Femara

DRUG DESCRIPTION

Femara tablets for oral administration contains 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1ylmethylene) dibenzonitrile, and its structural formula is

Femara (letrozole) Structural Formula Illustration

Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31, empirical formula C17H11N5, and a melting range of 184C-185C.

Femara is available as 2.5 mg tablets for oral administration.

Inactive Ingredients: Colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.

What are the possible side effects of letrozole (Femara)?

Stop using letrozole and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • hot flashes, warmth or redness in your face or chest;
  • headache, muscle or joint pain;
  • night sweats;
  • weight gain;
  • fatigue, feeling weak;
  • nausea; or
  • swelling in your hands, ankles, or feet.

This is not a complete list of side...

Read All Potential Side Effects and See Pictures of Femara

What are the precautions when taking letrozole (Femara)?

Before taking letrozole, tell your doctor or pharmacist if you are allergic to it; or to anastrozole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood fats (cholesterol), bone problems (such as osteopenia, osteoporosis), stroke or blood clots, heart disease (such as chest pain, heart attack, heart failure), high blood pressure, kidney problems, liver problems.

This drug may make you dizzy and tired, and may rarely cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are...

Read All Potential Precautions of Femara


Femara Consumer (continued)

SIDE EFFECTS: Hot flashes, hair loss, joint/bone/muscle pain, tiredness, unusual sweating, nausea, diarrhea, dizziness, and trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bone fractures, mental/mood changes (such as depression, anxiety), swelling of arms/legs, blurred vision.

This medication (and cancer) may rarely cause serious problems from blood clots (such as heart attack or stroke). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, slurred speech, weakness on one side of the body, vision changes, sudden/severe headache.

Tell your doctor immediately if any of these rare but very serious side effects occur: persistent nausea/vomiting, unusual tiredness, dark urine, yellowing eyes/skin..

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat/neck), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking letrozole, tell your doctor or pharmacist if you are allergic to it; or to anastrozole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood fats (cholesterol), bone problems (such as osteopenia, osteoporosis), stroke or blood clots, heart disease (such as chest pain, heart attack, heart failure), high blood pressure, kidney problems, liver problems.

This drug may make you dizzy and tired, and may rarely cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Letrozole is used mainly in women after menopause. If you have recently gone through menopause, discuss the need for use of reliable forms of birth control with your doctor. Do not use birth control products containing estrogen. Consult your doctor for more details. If you become pregnant or think you may be pregnant, tell your doctor immediately. (See also How to Use section.)

It is not known whether this drug passes into breast milk and may harm a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Femara Patient Information Including Side Effects

Brand Names: Femara

Generic Name: letrozole (Pronunciation: LET row zol)

  • What is letrozole (Femara)?
  • What are the possible side effects of letrozole (Femara)?
  • What is the most important information I should know about letrozole (Femara)?
  • What should I discuss with my healthcare provider before using letrozole (Femara)?
  • How should I take letrozole (Femara)?
  • What happens if I miss a dose (Femara)?
  • What happens if I overdose (Femara)?
  • What should I avoid while taking letrozole (Femara)?
  • What other drugs will affect letrozole (Femara)?
  • Where can I get more information?

What is letrozole (Femara)?

Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Letrozole is used to treat breast cancer in postmenopausal women. It is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years.

Letrozole may also be used for purposes other than those listed here.

What are the possible side effects of letrozole (Femara)?

Stop using letrozole and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • hot flashes, warmth or redness in your face or chest;
  • headache, muscle or joint pain;
  • night sweats;
  • weight gain;
  • fatigue, feeling weak;
  • nausea; or
  • swelling in your hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about letrozole (Femara)?

Before taking letrozole, tell your doctor if you have liver disease. You may need a dose adjustment or special tests to safely take this medication.

Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Use this medication exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

There may be other drugs that can affect letrozole. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

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