Learn about the summary of product characteristics for Arimidex, including its uses, dosage, side effects, and precautions. Find out how Arimidex is used in the treatment of breast cancer in postmenopausal women and its potential benefits and risks.
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Arimidex Summary of Product Characteristics
Popular Questions about Arimidex summary of product characteristics:
What is Arimidex?
Arimidex is a medication used to treat breast cancer in postmenopausal women.
How does Arimidex work?
Arimidex works by reducing the production of estrogen, which can fuel the growth of certain types of breast cancer.
What are the common side effects of Arimidex?
Common side effects of Arimidex include hot flashes, joint pain, weakness, mood changes, and bone thinning.
Can Arimidex be used by premenopausal women?
No, Arimidex is only approved for use in postmenopausal women.
Are there any serious side effects of Arimidex?
Yes, serious side effects of Arimidex can include bone fractures, heart problems, and liver damage.
How should Arimidex be taken?
Arimidex should be taken once a day, with or without food.
Can Arimidex interact with other medications?
Yes, Arimidex can interact with certain medications, so it’s important to inform your doctor about all the medications you are taking.
Is Arimidex covered by insurance?
Whether or not Arimidex is covered by insurance depends on your specific insurance plan. It’s best to check with your insurance provider.
What is Arimidex used for?
Arimidex is used to treat breast cancer in postmenopausal women.
How does Arimidex work?
Arimidex works by reducing the amount of estrogen in the body, which can slow down or stop the growth of certain types of breast cancer cells.
What are the possible side effects of Arimidex?
The possible side effects of Arimidex include hot flashes, joint pain, weakness, mood changes, bone loss, and increased risk of heart disease.
Can Arimidex be used by men?
Arimidex is not approved for use in men, as it is specifically designed for postmenopausal women with breast cancer.
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Arimidex Summary of Product Characteristics: What You Need to Know
Arimidex is a medication that is commonly prescribed to treat breast cancer in postmenopausal women. It belongs to a class of drugs known as aromatase inhibitors, which work by reducing the production of estrogen in the body. Estrogen is a hormone that can stimulate the growth of breast cancer cells, so by reducing its levels, Arimidex can help slow down the progression of the disease.
One of the key features of Arimidex is its ability to selectively inhibit the aromatase enzyme, which is responsible for converting androgens into estrogen. By targeting this enzyme, Arimidex can effectively block the production of estrogen in breast tissue, while having minimal impact on other tissues in the body. This makes it a highly effective and well-tolerated treatment option for postmenopausal women with hormone receptor-positive breast cancer.
It is important to note that Arimidex is not suitable for use in premenopausal women or men, as it can interfere with normal hormone production. Additionally, Arimidex should only be taken under the guidance of a healthcare professional, as it can have side effects and interactions with other medications.
“Arimidex is a medication that offers hope to postmenopausal women with hormone receptor-positive breast cancer. By inhibiting the production of estrogen, it can help slow down the progression of the disease and improve outcomes. However, it is important to use Arimidex under the guidance of a healthcare professional and to be aware of its potential side effects and interactions.”
Indications and Usage
Arimidex (anastrozole) is indicated for the treatment of postmenopausal women with hormone receptor-positive early breast cancer. It is used in the adjuvant setting, as well as for the treatment of advanced breast cancer in postmenopausal women.
Arimidex is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
Arimidex is not recommended for use in premenopausal women or in patients with moderate to severe hepatic impairment.
Arimidex should be taken orally once a day, with or without food. The recommended dose for early breast cancer is 1 mg per day, while the recommended dose for advanced breast cancer is 1 mg per day until disease progression.
Prior to starting Arimidex, patients should have their hormone receptor status confirmed. Regular monitoring of bone mineral density is recommended for patients at risk of osteoporosis.
Common side effects of Arimidex include hot flashes, nausea, fatigue, headache, and musculoskeletal symptoms. Serious side effects may include bone fractures, cardiovascular events, and hepatotoxicity.
| Early Breast Cancer | 1 mg per day |
| Advanced Breast Cancer | 1 mg per day until disease progression |
It is important to inform healthcare providers about all current medications and medical conditions before starting Arimidex. Arimidex may interact with certain medications, including estrogen-containing therapies and tamoxifen.
Patients should be advised to report any unusual symptoms or side effects to their healthcare provider. It is also important for patients to follow the prescribed dosing schedule and to not stop taking Arimidex without consulting their healthcare provider.
