Anastris

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Medically reviewed

Rosario Oropesa

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 Anastris

Quick Facts

Property Description
Active ingredient Anastrozole (INN)
Form Oral tablet, film-coated
Pharmacological class Selective Non-Steroidal Aromatase Inhibitor (AI)
Common use Hormonal therapy in estrogen-sensitive conditions
Origin Synthetic, 1,2,4-Triazole derivative

What Type of Medicine is Anastris (Anastrozole)?

Anastris is classified as a Selective Non-Steroidal Aromatase Inhibitor (AI) and is utilized in hormonal therapy. The active component, the generic substance Anastrozole, is a synthetic compound derived from the 1,2,4-Triazole chemical structure. This classification identifies it as an Antiestrogen whose primary mechanism is to significantly reduce the body’s estrogen levels. The pharmacological profile of the Anastrozole compound supports its use in this targeted approach.

This reduction is achieved because Anastrozole acts as a potent competitive inhibitor of the aromatase enzyme, which is responsible for the process of estrogen biosynthesis—the conversion of androgens into estrogens in peripheral tissues. By blocking this enzyme, the medication provides a targeted approach to suppressing estrogen production. The primary goal of this inhibition is to stop the hormone-dependent growth of certain conditions. This specific mechanism, which stops hormone production rather than blocking receptor action, is a key differentiating factor from older classes of hormonal agents.

Composition and Pharmaceutical Form of Anastris

The pharmaceutical product Anastris is a single-ingredient product designed as an oral formulation for systemic treatment. Each tablet contains only the active substance Anastrozole. It is typically supplied as a compact film-coated tablet, which ensures precise dosing and stability during administration.

As a prescription-only medicine, Anastris provides a standardized dose of the synthetic active ingredient. While the brand name Anastris is specific, its core composition (Anastrozole) and its classification are shared with other generic versions and the reference brand, making it a clinically recognized option in its class. The formulation utilizes common solid oral excipients necessary for tablet structure, but the entire therapeutic effect is derived exclusively from the Anastrozole component.

Regulatory References

  1. Anastrozole - NCI - National Cancer Institute
  2. U.S. National Library of Medicine notes that the primary goal of this inhibition is to stop the hormone-dependent growth of certain conditions

What side effects are possible with Anastris?

Possible Side Effects and Safety Information

The safety profile of Anastris (Anastrozole) is based strictly on documentation from regulatory agencies such as the FDA and the EMA. Adverse reactions are formally classified by frequency and the body system affected (System Organ Class).

Documented Adverse Reactions and Frequency

Adverse effects are categorized based on their documented rate of occurrence in clinical trials, ranging from Very Common (ge 10%) to Very Rare (< 0.01%).

Frequency Classification Examples of Adverse Reactions (SOC)
Very Common Hot flushes, Arthralgia (joint pain), Asthenia (weakness), Headache, Nausea, Rash.
Common Osteoporosis, Fractures, Hypercholesterolaemia (high cholesterol), Depression, Vomiting, Hair thinning, Vaginal dryness.
Uncommon Hepatitis, Hypercalcaemia (elevated calcium levels).
Rare/Very Rare Severe skin reactions (Erythema Multiforme, Stevens-Johnson Syndrome), Anaphylaxis.

Serious Safety Considerations

The official labeling notes the potential for severe hypersensitivity reactions, including Anaphylaxis and Angioedema. Severe skin reactions, such as Stevens-Johnson Syndrome, are documented as very rare but serious adverse events. Increased risk of fractures due to reduced bone mineral density is associated with long-term exposure, requiring monitoring.

Safety Constraints and Special Populations

Anastris is contraindicated in women who are pregnant or breast-feeding due to the potential for fetal harm. It is not approved for premenopausal or pediatric use. Caution is advised for individuals with moderate or severe hepatic impairment. Co-administration with Tamoxifen or estrogen-containing therapies is generally restricted, as noted in the regulatory prescribing information.

Overdose and Emergency Response

The regulatory overdose profile for Anastris (anastrozole) is defined by officially documented acute manifestations and specific severe outcomes that trigger immediate medical intervention. Documented overdose presentations may include acute gastrointestinal signs such as nausea, vomiting, and diarrhea. The guidance clearly outlines that severe neurological or systemic events—specifically seizure, collapse, trouble breathing, or the inability to be awakened—represent the non-negotiable conditions for seeking urgent medical help, requiring an immediate call to emergency services.

Management procedures officially described in government labeling are centered on symptomatic and supportive treatment. Since no specific antidote is known or documented, the regulatory standards require continuous, close observation of the patient and frequent monitoring of vital signs in a hospital setting. The official emergency instruction is to contact a Poison Control Helpline or immediately call emergency medical services if these severe clinical signs manifest. The overall overdose structure therefore focuses on swift response to critical, labeled symptoms and sustained supportive care to manage potential severe effects.

Therapeutic Uses of Anastris

What Anastris Treats: Main Uses and Benefits

Anastris is commonly used in managing hormone receptor-positive (ER+) breast cancer in postmenopausal women. The application of this medication is relevant across various stages of the disease. In the clinical setting, this medication helps address conditions associated with advanced or metastatic disease, particularly conditions marked by increased physiological stress. This approach assists with maintaining functional stability when systemic symptoms are more noticeable, especially in advanced cases.

Furthermore, Anastris supports a long-term reduction of recurrence risk when used as adjuvant therapy following initial treatment. This use is relevant for managing the concern over disease recurrence by contributing to the reduction of recurrence risk, thereby supporting general well-being during symptomatic phases. It is considered relevant for easing the risk of breast cancer in certain high-risk postmenopausal women. The clinical contexts of use include managing conditions associated with early-stage disease, advanced disease, and reducing the risk of breast cancer.


Quick Fact: Relief for Concern over Recurrence
Main Use: Relevant for conditions involving chronic disease management.
Benefit: Supports general well-being by contributing to the reduction of recurrence risk.
Context: Adjuvant therapy and chemoprevention in postmenopausal patients.

Regulatory References

  1. NIH DailyMed Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Anastris — official regulatory information

Category Official Regulatory Status
Allowed Population Postmenopausal women, including the elderly.
Absolute Contraindications Premenopausal women; Pregnant or breastfeeding women; Patients with known hypersensitivity to anastrozole or any excipient.
Conditional Use Use with caution is required for patients with severe renal impairment (GFR < 30 mL/min) and those with moderate to severe hepatic impairment.
Age Exclusion The pediatric population (children and adolescents) is not recommended for use, as safety and efficacy are not established.

Eligibility Classifications (High-Level)

The medicine is formally designated as Contraindicated for individuals who are pregnant, breastfeeding, or of premenopausal endocrine status. Use is conditionally limited to the adult population.

Resulting Eligibility Structure

  • Anastris is contraindicated in women who are pregnant, breastfeeding, or premenopausal.
  • Use requires caution in patients with severe renal or moderate to severe hepatic impairment.
  • The medicine is not recommended for children and adolescents.

Connection to the Overall Eligibility Profile

Regulatory documents strictly define the eligibility for Anastris primarily based on the patient’s endocrine status, formally contraindicating its use in all premenopausal women and excluding the pediatric population. The profile also clearly identifies specific clinical states, such as severe renal or hepatic impairment, where the medicine requires that administration be performed with caution, differentiating these conditional restrictions from absolute prohibitions.

What should I know about interactions with other medicines?

Anastris (Anastrozole) exhibits specific, documented interaction patterns, predominantly categorized by pharmacodynamic and pharmacokinetic effects. Official regulatory constraints mandate strict avoidance of certain co-administrations.

The use of estrogen-containing therapies, including hormonal contraceptives and hormone replacement products, is officially contraindicated. This is due to pharmacodynamic antagonism, where these agents directly oppose and diminish Anastrozole's therapeutic effect. Co-administration with Tamoxifen is also not recommended, as official studies confirmed this combination reduced the plasma concentration of Anastrozole by approximately 27%.

The regulatory profile addresses metabolic kinetics. Although in vitro data show Anastrozole inhibits Cytochrome P450 (CYP) enzymes (CYP1A2, 2C8/9, and 3A4), official documents conclude that clinically significant inhibition is unlikely in vivo. Regarding administration timing, consuming the tablet with food decreases the rate of absorption but does not change the overall systemic exposure (AUC). The supplement DHEA may officially oppose the drug’s action and is noted as an interacting substance.

For specific populations, official documentation indicates that systemic exposure is higher in patients with stable hepatic impairment due to a documented 30% reduction in clearance. The profile also confirms that Anastrozole does not alter the exposure or anticoagulant activity of Warfarin.

Mechanism of Action

Anastris (Anastrozole) alters the synthesis pathway for endogenous estrogens by acting as a selective competitive inhibitor of the aromatase enzyme (CYP19A1). This mechanism focuses exclusively on blocking the final step of estrogen biosynthesis, which results in a substantial decrease in circulating estrogen levels. The mechanism targets the enzyme located primarily in peripheral tissues (e.g., fat and muscle). Anastrozole reversibly binds to the enzyme's active site, competitively blocking it from converting androgen hormones (like Androstenedione and Testosterone) into estrogens (Estrone and Estradiol). This molecular action initiates a cascade that results in the suppression of circulating estrogen throughout the body. The consequence of this depletion is a state where estrogen signaling input to sensitive tissues is substantially diminished. Anastris demonstrates high selectivity, meaning it only targets the aromatase enzyme without causing major inhibition of other P450 enzymes involved in the synthesis of adrenal steroids, such as cortisol and aldosterone. However, the mechanism is constrained by the body's endocrine feedback systems; in premenopausal physiology, the initial drop in estrogen can trigger a surge of LH and FSH, leading to ovarian hyperstimulation that overrides the peripheral enzyme inhibition.

Dosage and Administration Information

How to Use Anastris: Standard Administration Guidelines

The usage of Anastris (Anastrozole) is governed by a fixed set of high-level procedural instructions. This oral medicine is administered under a standard, continuous daily protocol, with specific rules dictating the dose, frequency, duration, and contextual constraints.


Administration Scope Detail
Route of administration The approved route is oral administration as a tablet.
Dosing schedule The standardized dose is 1 mg of anastrozole.
Frequency and timing The tablet is taken once daily.
Timing in relation to meals Administration may occur with or without food.
Course duration Adjuvant use is typically for five years; for advanced disease, use continues until evidence of tumor progression.
Population adjustments No dose adjustment is necessary for elderly patients or those with mild-to-moderate renal or hepatic impairment.

Instruction Classifications (High-Level)

Classification Detail
Administration method type Oral
Frequency pattern Daily
Use-context constraints Use must be avoided with Tamoxifen or estrogen-containing therapies to prevent a potential reduction in pharmacological action.

Resulting Procedural Structure

Standard step sequence:

  • Administer the standard 1 mg tablet by the oral route.
  • Maintain a once-daily frequency, adhering to the standard daily schedule.
  • Take the dose independently of meals (with or without food).
  • Continue administration for the prescribed course duration, which is defined by the specific clinical scenario.

Connection to the overall use protocol:

The standard instructions establish a fixed 1 mg daily oral regimen that is consistent across the adult population and flexible regarding food intake. This strict adherence to a continuous daily schedule over a predefined period defines the procedural structure for using the medicine. This administration protocol ensures predictable systemic exposure required for long-term management.

Recent Clinical Evidence

Research evidence / Overview of Studies for Anastris

Evidence for Initial Adjuvant Therapy in Early-Stage Disease

Research explored whether Anastris could be evaluated as an initial hormonal therapy after surgery. This research was conducted primarily through large Randomized Controlled Trials (RCTs). These types of studies compare one group receiving Anastris with another group receiving a different agent to see how outcomes evolved over time.

Researchers examined time-dependent endpoints, including Disease-Free Survival (DFS) and the time it took for the disease to recur. The populations included in these trials were postmenopausal women diagnosed with hormone receptor-positive early-stage invasive breast cancer. Reports described that measurements of Overall Survival were observed across the arms being studied.

Evidence for Extended Adjuvant Therapy

This area of research has explored the outcomes of continuing hormonal therapy for a longer period after a person has completed the initial five years of treatment. Studies explored whether continuing Anastris further, compared to stopping treatment, was associated with different outcomes.

Randomized Controlled Trials explored this, monitoring outcomes reflecting daily functioning and recurrence patterns during the extended treatment period. Some trials described that the continued treatment period was associated with measured differences in the rate of recurrence compared to observation. Findings were mixed across different trials, and data show mixed patterns related to Overall Survival.

Evidence for Risk Reduction (Chemoprevention)

Research explored whether Anastris was associated with differences in the rate of breast cancer incidence in certain populations. Large, placebo-controlled trials monitored long-term outcomes in postmenopausal women who were considered to be at an increased risk of developing the disease. Findings indicate patterns observed in the rate of breast cancer incidence during the five-year treatment period, a pattern that continued to be observed in long-term follow-up after the treatment period was completed.

