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Medroxyprogesterone Acetate Injectable Suspension, USP

Physician Information

Women who use Medroxyprogesterone Acetate Injectable Suspension, USP may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.

It is unknown if use of Medroxyprogesterone Acetate Injectable Suspension, USP during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.

Medroxyprogesterone Acetate Injectable Suspension, USP should be used as a long-term birth control method (e.g. longer than 2 years) only if other birth control methods are inadequate. (See WARNINGS.)

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

DESCRIPTION

Medroxyprogesterone Acetate Injectable Suspension, USP contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone Acetate is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline powder that is stable in air and that melts between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.

The chemical name for Medroxyprogesterone Acetate is pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6α-).

The structural formula is as follows:

medroxyprogesterone acetate

Medroxyprogesterone Acetate Injectable Suspension, USP for intramuscular (IM) injection is available in vials and prefilled syringes, each containing 1 mL of Medroxyprogesterone Acetate sterile aqueous suspension 150 mg/mL.
Each mL contains:

Medroxyprogesterone acetate150 mg
Polyethylene glycol 335028.9 mg
Polysorbate 802.41 mg
Sodium chloride8.68 mg
Methylparaben1.37 mg
Propylparaben0.150 mg
Water for injection          qs

When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

CLINICAL PHARMACOLOGY

Medroxyprogesterone Acetate Injectable Suspension, USP, when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.

Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, USP, Medroxyprogesterone Acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL. The levels then decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of Medroxyprogesterone Acetate in serum, the apparent half-life for Medroxyprogesterone Acetate following IM administration of Medroxyprogesterone Acetate Injectable Suspension, USP is approximately 50 days.

Women with lower body weights conceive sooner than women with higher body weights after discontinuing Medroxyprogesterone Acetate Injectable Suspension, USP.

The effect of hepatic and/or renal disease on the pharmacokinetics of Medroxyprogesterone Acetate Injectable Suspension, USP is unknown.

INDICATIONS AND USAGE

Medroxyprogesterone Acetate Injectable Suspension, USP is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Medroxyprogesterone Acetate Injectable Suspension, USP long-term (see WARNINGS.) It is a long-term injectable contraceptive in women when administered at 3-month (13-week) intervals. Dosage does not need to be adjusted for body weight.

In five clinical studies using Medroxyprogesterone Acetate Injectable Suspension, USP, the 12-month failure rate for the group of women treated with Medroxyprogesterone Acetate Injectable Suspension, USP was zero (no pregnancies reported) to 0.7 by Life-Table method. Pregnancy rates with contraceptive measures are typically reported for only the first year of use as shown in Table 1. Except for intrauterine devices (IUD), implants, sterilization, and Medroxyprogesterone Acetate Injectable Suspension, USP, the efficacy of these contraceptive measures depends in part on the reliability of use. The effectiveness of Medroxyprogesterone Acetate Injectable Suspension, USP is dependent on the patient returning every 3 months (13 weeks) for reinjection.

Table 1 Lowest Expected and Typical Failure RatesLowest expected - when used exactly as directed.
Typical - includes those not following directions exactly.
Expressed as Percent of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use
MethodLowest ExpectedTypical
Source: Trussell et al1
Injectable progestogen
  Medroxyprogesterone0.30.3
  Acetate
Implants
  Norplant (6 capsules)0.2from Norplant® package insert.0.2
Female sterilization0.20.4
Male sterilization0.10.15
Pill3
  Combined0.1
  Progestogen only0.5
IUD3
  Progestasert2
  Copper T 380A0.8
Condom212
Diaphragm618
Cap618
Spermicides321
Sponge
  Parous women928
  Nulliparous women618
Periodic abstinence1–920
Withdrawal418
No method8585

CONTRAINDICATIONS

  • Known or suspected pregnancy or as a diagnostic test for pregnancy.
  • Undiagnosed vaginal bleeding.
  • Known or suspected malignancy of breast.
  • Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease.
  • Significant liver disease.
  • Known hypersensitivity to Medroxyprogesterone Acetate Injectable Suspension, USP (Medroxyprogesterone Acetate or any of its other ingredients).