Dosage and Administration
The recommended dose of Arimidex for adults is 1 mg once daily. The tablet should be taken orally, with or without food.
Arimidex is indicated for the treatment of postmenopausal women with hormone receptor-positive early breast cancer. It is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
The duration of treatment with Arimidex should be determined by the individual patient’s response and tolerance to the medication. Treatment may be continued until disease progression or unacceptable toxicity occurs.
If a dose of Arimidex is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. Double doses should not be taken to make up for a missed dose.
It is important to note that Arimidex should not be used in premenopausal women, as safety and efficacy have not been established in this population.
For patients with hepatic impairment, no dosage adjustment is necessary.
For patients with renal impairment, no dosage adjustment is necessary.
For patients with mild to moderate renal impairment, no dosage adjustment is necessary. However, caution should be exercised when administering Arimidex to patients with severe renal impairment, as there is limited data available in this population.
For patients with mild to moderate hepatic impairment, no dosage adjustment is necessary. However, caution should be exercised when administering Arimidex to patients with severe hepatic impairment, as there is limited data available in this population.
Contraindications
- Arimidex is contraindicated in patients with known hypersensitivity to anastrozole or any of the excipients in the formulation.
- Arimidex should not be used in premenopausal women, pregnant women, or women who may become pregnant. Anastrozole may cause fetal harm when administered to a pregnant woman.
- Arimidex is contraindicated in patients with severe hepatic impairment.
- Arimidex is contraindicated in patients with moderate to severe renal impairment.
- Arimidex is contraindicated in patients with a history of thromboembolic events.
- Arimidex is contraindicated in patients with known osteoporosis or at risk for osteoporosis.
These contraindications should be taken into consideration before prescribing Arimidex to patients. It is important to assess the patient’s medical history and current condition to determine if Arimidex is appropriate for use.
Warnings and Precautions
- Before starting treatment with Arimidex, patients should be evaluated for the presence of any pre-existing medical conditions, such as liver disease or osteoporosis.
- Arimidex should not be used in patients with a known hypersensitivity to anastrozole or any of the other ingredients in the formulation.
- Pregnant or breastfeeding women should not take Arimidex, as it may cause harm to the developing fetus or nursing infant.
- Arimidex may cause dizziness or drowsiness in some patients. Patients should use caution when driving or operating machinery until they know how the medication affects them.
- Patients taking Arimidex should have regular monitoring of their bone mineral density, as the medication may increase the risk of osteoporosis.
- There have been reports of an increased risk of cardiovascular events, such as heart attack or stroke, in patients taking Arimidex. Patients with a history of cardiovascular disease should be closely monitored while taking this medication.
- Arimidex may interact with other medications, including tamoxifen and estrogen-containing products. Patients should inform their healthcare provider of all medications they are taking, including over-the-counter drugs and herbal supplements.
- Patients should inform their healthcare provider if they experience any unusual or severe side effects while taking Arimidex.
Adverse Reactions
The following adverse reactions have been reported with the use of Arimidex:
- Hot flushes
- Headache
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain
- Joint pain
- Back pain
- Bone pain
- Increased sweating
- Rash
- Dry skin
- Weakness
- Fatigue
- Dizziness
- Insomnia
- Depression
- Anxiety
- Mood changes
- Loss of appetite
- Weight gain
- Hair thinning
- High blood pressure
These adverse reactions may occur in some patients, but they are not necessarily experienced by all individuals taking Arimidex. If you experience any of these symptoms or any other side effects while taking Arimidex, it is important to consult your healthcare provider.
Drug Interactions
- CYP3A4 Inhibitors: Arimidex is metabolized by CYP3A4, so co-administration with strong CYP3A4 inhibitors may increase plasma concentrations of Arimidex. Caution should be exercised when Arimidex is co-administered with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir.
- CYP3A4 Inducers: Arimidex is metabolized by CYP3A4, so co-administration with strong CYP3A4 inducers may decrease plasma concentrations of Arimidex. Caution should be exercised when Arimidex is co-administered with strong CYP3A4 inducers such as rifampicin, phenytoin, and carbamazepine.
- Tamoxifen: Co-administration of tamoxifen with Arimidex may reduce the efficacy of Arimidex. Therefore, concomitant use of tamoxifen and Arimidex is not recommended.
- Estrogen-containing products: Co-administration of estrogen-containing products with Arimidex may reduce the efficacy of Arimidex. Therefore, concomitant use of estrogen-containing products and Arimidex is not recommended.
- Warfarin: Arimidex may increase the anticoagulant effect of warfarin. Close monitoring of prothrombin time or INR is recommended in patients receiving concomitant treatment with warfarin.
- Letrozole: Co-administration of letrozole with Arimidex may increase the plasma concentrations of Arimidex. Caution should be exercised when Arimidex is co-administered with letrozole.
It is important to inform your healthcare provider about all medications, including prescription and over-the-counter drugs, vitamins, and herbal supplements, that you are taking before starting treatment with Arimidex. They can provide you with personalized advice and guidance regarding potential drug interactions.
Use in Specific Populations
Pregnancy:
- Arimidex is contraindicated during pregnancy as it may cause fetal harm.
- Women of childbearing potential should be advised to avoid becoming pregnant while taking Arimidex.
- If a pregnant woman inadvertently takes Arimidex, she should be informed of the potential risks to the fetus.
Lactation:
- It is not known whether Arimidex is excreted in human milk.
- Due to the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued during treatment with Arimidex.
Geriatric Use:
- No dosage adjustment is necessary for elderly patients.
- Clinical studies have not identified any differences in efficacy or safety between elderly and younger patients.
Hepatic Impairment:
- Arimidex should be used with caution in patients with mild to moderate hepatic impairment.
- There is no recommended dose adjustment for patients with mild to moderate hepatic impairment.
- However, Arimidex should be avoided in patients with severe hepatic impairment due to limited data.
Renal Impairment:
- No dosage adjustment is necessary for patients with renal impairment.
- Clinical studies have not identified any differences in efficacy or safety between patients with renal impairment and those with normal renal function.
Pediatric Use:
- The safety and effectiveness of Arimidex in pediatric patients have not been established.
- Arimidex is not indicated for use in children.
Sexual Function/Reproduction:
- Arimidex may impair fertility in males and females.
- Patients should be advised to seek counseling regarding fertility preservation before starting treatment with Arimidex.
Concomitant Medications:
- Arimidex may interact with certain medications, including tamoxifen, estrogen-containing therapies, and other hormonal treatments.
- Patients should inform their healthcare provider about all medications they are taking, including prescription, over-the-counter, and herbal products.
Other Populations:
- Arimidex has not been studied in patients with severe renal impairment or severe hepatic impairment.
- Therefore, caution should be exercised when using Arimidex in these patient populations.
Overdosage
There is limited information available on the effects of Arimidex overdose in humans. In clinical trials, doses up to 60 mg per day were well tolerated. However, higher doses have not been studied and may cause increased side effects.
In case of overdose, supportive measures should be taken. This may include monitoring vital signs, providing symptomatic treatment, and administering activated charcoal to reduce absorption of the drug.
In the event of an overdose, it is important to seek medical attention immediately. The local poison control center or emergency department should be contacted for further guidance.
Symptoms of overdose may include:
- Severe nausea and vomiting
- Extreme fatigue
- Headache
- Dizziness
- Hot flashes
- Abdominal pain
- Joint pain
- Blurred vision
Management of overdose:
In case of overdose, the patient should be closely monitored for any signs of toxicity. Symptomatic treatment should be provided as necessary. There is no specific antidote for Arimidex overdose.
It is important to note that Arimidex is extensively metabolized in the liver, and therefore, patients with severe hepatic impairment may be at increased risk of overdose. Close monitoring and dose adjustment may be necessary in these patients.
| Supportive measures | Monitor vital signs, provide symptomatic treatment |
| Activated charcoal | May be administered to reduce drug absorption |
| Medical attention | Seek immediate medical attention in case of overdose |
| Poison control center | Contact local poison control center or emergency department for guidance |
Clinical Pharmacology
- Arimidex (anastrozole) is a selective non-steroidal aromatase inhibitor.
- Arimidex inhibits the conversion of androgens to estrogens by inhibiting the aromatase enzyme.
- It reduces the plasma concentration of estradiol, leading to tumor regression in estrogen-dependent tumors.
- Arimidex has no progestogenic, androgenic, or estrogenic activity.
- It is highly selective and has a high affinity for the aromatase enzyme.