What Is Still Uncertain About Anastris Research

While research contributes to the broader evidence landscape, several limitations and uncertainties exist. Long-term effects are not fully established regarding Overall Survival across all trial settings, particularly in the extended adjuvant setting where findings were mixed between different long-term treatment lengths. Furthermore, comparative evidence is lacking in large trials that have examined Anastris against the newest combination therapies available for advanced disease.

Key Studies & References

  1. Label: ANASTROZOLE tablet, coated - DailyMed (FDA Drug Label)
  2. Anastrozole: MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Anastris (FAQ)


Q: Does taking Anastris require special blood tests or monitoring?

Official documents state that taking Anastris is associated with changes in bone mineral density and increased blood cholesterol levels. For this reason, a healthcare provider may recommend specific monitoring during the course of treatment. This monitoring can include blood cholesterol checks or a bone mineral density test (like a DEXA scan).


Q: Why do some people experience initial nausea with Anastris?

Nausea is a very common adverse reaction documented in clinical trials for Anastris. Like other mild side effects, it may occur shortly after starting treatment. Official information suggests that this type of reaction is often temporary and may improve over the initial months as the body adjusts to the medicine.


Q: Is it normal to feel a bit more tired when first starting Anastris?

Feeling weak or tired, referred to as fatigue or asthenia, is a very common side effect reported in clinical trial data that may begin in the first few days. Patients are encouraged to discuss the persistence of any fatigue with their healthcare professional.


Q: What does 'contraindication' mean regarding Anastris?

In regulatory documents, a contraindication describes a condition or factor that officially makes the use of a medicine inadvisable or prohibited because it may cause harm. For Anastris, this means that the drug is prohibited from being used if a patient is pregnant, premenopausal, breastfeeding, or has a known hypersensitivity to the drug.


Q: How do drug-drug interactions with Anastris usually manifest?

Official documents indicate two main interaction effects. The co-administered drug might directly counteract Anastris's therapeutic effect (known as pharmacodynamic antagonism), or it may cause a reduction in the plasma concentration of Anastris, making less of the drug available in the body.


Q: Does Anastris affect mood?

Yes, official records list mood changes and depression as reported side effects in clinical trials. These effects are formally documented. Patients are advised to report any changes in mood to a healthcare professional.


Q: Is the research evidence for Anastris strong or still ongoing?

Research supporting the uses of Anastris has been conducted primarily through large randomized controlled trials. Official summaries note that while these studies provide substantial evidence, certain outcomes, such as Overall Survival, have shown mixed patterns across different trials, meaning the long-term effects are not fully established in all treatment settings.


Q: Is Anastris a type of steroid?

No. Anastris (Anastrozole) is officially classified as a non-steroidal aromatase inhibitor (AI). This classification identifies it as a synthetic compound that targets the aromatase enzyme, which is chemically distinct from steroid-based medicines.


Q: How quickly should I expect Anastris to start making a difference?

Based on pharmacokinetic data, the drug's concentration in the body reaches stable, therapeutic levels, known as steady-state, after approximately 7 days of once-daily dosing. This period indicates when the drug’s concentration reaches a stable level.


Q: What is Anastris used for, besides the main condition?

The regulatory label lists several approved uses beyond initial adjuvant treatment of early breast cancer. These include first-line treatment for advanced disease, and second-line treatment for advanced disease following a course of Tamoxifen therapy.


Q: Is Anastris the same class of drug as [Competitor Drug Name]?

Anastris is officially classified as a Selective Non-Steroidal Aromatase Inhibitor (AI). This classification reflects its specific function as an antiestrogen to suppress estrogen production in the body.


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

Official instructions describe the procedure for managing a missed dose. A patient is advised to take the missed dose as soon as they remember, unless it is nearly time for the next scheduled dose. The regulatory guidance strictly advises against taking two doses at the same time.


Q: Is it true that Anastris can cause weight changes?

Yes, weight gain is listed as a common side effect reported in clinical trials and is part of the official safety profile. Patients are encouraged to be aware of and report any significant changes in weight during the course of treatment.


Q: Can men use Anastris?

Anastris is officially approved and indicated only for use in postmenopausal women with hormone receptor-positive breast cancer. The drug is not indicated for the male population in the official regulatory documents.


