A progestin - It is used to treat the symptoms of endometrial and renal cancer
FDA Alerts
Bone Mineral Density
Use of parenteral medroxyprogesterone preparations (i.e., Depo-Provera® Contraceptive, depo-subQ provera 104®, or medroxyprogesterone acetate contraceptive injection) may result in loss of bone mineral density (BMD). Bone loss is greater with increasing duration of therapy and may not be completely reversible.
Not known whether use of these parenteral preparations in young women (e.g., during adolescence, early adulthood) will reduce peak bone mass and increase risk of osteoporotic fractures later in life. Loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion.
Use parenteral medroxyprogesterone for long-term contraception (e.g., >2 years) only if other contraceptive methods are inadequate.
Prevention of Endometrial Changes Associated with Estrogens
Reduction of the incidence of endometrial hyperplasia and the attendant risk of endometrial carcinoma in postmenopausal women receiving estrogen replacement therapy.
Parenteral medroxyprogesterone: Consider benefits vs risks (e.g., loss of BMD in women of all ages, possible impact on peak bone mass in adolescents, additional impact of pregnancy and/or nursing on BMD). (See Boxed Warning and Effects on Bone under Cautions.)
Endometriosis
Management of pain associated with endometriosis. Benefit of therapy for >6 months not established. Consider benefits vs risk of BMD loss in women of all ages and the possible impact on peak bone mass in adolescents. (See Boxed Warning and Effects on Bone under Cautions.)
Management of GnRH-dependent (central) forms of precocious puberty†; however, GnRH analogs generally are preferred.†
Management of GnRH-independent (peripheral) forms of precocious puberty†, including familial male precocious puberty (testotoxicosis)† and McCune-Albright syndrome†.†
Dosage and Administration
Administration
Administer orally, IM, or sub-Q.
Oral Administration
Administer orally.
Oral dosage preparations containing medroxyprogesterone acetate in combination with conjugated estrogens USP as monophasic or biphasic regimens are commercially available in a mnemonic dispensing package that is designed to aid the user in complying with the prescribed dosage schedule.
IM Administration
Administer by IM injection deeply into gluteal, deltoid, or anterior thigh muscle.
Vigorously shake injectable suspension immediately before each use.
Sub-Q Administration
depo-subQ provera 104®: Administer by sub-Q injection into anterior thigh or abdomen; not formulated for IM injection.
Vigorously shake injectable suspension before administration.
Dosage
Available as medroxyprogesterone acetate; dosage expressed in terms of the salt.
When used as a contraceptive or for the management of endometriosis, dosage does not need to be adjusted based on weight.
Adults
Prevention of Endometrial Changes Associated with Estrogens
Oral
1.5–5 mg daily. Alternatively, 5–10 mg daily for 12–14 consecutive days per month.
150 mg every 3 months. Exclude possibility of pregnancy before administering the first dose and whenever ≥13 weeks have elapsed since the previous dose. Initiate during the first 5 days of a normal menstrual cycle, at 6 weeks postpartum in women who breast-feed, or within 5 days postpartum in those who do not breast-feed.
Medroxyprogesterone acetate 25 mg and estradiol cypionate 5 mg (0.5 mL) monthly (every 28–30 days; not to exceed 33 days). Initiate during the first 5 days of a normal menstrual cycle, within 5 days of a complete first-trimester abortion, no earlier than 6 weeks postpartum in women who breast-feed, or no earlier than 4 weeks postpartum in those who do not breast-feed.
If >33 days have elapsed since the previous injection, use an alternative (i.e., barrier) method of contraception and rule out pregnancy prior to continuing Lunelle®. Shortening the injection interval may alter menstrual pattern.
When switching from other contraceptive methods, initiate Lunelle® in a manner that ensures continuous contraceptive coverage based on the mechanism of action of both methods (e.g., patients switching from oral contraceptives should be given an initial injection within 7 days after taking the last hormonally active tablet).
Medroxyprogesterone (depo-subQ provera 104®)
Sub-Q
104 mg every 3 months (12–14 weeks). Exclude possibility of pregnancy before administering the first dose and whenever ≥14 weeks have elapsed since the previous dose. Initiate during the first 5 days of a normal menstrual cycle or ≥ 6 weeks postpartum in women who breast-feed.
When switching from other contraceptive methods, initiate depo-subQ provera 104® in a manner that ensures continuous contraceptive coverage based on the mechanism of action of both methods. Patients switching from combined contraceptives (estrogen plus progestin) should be given an initial injection within 7 days after taking the last hormonally active tablet or removing a transdermal patch or vaginal ring. Contraceptive coverage will be maintained when switching from medroxyprogesterone acetate contraceptive IM injection (e.g., Depo Provera® contraceptive injection) to depo-subQ provera 104® if the next injection is given within the dosing period recommended for the IM contraceptive injection.
Endometriosis
Sub-Q
depo-subQ provera 104®: 104 mg every 3 months (12–14 weeks). Exclude possibility of pregnancy before administering the first dose and whenever ≥14 weeks have elapsed since the previous dose. Initiate during the first 5 days of a normal menstrual cycle or ≥ 6 weeks postpartum in women who breast-feed.
Benefit of therapy for >6 months not established; treatment for >2 years not recommended. (See Effects on Bone under Cautions.)
Amenorrhea
Oral
5–10 mg daily for 5–10 days.
To induce optimum secretory transformation of an endometrium that has been adequately primed with endogenous or exogenous estrogen, 10 mg daily for 10 days.
Uterine Bleeding
Oral
5–10 mg daily for 5–10 days beginning on the assumed or calculated 16th or 21st day of the menstrual cycle.
To induce optimum secretory transformation of an endometrium that has been adequately primed with endogenous or exogenous estrogen, 10 mg daily for 10 days, beginning on the calculated 16th day of the menstrual cycle.
Endometrial Carcinoma
IM
Initially, 400–1000 mg once weekly. When improvement is noted and disease has stabilized (within weeks or months), maintain response with as little as 400 mg/month.
Renal Carcinoma
IM
Initially, 400–1000 mg once weekly. When improvement is noted and disease has stabilized (within weeks or months), maintain response with as little as 400 mg/month.
Paraphilia in Males
IM
Initially, 200 mg 2 or 3 times daily. Alternatively, 500 mg once weekly.†
Adjust dose and/or frequency to an effective maintenance level according to patient response and tolerance and/or plasma testosterone concentration. Consult published protocols for more specific dosage information in these males.†
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