Generic Name and Composition

Arimidex contains the active ingredient anastrozole. Each tablet comprises 1 mg of anastrozole. Excipients include lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.

Pharmaceutical Form

Arimidex is available as a film-coated tablet for oral administration. Tablets are typically white and round, with an imprinted identifier.

Indications for Use

Prescribed primarily for postmenopausal women diagnosed with hormone receptor-positive early breast cancer. Also indicated for advanced breast cancer in postmenopausal women.

Mechanism of Action

Arimidex functions as an aromatase inhibitor. It impedes the enzyme aromatase, which converts androgens into estrogens, thereby lowering estrogen levels in the body and slowing the growth of estrogen-receptor-positive cancer cells.

Dosage Guidelines

The standard dose is one tablet taken once daily. Arimidex can be taken with or without food. Consistency in timing may aid in maintaining stable drug levels in the bloodstream.

Administration Instructions

Swallow tablets whole with water. Do not crush or chew. In case of a missed dose, take it when remembered unless it is close to the time for the next dose. Do not double doses.

Pharmacokinetics

Anastrozole is rapidly absorbed after oral administration. Peak plasma concentrations occur within two hours. Steady-state concentration is typically achieved after seven days. The elimination half-life is around 50 hours.

Drug Interactions

Certain medications can affect anastrozole’s efficacy. Avoid concurrent use with tamoxifen and estrogen-containing therapies. Caution with co-administration of medications that induce or inhibit CYP450 enzymes.

Special Populations

Not recommended for premenopausal women. In elderly patients and those with mild to moderate liver impairment, no dosage adjustment is necessary. Use cautiously in patients with severe hepatic impairment.

Storage Conditions

Store at room temperature, between 20°C and 25°C (68°F and 77°F). Keep in the original package to protect from light and moisture.

Clinical Studies

Clinical trials demonstrate significant efficacy in reducing the risk of breast cancer recurrence. Studies showed improved disease-free survival rates in women taking Arimidex compared to those on tamoxifen.

Pharmacodynamic Properties

Arimidex significantly reduces serum estradiol concentrations, achieving suppression within 24 hours. This suppression remains consistent throughout continuous administration.

Contraindications

Hypersensitivity to anastrozole or any tablet excipients. Contraindicated in pregnant or breastfeeding women due to potential harm to the fetus or infant.

Monitoring Parameters

Baseline and periodic bone mineral density assessments are crucial due to potential bone density reduction. Regular liver function tests are advised given the risk of hepatotoxicity.

Potential Side Effects

Common adverse reactions include hot flashes, arthralgia, and nausea. Occasional side effects may involve osteoporosis, increased cholesterol levels, and liver function alterations.

Patient Counseling Information

Instruct patients to report any unusual symptoms, including signs of hypersensitivity and severe bone pain. Emphasize the importance of adhering to the prescribed dosage regimen.

Pregnancy and Lactation

Category X: Arimidex can cause fetal harm. Women of childbearing potential should use effective contraception. It is unknown if anastrozole is excreted in human milk.

Overdose Management

In case of overdose, supportive measures should be instituted. There is no specific antidote. Close monitoring of vital signs and symptomatic treatment are recommended.

Renewability and Refilling

Arimidex is typically prescribed for long-term use. Regular follow-ups determine the need for continuation or dosage adjustments.

Post-Market Surveillance

Ongoing surveillance includes monitoring for rare adverse effects and long-term efficacy in various populations. Reports contribute to updating treatment guidelines and safety information.

Mechanism Clarification

Anastrozole’s inhibition of aromatase leads to decreased estrogen synthesis. This action assists in managing estrogen-dependent breast cancer effectively.

Combination Therapy Benefits

Combining Arimidex with other cancer therapies can enhance treatment outcomes. However, co-administration with tamoxifen is generally avoided due to reduced anti-tumor efficacy.

Compliance Tips

Using reminders, such as alarms or pill organizers, may improve adherence. Highlighting the drug’s role in preventing cancer recurrence can motivate compliance.