MEGACE

Breast cancer: 160 mg/day taken once daily. At least two months of continuous treatment is considered an adequate period for determining the efficacy of Megace.

Children:

Safety and effectiveness in paediatric patients have not been established. Megace is not recommended for use in children.

Elderly:

In general, use in elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 4.

The main side-effect experienced by patients while taking megestrol acetate, particularly at high doses, is weight gain, which is usually not associated with water retention, but which is secondary to an increased appetite and food intake.

Weight gain is associated with an increase in fat and body cell mass. Constipation and urinary frequency have also been reported in patients who received high doses of megestrol acetate in clinical trials. A rarely encountered side effect of prolonged administration of megestrol acetate is urticaria, presumably an idiosyncratic reaction to the drug.

The drug is devoid of the myelosuppressive activity characteristic of many cytotoxic drugs and it causes no significant changes in haematology, blood chemistry or urinalysis. Pituitary adrenal axis abnormalities including glucose intolerance, new onset diabetes, exacerbation of pre-existing diabetes with decreased glucose tolerance and Cushing’s syndrome have been reported with the use of megestrol acetate.

Clinically apparent adrenal insufficiency has been rarely reported in patients shortly after discontinuing megestrol acetate. The possibility of adrenal suppression should be considered in all patients taking or withdrawing from chronic megestrol acetate therapy.

Replacement stress doses of glucocorticoids may be indicated. The list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (< 1/10000), and not known (cannot be estimated from the available data).

System Organ Class Frequency MedDRA Term Neoplasms benign, malignant, and unspecified (including cysts and polyps) Common Tumour flare # Endocrine disorders Very common Adrenal insufficiency, cushingoid, Cushing’s syndrome Metabolism and nutrition disorders Very common Diabetes mellitus, glucose tolerance impaired, hyperglycaemia, increased appetite Psychiatric disorders Common Mood altered Nervous system disorders Common Carpal tunnel syndrome, lethargy Cardiac disorders Common Cardiac failure Vascular disorders Very common Thrombophlebitis, pulmonary embolism*, hypertension, hot flush Respiratory, Very Dyspnoea † Source of frequencies: Megestrol Acetate Oral, Corporate Product Labeling Profile (CPLP) dated 12 November 1996.

Precautions:

Megace should be used with caution in patients with a history of thrombophlebitis and in patients with severe impaired liver function. This product should be used under the supervision of a specialist and the patients kept under regular surveillance.

This product can exert adrenocortical effects. This should be borne in mind in patient surveillance. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Insufficient data from clinical studies of megesterol acetate are available for patients 65 years of age and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

In general, use in elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Megestrol acetate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken during treatment with megestrol acetate, and it may be useful to monitor renal function.

1.