Altrol (anastrozole) tablets for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. Each tablet contains as inactive ingredients: lactose, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.
INDICATIONS
Adjuvant Treatment
Altrol is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
First-Line Treatment
Altrol is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
Second-Line Treatment
Altrol is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Altrol.
DOSAGE AND ADMINISTRATION
Recommended Dose
The dose of Altrol is one 1 mg tablet taken once a day. For patients with advanced breast cancer, Altrol should be continued until tumor progression. Altrol can be taken with or without food.
For adjuvant treatment of early breast cancer in postmenopausal women, the optimal duration of therapy is unknown. In the ATAC trial Altrol was administered for five years.
No dosage adjustment is necessary for patients with renal impairment or for elderly patients.
Patients with Hepatic Impairment
No changes in dose are recommended for patients with mild-to-moderate hepatic impairment. Altrol has not been studied in patients with severe hepatic impairment.
Storage
In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with Altrol in the ATAC trial (17% of patients on Altrol and 10% of patients on tamoxifen). Consider risk and benefits of Altrol therapy in patients with pre-existing ischemic heart disease.
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What are anastrozole tablets?
ANASTROZOLE (Arimidex®) blocks the production of the hormone estrogen. Some types of breast cancer depend on estrogen to grow, and anastrozole can stop tumor growth by blocking estrogen production. Anastrozole is for the treatment of breast cancer in postmenopausal women only. Generic anastrozole tablets are not yet available.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
• liver disease
• an unusual or allergic reaction to anastrozole, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding
How should I take this medicine?
Take anastrozole tablets by mouth at the same time each day with or without food. Follow the directions on the prescription label. Swallow the tablets with a drink of water. Do not take your medicine more often than directed. Do not stop taking except on your prescriber's advice.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you vomit after taking a dose, call your prescriber or health care professional for advice.
What drug(s) may interact with anastrozole?
• any medicine containing estrogens (This may include some herbal products and some birth control pills)
• DHEA
Tell your prescriber or health care professional about all other medicines you are taking, including nonprescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What should I watch for while taking anastrozole?
Visit your prescriber or health care professional for regular checks on your progress. Let your prescriber or health care professional know about any unusual vaginal bleeding.
Do not treat yourself for diarrhea, nausea, vomiting or other side effects. Ask your prescriber or health care professional for advice.
What side effects may I notice from taking anastrozole?
Side effects that you should report to your prescriber or health care professional as soon as possible:
• any new or unusual symptoms
• difficulty breathing
• chest pain
• leg pain or swelling
• vaginal bleeding
• vomiting
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• back or bone pain
• cough, or throat infection
• diarrhea or constipation
• dizziness
• headache
• hot flashes
• loss of appetite
• nausea
• stomach pain
• sweating
• weakness and tiredness
• weight gain
Uses
Treats certain types of breast cancer in women who have gone through menopause.
Storage
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Keep all medicine away from children and never share your medicine with anyone. Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
- APPEARANCE: Tablet. Medicines used to treat cancer are very strong and can have many side effects.
- Before receiving this medicine, make sure you understand all the risks and benefits.
- It is important for you to work closely with your doctor during your treatment. Your doctor will tell you how much of this medicine to use and how often.
- Do not use more medicine or use it more often than your doctor tells you to. You may take this medicine with or without food.
- Call your doctor right away if you notice any of these side effects: Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing. Chest pain. Severe diarrhea. Severe nausea or vomiting. Vaginal bleeding or discharge.
Anastrozole (an-ASS-troh-zole ) is a medicine, used extensively in the treatment of breast cancer. Many of the breast cancer tumors grow in response to estrogen. This medicine interferes with the production of estrogen in the body, resulting in the reduction of the amount of estrogen that the tumor is exposed to, thus limiting or resisting the growth of the tumor.
Letrozole (LET-roe-zole) is used for the treatment of certain types of breast cancer in women. Female hormones that occur naturally in the body can cause an increase in the growth of some breast cancers. Letrozole functions through decreasing the amounts of these hormones in the female body. The medicine is prescribed & useful for women who have already stopped menstruating.
The Scottish Medicines Consortium issues advice on anastrozole 1mg tablets for the supporting treatment of postmenopausal women with early invasive breast cancer which is hormone sensitive.
The Scottish Medicines Consortium (SMC) has, after a full submission, completed its assessment on the above product. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) that anastrozole 1mg tablets are accepted for restricted use for the supporting treatment of postmenopausal women with early invasive breast cancer which is hormone sensitive.
Anastrozole has shown benefit over standard anti-oestrogen therapy in terms of disease-free survival in this patient group. It offers an alternative to tamoxifen and has a different range of adverse effects. Treatment with anastrozole should be started by a breast cancer specialist.
What is Arimidex (Anastrozole)?
- Arimidex (Anastrozole) blocks the use of estrogen by certain types of breast cancer that require estrogen to grow.
- Arimidex (Anastrozole) is used to treat breast cancer.
- Arimidex (Anastrozole) may also be used for purposes other than those listed in this medication guide.
How should I take Arimidex (Anastrozole)?
Take Arimidex (Anastrozole) exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass (8 ounces) of water.
Arimidex (Anastrozole) is usually taken once a day. Follow your doctor's instructions.
Arimidex (Anastrozole) can be taken with or without food.
Store Arimidex (Anastrozole) at room temperature away from moisture and heat.
What happens if I overdose?
An overdose of Arimidex (Anastrozole) is unlikely to threaten life. Call an emergency room or a poison control center for advice if you suspect that a very large dose of anastrozole has been ingested.
What should I avoid while taking Arimidex (Anastrozole)?
There are nos restrictions on food, beverages, or activities while taking Arimidex (Anastrozole) unless otherwise directed by your doctor.
Arimidex (Anastrozole) side effects
Stop taking Arimidex (Anastrozole) and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives) to anastrozole.
Other, less serious side effects may be more likely to occur. Continue to take Arimidex (Anastrozole) and talk to your doctor if you experience
- diarrhea;
- nausea or vomiting;
- constipation;
- weakness;
- muscle or bone pain;
- headache;
- hot flashes;
- shortness of breath or coughing;
- dizziness;
- swelling or water retention;
- loss of appetite;
- vaginal dryness;
- weight gain; or
- rash.
Docetaxel Injection
The anti cancer medicines are available as docetaxel injection of 20mg or 0.5ml composition. These injections bear accurate compositions of anti cancer medicine and are effective in slowing down the growth and spread of cancer cells in the body. Our docetaxel injections are used for the treatment of :
- Breast cancer
- Lung cancer
- Prostate cancer
- Stomach cancer
- Head and neck cancer
- Ovarian cancer
- Gastric cancer
- Pancreatic cancer
- Hormone refractory cancer
Mechanism of Action
Many breast cancers have estrogen receptors and growth of these tumors can be stimulated by estrogen. In postmenopausal women, the principal source of circulating estrogen (primarily estradiol) is conversion of adrenally-generated androstenedione to estrone by aromatase in peripheral tissues, such as adipose tissue, with further conversion of estrone to estradiol. Many breast cancers also contain aromatase; the importance of tumor-generated estrogens is uncertain.
Treatment of breast cancer has included efforts to decrease estrogen levels, by ovariectomy premenopausally and by use of anti-estrogens and progestational agents both pre- and post-menopausally; and these interventions lead to decreased tumor mass or delayed progression of tumor growth in some women.
Anastrozole is a potent and selective non-steroidal aromatase inhibitor. It significantly lowers serum estradiol concentrations and has no detectable effect on formation of adrenal corticosteroids or aldosterone.
Pharmacokinetics
Inhibition of aromatase activity is primarily due to anastrozole, the parent drug. Studies with radiolabeled drug have demonstrated that orally administered anastrozole is well absorbed into the systemic circulation with 83 to 85% of the radiolabel recovered in urine and feces. Food does not affect the extent of absorption. Elimination of anastrozole is primarily via hepatic metabolism (approximately 85%) and to a lesser extent, renal excretion (approximately 11%), and anastrozole has a mean terminal elimination half-life of approximately 50 hours in postmenopausal women. The major circulating metabolite of anastrozole, triazole, lacks pharmacologic activity. The pharmacokinetic parameters are similar in patients and in healthy postmenopausal volunteers. The pharmacokinetics of anastrozole are linear over the dose range of 1 to 20 mg and do not change with repeated dosing. Consistent with the approximately 2-day terminal elimination half-life, plasma concentrations approach steady-state levels at about 7 days of once daily dosing and steady-state levels are approximately three- to four-fold higher than levels observed after a single dose of ARIMIDEX. Anastrozole is 40% bound to plasma proteins in the therapeutic range.
Metabolism and Excretion
Studies in postmenopausal women demonstrated that anastrozole is extensively metabolized with about 10% of the dose excreted in the urine as unchanged drug within 72 hours of dosing, and the remainder (about 60% of the dose) is excreted in urine as metabolites. Metabolism of anastrozole occurs by N-dealkylation, hydroxylation and glucuronidation. Three metabolites of anastrozole have been identified in human plasma and urine. The known metabolites are triazole, a glucuronide conjugate of hydroxy-anastrozole, and a glucuronide of anastrozole itself. Several minor (less than 5% of the radioactive dose) metabolites have not been identified.
Because renal elimination is not a significant pathway of elimination, total body clearance of anastrozole is unchanged even in severe (creatinine clearance less than 30 mL/min/1.73m2) renal impairment, dosing adjustment in patients with renal dysfunction is not necessary (see Special Populations and DOSAGE AND ADMINISTRATION sections). Dosage adjustment is also unnecessary in patients with stable hepatic cirrhosis (see Special Populations and DOSAGE AND ADMINISTRATION sections).
Special Populations
Geriatric
Anastrozole pharmacokinetics have been investigated in postmenopausal female volunteers and patients with breast cancer. No age related effects were seen over the range <50>80 years.
Race
Estradiol and estrone sulfate levels were similar between Japanese and Caucasian postmenopausal women who received 1 mg of anastrozole daily for 16 days. Anastrozole mean steady-state minimum plasma concentrations in Caucasian and Japanese postmenopausal women were 25.7 and 30.4 ng/mL, respectively.
Renal Insufficiency
Anastrozole pharmacokinetics have been investigated in subjects with renal insufficiency. Anastrozole renal clearance decreased proportionally with creatinine clearance and was approximately 50% lower in volunteers with severe renal impairment (creatinine clearance < class="sup">2) compared to controls. Since only about 10% of anastrozole is excreted unchanged in the urine, the reduction in renal clearance did not influence the total body clearance (See DOSAGE AND ADMINISTRATION).
Hepatic Insufficiency
Hepatic metabolism accounts for approximately 85% of anastrozole elimination. Anastrozole pharmacokinetics have been investigated in subjects with hepatic cirrhosis related to alcohol abuse. The apparent oral clearance (CL/F) of anastrozole was approximately 30% lower in subjects with stable hepatic cirrhosis than in control subjects with normal liver function. However, plasma anastrozole concentrations in the subjects with hepatic cirrhosis were within the range of concentrations seen in normal subjects across all clinical trials (see DOSAGE AND ADMINISTRATION), so that no dosage adjustment is needed.
The randomized study examined the ability of Femara to inhibit total body aromatization and suppress plasma estrogen levels in 12 postmenopausal women with metastatic breast cancer compared with Arimidex (anastrozole). The differences between the two drugs in inhibiting total body aromatization (ovaries excepted) were statistically significant as was the suppression of two of the three major estrogens.
"We know that hormone sensitive breast cancers rely on estrogen for growth, and in this study, Femara was shown to be a more effective inhibitor of total body aromatization and suppressor of plasma estrogen levels as compared to anastrozole," said Per Eystein Lonning, professor of Oncology,
The primary objective of the study was to compare the effects of the nonsteroidal aromatase inhibitors Femara and anastrozole on total body aromatization (the capacity of the whole body to produce estrogens) and plasma estrogen levels.
The trial was a randomized, crossover study of 12 postmenopausal women with metastatic breast cancer whose disease was suitable for treatment with an aromatase inhibitor. Patients were treated sequentially with anastrozole 1 mg followed by Femara 2.5 mg once daily
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