(let' roe zole)
P : Contraindicated in pregnancy
L : Contraindicated in lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication(s) & Dosage||Oral
Advanced or locally advanced breast cancer, Adjuvant therapy for postmenopausal women with hormone receptor positive early breast cancer
Adult: 2.5 mg once daily.
Hepatic impairment: Reduce dose by 50% in patients with cirrhosis and severe hepatic impairment; recommended dose: 2.5 mg on alternate days.
Special Populations: In renal failure: No dosage adjustment is required in patients with CrCl of at least 10 mL/min. In hepatic failure: No dosage adjustment is required in patients with mild to moderate hepatic impairment. Use with caution.
|Administration||May be taken with or without food.
|Contraindications||Premenopausal women and children; hypersensitivity.|
|Special Precautions||Severe renal impairment; severe hepatic impairment; osteoporosis. Caution when driving or operating machinery.|
|Adverse Drug Reactions||Hot flushes, arthralgia, nausea, vomiting, fatigue, dizziness, headache, dyspepsia, constipation, diarrhoea, anorexia, alopoecia, increased sweating, rash, peripheral oedema, osteoporosis, musculoskeletal pain, vaginal irritation.
Potentially Fatal: Thromboembolic events.
|Drug Interactions||Plasma levels reduced by tamoxifen. Please consult detailed drug interactions before prescribing.|
|Pregnancy Category (FDA)
||Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.|
||Letrozole competitively binds to the heme group of aromatase, a cytochrome P450 enzyme which catalyzes conversion of androgen to oestrogen, leading to inhibition of the enzyme and a significant reduction in plasma oestrogen levels.
Absorption: Rapidly and completely absorbed from the GI tract.
Distribution: Weakly bound to plasma proteins and has a large volume of distribution of about 1.9 l/kg.
Metabolism: Slow hepatic metabolism to inactive metabolites.
Excretion: Via urine (6% as unchanged drug); elimination half life of about 2 days.
|ATC Classification||L02BG04 - letrozole ; Belongs to the class of enzyme inhibitors. Used in endocrine therapy.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|FEMARA||Novartis (Bangladesh) Ltd.||Letrozole 2.5mg||Tablet||30's MRP 10,223.00|
|LEROZOLLET||Square Pharmaceuticals Ltd.||Letrozole 2.5mg||Tablet||1x5's: 201.35 MRP|
|LETROL||Renata Limited||Letrozole 2.5mg||Tablet||5's: 200.75 MRP|
|ZOLETA||Nuvista Pharma Limited||Letrozole 2.5mg||Tablet||5's: 125.00 MRP|
Why is this medication prescribed?
Letrozole is used treat early breast cancer in women who have experienced menopause (change of life; end of monthly menstrual periods) and who have had other treatments, such as radiation or surgery to remove the tumor. It is also used to treat early breast cancer in women who have experienced menopause and who have already been treated with a medication called tamoxifen for 5 years. Letrozole is also used in women who have experienced menopause as a first treatment of breast cancer that has spread within the breast or to other areas of the body or in women whose breast cancer has worsened while they were taking tamoxifen. Letrozole is in a class of medications called nonsteroidal aromatase inhibitors. It works by decreasing the amount of estrogen produced by the body. This can slow or stop the growth of some types of breast cancer cells that need estrogen to grow.
How should this medicine be used?
Letrozole comes as a tablet to take by mouth once a day with or without food. Take letrozole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take letrozole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You may need to take letrozole for several years or longer. Continue to take letrozole even if you feel well. Do not stop taking letrozole without talking to your doctor.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking letrozole,
- tell your doctor if you are allergic to letrozole, any other medications, or any of the ingredients in letrozole tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: medications that contain estrogen such as hormone replacement therapy (HRT) and hormonal contraceptives (birth control pills, patches, rings, and injections); raloxifene and tamoxifen.
- tell your doctor if you have high cholesterol, osteoporosis (condition in which the bones are fragile and break easily), or liver disease.
- you should know that letrozole should only be taken by women who have experienced menopause and cannot become pregnant. However, if you are pregnant or breast-feeding, you should tell your doctor before you begin taking this medication. Letrozole may harm the fetus.
- you should know that letrozole may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Letrozole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
loss of appetite
changes in weight
muscle, joint, or bone pain
swelling of the hands, feet, ankles, or lower legs
difficulty falling asleep or staying asleep
vaginal bleeding or irritation
Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:
unusual bleeding or bruising
pain in the upper right part of the stomach
yellowing of the skin or eyes
pain, warmth, or heaviness in the back of the lower leg
sudden speech problems
sudden weakness or numbness of an arm or leg
Letrozole may cause or worsen osteoporosis. It can decrease the density of your bones and increase the chance of broken bones and fractures. Talk to your doctor about the risks of taking this medication.
Letrozole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your HCP about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.