Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Medroxyprogesterone acetate sterile suspension, 150 mg/mL Medroxyprogesterone acetate injectable suspension, USP is a sterile, white to off white suspension and is supplied in the following package configurations: 150 mg per mL: 1 mL Single-Dose Vial Packaged Individually NDC 55150-329-01 1 mL Single-Dose Vials in a Carton of 25 NDC 55150-329-25 Vials MUST be stored upright at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Medroxyprogesterone acetate prefilled syringes packaged with 22-gauge x 1 1/2 inch Terumo ® SurGuard™ Medroxyprogesterone acetate injectable suspension, USP is a sterile, white to off white aqueous suspension and is supplied in the following package configurations: 150 mg per mL: 1 mL prefilled syringe NDC 55150-330-01 Packaged individually in a carton with 22-gauge x 1 1/2 inch Terumo ® SurGuard TM Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The vial stopper and plunger rubber stopper are not made with natural rubber latex.; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container Label Rx only NDC 55150-329-01 medroxyPROGESTERone Acetate Injectable Suspension, USP 150 mg per mL For Intramuscular Use Only 1 mL Single-Dose Vial PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container-Carton (1 Vial) Rx only NDC 55150-329-01 medroxyPROGESTERone Acetate Injectable Suspension, USP 150 mg per mL For Intramuscular Use Only 1 mL Single-Dose Vial eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container-Carton (1 Vial); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container-Carton (25 Vials) Rx only NDC 55150-329-25 medroxyPROGESTERone Acetate Injectable Suspension, USP 150 mg per mL For Intramuscular Use Only 25 x 1 mL Single-Dose Vials eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container-Carton (25 Vials); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg per mL - Syringe Label Rx only NDC 55150-330-01 medroxyPROGESTERone Acetate Injectable Suspension, USP 150 mg per mL Intramuscular Use Only Shake vigorously before use 1 mL Single-Dose Prefilled Syringe PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg per mL - Syringe Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg per mL - Syringe-Carton (1 Syringe) Rx only NDC 55150-330-01 medroxyPROGESTERone Acetate Injectable Suspension, USP 150 mg per mL Intramuscular Use Only eugia 1 mL Single-Dose Prefilled Syringe PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg per mL - Syringe-Carton (1 Syringe)
- 16 HOW SUPPLIED/STORAGE AND HANDLING Medroxyprogesterone acetate sterile suspension, 150 mg/mL Medroxyprogesterone acetate injectable suspension, USP is a sterile, white to off white suspension and is supplied in the following package configurations: 150 mg per mL: 1 mL Single-Dose Vial Packaged Individually NDC 55150-329-01 1 mL Single-Dose Vials in a Carton of 25 NDC 55150-329-25 Vials MUST be stored upright at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Medroxyprogesterone acetate prefilled syringes packaged with 22-gauge x 1 1/2 inch Terumo ® SurGuard™ Medroxyprogesterone acetate injectable suspension, USP is a sterile, white to off white aqueous suspension and is supplied in the following package configurations: 150 mg per mL: 1 mL prefilled syringe NDC 55150-330-01 Packaged individually in a carton with 22-gauge x 1 1/2 inch Terumo ® SurGuard TM Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The vial stopper and plunger rubber stopper are not made with natural rubber latex.
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container Label Rx only NDC 55150-329-01 medroxyPROGESTERone Acetate Injectable Suspension, USP 150 mg per mL For Intramuscular Use Only 1 mL Single-Dose Vial PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container-Carton (1 Vial) Rx only NDC 55150-329-01 medroxyPROGESTERone Acetate Injectable Suspension, USP 150 mg per mL For Intramuscular Use Only 1 mL Single-Dose Vial eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container-Carton (1 Vial)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container-Carton (25 Vials) Rx only NDC 55150-329-25 medroxyPROGESTERone Acetate Injectable Suspension, USP 150 mg per mL For Intramuscular Use Only 25 x 1 mL Single-Dose Vials eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-150 mg per mL - Container-Carton (25 Vials)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg per mL - Syringe Label Rx only NDC 55150-330-01 medroxyPROGESTERone Acetate Injectable Suspension, USP 150 mg per mL Intramuscular Use Only Shake vigorously before use 1 mL Single-Dose Prefilled Syringe PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg per mL - Syringe Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg per mL - Syringe-Carton (1 Syringe) Rx only NDC 55150-330-01 medroxyPROGESTERone Acetate Injectable Suspension, USP 150 mg per mL Intramuscular Use Only eugia 1 mL Single-Dose Prefilled Syringe PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg per mL - Syringe-Carton (1 Syringe)
Overview
Medroxyprogesterone acetate injectable suspension, USP contains medroxyprogesterone acetate USP, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate USP is active by the parenteral and oral routes of administration. It is a white to almost white microcrystalline powder that is stable in air and that melts between 205.0°C and 209.0°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 injectable suspension, USP for intramuscular (IM) injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile, white to off white suspension 150 mg/mL. Medroxyprogesterone acetate injectable suspension, USP vials and prefilled syringes: Each mL of sterile aqueous suspension contains: Medroxyprogesterone acetate 150 mg Polyethylene glycol 3350 28.9 mg Polysorbate 80 2.41 mg Sodium chloride 8.68 mg Methylparaben 1.37 mg Propylparaben 0.150 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both. medroxyprogesterone-str.jpg
Indications & Usage
Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use : The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ]. Medroxyprogesterone acetate injectable suspension is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use : The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. ( 1 , 5.1 )
Dosage & Administration
The recommended dose is 150 mg of medroxyprogesterone acetate injectable suspension every 3 months (13 weeks) administered by deep, intramuscular (IM) injection in the gluteal or deltoid muscle. ( 2.1 ) 2.1 Prevention of Pregnancy Both the 1 mL vial and the 1 mL prefilled syringe of medroxyprogesterone acetate injectable suspension 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 every 3 months (13 weeks) administered by deep intramuscular (IM) injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection. As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection. Use for longer than 2 years is not recommended (unless other birth control methods are considered inadequate) due to the impact of long-term medroxyprogesterone acetate injectable suspension treatment on bone mineral density (BMD) [see Warnings and Precautions (5.1) ] . Dosage does not need to be adjusted for body weight [see Clinical Studies (14.1) ] . To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period or within the first 5-days post-partum. In post-partum mothers who exclusively breastfeed, administer medroxyprogesterone acetate injectable suspension during or after the sixth post-partum 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 medroxyprogesterone acetate injectable suspension depends on adherence to the dosage schedule of administration. 2.2 Switching from Other Methods of Contraception When switching from other contraceptive methods, medroxyprogesterone acetate injectable suspension should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g., patients switching from oral contraceptives should have their first injection of medroxyprogesterone acetate injectable suspension on the day after the last active tablet or at the latest, on the day following the final inactive tablet).
Warnings & Precautions
Thromboembolic Disorders: Discontinue medroxyprogesterone acetate injectable suspension in patients who develop thrombosis. ( 5.2 ) Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 ) Meningioma: Discontinue medroxyprogesterone acetate injectable suspension if meningioma is diagnosed. Monitor patients for signs and symptoms of meningioma. ( 5.4 ) Ectopic Pregnancy: Consider ectopic pregnancy if a woman using medroxyprogesterone acetate injectable suspension becomes pregnant or complains of severe abdominal pain. ( 5.5 ) Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. ( 5.6 ) Liver Function: Discontinue medroxyprogesterone acetate injectable suspension if jaundice or disturbances of liver function develop. ( 5.8 ) Carbohydrate Metabolism: Monitor diabetic patients carefully. ( 5.13 ) 5.1 Loss of Bone Mineral Density Use of medroxyprogesterone acetate injectable suspension reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD). 