• Aromita indications
• Uses of Aromita in details
• Aromita description
• Aromita dosage
• Aromita interactions
• Aromita side effects
• Aromita contraindications

What is Aromita?

Aromita is used to treat certain types of breast cancer in women who have already stopped menstruating (postmenopausal). It is also used for women who have already had other cancer treatments (e.g., tamoxifen).

Many breast cancer tumors grow in response to estrogen. Aromita interferes with the production of estrogen in the body. As a result, the amount of estrogen that the tumor is exposed to is reduced, limiting the growth of the tumor.

Aromita is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Aromita is used in certain patients with the following medical conditions:

• Breast cancer, neoadjuvant treatment for hormone receptor-positive, operable or potentially operable, locally advanced disease in postmenopausal women (treatment for advanced breast cancer that may respond to surgery in women who have already stopped menstruating).

Aromita indications

Adjuvant Treatment

Aromita tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

First-Line Treatment

Aromita tablets are 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

Aromita tablets are 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 Aromita tablets.

How should I use Aromita?

Use Aromita as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient information leaflet is available with Aromita. Talk to your pharmacist if you have questions about this information.
• Take Aromita by mouth with or without food.
• Continue to take Aromita even if you feel well. Do not miss any doses.
• If you miss a dose of Aromita, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aromita.

Uses of Aromita in details

Use: Labeled Indications

Breast cancer:

First-line treatment of locally-advanced or metastatic breast cancer (hormone receptor-positive or unknown) in postmenopausal women

Adjuvant treatment of early hormone receptor-positive breast cancer in postmenopausal women

Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy

Off Label Uses

Endometrial or uterine cancers (recurrent or metastatic)

Hormonal agents such as progestational agents or tamoxifen may be used in the management of recurrent or metastatic endometrial cancer; in select patients, aromatase inhibitors, including Aromita, may be considered. A small phase II trial evaluated Aromita in a group of unselected patients with advanced recurrent or persistent endometrial cancer; the results showed minimal activity of Aromita.

Aromita description

Aromita is a drug indicated in the treatment of breast cancer in post-menopausal women. It is used both in adjuvant therapy (i.e. following surgery) and in metastatic breast cancer. It decreases the amount of estrogens that the body makes. Aromita belongs in the class of drugs known as aromatase inhibitors. It inhibits the enzyme aromatase, which is responsible for converting androgens (produced by women in the adrenal glands) to estrogens.

Aromita dosage

Aromita Dosage

Generic name: Aromita 1mg

Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Recommended Dose

The dose of Aromita is one 1 mg tablet taken once a day. For patients with advanced breast cancer, Aromita should be continued until tumor progression. Aromita 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, Aromita 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. Aromita has not been studied in patients with severe hepatic impairment.

More about Aromita (Aromita)

• Side Effects
• During Pregnancy
• Dosage Information
• Drug Images
• Drug Interactions
• Support Group
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• En Espanol
• 43 Reviews - Add your own review/rating
• Generic Availability

Consumer resources

• Aromita
• Aromita (Advanced Reading)

Professional resources

• Aromita (AHFS Monograph)
• Aromita (FDA)

Related treatment guides

• Breast Cancer, Metastatic
• Breast Cancer
• McCune-Albright Syndrome
• Pubertal Gynecomastia

Aromita interactions

See also:
What other drugs will affect Aromita?

Aromita inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro. Clinical studies with antipyrine and warfarin showed that Aromita at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and R- and S-warfarin indicating the co-administration of Aromita with other medicinal products is unlikely to result in clinically significant medicinal product interactions mediated by CYP enzymes.

The enzymes mediating metabolism of Aromita have not been identified. Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of Aromita. The effect of potent CYP inhibitors is unknown.

A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with Aromita who also received other commonly prescribed medicinal products. There were no clinically significant interactions with bisphosphonates.

Co-administration of tamoxifen or estrogen-containing therapies with Aromita should be avoided as this may diminish its pharmacological action.

Aromita side effects

See also:
What are the possible side effects of Aromita?

Unless specified, the following frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer treated for 5 years (ATAC Study).

The table below presents the frequency of pre-specified adverse events in the ATAC study, irrespective of causality, reported in patients receiving trial therapy and up to 14 days after cessation of trial therapy.

The ATAC trial data showed that patients receiving Aromita had an increase in joint disorders (including arthritis, arthrosis, and arthralgia) compared with patients receiving tamoxifen. Patients receiving Aromita had an increase in the incidence of fractures (including fractures of spine, hip and wrist) compared with patients receiving tamoxifen. These differences were statistically significant. Fracture rates of 22 per 1,000 patient-years and 15 per 1000 patient-years were observed for the Aromita and tamoxifen groups, respectively, after a median follow up of 68 months. The observed fracture rate for Aromita is similar to the range reported in age-matched postmenopausal populations. It has not been determined whether the rates of fracture and osteoporosis seen in ATAC in patients on Aromita treatment reflect a protective effect of tamoxifen, a specific effect of Aromita, or both.

The incidence of osteoporosis was 10.5% in patients treated with Aromita and 7.3% in patients treated with tamoxifen.

Patients receiving Aromita had a decrease in hot flushes, vaginal bleeding, vaginal discharge, endometrial cancer, venous thromboembolic events (including deep venous thrombosis) and ischaemic cerebrovascular events compared with patients receiving tamoxifen. These differences were statistically significant.

Results from the ATAC trial bone substudy, at 12 and 24 months demonstrated that patients receiving Aromita had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline.

Slight increases in total cholesterol have also been observed in clinical trials with Aromita, although the clinical significance has not been determined.

Aromita contraindications

See also:
What is the most important information I should know about Aromita?

Do not use Aromita if you are pregnant. It could harm the unborn baby.

You may need to take a pregnancy test before using Aromita, to make sure you are not pregnant.

You should not use this medication if you are allergic to Aromita, if you are breast-feeding a baby, or if you have not yet completed menopause. Aromita is not for use in men or children.

Before using Aromita, tell your doctor if you have heart disease, circulation problems, a history of stroke or blood clot, severe liver disease, high cholesterol, osteoporosis, or low bone mineral density.

Aromita may not work as well if you take it together with tamoxifen or an estrogen medication (such as hormone replacement therapy, estrogen creams, or birth control pills, injections, implants, skin patches, and vaginal rings). Before you start taking Aromita, tell your doctor if you also take tamoxifen or estrogen.

You may need to keep taking Aromita for up to 5 years. Follow your doctor's instructions.

Active ingredient matches for Aromita:

Anastrozole

References

1. DailyMed. "ANASTROZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "anastrozole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "anastrozole". http://www.drugbank.ca/drugs/DB01217 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology