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

What is Biostrol?

Biostrol 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. Biostrol 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.

Biostrol 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, Biostrol 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).

Biostrol indications

Adjuvant Treatment

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

First-Line Treatment

Biostrol 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

Biostrol 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 Biostrol tablets.

How should I use Biostrol?

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

• An extra patient information leaflet is available with Biostrol. Talk to your pharmacist if you have questions about this information.
• Take Biostrol by mouth with or without food.
• Continue to take Biostrol even if you feel well. Do not miss any doses.
• If you miss a dose of Biostrol, 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 Biostrol.

Uses of Biostrol 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 Biostrol, may be considered. A small phase II trial evaluated Biostrol in a group of unselected patients with advanced recurrent or persistent endometrial cancer; the results showed minimal activity of Biostrol.

Biostrol description

Biostrol 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. Biostrol 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.

Biostrol dosage

Biostrol Dosage

Generic name: Biostrol 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 Biostrol is one 1 mg tablet taken once a day. For patients with advanced breast cancer, Biostrol should be continued until tumor progression. Biostrol 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, Biostrol 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. Biostrol has not been studied in patients with severe hepatic impairment.

More about Biostrol (Biostrol)

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

Consumer resources

• Biostrol
• Biostrol (Advanced Reading)

Professional resources

• Biostrol (AHFS Monograph)
• Biostrol (FDA)

Related treatment guides

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

Biostrol interactions

See also:
What other drugs will affect Biostrol?

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

The enzymes mediating metabolism of Biostrol have not been identified. Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of Biostrol. 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 Biostrol 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 Biostrol should be avoided as this may diminish its pharmacological action.

Biostrol side effects

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

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 Biostrol had an increase in joint disorders (including arthritis, arthrosis, and arthralgia) compared with patients receiving tamoxifen. Patients receiving Biostrol 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 Biostrol and tamoxifen groups, respectively, after a median follow up of 68 months. The observed fracture rate for Biostrol 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 Biostrol treatment reflect a protective effect of tamoxifen, a specific effect of Biostrol, or both.

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

Patients receiving Biostrol 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 Biostrol 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 Biostrol, although the clinical significance has not been determined.

Biostrol contraindications

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

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

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

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

Before using Biostrol, 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.

Biostrol 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 Biostrol, tell your doctor if you also take tamoxifen or estrogen.

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

Active ingredient matches for Biostrol:

Anastrozole in Netherlands.

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