WARNINGS

1. Loss of Bone Mineral Density

Use of Medroxyprogesterone Acetate Injectable Suspension, USP reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD) as bone metabolism accommodates to a lower estrogen level. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of Medroxyprogesterone Acetate Injectable Suspension, USP by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. In both adults and adolescents, the decrease in BMD appears to be at least partially reversible after Medroxyprogesterone Acetate Injectable Suspension, USP is discontinued and ovarian estrogen production increases. A study to assess the reversibility of loss of BMD in adolescents is ongoing.

Medroxyprogesterone Acetate Injectable Suspension, USP should be used as a long-term birth control method (e.g. longer than 2 years) only if other birth control methods are inadequate. BMD should be evaluated when a woman needs to continue to use Medroxyprogesterone Acetate Injectable Suspension, USP long term. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity.

Other birth control methods should be considered in the risk/benefit analysis for the use of Medroxyprogesterone Acetate Injectable Suspension, USP in women with osteoporosis risk factors. Medroxyprogesterone Acetate Injectable Suspension, USP can pose an additional risk in patients with risk factors for osteoporosis (e.g., metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids). Although there are no studies addressing whether calcium and Vitamin D may lessen BMD loss in women using Medroxyprogesterone Acetate Injectable Suspension, USP, all patients should have adequate calcium and Vitamin D intake.

2. Bleeding Irregularities

Most women using Medroxyprogesterone Acetate Injectable Suspension, USP experience disruption of menstrual bleeding patterns. Altered menstrual bleeding patterns include irregular or unpredictable bleeding or spotting, or rarely, heavy or continuous bleeding. If abnormal bleeding persists or is severe, appropriate investigation should be instituted to rule out the possibility of organic pathology, and appropriate treatment should be instituted when necessary.

As women continue using Medroxyprogesterone Acetate Injectable Suspension, USP, fewer experience irregular bleeding and more experience amenorrhea. By month 12 amenorrhea was reported by 55% of women, and by month 24 amenorrhea was reported by 68% of women using Medroxyprogesterone Acetate Injectable Suspension, USP.2

3. Cancer Risks

Long-term case-controlled surveillance of users of Medroxyprogesterone Acetate Injectable Suspension, USP found slight or no increased overall risk of breast cancer3 and no overall increased risk of ovarian,4 liver,5 or cervical6 cancer and a prolonged, protective effect of reducing the risk of endometrial7 cancer in the population of users.

A pooled analysis14 from two case-control studies, the World Health Organization Study3 and the New Zealand Study13, reported the relative risk (RR) of breast cancer for women who had ever used Medroxyprogesterone Acetate Injectable Suspension, USP as 1.1 (95% confidence interval (CI) 0.97 to 1.4). Overall, there was no increase in risk with increasing duration of use of Medroxyprogesterone Acetate Injectable Suspension, USP. The RR of breast cancer for women of all ages who had initiated use of Medroxyprogesterone Acetate Injectable Suspension, USP within the previous 5 years was estimated to be 2.0 (95% CI 1.5 to 2.8).

The World Health Organization Study3, a component of the pooled analysis14 described above, showed an increased RR of 2.19 (95% CI 1.23 to 3.89) of breast cancer associated with use of Medroxyprogesterone Acetate Injectable Suspension, USP in women whose first exposure to drug was within the previous 4 years and who were under 35 years of age. However, the overall RR for ever-users of Medroxyprogesterone Acetate Injectable Suspension, USP was only 1.2 (95% CI 0.96 to 1.52).

[NOTE: A RR of 1.0 indicates neither an increased nor a decreased risk of cancer associated with the use of the drug, relative to no use of the drug. In the case of the subpopulation with a RR of 2.19, the 95% CI is fairly wide and does not include the value of 1.0, thus inferring an increased risk of breast cancer in the defined subgroup relative to nonusers. The value of 2.19 means that women whose first exposure to drug was within the previous 4 years and who are under 35 years of age have a 2.19 fold (95% CI 1.23 to 3.89-fold) increased risk of breast cancer relative to nonusers. The National Cancer Institute8 reports an average annual incidence rate for breast cancer for US women, all races, age 30 to 34 years of 26.7 per 100,000. A RR of 2.19, thus, increases the possible risk from 26.7 to 58.5 cases per 100,000 women. The attributable risk, thus, is 31.8 per 100,000 women per year.]

A statistically insignificant increase in RR estimates of invasive squamous-cell cervical cancer has been associated with the use of Medroxyprogesterone Acetate Injectable Suspension, USP in women who were first exposed before the age of 35 years (RR 1.22 to 1.28 and 95% CI 0.93 to 1.70). The overall, nonsignificant relative rate of invasive squamous-cell cervical cancer in women who ever used Medroxyprogesterone Acetate Injectable Suspension, USP was estimated to be 1.11 (95% CI 0.96 to 1.29). No trends in risk with duration of use or times since initial or most recent exposure were observed.

4. Thromboembolic Disorders

The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, pulmonary embolism, cerebrovascular disorders, and retinal thrombosis). Should any of these occur or be suspected, the drug should not be readministered.

5. Ocular Disorders

Medication should not be readministered pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should not be readministered.

6. Unexpected Pregnancies

To ensure that Medroxyprogesterone Acetate Injectable Suspension, USP is not administered inadvertently to a pregnant woman, the first injection must be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding, and if exclusively breast-feeding, ONLY at the sixth postpartum week (see DOSAGE AND ADMINISTRATION).

Neonates from unexpected pregnancies that occur 1 to 2 months after injection of Medroxyprogesterone Acetate Injectable Suspension, USP may be at an increased risk of low birth weight, which, in turn, is associated with an increased risk of neonatal death. The attributable risk is low because such pregnancies are uncommon.9,10

A significant increase in incidence of polysyndactyly and chromosomal anomalies was observed among infants of users of Medroxyprogesterone Acetate Injectable Suspension, USP, the former being most pronounced in women under 30 years of age. The unrelated nature of these defects, the lack of confirmation from other studies, the distant preconceptual exposure to Medroxyprogesterone Acetate Injectable Suspension, USP, and the chance effects due to multiple statistical comparisons, make a causal association unlikely.11

Neonates exposed to Medroxyprogesterone Acetate in utero and followed to adolescence, showed no evidence of any adverse effects on their health including their physical, intellectual, sexual, or social development.

Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses. The risk of hypospadias (five to eight per 1,000 male births in the general population) may be approximately doubled with exposure to these drugs. There are insufficient data to quantify the risk to exposed female fetuses, but because some of these drugs induce mild virilization of the external genitalia of the female fetus and because of the increased association of hypospadias in the male fetus, it is prudent to avoid the use of these drugs during the first trimester of pregnancy.

To ensure that Medroxyprogesterone Acetate Injectable Suspension, USP is not administered inadvertently to a pregnant woman, it is important that the first injection be given only during the first 5 days after the onset of a normal menstrual period within 5 days postpartum if not breast-feeding and if breast-feeding, at the sixth week postpartum (see DOSAGE AND ADMINISTRATION).

7. Ectopic Pregnancy

Health-care providers should be alert to the possibility of an ectopic pregnancy among women using Medroxyprogesterone Acetate Injectable Suspension, USP who become pregnant or complain of severe abdominal pain.

8. Lactation

Detectable amounts of drug have been identified in the milk of mothers receiving Medroxyprogesterone Acetate Injectable Suspension, USP. In nursing mothers treated with Medroxyprogesterone Acetate Injectable Suspension, USP, milk composition, quality, and amount are not adversely affected. Neonates and infants exposed to medroxyprogesterone from breast milk have been studied for developmental and behavioral effects through puberty. No adverse effects have been noted.

9. Anaphylaxis and Anaphylactoid Reaction

Anaphylaxis and anaphylactoid reaction have been reported with the use of Medroxyprogesterone Acetate Injectable Suspension, USP. If an anaphylactic reaction occurs appropriate therapy should be instituted. Serious anaphylactic reactions require emergency medical treatment.

PRECAUTIONS

GENERAL

DRUG INTERACTIONS

Aminoglutethimide administered concomitantly with the Medroxyprogesterone Acetate Injectable Suspension, USP may significantly depress the serum concentrations of medroxyprogesterone acetate.12 Users of Medroxyprogesterone Acetate Injectable Suspension, USP should be warned of the possibility of decreased efficacy with the use of this or any related drugs.

LABORATORY TEST INTERACTIONS

The pathologist should be advised of progestin therapy when relevant specimens are submitted.

The following laboratory tests may be affected by progestins including Medroxyprogesterone Acetate Injectable Suspension, USP:

  • (a)Plasma and urinary steroid levels are decreased (eg, progesterone, estradiol, pregnanediol, testosterone, cortisol).
  • (b)Gonadotropin levels are decreased.
  • (c)Sex-hormone-binding-globulin concentrations are decreased.
  • (d)Protein-bound iodine and butanol extractable protein-bound iodine may increase.
    T3-uptake values may decrease.
  • (e)Coagulation test values for prothrombin (Factor II), and Factors VII, VIII, IX, and X may increase.
  • (f)Sulfobromophthalein and other liver function test values may be increased.
  • (g)The effects of Medroxyprogesterone Acetate on lipid metabolism are inconsistent. Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol have been observed in studies.

CARCINOGENESIS

See "WARNINGS" section 3.

PREGNANCY

NURSING MOTHERS

See "WARNINGS" section 8.

PEDIATRIC USE

Medroxyprogesterone Acetate Injectable Suspension, USP is not indicated before menarche. Use of Medroxyprogesterone Acetate Injectable Suspension, USP is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of Medroxyprogesterone Acetate Injectable Suspension, USP by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.

INFORMATION FOR THE PATIENT

See Patient Labeling.

Patient labeling is included with each single-dose vial and prefilled syringe of Medroxyprogesterone Acetate Injectable Suspension, USP to help describe its characteristics to the patient. It is recommended that prospective users be given this labeling and be informed about the risks and benefits associated with the use of Medroxyprogesterone Acetate Injectable Suspension, USP, as compared with other forms of contraception or with no contraception at all. It is recommended that physicians or other health-care providers responsible for those patients advise them at the beginning of treatment that their menstrual cycle may be disrupted and that irregular and unpredictable bleeding or spotting results, and that this usually decreases to the point of amenorrhea as treatment with Medroxyprogesterone Acetate Injectable Suspension, USP continues, without other therapy being required.

ADVERSE REACTIONS

In the largest clinical trial with Medroxyprogesterone Acetate Injectable Suspension, USP, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of Medroxyprogesterone Acetate Injectable Suspension, USP.

The following adverse reactions were reported by more than 5% of subjects:

  •   Menstrual irregularities (bleeding or amenorrhea, or both)
  •   Abdominal pain or discomfort
  •   Weight changes
  •   Dizziness
  •   Headache
  •   Asthenia (weakness or fatigue)
  •   Nervousness

Adverse reactions reported by 1% to 5% of subjects using Medroxyprogesterone Acetate Injectable Suspension, USP were:

  •   Decreased libido or anorgasmia
  •   Pelvic pain
  •   Backache
  •   Breast pain
  •   Leg cramps
  •   No hair growth or alopecia
  •   Depression
  •   Bloating
  •   Nausea
  •   Rash
  •   Insomnia
  •   Edema
  •   Leukorrhea
  •   Hot flashes
  •   Acne
  •   Arthralgia
  •   Vaginitis

Events reported by fewer than 1% of subjects included: galactorrhea, melasma, chloasma, convulsions, changes in appetite, gastrointestinal disturbances, jaundice, genitourinary infections, vaginal cysts, dyspareunia, paresthesia, chest pain, pulmonary embolus, allergic reactions, anemia, drowsiness, syncope, dyspnea and asthma, tachycardia, fever, excessive sweating and body odor, dry skin, chills, increased libido, excessive thirst, hoarseness, pain at injection site, blood dyscrasia, rectal bleeding, changes in breast size, breast lumps or nipple bleeding, axillary swelling, breast cancer, prevention of lactation, sensation of pregnancy, lack of return to fertility, paralysis, facial palsy, scleroderma, osteoporosis, uterine hyperplasia, cervical cancer, varicose veins, dysmenorrhea, hirsutism, unexpected pregnancy, thrombophlebitis, deep vein thrombosis.

Postmarketing Experience

There have been rare cases of osteoporosis including osteoporotic fractures reported postmarketing in patients taking Medroxyprogesterone Acetate Injectable Suspension, USP. In addition, there have been voluntary reports of anaphylaxis and anaphylactoid reaction associated with the use of Medroxyprogesterone Acetate Injectable Suspension, USP.

DOSAGE AND ADMINISTRATION

Both the 1 mL vial and the 1 mL prefilled syringe of Medroxyprogesterone Acetate Injectable Suspension, USP should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.

The recommended dose is 150 mg of Medroxyprogesterone Acetate Injectable Suspension, USP every 3 months (13 weeks) administered by deep, IM injection in the gluteal or deltoid muscle. To ensure the patient is not pregnant at the time of the first injection, the first injection MUST be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum week. If the time interval between injections is greater than 13 weeks, the physician should determine that the patient is not pregnant before administering the drug. The efficacy of depends on adherence to the dosage schedule of a Medroxyprogesterone Acetate Injectable Suspension, USP administration.

HOW SUPPLIED

Medroxyprogesterone Acetate Injectable Suspension, USP (Medroxyprogesterone Acetate sterile aqueous suspension 150 mg/mL) is available as:

NDC 59762-4537-1                  1 mL vial
NDC 59762-4537-2                  25 × 1 mL vials

Medroxyprogesterone Acetate Injectable Suspension, USP prefilled syringes are available packaged with 22-gauge × 1 1/2 inch BD SafetyGlide™ Needles in the following presentation:

NDC 59762-4538-1                  1 mL prefilled syringe

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

REFERENCES

  • Trussell J, Hatcher RA, Cates W Jr, Stewart FH, Kost K. A guide to interpreting contraceptive efficacy studies. Obstet Gynecol. 1990; 76:558–567.
  • Schwallie PC, Assenzo JR. Contraceptive use-efficacy study utilizing Medroxyprogesterone Acetate administered as an intramuscular injection once every 90 days. Fertil Steril. 1973; 24:331–339.
  • WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Breast cancer and depot-medroxyprogesterone acetate: a multi-national study. Lancet. 1991; 338:833–838.
  • WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Depot-Medroxyprogesterone Acetate (DMPA) and risk of epithelial ovarian cancer. Int J Cancer. 1991; 49:191–195.
  • WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Depot-Medroxyprogesterone Acetate (DMPA) and risk of liver cancer. Int J Cancer. 1991; 49:182185.
  • WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Depot-Medroxyprogesterone Acetate (DMPA) and risk of invasive squamous-cell cervical cancer. Contraception. 1992; 45:299–312.
  • WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Depot-Medroxyprogesterone Acetate (DMPA) and risk of endometrial cancer. Int J Cancer. 1991; 49:186–190.
  • Surveillance, Epidemiology, and End Results: Incidence and Mortality Data, 1973–1977. National Cancer Institute Monograph, 57: June 1981. (NIH publication No. 81-2330).
  • Gray RH, Pardthaisong T. In Utero exposure to steroid contraceptives and survival during infancy. Am J Epidemiol. 1991; 134:804–811.
  • Pardthaisong T, Gray RH. In Utero exposure to steroid contraceptives and outcome of pregnancy. Am J Epidemiol. 1991; 134:795–803.
  • Pardthaisong T, Gray RH, McDaniel EB, Chandacham A. Steroid contraceptive use and pregnancy outcome. Teratology. 1988; 38:51–58.
  • Van Deijk WA, Biljham GH, Mellink WAM, Meulenberg PMM. Influence of aminoglutethimide on plasma levels of medroxyprogesterone acetate: its correlation with serum cortisol. Cancer Treatment Reports. 1985; 69:1, 85–90.
  • Paul C, Skegg DCG, Spears GFS. Depot medroxyprogesterone (Depo-Provera) and risk of breast cancer. Br Med J. 1989; 299:759–762.
  • Skegg DCG, Noonan EA, Paul C, Spears GFS, Meirik O, Thomas DB. Depot Medroxyprogesterone Acetate and Breast Cancer: A Pooled Analysis from the World Health Organization and New Zealand Studies. JAMA. 1995; 273(10):799–804.

Rx only

LAB-0150-4.0

Medroxyprogesterone Acetate Injectable Suspension, USP

Patient Labeling

Rx only

LAB-0152-4.0

Revised May 2006

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