Letrozole Tablets Instructions
Please read the instruction manual carefully and use under the guidance of a physician
[Drug Name
Generic Name: Letrozole Tablets
English Name: Letrozole Tablets
Hanyu Pinyin: Laiquzuo Pian
[Ingredients
The main ingredient of this product is: Letrozole
Chemical name:4,4′-(1H-1,2,4-triazol-1-yl-methylene)-dibenzonitrile. span style=”font-size:10pt”>
Chemical structure formula.
Molecular Formula: C17H11N5
Molecular Weight: 285.31
[Properties
This product is a dark yellow, round, film-coated tablet with slightly biconvex beveled edges (with the letters HR printed on one side and LE printed on the other).
[Indications
Adjuvant therapy for patients with early postmenopausal breast cancer who are estrogen or progesterone receptor positive.
Adjuvant therapy in postmenopausal patients with early-stage breast cancer who have received adjuvant tamoxifen for 5 years and who are estrogen or progesterone receptor positive.
Treatment of postmenopausal patients with advanced breast cancer who are estrogen receptor-positive, progesterone receptor-positive, or have unknown receptor status, who should undergo spontaneous or artificially induced menopause.
[Specifications
2.5mg
[Dosage].
The recommended dose of this product is 2.5mg once daily.
For patients who have received tamoxifen as adjuvant therapy for 5 years, this product should be taken continuously until disease recurs. In patients with metastatic disease, treatment with this product should be continued until tumor progression is confirmed.
This product should be taken orally, both before and after meals, as food has no effect on its degree of absorption.
If a dose is missed, the patient should make up the dose as soon as he/she remembers. However, if it is almost time for the next dose, the missed dose should be skipped and the dose should be taken according to the regular dosing schedule. The dose should not be doubled because systemic exposure in excess of the dose ratio was observed at daily doses above the recommended dose of 2.5 mg (see [Pharmacokinetics]).
Special Populations
Hepatic impairment
For patients with mild to moderate hepatic impairment (Child-Pugh score A or B), no dose adjustment is required. Data for patients with severe hepatic impairment (Child-Pugh score C) are insufficient, but these patients should be dosed under close monitoring if needed (see [Precautions] and [Pharmacokinetics]).
Impaired renal function
For patients with impaired renal function but creatinine clearance CLcr≥ 10 ml/min, no dose adjustment is required. Data are insufficient for patients with impaired renal function and a CLcr<10 ml/min (see [Precautions] and [Pharmacokinetics]).
[Adverse Reactions
Summary of Safety Features
Letrozole has been shown to be effective in all patients receiving first-line therapy and second-line therapy for advanced breast cancer patients, as well as in patients with early-stage breast cancer receiving adjuvant therapy and receiving follow-up intensive adjuvant therapy after standard adjuvant therapy with tamoxifen, showed a good safety profile. Approximately81%of patients receiving adjuvant therapy(Letrozole and tamoxifen control group),87-88% of patients in the sequential treatment group, with a median treatment duration60months;80%of patients receiving follow-up intensive adjuvant therapy(letrozole and placebo controls, median treatment duration60months) and one-third of patients treated with letrozole for advanced metastases as well as neoadjuvant therapy experienced adverse reactions. Adverse reactions observed in clinical studies were mild to moderate, and many were associated with estrogen deprivation.
The most common adverse reactions in clinical trials were hot flashes, arthralgia, nausea, and fatigue. Many adverse reactions are due to normal pharmacologic effects of estrogen deprivation(e.g., hot flashes, hair loss, and vaginal bleeding). span style=”font-family:Times New Roman”>). The adverse reactions listed in Table 1 were derived from clinical studies and post-marketing reports.
Table1 List summarizing adverse reactions with letrozole in clinical trials and post-marketing reports
Adverse reactions are categorized by frequency of occurrence. The first is the most frequent,
using the following customary expressions
: very common: ≥10%; common: ≥1%, <10%; uncommon: ≥0.1%, <1%; rare: ≥0.01%,< 0.1%; Rare:< 0.01%; unknown(cannot be estimated based on the data available).
Table1 Adverse Drug Reactions
InfectionunusualUrinary tract infectionBenign, malignant and undetermined tumors (including cysts and polyps)UnusualTumor pain1Abnormalities of the blood and lymphatic systemunusualLeukopeniaImmune System DisordersunknownAllergic reactionMetabolic and nutritional disordersvery commonhypercholesterolemiaCommonDecreased appetite, increased appetite Mental DisordersCommonDepressionunusualAnxiety (including hypersensitivity), irritabilityNeurological abnormalitiesCommonHeadache, dizziness, vertigoUnusualDrowsiness, insomnia, memory deficits, hyperalgesia (including abnormal sensation, dull sensation), taste disorders, cerebrovascular accidents, carpal tunnel syndromeEye Diseaseunusualcataracts, eye irritation, blurred visionCardiac system abnormalitiesCommonHeart palpitationsunusual Tachycardia, ischemic cardiac events (including new or worsening angina, angina requiring surgery, myocardial infarction, and myocardial ischemia)Vascular System abnormalitiesvery commonHot flashesCommonhypertensionunusualThrombophlebitis (including superficial and deep thrombophlebitis)Rarely seenPulmonary embolism, arterial thrombosis, cerebral infarctionRespiratory, thoracic and mediastinal abnormalities unusualHard to breathe, coughing