Femara (letrozole tablets)

IMPORTANT SAFETY INFORMATION

Femara is only indicated in postmenopausal women. You should not take Femara if you are premenopausal. Your doctor should discuss the need for adequate birth control if you have the potential to become pregnant, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. Learn more about Important Safety Information for Femara.

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Glossary

Glossary

Many women feel they have to learn a new language to understand breast cancer. The glossary below will help familiarize you with many of the most commonly used terms.

absorption

The uptake of a drug into or across tissues.

adjuvant therapy

Therapy used to help reduce the risk of breast cancer returning after surgery. Adjuvant therapy may include chemotherapy, radiation, and/or hormone therapy.

androgen

One of a group of hormones found in both men and women.

anticancer

Having activity against cancer.

antiestrogen therapy

Drug that blocks the action of estrogen.

arm lymphedema

Swelling of the arm, caused by an abnormal collection of too much lymph fluid (clear fluid that contains white blood cells and antibodies and is circulated throughout the body by the lymphatic system).

aromatase

Enzyme that converts androgen into estrogen.

aromatase inhibitor

A category of drug that inhibits aromatase, an enzyme used in the formation of estrogens.

axillary lymph nodes

Lymph nodes located under the arms.

benign

Not cancerous; does not invade nearby tissue or spread to other parts of the body.

bone scan

Procedure by which an image of the bones is produced by injection of a radioisotope; used to determine if the cancer has spread to the bones.

breast biopsy

The surgical removal of a small piece of breast tissue for microscopic examination to determine if cancer cells are present.

catheter

A tubular instrument that allows passage of fluid from or into a body cavity or blood vessel.

cellulitis

Inflammation under the skin or loose connective tissue.

chemotherapy

The use of drugs to treat disease; when used to treat cancer, the goal is to kill cancer cells.

clinical trial

A scientific study conducted in people to determine the safety and effectiveness of a treatment.

CT (computed tomography) scan

Special type of x-ray that produces detailed images of the human body.

ductal carcinoma

Breast cancer consisting of tumors in the ducts of the breast.

ductal carcinoma in situ (DCIS)

Breast cancer, consisting of tumors of the milk ducts, that has not yet spread.

early stage breast cancer

Cancer that has not progressed beyond the breast tissue and local axillary lymph nodes.

efficacy:

The ability of a drug to produce a desired effect.

endometrial

Relating to or composed of the mucous membrane that lines the uterus.

enzyme

Protein produced by a living cell that enables the body to carry out necessary chemical reactions.

estrogen

Generic term for any substance, natural or synthetic (formed by the ovary, placenta, testes, and possibly the adrenal cortex, as well as by certain plants), that exerts biologic effects characteristic of estrogenic hormones. Estrogen controls the course of the menstrual cycle.

estrogen dependent

Breast cancers that grow because of estrogen.

estrogen receptor

Protein inside certain cells that binds to estrogen.

estrogen receptor-negative

Cancer cells that do not contain estrogen receptors.

estrogen receptor-positive

Cancer cells that contain estrogen receptors.

excision

Removal of part or all of the breast and surrounding breast tissue.

gastrointestinal tract

Organs of digestion, including the stomach and intestines.

growth factor

Any substance that promotes the growth of cells within the body.

hormone

Substance produced by living cells that circulates in the bloodstream and affects cells and tissues far from where it originates.

hormone-dependent

Cells that require the action of hormones for their growth.

hormone receptor-negative

Cancer cells that do not contain estrogen receptors.

hormone receptor-positive

Cancer cells that contain estrogen receptors.

hormone replacement therapy (HRT)

Estrogen given in pill form to replace the estrogen lost after menopause; may or may not be given in conjunction with progesterone.

hormone therapy

Any therapy that blocks hormonal stimulation of the growth of cancer cells.

in situ

In the natural or original position or place.

infection (including cellulitis and abscess)

Multiplication of parasitic organisms within the body.

infiltrating/invasive carcinoma

Cancer that has spread beyond the layer of tissue in which it started, growing into surrounding, normal tissues.

lobular carcinoma

Breast cancer that begins in the lobules of the breast.

lumpectomy

Surgical removal of a tumor from the breast without removing much of the surrounding tissue or lymph nodes.

lymph

A liquid that contains cells that help the body fight infection.

lymph node/nodes

Small, bean-shaped organs that make and store the cells that fight infection; they are found in many places in the body, including under the arms, behind the ears, and more.

malignant

Composed of cancer cells; not benign.

mammogram

An x-ray picture of the breast.

margins

The area of tissue surrounding a tumor when it is removed through surgery.

