Altraz

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Medically reviewed

Laura Arias

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 Altraz

Property Description
Active ingredient Anastrozole (INN)
Form Oral Tablet (Film-coated)
Pharmacological class Non-Steroidal Aromatase Inhibitor
General purpose Reduction of systemic estrogen
Origin Synthetic compound

What is Altraz and What is its Composition?

Altraz is a synthetic, single-agent pharmaceutical entity presented as an oral formulation in the form of a film-coated tablet. Its sole active component is the substance Anastrozole (INN), which belongs to the class of non-steroidal aromatase inhibitors.

Anastrozole is chemically a triazole compound with the molecular formula C17H19N5, synthesized to be highly selective for its target enzyme. The drug is combined with inert pharmaceutical excipients to create the solid unit dosage form, designed for reliable systemic absorption via the oral route of administration.

Altraz: Classification and Distinctive Action

Altraz is classified pharmacologically as a potent and highly selective Non-Steroidal Aromatase Inhibitor (NSAI), placing it within the broader grouping of Antineoplastic Agents. This designation defines its unique therapeutic strategy: the competitive and reversible binding to the Aromatase enzyme (CYP19A1).

The general therapeutic purpose of Altraz is to achieve a substantial and sustained reduction of systemic estrogen in the body. By inhibiting the Aromatase enzyme—the primary catalyst for converting other hormones into estrogen in peripheral tissues—Altraz acts to remove the main hormonal stimulus. This effective enzyme blockade provides a specific, controlled hormonal environment which serves to manage the progression of certain hormone-dependent disease processes.

What side effects are possible with Altraz?

The possible side effects and safety characteristics of Altraz (Anastrozole) are strictly documented in governmental regulatory information, classifying adverse reactions by frequency and physiological system. This classification provides a descriptive framework for the medicine's risk profile.

Adverse Reaction Scope

Adverse reactions are formally grouped by System Organ Class (SOC) and frequency, based on data from clinical trials and post-marketing surveillance. The most frequently documented effects often involve the musculoskeletal system, general systemic state, and vascular disorders.

Frequency Classification (Examples):

Classification Examples of Reactions
Very Common (ge 1/10) Hot flushes, Asthenia (weakness), Arthralgia (joint pain)/stiffness, Headache, Nausea, Rash
Common (ge 1/100 to < 1/10) Hypercholesterolaemia (high cholesterol), Somnolence, Diarrhoea, Bone pain, Osteoporosis, Vaginal bleeding, Carpal Tunnel Syndrome
Rare (ge 1/10,000 to < 1/1,000) Erythema multiforme, Anaphylactoid reaction, Cutaneous vasculitis
Very Rare (< 1/10,000) Stevens-Johnson Syndrome, Angioedema

Serious Adverse Reactions and Safety Constraints

Regulatory documents list serious events, including severe cutaneous reactions (such as Stevens-Johnson Syndrome) and severe allergic reactions (e.g., Angioedema) [1.1]. Hepatitis and increased incidence of ischemic cardiovascular events in patients with pre-existing ischemic heart disease are also documented safety concerns [2.4].

Population-Specific Safety: The medicine is contraindicated in premenopausal women and during pregnancy or lactation [3.4]. Furthermore, a reduction in Bone Mineral Density (BMD) is associated with long-term use, increasing the risk of fracture [3.2].

Regulatory Safety Summary

The regulatory safety profile highlights highly frequent musculoskeletal and general complaints (e.g., joint pain, hot flushes) [1.1]. This framework sets explicit boundaries by defining use as strictly contraindicated based on patient status, such as premenopausal women, and specifies caution for individuals with pre-existing ischemic heart disease [3.4, 2.4]. The profile also defines specific safety notes related to the duration of exposure, particularly concerning bone health and the need for cholesterol level monitoring [3.2, 2.4].

Overdose and Emergency Response

If a quantity of Altraz exceeding the standard prescribed dose is ingested, immediate medical attention is required as mandated by regulatory authorities. This action is crucial because specific clinical data on the consequences and symptom profile of acute, high-dose exposure to Anastrozole are officially considered incomplete.