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 by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. A study to assess the reversibility of loss of BMD in adolescents was conducted with medroxyprogesterone acetate injectable suspension. After discontinuing medroxyprogesterone acetate injectable suspension in these adolescents, mean BMD loss at the total hip and femoral neck did not fully recover by 5 years (60 months) post-treatment in the sub-group of adolescents who were treated for more than 2 years [see Clinical Studies (14.3) ] . Similarly, in adults, there was only partial recovery of mean BMD at the total hip, femoral neck, and lumbar spine towards baseline by 2 years post-treatment [see Clinical Studies (14.2) ] . The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. BMD should be evaluated when a woman needs to continue to use medroxyprogesterone acetate injectable suspension 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 in women with osteoporosis risk factors. Medroxyprogesterone acetate injectable suspension 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). 5.2 Thromboembolic Disorders There have been reports of serious thrombotic events in women using medroxyprogesterone acetate injectable suspension (150 mg). However, medroxyprogesterone acetate injectable suspension has not been causally associated with the induction of thrombotic or thromboembolic disorders. Any patient who develops thrombosis while undergoing therapy with medroxyprogesterone acetate injectable suspension should discontinue treatment unless she has no other acceptable options for birth control. Do not re-administer medroxyprogesterone acetate injectable suspension 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. Do not re-administer if examination reveals papilledema or retinal vascular lesions. 5.3 Cancer Risks Breast Cancer Women who have or have had a history of breast cancer should not use hormonal contraceptives, including medroxyprogesterone acetate injectable suspension, because breast cancer may be hormonally sensitive [see Contraindications (4) ]. Women with a strong family history of breast cancer should be monitored with particular care. The results of five large case-control studies assessing the association between depo-medroxyprogesterone acetate (DMPA) use and the risk of breast cancer are summarized in Figure 1. Three of the studies suggest a slightly increased risk of breast cancer in the overall population of users; these increased risks were statistically significant in one study. One recent US study 1 evaluated the recency and duration of use and found a statistically significantly increased risk of breast cancer in recent users (defined as last use within the past five years) who used DMPA for 12 months or longer; this is consistent with results of a previous study 2 . Figure 1. Risk estimates for breast cancer in DMPA users Odds ratio estimates were adjusted for the following covariates: Lee et al. (1987): age, parity, and socioeconomic status. Paul et al. (1989): age, parity, ethnic group, and year of interview. WHO (1991): age, center, and age at first live birth. Shapiro et al. (2000): age, ethnic group, socioeconomic status, and any combined estrogen/progestogen oral contraceptive use. Li et al. (2012): age, year, BMI, duration of OC use, number of full-term pregnancies, family history of breast cancer, and history of screening mammography. Based on the published SEER-18 2011 incidence rate (age-adjusted to the 2000 US Standard Population) of breast cancer for US women, all races, age 20 to 49 years, a doubling of risk would increase the incidence of breast cancer in women who use medroxyprogesterone acetate injectable suspension from about 72 to about 144 cases per 100,000 women. Cervical Cancer A statistically nonsignificant increase in relative risk (RR) estimates of invasive squamous-cell cervical cancer has been associated with the use of medroxyprogesterone acetate injectable suspension 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 RR of invasive squamous-cell cervical cancer in women who ever used medroxyprogesterone acetate injectable suspension 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. Other Cancers Long-term case-controlled surveillance of users of medroxyprogesterone acetate injectable suspension found no overall increased risk of ovarian or liver cancer. Figure 1 Risk estimates for breast cancer in DMPA users 5.4 Meningioma Cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long term use. Monitor patients on medroxyprogesterone acetate injectable suspension for signs and symptoms of meningioma. Discontinue medroxyprogesterone acetate injectable suspension if a meningioma is diagnosed. 5.5 Ectopic Pregnancy Be alert to the possibility of an ectopic pregnancy among women using medroxyprogesterone acetate injectable suspension who become pregnant or complain of severe abdominal pain. 5.6 Anaphylaxis and Anaphylactoid Reaction Anaphylaxis and anaphylactoid reaction have been reported with the use of medroxyprogesterone acetate injectable suspension. Institute emergency medical treatment if an anaphylactic reaction occurs. 5.7 Injection Site Reactions Injection site reactions have been reported with use of medroxyprogesterone acetate injectable suspension [see Adverse Reactions (6.2) ] . Persistent injection site reactions may occur after administration of medroxyprogesterone acetate injectable suspension due to inadvertent subcutaneous administration or release of the drug into the subcutaneous space while removing the needle [see Dosage and Administration (2.1) ]. 5.8 Liver Function Discontinue medroxyprogesterone acetate injectable suspension use if jaundice or acute or chronic disturbances of liver function develop. Do not resume use until markers of liver function return to normal and medroxyprogesterone acetate injectable suspension causation has been excluded. 