MEGESTROL ACETATE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Megestrol Acetate (UNII: TJ2M0FR8ES) (MEGESTROL - UNII:EA6LD1M70M)

Available from:

TWi Pharmaceuticals, Inc.

INN (International Name):

MEGESTROL ACETATE

Composition:

MEGESTROL ACETATE 125 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Megestrol acetate 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). Limitations of Use Therapy with megestrol acetate oral suspension 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. Megestrol acetate oral suspension is not intended for prophylactic use to avoid weight loss. - History of hypersensitivity to megestrol acetate or any component of the formulation. - Pregnancy [see Warnings and Precautions (5.2), Use in Specific Populations (8.1, 8.3)]. Risk Summary Based on animal data, megestrol acetate may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy [see Contraindications (4)] . There are no available human data to assess for any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. There are no adequate animal developmental toxicity data at clinically relevant doses. Pregnant rats treated with low doses of megestrol acetate  resulted in a reduction in fetal weight and number of live births, and feminization of male fetuses at doses below maximum recommended clinical dosing based on body surface area (see Data ).  Advise a pregnant women of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Reproduction studies were performed in pregnant rats at oral doses ranging from 0.05 to 12.5 mg/kg/day, which are below the maximum recommended clinical dose based on body surface area. Reduction in fetal weight and number of live births were observed at 12.5 mg/kg/day (5 times lower than the maximum clinical dose) when dams were dosed on days 12 through 18 of pregnancy. Feminization of male fetuses also occurred when dams were dosed on days 13 through 20 of pregnancy at 3 mg/kg/day, approximately 22 times below the maximum clinical dose. Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Megestrol acetate is present in human milk. There are no data on the effects of megesterol acetate on the breastfed infant or the effects on milk production. Because of the potential for HIV transmission and adverse effects on a breastfed infant, instruct mothers not to breastfeed if they are taking megestrol acetate oral suspension. Pregnancy testing Pregnancy testing is recommended prior to treatment with megestrol acetate oral suspension [see Dosage and Administration (2.1), Use in Specific Populations (8.1)]. Contraception Megestrol acetate oral suspension may cause fetal harm when administered during pregnancy [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with megestrol acetate oral suspension. Safety and effectiveness in pediatric patients have not been established. 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. Megestrol acetate has had limited use in HIV infected women. All 10 women in the clinical trials reported breakthrough bleeding. Megestrol acetate oral suspension is a progesterone derivative, which may induce vaginal bleeding in women.

Product summary:

Megestrol acetate oral suspension is a milky white, lemon-lime flavored oral suspension containing 125 mg per mL. Available in bottles of 150 mL (5 fl oz) NDC 24979-041-13. Store megestrol acetate oral suspension between 20° to 25° C (68° to 77° F) and dispense in a tight container. Protect from heat. Health Hazard Data There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or overdose at levels approaching recommended dosing levels could result in side effects described above [see Warnings and Precautions (5) and Adverse Reactions (6)]. Women at risk of pregnancy should avoid such exposure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEGESTROL ACETATE- MEGESTROL ACETATE SUSPENSION
TWI PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEGESTROL ACETATE
ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR MEGESTROL
ACETATE ORAL SUSPENSION.
MEGESTROL ACETATE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 12/2018
Warnings and Precautions (5.2) 12/2018
INDICATIONS AND USAGE
Megestrol acetate oral suspension is a progestin indicated for the
treatment of anorexia, cachexia, or an
unexplained significant weight loss in patients with a diagnosis of
acquired immunodeficiency syndrome
(AIDS) (1).
DOSAGE AND ADMINISTRATION
Obtain a negative pregnancy test in females of reproductive potential
prior to initiating treatment (2.1)
The recommended adult initial dosage of megestrol acetate oral
suspension is 625 mg/day (5 mL/day
or one teaspoon daily) (2.2).
Shake container well before using (2.2).
DOSAGE FORMS AND STRENGTHS
Oral suspension containing 125 mg of megestrol acetate per mL (3).
CONTRAINDICATIONS
History of hypersensitivity to megestrol acetate or any component of
the formulation (4).
Pregnancy (4)(8.1).
WARNINGS AND PRECAUTIONS
Use with caution in patients with a history of thromboembolic disease
(5.1).
Fetal Effects: May cause fetal harm. Females of reproductive potential
should be advised to avoid
becoming pregnant (5.2).
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 in the
stressed and non-stressed state
(5.3).
New onset and exacerbation of pre-existing diabetes have been reported
(5.4).
ADVERSE REACTIONS
The most common adverse events occurring in > 5% of all patients
receiving 800mg/20mL of megestrol
acetate oral suspension in the two clinical efficacy trials were
nausea