- Arimidex is well-absorbed orally, with peak plasma concentrations reached within 2 hours.
- It is extensively metabolized in the liver, primarily by the cytochrome P450 enzyme system.
- The main metabolite, triazole, has similar pharmacological activity to the parent compound.
- Arimidex is mainly excreted in the urine, with a small proportion excreted in the feces.
- There is no evidence of accumulation of Arimidex with daily administration.
- The pharmacokinetics of Arimidex are not affected by age, race, or renal impairment.
Mechanism of Action
Arimidex selectively inhibits the aromatase enzyme, which is responsible for the conversion of androgens to estrogens. By inhibiting this enzyme, Arimidex reduces the plasma concentration of estradiol, a potent estrogen. This leads to tumor regression in estrogen-dependent tumors.
Pharmacokinetics
Arimidex is well-absorbed orally, with peak plasma concentrations reached within 2 hours. It is extensively metabolized in the liver, primarily by the cytochrome P450 enzyme system. The main metabolite, triazole, has similar pharmacological activity to the parent compound. Arimidex is mainly excreted in the urine, with a small proportion excreted in the feces. There is no evidence of accumulation of Arimidex with daily administration. The pharmacokinetics of Arimidex are not affected by age, race, or renal impairment.
Drug Interactions
Arimidex is primarily metabolized by the cytochrome P450 enzyme system. Therefore, drugs that are known to inhibit or induce this enzyme system may alter the pharmacokinetics of Arimidex. However, no clinically significant drug interactions have been reported with Arimidex.
How Supplied/Storage and Handling
Arimidex is supplied as film-coated tablets for oral administration. Each tablet contains 1 mg of anastrozole.
The tablets are white, round, biconvex, and film-coated. The tablets are debossed with “Adx 1” on one side and plain on the other side.
Arimidex is available in blister packs containing 28, 30, 84, or 90 tablets.
Storage
Arimidex tablets should be stored at controlled room temperature, between 20°C and 25°C (68°F and 77°F).
The tablets should be kept in the original blister pack to protect them from moisture.
Do not remove the tablets from the blister pack until you are ready to take a dose.
Keep Arimidex out of the reach and sight of children.
Handling
Handle Arimidex tablets with dry hands.
Do not break or crush the tablets.
If a tablet is accidentally broken, avoid contact with the skin or eyes. If contact occurs, wash the affected area thoroughly with soap and water. If irritation persists, seek medical advice.
Do not dispose of Arimidex tablets in household waste or wastewater. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
It is important to follow the storage and handling instructions to ensure the effectiveness and safety of Arimidex.
Patient Counseling Information
Important Information for Patients
- Patients should be informed about the potential risks and benefits of Arimidex treatment.
- Patients should be advised to read the patient information leaflet provided with Arimidex and to follow the instructions for use.
- Patients should be informed that Arimidex is prescribed to treat breast cancer and should not be used for any other condition unless specifically prescribed by their healthcare provider.
Adverse Reactions
Patients should be informed about the potential adverse reactions of Arimidex and to seek medical attention if they experience any of the following:
- Severe allergic reactions, such as swelling of the face, lips, tongue, or throat, or difficulty breathing
- New or worsening bone pain
- Severe skin reactions, such as rash, blisters, or peeling skin
- Severe or persistent stomach pain
- Unusual bleeding or bruising
Drug Interactions
Patients should be advised to inform their healthcare provider about all the medications they are currently taking, including prescription and over-the-counter drugs, herbal supplements, and vitamins. Arimidex may interact with certain medications, such as tamoxifen, and this can affect the effectiveness of the treatment.
Pregnancy and Breastfeeding
Patients should be advised not to use Arimidex if they are pregnant, planning to become pregnant, or breastfeeding. Arimidex may cause harm to the unborn baby or nursing infant.
Missed Dose
Patients should be advised to take Arimidex as prescribed by their healthcare provider and to contact their healthcare provider if they miss a dose. Patients should not take a double dose to make up for a missed dose.
Storage and Handling
Patients should be advised to store Arimidex at room temperature, away from moisture and heat. The medication should be kept out of the reach of children.
Additional Information
Patients should be encouraged to ask their healthcare provider any questions they may have about Arimidex or their treatment plan. It is important for patients to have a clear understanding of their medication and to follow their healthcare provider’s instructions for use.
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