Knowledge of the precise signs and symptoms that characterize an overdose is limited. Regulatory documents confirm the absence of a defined clinical profile; for instance, the highest documented single dose administered to a human subject (60 mg) was reported as well-tolerated. Nevertheless, urgent medical help must be sought for any suspected ingestion beyond the standard therapeutic dose.

A critical point in the official management strategy is that no specific pharmacologic antidote is known to counteract the effects of Anastrozole overdose. Due to this constraint, the mandated management approach is strictly supportive and symptomatic. This requires the close monitoring of the patient’s vital signs and general clinical status. Furthermore, in select cases, consideration of dialysis may be part of the official management protocol. The regulatory guidance for Altraz overdose, therefore, places paramount emphasis on immediate emergency action and continuous supportive observation.

Therapeutic Uses of Altraz

What Altraz Treats: Main Uses and Benefits

The primary purpose of Altraz (Anastrozole) therapy is to provide supportive, long-term systemic management of conditions characterized by periods of heightened symptoms related to hormone receptor-positive malignancy in postmenopausal women. The medication is utilized across multiple clinical contexts focused on managing the condition and its associated risks.

The medication is relevant in therapeutic areas including the adjuvant treatment of early-stage breast cancer, management of advanced or metastatic disease, and prophylactic use for risk reduction in high-risk individuals. It is commonly used in situations where symptoms may intensify temporarily related to disease progression.

Clinical Scenarios and Patient Benefit

Altraz is applied in the adjuvant setting following surgery to help ease the likelihood of disease recurrence, which contributes to improved comfort during periods of heightened symptoms. It is also applied in controlling advanced disease to help slow progression, which supports patient comfort and general well-being during phases when symptoms become more noticeable. This supportive relief contributes to easing the overall symptom load and helps patients cope more steadily with symptom fluctuations.


Quick Fact: Management for Recurrence Risk

This medicine is commonly used to help with managing the symptoms linked to conditions characterized by periods of heightened symptoms, supporting the long-term goal of reducing the chance of recurrence in eligible postmenopausal women.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

The official eligibility profile for Altraz (Anastrozole) is strictly defined by regulatory authorities based on patient population, physiological status, and prior medical conditions.

Altraz is documented for use exclusively in postmenopausal women. Use is absolutely contraindicated in women of premenopausal endocrine status, which includes pregnant women. Patients with known hypersensitivity to anastrozole or any excipient in the tablet formulation also must not use the medicine. Furthermore, use is not recommended for lactating women (nursing mothers) and is generally avoided in cases of severe hepatic impairment.

For certain populations, use is conditional. Patients with pre-existing ischemic heart disease require a clinical assessment of risks and benefits before use. Similarly, patients at risk of decreased bone mineral density must have their bone health monitored throughout treatment. The regulatory label clarifies that use is not established in pediatric patients (children and adolescents). However, no specific age-related dose restrictions apply to older adults (geriatric patients), and the medicine is permitted for use in patients with renal impairment (including severe) and mild-to-moderate hepatic impairment without the need for a dose adjustment.

What should I know about interactions with other medicines?

The official regulatory profile for Altraz (Anastrozole) establishes clear restrictions on co-administration with other specified medicinal products and notes pharmacokinetic differences in certain populations.

Interaction Classifications

Property Classification
Interaction severity Contraindicated combinations; Clinically significant altered exposure
Regulatory basis Established by the FDA and the EMA SmPC
Interaction-context constraints Unlikely to cause clinically significant CYP-mediated drug interactions

Official Interaction Statements

  • Co-administration with Tamoxifen is Contraindicated and results in a 27% reduction in Anastrozole plasma concentration; no additional efficacy benefit was demonstrated with combination use.
  • Co-administration with Estrogen-containing therapies is Contraindicated because the estrogen would diminish or negate the pharmacological action of Altraz through pharmacodynamic antagonism.
  • Altraz is officially documented as unlikely to cause clinically significant drug interactions mediated by cytochrome P450 (CYP) enzymes on other medicines, as shown in studies with substances like warfarin and antipyrine.
  • Food does not affect the extent of Altraz absorption.
  • In patients with stable hepatic cirrhosis, the apparent oral clearance of Anastrozole is approximately 30% lower, resulting in officially documented increased systemic exposure.

This profile is structured to define constraints on co-administration, specifically prohibiting agents that cause pharmacodynamic antagonism, while generally indicating a low risk for metabolic interactions with most other prescribed drugs.

Mechanism of Action

Altraz, containing anastrozole, functions as a non-steroidal, selective aromatase inhibitor. Its biological target is the cytochrome P450 enzyme, aromatase (estrogen synthetase), predominantly located in peripheral tissues like adipose tissue, muscle, liver, and in the adrenal glands of postmenopausal individuals. The interaction type is one of reversible, competitive binding to the heme component of the aromatase enzyme.

This molecular interaction directly blocks the final step of the steroidogenesis pathway: the conversion of androgens, specifically androstenedione and testosterone, into estrogens, primarily estrone and estradiol, respectively. This inhibition of the aromatase enzyme dramatically suppresses extragonadal estrogen biosynthesis.

The downstream cascade is a significant reduction in circulating and local tissue estradiol concentrations. This system-level physiological consequence modulates estrogen-dependent cellular signaling pathways by limiting the ligand available to bind and activate estrogen receptors in target cells.

Dosage and Administration Information

Instruction Map: How to Use Altraz — Administration Guidelines

This map consolidates the instructions for the use of Altraz (Anastrozole). The administration guidelines establish a standardized approach, focusing strictly on procedural requirements.


Administration Scope

Category Instruction
Route of administration Oral route only.
Dosing schedule 1 mg (milligram) taken once daily.
Timing in relation to meals (if applicable) May be taken with or without food.
Preparation requirements (if applicable) The film-coated tablet must be swallowed whole.
Age-group administration rules Older Adults: No dosage adjustment necessary. Pediatric Population: Not recommended for use.
Missed-dose rules If a dose is missed, the patient should skip the missed dose and resume the normal schedule; do not double doses.
Special procedural conditions Should be taken at the same time each day. Treatment is typically continued for 5 years in the adjuvant setting, or until disease progression for advanced disease.

Instruction Classifications (High-Level)

Classification Detail
Administration method type Oral
Frequency pattern Daily (once a day)
Use-context constraints Avoid co-administration with Tamoxifen or estrogen-containing therapies. Caution advised in severe renal or hepatic impairment (dose change not recommended for mild-to-moderate impairment).

Resulting Procedural Structure

Procedural sequence:

  • Take the single 1 mg film-coated tablet orally once daily.
  • The tablet can be consumed with or without food but must be taken at the same time each day.
  • For missed doses, skip the missed dose and do not double the next dose.

Connection to the overall use protocol

The instructions establish a fixed, continuous oral regimen defined by the 1 mg daily dose and consistent frequency, independent of meal consumption. The protocol specifies time-bound durations for adjuvant use and event-driven duration for advanced use, while also detailing dose-handling rules for missed doses and high-level cautions for specific patient populations.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Altraz (Anastrozole)

Evidence in the Initial Adjuvant Treatment Setting

Key clinical research for Altraz was conducted in postmenopausal women with early-stage, hormone receptor-positive breast cancer. Researchers used large-scale, international Randomized Controlled Trials (RCTs) to evaluate five years of Altraz use compared to five years of Tamoxifen use. These studies examined outcomes over long periods, including Disease-Free Survival (DFS) and the endpoint of the cancer returning (recurrence).

Findings described patterns observed in the studies consistent with the observations of a lower rate of disease recurrence among the groups receiving Altraz during the specified treatment period. Research also described the observed difference in the reported incidence of new cancer in the opposite breast in those groups. Measurements of Overall Survival were reported as similar in many initial analyses of the study groups. There is no consensus from direct evidence on whether upfront use or a switching strategy is definitively preferable.

Evidence in Advanced and Metastatic Disease

Altraz was evaluated in women with advanced or metastatic breast cancer, often as the initial hormonal therapy given. The research here consisted of Randomized, Double-Blind Trials that evaluated Altraz against Tamoxifen. These studies monitored outcomes related to disease control, such as the Time to Progression (TTP) and the rate at which tumors shrank or stabilized (Objective Response Rate).

Research described changes measured during the study period, with data showing patterns related to Time to Progression (TTP) that were similar to those observed in comparison groups, with some reports noting differences. The results apply only to the populations studied. Comparative evidence is lacking for using Altraz after a patient has already failed another specific type of treatment, such as a different aromatase inhibitor.

Evidence for Extended Duration and Long-Term Follow-Up

Researchers have also explored whether continuing Altraz beyond the initial five-year period—known as extended adjuvant therapy—provides additional findings. These studies involved Randomized Controlled Trials that compared taking an additional three to five years of Altraz versus observation. Some trials reported patterns of a lower incidence of late recurrence in the groups receiving extended Altraz therapy. The Overall Survival measurements have generally been similar between the extended treatment groups and the observation groups throughout the follow-up periods reported so far.

Key Studies & References

  1. WHO Model List of Essential Medicines

Frequently Asked Questions (FAQ)

Common questions about Altraz (FAQ)


Q: What are the most common side effects people report when first starting Altraz?

The most commonly reported adverse reactions include hot flushes, nausea, and joint pain. Evidence from clinical settings indicates that these and other initial side effects may sometimes lessen or improve after the first few months of treatment. This pattern is consistent with official regulatory documentation of common side effects.


Q: Is it normal to feel more tired or drowsy when taking Altraz?

The official regulatory profile lists both somnolence (drowsiness) and asthenia (weakness) as common adverse reactions. This means these effects have been observed frequently in research studies involving the medicine.


Q: Are there any long-term side effects associated with Altraz use?

Official regulatory information notes that long-term use is associated with a reduction in bone mineral density, which may lead to an increased risk of fracture. Additionally, the official label notes that monitoring of cholesterol levels is recommended because potential increases have been observed in clinical settings.


Q: Can Altraz be taken at the same time as common over-the-counter pain relievers?

The medicine is generally documented as unlikely to cause clinically significant interactions with many other drugs. However, the official label advises that patients should inform their healthcare professional about all nonprescription and over-the-counter medicines, vitamins, and herbal products being used.


Q: Does Altraz interact negatively with vitamins or herbal supplements like St. John's Wort?

Official regulatory sources include the general recommendation that patients should inform a healthcare professional about all vitamins, herbal products, and supplements taken. This is due to limited specific data on potential negative interactions when combining Altraz with complementary medicines.


Q: Why do official documents describe Altraz's effects in a neutral way instead of saying it 'works'?

Official documents use descriptive, neutral language because the primary pharmacological action is the verified suppression of the Aromatase enzyme and estrogen levels. The relationship between this physiological suppression and long-term clinical outcomes is a complex area of ongoing study that requires careful, non-promissory documentation.


Q: How does Altraz compare to other treatments in terms of how often a dose is taken?

The official instructions establish that this medicine is typically taken once daily (qDay). This defines its frequency pattern as a standard, continuous oral regimen.


Q: Do I need to have regular blood tests while taking Altraz?

Regulatory information indicates that monitoring of certain health parameters, including cholesterol levels and bone mineral density, is outlined for the course of treatment.


Q: Why is Altraz sometimes described as a 'maintenance' medicine?

The medicine is prescribed as a fixed, continuous oral regimen for a specified long duration, such as typically five years in the adjuvant setting. This defined, long-term pattern of use is consistent with the concept of maintenance therapy.


Q: Is a mild rash a common or serious side effect of Altraz?

Rash is classified in the regulatory profile as a Very Common adverse reaction, meaning it is often reported. However, official documents also list severe cutaneous reactions, such as Stevens-Johnson Syndrome, as very rare adverse reactions.


Q: What does 'potential for a serious interaction' mean in the patient information?

This terminology describes the risk that combining Altraz with certain other medications may lead to a loss of the medicine's therapeutic effect or result in a major safety risk. For example, co-administration with Estrogen-containing therapies or Tamoxifen is officially contraindicated.


Q: Does Altraz have a generic version available, and is it the same as the brand name?

The active ingredient, anastrozole, is approved in generic form. Regulatory documentation confirms that the generic formulation is determined to be bioequivalent and therapeutically equivalent to the brand-name drug.


Q: How long does it usually take for Altraz to start working or feel a change?

Pharmacokinetic studies indicate that plasma concentrations of the medicine reach a stable or steady-state level after approximately seven days of daily use. This timeframe reflects when consistent plasma levels in the body are typically achieved.


Q: Do the side effects of Altraz usually go away after a few weeks of use?

Official information notes that some common adverse reactions, such as hot flushes and tiredness, have been described in clinical contexts as often improving or resolving during the first few months of treatment.


Q: Can taking Altraz cause weight gain or weight changes?

The adverse reaction profile derived from clinical trials lists weight gain as a reported side effect. This finding is included in the medicine's official safety information.


Q: Is it safe to consume alcohol while being treated with Altraz?

Regulatory studies have shown that the apparent clearance of the medicine is lower in patients with hepatic impairment, including those with cirrhosis related to alcohol use. This highlights the importance of assessing pre-existing liver conditions.


Q: What is the significance of the FDA approval date for Altraz?

The active ingredient, anastrozole, was first approved by the FDA in 1995 for its indicated uses. This date marks the official regulatory clearance for its use in treatment in the United States.


Q: Can Altraz affect my ability to drive or operate machinery?

Official labeling states that the medicine is unlikely to impair the ability to drive or operate machinery. However, caution should be observed due to reported adverse reactions like somnolence (drowsiness) and asthenia (weakness).


Q: Is it true that Altraz can cause sleep disturbances or insomnia?

The regulatory adverse reaction profile includes sleep problems and insomnia as commonly reported effects. This information is based on observations made during clinical trials.


Q: Can Altraz cause changes in mood or mental state?

The official safety information includes depression as a very common psychiatric adverse reaction. This finding is part of the established regulatory safety profile.


Q: Is Altraz safe for use in people who have high blood pressure?

While high blood pressure is not an absolute contraindication, regulatory information indicates that the medicine has been associated with an increase in high blood pressure. Patients with this or other cardiovascular conditions are typically assessed for risk.


Q: Can I take Altraz if I have been diagnosed with diabetes?

Official documentation requires consideration and assessment for patients with known risk factors for cardiovascular events. These risk factors may include conditions like diabetes.


Q: Does Altraz carry a boxed warning or 'Black Box' warning?

The U.S. FDA labeling includes a serious safety warning regarding the risk of embryo-fetal toxicity if the medicine is used during pregnancy. This warning is a key component of the official safety profile.


Q: Is it true that generic Altraz may not be as effective as the brand-name version?

Regulatory documentation confirms that the generic active ingredient, anastrozole, is determined to be therapeutically equivalent to the brand-name formulation. This equivalence is based on established scientific and governmental standards.


Q: Can Altraz be taken alongside common cold or flu remedies?

Official labeling includes the general guidance that patients should not take non-prescription medicines, including those for cold or flu symptoms, without first discussing them with their healthcare professional.


Q: How does my lifestyle (e.g., smoking) potentially affect Altraz's use?

Regulatory safety information documents that pre-existing risk factors, such as smoking, are a safety concern regarding cardiovascular events in the overall profile of the medicine.


Q: Does the efficacy of Altraz vary based on ethnicity or genetics?

Pharmacokinetic data collected for the medicine indicated that key hormone levels (estradiol and estrone sulfate) were observed to be similar between Caucasian and Japanese postmenopausal women during testing.


Q: Does Altraz have any known effects on eye health or vision?

The regulatory profile notes that dry eye has been observed in some clinical settings. Furthermore, some reports have described effects such as cataracts in studies evaluating the medicine.

How should Altraz be stored and disposed of?

Storage and Disposal of Altraz (Anastrozole)

Altraz tablets must be stored according to specific regulatory requirements to ensure product stability and safety.

Storage Conditions

Altraz must be kept at Controlled Room Temperature, officially defined as 20 C to 25 C (68 F to 77 F). The medicine must be stored in a closed, dry container and should be protected from both heat and freezing. Official labeling requires that the tablets be kept strictly out of the reach of children and pets.

Disposal Instructions

To dispose of unused or outdated Altraz, the recommended procedure is to utilize an authorized drug take-back program. If a take-back option is unavailable, the product should be mixed with an undesirable substance (such as dirt or coffee grounds) and sealed in a container before being placed in the household trash. Personal information must be scratched out from the prescription label before discarding the original packaging.

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

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