Prescription Drug Information: MEGACE ES

MEGACE ES — megestrol acetate suspension
Physicians Total Care, Inc.

1 INDICATIONS AND USAGE

Megace® ES oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).

1.1 Limitations of Use

1.1.1 Other Treatable Causes

Therapy with megestrol acetate for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, renal disease or psychiatric diseases.

1.1.2 Prophylactic Use

Megestrol acetate is not intended for prophylactic use to avoid weight loss.

2 DOSAGE AND ADMINISTRATION

The recommended adult initial dosage of Megace® ES oral suspension is 625 mg/day (5 mL/day or one teaspoon daily). Please refer to the table below for correct dosing and administration. Shake container well before using.

Table 1: Differences in Dosing between Megace® ES and Megace® oral suspension
Megace® ES Oral Suspension Megace® and other megestrol acetate oral suspensions
mg/mL 125 mg/mL 40 mg/mL
Recommended Daily Dose 625 mg 800 mg
Daily Volume Intake 5 mL (teaspoon) 20 mL (dosing cup)

3 DOSAGE FORMS AND STRENGTHS

Megace® ES is a milky white, lemon-lime flavored oral suspension containing 125 mg of megestrol acetate per mL. Megace® ES does not contain the same amount of megestrol acetate as Megace® oral suspension or any of the other megestrol acetate oral suspensions (2.0).

4 CONTRAINDICATIONS

4.1 Hypersensitivity Reaction

History of hypersensitivity to megestrol acetate or any component of the formulation.

4.2 Pregnancy

Known or suspected pregnancy.

5 WARNINGS AND PRECAUTIONS

5.1 General

  • Effects on HIV viral replication have not been determined.
  • Use with caution in patients with a history of thromboembolic disease.

5.2 Fetal Effects

Megestrol acetate may cause fetal harm when administered to a pregnant woman. For animal data on fetal effects, see NONCLINICAL TOXICOLOGY: Impairment of Fertility (13.1). There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

5.3 Adrenal Insufficiency

The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated. Clinical cases of overt Cushing’s Syndrome have been reported in association with the chronic use of megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealed the frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol acetate therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic Megace® ES therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic Megace® ES therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid during stress or serious intercurrent illness (e.g., surgery, infection).

5.4 Use in Diabetics

Clinical cases of new onset diabetes mellitus and exacerbation of pre-existing diabetes mellitus have been reported in association with the chronic use of megestrol acetate.

6 ADVERSE REACTIONS

6.1 Serious and Otherwise Important Adverse Reactions

The following serious reactions and otherwise important adverse drug reactions are discussed in greater detail in other sections of the labeling:

  • Hypersensitivity [see Contraindications (4.1)]
  • Pregnancy [see Contraindications (4.2)]
  • Fetal Effects [see Warnings and Precautions (5.2)]
  • Thromboembolic Disease [see Warnings and Precautions (5.1)]
  • Adrenal Insufficiency [see Warnings and Precaution (5.3) ]

6.2 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial for megestrol acetate oral suspension are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks.

Table 2: Adverse Events
Percent of Patients Reporting Adverse Events
Trial 1 (N=236) Trial 2 (N=87) Open Label Trial
Placebo Placebo
Megestrol Acetate mg/day 0 100 400 800 0 800 1200
No. of Patients N=34 N=68 N=69 N=65 N=38 N=49 N=176
Diarrhea 15 13 8 15 8 6 10
Impotence 3 4 6 14 0 4 7
Rash 9 9 4 12 3 2 6
Flatulence 9 0 1 9 3 10 6
Hypertension 0 0 0 8 0 0 4
Asthenia 3 2 3 6 8 4 5
Insomnia 0 3 4 6 0 0 1
Nausea 9 4 0 5 3 4 5
Anemia 6 3 3 5 0 0 0
Fever 3 6 4 5 3 2 1
Libido Decreased 3 4 0 5 0 2 1
Dyspepsia 0 0 3 3 5 4 2
Hyperglycemia 3 0 6 3 0 0 3
Headache 6 10 1 3 3 0 3
Pain 6 0 0 2 5 6 4
Vomiting 9 3 0 2 3 6 4
Pneumonia 6 2 0 2 3 0 1
Urinary Frequency 0 0 1 2 5 2 1

Adverse events which occurred in 1% to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo.

Body as a Whole — abdominal pain, chest pain, infection, moniliasis and sarcoma

Cardiovascular System — cardiomyopathy and palpitation

Digestive System — constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis

Hemic and Lymphatic System — leukopenia

Metabolic and Nutritional — LDH increased, edema and peripheral edema

Nervous System — paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking

Respiratory System — dyspnea, cough, pharyngitis and lung disorder

Skin and Appendages — alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder

Special Senses — amblyopia

Urogenital System — albuminuria, urinary incontinence, urinary tract infection and gynecomastia.

6.3 Postmarketing Experience

Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis, deep vein thrombosis, and pulmonary embolism; and glucose intolerance [see WARNINGS and PRECAUTIONS (5.1, 5.4)].

7 DRUG INTERACTIONS

7.1 Indinavir

Due to the significant decrease in the exposure of indinavir by megestrol acetate, administration of a higher dose of indinavir should be considered when coadministering with megestrol acetate [See Clinical Pharmacology ( 12.3)].

7.2 Zidovudine and Rifabutin

No dosage adjustment for zidovudine and rifabutin is needed when megestrol acetate is coadministered with these drugs [See Clinical pharmacology ( 12.3)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category X [ see WARNINGS and PRECAUTIONS: (5.2)]. No adequate animal teratology information is available at clinically relevant doses. Pregnant rats treated with low doses of megestrol acetate (0.02-fold the recommended clinical dose resulted in a reduction in fetal weight and number of live births, and feminization of male fetuses.

8.3 Nursing Mothers


8.4 Pediatric Use

8.5 Geriatric Use

Clinical studies of megestrol acetate oral suspension in the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with AIDS did not include sufficient numbers of patients aged 65 years 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, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, 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 in dose selection, and it may be useful to monitor renal function.

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