mastectomy

Surgery that removes the entire breast. Types of mastectomy include simple, radical, modified radical, and extended radical.

menopause

Cessation of menstruation (usually between the ages of 45 and 55).

metastasis

The spread of a disease from the original site to another part of the body.

neoadjuvant therapy

The use of chemotherapy, radiation, and/or hormone therapy to reduce tumor bulk or size before surgery.

nodal status

Whether the cancer has spread from the original site to the lymph nodes. Cancer that has spread to the lymph nodes is referred to as lymph node-positive. Cancer that has not spread to the lymph nodes is referred to as lymph node-negative.

noninvasive cancer

Cancer cells that remain within the borders of a duct or lobule and have not grown into the surrounding tissues. These tumors are also known as in situ tumors (tumors that remain in the site of origin).

oncologist

A doctor who specializes in treating people with cancer. Some oncologists specialize in one type of cancer treatment. For example, a radiation oncologist treats cancer with radiation, and a medical oncologist treats cancer with medications. Some oncologists also specialize in one kind of cancer. For example, a breast cancer oncologist diagnoses and treats patients with breast cancer.

osteoporosis

The weakening of bone, wherein bone mass reaches the low end of a normal range.

ovaries

The pair of female reproductive organs on either side of the uterus that produce eggs and hormones.

partial mastectomy

Removal of the tumor, along with varying amounts of surrounding normal tissue. See also lumpectomy and quadrantectomy.

phantom breast syndrome

A sensation of residual breast tissue after mastectomy.

placebo

A medical treatment administered to the control group of a clinical trial.

postmenopausal

The time after menopause when menstruation has stopped.

premenopausal

The years when menstruation is still occurring.

prognosis

The probable outcome or course of a disease; the chance of recovery.

prostheses

A specially made replacement for a part of the body that has been removed, such as a breast or a limb.

quadrantectomy

A form of partial mastectomy involving excision of tumor in one quadrant of breast tissue.

radiation

High-energy emissions from x-rays, gamma-rays, neutrons, and other sources.

radiation therapy

The use of electromagnetic radiation for the local treatment of cancer.

receptors

An organ having nerve endings that respond to stimulation.

reconstruction

Surgery to rebuild a breast's shape after a mastectomy.

recurrence

When cancer returns after treatment, either at the original site or in another part of the body.

remission

Complete or partial disappearance of the signs and symptoms of disease. A remission, however, is not necessarily a cure.

response

The result of therapy as it applies to shrinking tumors.

seed

A small, cylindrical shell of gold or other suitable materials used to apply radiation therapy.

seroma

A tumor caused by the accumulation of serum within the body.

settings

A way to describe the extent of the cancer, based on such factors as tumor size, whether lymph nodes have been affected, and whether cancer has spread to other parts of the body.

stages/staging

A way to describe the extent of the cancer, based on such factors as tumor size, whether lymph nodes have been affected, and whether cancer has spread to other parts of the body.

surgery

When related to the treatment of cancer, any operative procedure in which the cancer is manually removed.

tamoxifen

An oral antiestrogen used in the treatment of patients with breast cancer.

toxicity

A specific harmful effect associated with therapy.

tumor

A group of cancerous cells.

tumor properties

Characteristics of the tumor, including size and if it is hormone receptor positive.

Indication
Femara® (letrozole) 2.5 mg tablets are approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone receptor-positive early stage breast cancer.

Important Safety Information

Femara is only indicated in postmenopausal women. You should not take Femara if you are premenopausal. Your doctor should discuss the need for adequate birth control if you have the potential to become pregnant, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. You should not take Femara if you are pregnant as it may cause harm to an unborn child. You should also discuss with your doctor what to do if you are nursing a child.

The use of Femara may cause decreases in the density of your bones, increases in bone fractures and osteoporosis. Monitoring of the density of your bones may be required.

Some patients taking Femara had an increase in cholesterol. Your doctor may require the monitoring of cholesterol in your blood.

Some women reported fatigue, dizziness and drowsiness with Femara. Until you know how it affects you, use caution before driving or operating machinery.

Some women had moderate, temporary decreases in white blood cell counts. The medical significance of this is not known.

The most serious side effects seen with Femara are bone effects (fractures, decreased bone density and osteoporosis) and increases in cholesterol. Other common side effects seen with Femara include joint pain, nausea, weight decrease, vaginal irritiation, and pain in the extremitites. Other important less commonly reported side effects include blood clots, other cancers, stroke, heart attack and endometrial cancer.

Femara is a once-daily, convenient prescription tablet. Your doctor may tell you to take Femara every other day if you have severe liver disease. Always take your medicine exactly as prescribed by your doctor.

For full prescribing information, please click here.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.


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