATE with herbal supplements?

Official labeling specifies that certain herbal products, particularly those classified as strong CYP3A enzyme inducers like St. John's wort, are contraindicated. Regulatory documents state that these substances may significantly reduce the concentration of the drug in the body, potentially compromising effectiveness.


Q: Are there any ongoing clinical trials for ASUMATE?

Information on ongoing clinical trials for medicines is maintained by government health agencies on trial registries, such as the NIH's ClinicalTrials.gov. These regulatory registries provide the most current and official status of research activity.


Q: Do I need any special lab tests before or during ASUMATE treatment?

Regulatory documents state that a periodic history and physical examination is appropriate, and this often includes relevant laboratory tests. Patients with certain pre-existing conditions, such as hyperlipidemias or liver issues, may require specific monitoring of blood lipids or liver function.


Q: What should I do if I notice a change in my appetite after starting ASUMATE?

Changes in appetite are listed as a possible side effect in regulatory sources. However, loss of appetite is also specifically noted as a symptom associated with potential liver injury, which is a serious, rare adverse reaction. Any significant or persistent change should be discussed with a healthcare provider.


Q: Is ASUMATE habit-forming or addictive?

According to the official product information and regulatory classifications, ASUMATE is not listed as a controlled substance. It is not considered to be a medication with habit-forming or addictive properties.


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

The official documentation does not contain a general prohibition against driving or operating machinery while using this medicine. However, side effects such as dizziness or sudden severe headaches are noted in regulatory documents. Caution is advised if these symptoms occur.


Q: Does ASUMATE have any withdrawal effects if stopped suddenly?

The cessation of ASUMATE does not cause typical drug withdrawal symptoms, as it is not an addictive medication. Instead, normal ovarian function and previous menstrual patterns are expected to return after stopping the medicine.


Q: What should I know about ASUMATE and alcohol consumption?

Regulatory information notes that the medication may have interactions with alcohol. This is listed in the same category as certain food interactions. Referencing the drug’s patient information materials can provide specific details regarding restrictions or monitoring requirements.


Q: Can ASUMATE be used by people with kidney problems?

The official regulatory profile indicates that use is generally contraindicated for patients with severe kidney problems, such as those undergoing hemodialysis or peritoneal dialysis. For others with renal disease, specific guidance for use may not be established in official labeling.


Q: Do all versions of ASUMATE contain the same active ingredients?

Yes, all brand and generic versions of this specific combination hormonal contraceptive formulation must contain the same two active ingredients. These ingredients are Ethinyl Estradiol and Levonorgestrel, as defined in regulatory documentation.


Q: Can ASUMATE interfere with vitamins or mineral supplements?

Regulatory documents include potential interactions with certain vitamins (e.g., Vitamin B12) and nutritional supplements (e.g., fish oil). These interactions may potentially affect the drug’s effectiveness or cause altered exposure.


Q: How long does it take for side effects from ASUMATE to usually go away?

Official labeling notes that some common side effects, such as irregular or breakthrough bleeding and spotting, are expected, particularly during the first three months of treatment. This period is generally understood as the time for the body to adjust.


Q: Does ASUMATE affect blood sugar levels?

Regulatory documents list a specific warning that the medication may decrease glucose tolerance in some users. This means the medicine could influence the body's ability to process sugar. Patients with diabetes may require closer monitoring, as noted in official warnings.


Q: Are there different strengths or doses of ASUMATE available?

Combination hormonal contraceptives with these active ingredients are available in many different strengths and dosage regimens. Regulatory documents list various strengths for the Ethinyl Estradiol component, and packages may follow different cyclic patterns, such as monophasic, triphasic, or extended-cycle.


Q: Can ASUMATE be crushed or broken if I have trouble swallowing pills?

The oral tablet is intended to be swallowed whole as directed. Official product information does not include instructions permitting the tablet form to be crushed, cut, or otherwise altered.


Q: What are the signs of a serious allergic reaction to ASUMATE?

Official patient labeling includes signs of a serious allergic reaction, which can involve hives, difficult breathing, or itching. Symptoms of a serious allergic reaction may include swelling of the face, eyes, lips, tongue, or throat, as noted in regulatory documents.


Q: What is the expected experience when starting ASUMATE?

The expected initial experience is a synthesis of the medicine's protocol and potential common side effects. This involves adhering to a consistent schedule and typically requires the use of a backup contraceptive method during the initial week. Users may experience transient side effects, such as headache or irregular bleeding, during the first few cycles.


Q: Can ASUMATE be used with certain depression medications?

Official drug interaction lists include numerous common depression and psychiatric medications that have the potential to interact with this drug. Regulatory sources indicate that these interactions may sometimes potentially impacting its effectiveness.


Q: Do I need a follow-up appointment soon after starting ASUMATE?

Official labeling states that periodic follow-up visits and physical examinations are an appropriate part of the ongoing care for all women using this medication. This allows for a regular assessment of health status and potential side effects.

How should ASUMATE be stored and disposed of?

How to Store and Dispose of ASUMATE

This information details the official storage, handling, and disposal requirements for ASUMATE, based on regulatory documentation.

Storage and Handling

ASUMATE must be stored in a cool, dry place and the container must be kept tightly closed to protect the contents. During handling, individuals must wear protective gear, such as goggles or safety glasses and rubber gloves, and avoid breathing the dust from the powder. After handling the product, individuals must wash thoroughly with soap and water before eating, drinking, or using tobacco.

Disposal Requirements

For disposal, it is critical not to contaminate food, water, or feed. The material must be discarded according to institutional procedures and applicable State, Federal, and Local regulations. The product is officially classified as toxic to fish and aquatic organisms, which governs environmental disposal constraints and necessitates adherence to controlled-waste procedures.

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

Available in countries:

Equivalent of ASUMATE found in:

A-Z Index: