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AG-LETROZOLE is a brand name for Letrozole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AG-Letrozole (letrozole) film-coated tablets is indicated for: • The adjuvant treatment of postmenopausal women with hormone receptor-positive invasive early breast cancer. Clinical effectiveness is based on superior Disease-Free Survival (DFS) compared to tamoxifen. Overall survival was not significantly different…
Verbatim from this product's HC label. Tap a section to expand.
5 mg tablet once daily. In the adjuvant setting, the intended duration of treatment is 5 years. In the extended adjuvant setting, treatment with AG-Letrozole is intended for 5 years and should be initiated within 3 months of completion of approximately 5 years of prior standard adjuvant tamoxifen therapy.
In the first- and second-line advanced breast cancer settings, AG-Letrozole treatment should continue until further tumour progression is evident.
Special populations Hepatic impairment:
No dose adjustment of AG-Letrozole is required for patients with mild to moderate hepatic impairment (Child-Pugh score A or B). Insufficient data are available to recommend Serious Warnings and Precautions AG-Letrozole should be prescribed and managed by a qualified physician who is experienced in the use of anti-cancer agents.
AG-Letrozole increases the risk of osteoporosis and bone fractures (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal). PrAG-Letrozole (letrozole) Tablets Page 7 of 67 a dose adjustment in breast cancer patients with severe hepatic impairment (Child-Pugh C).
However, since letrozole elimination depends mainly on intrinsic metabolic clearance, caution is recommended. 3 Pharmacokinetics).
Renal impairment:
No dosage adjustment is required for patients with renal impairment with a creatinine clearance (CLcr) ≥10 mL/min. 3 Pharmacokinetics).
Pediatrics (< 18 years of age):
Letrozole is contraindicated in children and adolescents. The safety and efficacy of letrozole in children and adolescents (under 18 years of age) have not been established.
Geriatrics ( 65 years of age):
No dose adjustment is required for elderly patients. 3 Pharmacokinetics, Absorption). 5 Missed Dose The missed dose should be taken as soon as the patient remembers. However, if it is almost time for the next dose, the missed dose should be skipped, and the patient should go back to the regular dosage schedule.
3 Pharmacokinetics).
). 1% vs. 4%, respectively. A significantly higher incidence of events was seen for letrozole vs. 8% vs. 2% vs. 0%). 8% vs. 5% vs. 4% vs. 4% vs. 2% vs. 2% respectively). 3 % vs. 3%, respectively (a non- significant difference). 80). 1%) than with tamoxifen.
37). 67). 53) (see 8 ADVERSE REACTIONS). 0%)], but the difference was not statistically significant. Of the 19 deaths attributed to a cardiovascular cause in the placebo arm, 12 occurred in the group of 1026 patients who did not switch to letrozole after study unblinding, and 7 occurred in the group of 1551 patients who switched to letrozole.
A total of 7 patients died from a stroke – 6 in the letrozole arm and 1 after switching from placebo to letrozole after study unblinding. Driving and operating machinery No studies on the effects of letrozole on the ability to drive and use machines have been performed.
However, since fatigue, dizziness, and uncommonly somnolence have been observed with the use of letrozole, caution is advised when driving or operating machinery while such symptoms persist. PrAG-Letrozole (letrozole) Tablets Page 10 of 67 Endocrine and Metabolism Hyperlipidemia: The use of aromatase inhibitors, including AG-Letrozole, may increase lipid levels.
6% of patients treated with tamoxifen. In a smaller study (D2407) comparing 2 years of adjuvant treatment with letrozole or tamoxifen, significant differences were observed between treatments at all time-points in total cholesterol, LDL cholesterol and the HDL: LDL ratio in favour of tamoxifen.
Clinically relevant changes in total cholesterol at 2 years occurred significantly more often for patients treated with letrozole (17%) than with tamoxifen (5%). Monitoring of serum cholesterol is advised for patients treated with AG-Letrozole.
(see also 8 ADVERSE REACTIONS, 10 CLINICAL PHARMACOLOGY, 14 CLINICAL TRIALS).
, Musculoskeletal 12/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES...........................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................
1 Pediatrics ...................................................................................................................... 2 Geriatrics ......................................................................................................................
4 2 CONTRAINDICATIONS................................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX................................................................. 5 4 DOSAGE AND ADMINISTRATION ................................................................................
2 Recommended Dose and Dosage Adjustment............................................................. 4 Administration.............................................................................................................. 5 Missed Dose .................................................................................................................
6 5 OVERDOSAGE............................................................................................................ 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................
1 Special Populations .................................................................................................... 1 Pregnant Women .............................................................................................
AG-Letrozole is contraindicated in: • Patients who are hypersensitive to letrozole, other aromatase inhibitors, or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Premenopausal women (see 7 WARNINGS AND PRECAUTIONS). 1 Pregnant Women). 2 Breast-feeding). • Children or adolescents under 18 years of age.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Letrozole in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Monitoring and Laboratory Tests Plasma Lipids:
Women should have their cholesterol levels assessed and managed according to current clinical practice and guidelines (see 7 WARNINGS & PRECAUTIONS- Endocrine and Metabolism).
Bone Mineral Density:
Monitoring of overall bone health is recommended during treatment with AG-Letrozole. (See 7 WARNINGS & PRECAUTIONS- Musculoskeletal). In patients whose menopausal status is unclear or who become amenorrheic after chemotherapy, luteinising hormone (LH), follicle- stimulating hormone (FSH) and/or estradiol levels should be measured before initiating treatment with AG-Letrozole and regularly during the first 6 months of treatment.
Musculoskeletal Bone Mineral Density:
The use of estrogen lowering agents, including AG-Letrozole, may cause a reduction in bone mineral density (BMD) with a possible consequent increased risk of osteoporosis and fracture. 7%). 2%). 4%). Similarly, […]
2 Breast-feeding.................................................................................................. 3 Pediatrics (< 18 years of age) ........................................................................... 4 Geriatrics(≥ 65 years of age) ............................................................................
11 8 ADVERSE REACTIONS ............................................................................................... 1 Adverse Reaction Overview .......................................................................................
2 Clinical Trial Adverse Reactions ................................................................................. 5 Post-Market Adverse Reactions ................................................................................. 28 9 DRUG INTERACTIONS ..............................................................................................
2 Drug Interactions Overview ....................................................................................... 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions .............................................................................................. 7 Drug-Laboratory Test Interactions.............................................................................
31 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ...............................................................................................
2 Pharmacodynamics .................................................................................................. 3 Pharmacokinetics .....................................................................................................
36 11 STORAGE, STABILITY AND DISPOSAL ............................................................................ 38 12 SPECIAL HANDLING INSTRUCTIONS .......................................................................... 38 PART II: SCIENTIFIC INFORMATION......................................................................................
39 13 PHARMACEUTICAL INFORMATION........................................................................... 39 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication ...................................................................................... 57 15 MICROBIOLOGY ......................................................................................................
57 16 NON-CLINICAL TOXICOLOGY .................................................................................... 60 PrAG-Letrozole (letrozole) Tablets Page 5 of 67 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS AG-Letrozole (letrozole) film-coated tablets is indicated for: • The adjuvant treatment of postmenopausal women with hormone receptor-positive invasive early breast cancer.
Clinical effectiveness is based on superior Disease-Free Survival (DFS) compared to tamoxifen. Overall survival was not significantly different between the two treatments (see 14 CLINICAL TRIALS). • The extended adjuvant treatment of hormone receptor positive invasive early breast cancer in postmenopausal women who have received approximately 5 years of prior standard adjuvant tamoxifen therapy.
Clinical effectiveness is based on superior Disease-Free Survival (DFS) compared to placebo in […]