Aromasin Tablets 25 mg

Exemestane tablets are an aromatase inhibitor indicated for: adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). …

• Recommended Dose: One 25 mg tablet once daily after a meal
• Recommended Dose The recommended dose of exemestane tablets in early and advanced breast cancer is one 25 mg tablet once daily after a meal. adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy. the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy
• Dose Modifications Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure
• For patients receiving exemestane tablets with a strong CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of exemestane tablets is 50 mg once daily after a meal [see Drug Interactions and Clinical Pharmacology ]

Exemestane Tablets, USP are white colored, round, biconvex, film-coated tablets debossed with "X" on one side and "1" on other side. Each tablet contains 25 mg of exemestane. Tablets: 25 mg ( 3 )

• Safety and effectiveness
• In pediatric patients have not been established

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Bone Effects Advise patients that exemestane tablets lower the level of estrogen in the body
• This may lead to reduction in bone mineral density (BMD) over time
• The lower the BMD, the greater the risk of osteoporosis and fracture [see Warnings and Precautions ]
• Other Estrogen-Containing Agents Advise patients that they should not take estrogen-containing agents while they are taking exemestane tablets as these could interfere with its pharmacologic action [see Warnings and Precautions ] . …

• Exemestane tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients
• Patients with a known hypersensitivity to the drug or to any of the excipients

Strong CYP 3A4 inducers: Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure. Increase the exemestane tablets dose to 50 mg ( 2.2 , 7 ). Drugs That Induce CYP 3A4 Co-medications that induce CYP 3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's Wort) may significantly decrease exposure to exemestane. Dose modification is recommended for patients who are also receiving a strong CYP 3A4 inducer [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ] .

Reductions in bone mineral density (BMD) over time are seen with exemestane use ( 5.1 ). Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed ( 5.2 ). Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception ( 5.6 , 8.1 , 8.3 ). 5.1 Reductions in Bone Mineral Density (BMD) Reductions in bone mineral density (BMD) over time are seen with exemestane use. Table 1 describes changes in BMD from baseline to 24 months in patients receiving exemestane compared to patients receiving tamoxifen (IES) or placebo (027). …

The following clinically significant adverse reactions are described elsewhere in the labeling: Reductions in Bone Mineral Density (BMD) [see Warnings and Precautions (5.1) ] Early breast cancer: Adverse reactions occurring in ≥10% of patients in any treatment group (exemestane tablets vs. tamoxifen) were hot flushes (21% vs. 20%), fatigue (16% vs. 15%), arthralgia (15% vs. 9%), headache (13% vs. 11%), insomnia (12% vs. 9%), and increased sweating (12% vs. 10%). Discontinuation rates due to AEs were similar between exemestane tablets and tamoxifen (6% vs. 5%). …

8.1 Pregnancy Risk Summary Based on findings in animal studies and its mechanism of action , exemestane tablets can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . Limited human data from case reports are insufficient to inform a drug-associated risk. …

Clinical trials have been conducted with exemestane given as a single dose to healthy female volunteers at doses as high as 800 mg and daily for 12 weeks to postmenopausal women with advanced breast cancer at doses as high as 600 mg. These dosages were well tolerated. There is no specific antidote to overdosage and treatment must be symptomatic. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated. A male child (age unknown) accidentally ingested a 25-mg tablet of exemestane. …

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