Aromasin and Night Sweats

Aromasin side effects include those that cause sweating and night sweats otherwise known as nocturnal hydrosis.  This tablet has many warnings associated with it regardless of purchasing discount or generic.  This information is always subject to change please consult you doctor before taking this medicine.

DESCRIPTION

Aromasin ^® Tablets for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator. Exemestane is chemically described as 6-methyl-enandrosta-1,4-diene-3,17-dione. Its molecular formula is C ₂₀ H ₂₄ 0 ₂ and its structural formula is as follows:

WARNINGS

Aromasin Tablets may cause fetal harm when administered to a pregnant woman. Radioactivity related to ¹⁴ C-exemestane crossed the placenta of rats following oral administration of 1 mg/kg exemestane. The concentration of exemestane and its metabolites was approximately equivalent in maternal and fetal blood. When rats were administered exemestane from 14 days prior to mating until either days 15 or 20 of gestation, and resuming for the 21 days of lactation, an increase in placental weight was seen at 4 mg/kg/day (approximately 1.5 times the recommended human daily dose on a mg/m ² basis). Prolonged gestation and abnormal or difficult labor was observed at doses equal to or greater than 20 mg/kg/day. Increased resorption, reduced number of live fetuses, decreased fetal weight, and retarded ossification were also observed at these doses. No malformations were noted when exemestane was administered to pregnant rats during the organogenesis period at doses up to 810 mg/kg/day (approximately 320 times the recommended human dose on a mg/m ² basis). Daily doses of exemestane, given to rabbits during organogenesis caused a decrease in placental weight at 90 mg/kg/day (approximately 70 times the recommended human daily dose on a mg/m ² basis). Abortions, an increase in resorptions, and a reduction in fetal body weight were seen at 270 mg/kg/day. There was no increase in the incidence of malformations in rabbits at doses up to 270 mg/kg/day (approximately 210 times the recommended human dose on a mg/m ² basis).

There are no studies in pregnant women using Aromasin. Aromasin is indicated for postmenopausal women. If there is exposure to Aromasin during pregnancy, the patient should be apprised of the potential hazard to the fetus and potential risk for loss of the pregnancy.

PRECAUTIONS

General.   Aromasin Tablets should not be administered to premenopausal women. Aromasin should not be coadministered with estrogen-containing agents as these could interfere with its pharmacologic action.

Hepatic Insufficiency.   The pharmacokinetics of exemestane have been investigated in subjects with moderate or severe hepatic insufficiency (Childs-Pugh B or C). Following a single 25-mg oral dose, the AUC of exemestane was approximately 3 times higher than that observed in healthy volunteers. The safety of chronic dosing in patients with moderate or severe hepatic impairment has not been studied. Based on experience with exemestane at repeated doses up to 200 mg daily that demonstrated a moderate increase in non-life threatening adverse events, dosage adjustment does not appear to be necessary.

Renal Insufficiency.   The AUC of exemestane after a single 25-mg dose was approximately 3 times higher in subjects with moderate or severe renal insufficiency (creatinine clearance <35 mL/min/1.73 m ² ) compared with the AUC in healthy volunteers. The safety of chronic dosing in patients with moderate or severe renal impairment has not been studied. Based on experience with exemestane at repeated doses up to 200 mg daily that demonstrated a moderate increase in non-life threatening adverse events, dosage adjustment does not appear to be necessary.

Laboratory Tests.   Approximately 20% of patients receiving exemestane in clinical studies, experienced Common Toxicity Criteria (CTC) grade 3 or 4 lymphocytopenia. Of these patients, 89% had a pre-exisiting lower grade lymphopenia. Forty percent of patients either recovered or improved to a lesser severity while on treatment. Patients did not have a significant increase in viral infections, and no opportunistic infections were observed. Elevations of serum levels of AST, ALT, alkaline phosphatase and gamma glutamyl transferase > 5 times the upper value of the normal range (i.e., >/= CTC grade 3) have been rarely reported but appear mostly attributable to the underlying presence of liver and/or bone metastases. In the comparative study, CTC grade 3 or 4 elevation of gamma glutamyl transferase without documented evidence of liver metastasis was reported in 2.7% of patients treated with Aromasin and in 1.8% of patients treated with megestrol acetate.

ADVERSE REACTIONS

A total of 1058 patients were treated with exemestane 25 mg once daily in the clinical trials program. Exemestane was generally well tolerated, and adverse events were usually mild to moderate. Only one death was considered possibly related to treatment with exemestane; an 80-year-old woman with known coronary artery disease had a myocardial infarction with multiple organ failure after 9 weeks on study treatment. In the clinical trials program, only 3% of the patients discontinued treatment with exemestane because of adverse events, mainly within the first 10 weeks of treatment; late discontinuations because of adverse events were uncommon (0.3%).

In the comparative study, adverse reactions were assessed for 358 patients treated with Aromasin and 400 patients treated with megestrol acetate. Fewer patients receiving Aromasin discontinued treatment because of adverse events than those treated with megestrol acetate (2% vs. 5%). Adverse events that were considered drug related or of indeterminate cause included hot flashes (13% vs. 5%), nausea (9% vs. 5%), fatigue (8% vs. 10%), increased
sweating (4% vs. 8%), and increased appetite (3% vs. 6%). The proportion of patients experiencing an excessive weight gain (>10% of their baseline weight) was significantly higher with megestrol acetate than with Aromasin (17% vs. 8%). Table 3 shows the adverse events of all CTC grades, regardless of causality, reported in 5% or greater of patients in the study treated either with Aromasin or megestrol acetate.

Less frequent adverse events of any cause (from 2% to 5%) reported in the comparative study for patients receiving Aromasin 25 mg once daily were fever, generalized weakness, paresthesia, pathological fracture, bronchitis, sinusitis, rash, itching, urinary tract infection, and lymphedema.