Q: Does Anastris interact with common pain relievers like ibuprofen?

Official regulatory documentation does not list specific interaction warnings for Anastris with common over-the-counter pain relievers such as ibuprofen. Patients are generally advised to discuss all concomitant medications with a healthcare professional.


Q: What should I do if a minor side effect of Anastris seems persistent?

Official guidance states that any persistent side effects, or any change in health, is encouraged to be discussed with a healthcare provider or pharmacist for evaluation.


Q: Is Anastris known to affect sleep patterns?

Yes, Insomnia (trouble sleeping) is listed as a common side effect reported in clinical trials. This is a documented effect of the medicine.


Q: Does the body build a tolerance to Anastris over time?

Based on pharmacokinetic studies, the drug's properties and the resulting plasma concentrations do not change with repeated daily dosing. This suggests that the drug's pharmacological profile is expected to remain stable over the course of treatment.


Q: Is Anastris safe to take with common allergy medications?

The official label does not specifically list interaction warnings with common allergy medications like antihistamines. Regulatory guidance advises patients to discuss all over-the-counter medicines with their healthcare professional before use.


Q: What happens when you stop taking Anastris?

The drug has a terminal elimination half-life of approximately 50 hours. Official studies describe that the serum estrogen levels, which are suppressed by the drug, can remain low for up to 6 days after the treatment has stopped.


Q: Are the side effects of Anastris permanent?

Many of the milder side effects may improve or go away once treatment is completed. However, long-term use is associated with decreased bone mineral density, which can increase the risk of fractures—a documented, serious long-term risk.


Q: Can I take Anastris if I have high blood pressure?

Increased blood pressure is listed as a less common side effect in clinical trials. Although high blood pressure itself is not a contraindication, official documents advise healthcare providers to consider the risks and benefits for patients with pre-existing ischemic heart disease.


Q: Are there specific lifestyle changes that affect how well Anastris works?

Official documentation advises patients to discuss the use of the medicine with food, alcohol, or tobacco with their healthcare professional. This discussion helps ensure all health factors are considered for the treatment plan.


Q: How long does the effect of one dose of Anastris last in the body?

The mean terminal elimination half-life of the drug is approximately 50 hours in postmenopausal women. The half-life describes the time it takes for the concentration of the drug in the body to decrease by half.


Q: Can Anastris affect fertility in women?

The medicine is contraindicated in women who are premenopausal, pregnant, or breastfeeding. Official label documentation advises females of reproductive potential to use effective contraception during treatment and for a specified time after the last dose.


Q: Is Anastris a controlled substance?

Anastris is officially classified as a prescription-only medicine. It is not listed as a federally controlled substance by the U.S. Drug Enforcement Administration.


Q: Does Anastris cause dependency?

Official safety information indicates that Anastris is not associated with potential for abuse or physical dependence. It is not considered an addictive substance.


Q: How long has Anastris been approved for use?

The active ingredient, Anastrozole, was first approved for use in the United States in 1995. This history of use contributes to the extensive body of official safety and efficacy documentation.


Q: What is the risk of overdose with Anastris?

There are no known symptoms specifically associated with an overdose of Anastris, and no life-threatening effects have been reported in safety documentation. Official regulatory guidance advises immediate contact with a healthcare provider if an overdose is suspected.


Q: Does Anastris interact with herbal supplements like St. John's Wort?

Official documentation generally advises patients to avoid taking herbal remedies or supplements for menopause symptoms while on treatment. This is because these products may contain ingredients that could affect how Anastris works. Patients are encouraged to discuss all herbal supplements and vitamins with their doctor.

How should Anastris be stored and disposed of?

Storage and Disposal Requirements for Anastris (Anastrozole)

Storage & Disposal Scope Requirement
Storage Temperature Store at room temperature, generally not exceeding 30 C.
Environment & Protection Must be kept away from excess heat and moisture and protected from direct light. The product must not be frozen.
Container Integrity The medicine must remain in its original container, which should be kept tightly closed to maintain product stability.
Child Safety Keep this medication out of the sight and reach of children.

Disposal Guidelines

Official disposal rules state that Anastris must not be thrown away via wastewater or household waste. Patients are instructed to consult a pharmacist or healthcare professional for the proper procedure on how to discard unused or expired medicine, aligning with pharmaceutical waste regulations.

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

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