5.9 Convulsions There have been a few reported cases of convulsions in patients who were treated with medroxyprogesterone acetate injectable suspension. Association with drug use or pre-existing conditions is not clear. 5.10 Depression Monitor patients who have a history of depression and do not re-administer medroxyprogesterone acetate injectable suspension if depression recurs. 5.11 Bleeding Irregularities Most women using medroxyprogesterone acetate injectable suspension experience disruption of menstrual bleeding patterns. Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding. Rule out the possibility of organic pathology if abnormal bleeding persists or is severe, and institute appropriate treatment. As women continue using medroxyprogesterone acetate injectable suspension, fewer experience irregular bleeding and more experience amenorrhea. In clinical studies of medroxyprogesterone acetate injectable suspension, 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. 5.12 Weight Gain Women tend to gain weight while on therapy with medroxyprogesterone acetate injectable suspension. From an initial average body weight of 136 lb, women who completed 1 year of therapy with medroxyprogesterone acetate injectable suspension gained an average of 5.4 lb. Women who completed 2 years of therapy gained an average of 8.1 lb. Women who completed 4 years gained an average of 13.8 lb. Women who completed 6 years gained an average of 16.5 lb. Two percent of women withdrew from a large-scale clinical trial because of excessive weight gain. 5.13 Carbohydrate Metabolism A decrease in glucose tolerance has been observed in some patients on medroxyprogesterone acetate injectable suspension treatment. Monitor diabetic patients carefully while receiving medroxyprogesterone acetate injectable suspension. 5.14 Fluid Retention Because progestational drugs including medroxyprogesterone acetate injectable suspension may cause some degree of fluid retention, monitor patients with conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction. 5.15 Return of Fertility Return to ovulation and fertility is likely to be delayed after stopping medroxyprogesterone acetate injectable suspension. In a large US study of women who discontinued use of medroxyprogesterone acetate injectable suspension to become pregnant, data are available for 61% of them. Of the 188 women who discontinued the study to become pregnant, 114 became pregnant. Based on Life-Table analysis of these data, it is expected that 68% of women who do become pregnant may conceive within 12 months, 83% may conceive within 15 months, and 93% may conceive within 18 months from the last injection. The median time to conception for those who do conceive is 10 months following the last injection with a range of 4 to 31 months, and is unrelated to the duration of use. No data are available for 39% of the patients who discontinued medroxyprogesterone acetate injectable suspension to become pregnant and who were lost to follow-up or changed their mind. 5.16 Sexually Transmitted Infections Patients should be counseled that medroxyprogesterone acetate injectable suspension does not protect against HIV infection (AIDS) and other sexually transmitted infections. 5.17 Monitoring A woman who is taking hormonal contraceptive should have a yearly visit with her healthcare professional for a blood pressure check and for other indicated healthcare. 5.18 Interference with Laboratory Tests The use of medroxyprogesterone acetate injectable suspension may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins [see Drug Interactions (7.2) ].
Boxed Warning
LOSS OF BONE MINERAL DENSITY Women who use medroxyprogesterone acetate injectable suspension may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible [see Warnings and Precautions (5.1) ]. It is unknown if use of medroxyprogesterone acetate injectable suspension 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 [see Warnings and Precautions (5.1) ]. Medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Indications and Usage (1) and Warnings and Precautions (5.1) ]. WARNING: LOSS OF BONE MINERAL DENSITY See full prescribing information for complete boxed warning . Women who use medroxyprogesterone acetate injectable suspension may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. ( 5.1 ) It is unknown if use of medroxyprogesterone acetate injectable suspension 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. ( 5.1 ) Medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. ( 1 , 5.1 )
Contraindications
The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: Active thrombophlebitis, or current or history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2) ]. Known or suspected malignancy of breast [see Warnings and Precautions (5.3) ] . Known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients [see Warnings and Precautions (5.6) ] . Significant liver disease [see Warnings and Precautions (5.8) ] . Undiagnosed vaginal bleeding [see Warnings and Precautions (5.11) ] . Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. ( 4 ) Known or suspected malignancy of breast. ( 4 ) Known hypersensitivity to medroxyprogesterone acetate injectable suspension (medroxyprogesterone acetate or any of its other ingredients). ( 4 ) Significant liver disease. ( 4 ) Undiagnosed vaginal bleeding. ( 4 )
Adverse Reactions
The following important adverse reactions observed with the use of medroxyprogesterone acetate injectable suspension are discussed in greater detail in the Warnings and Precautions section ( 5 ): Loss of Bone Mineral Density [see Warnings and Precautions (5.1) ] Thromboembolic disease [see Warnings and Precautions (5.2) ] Breast Cancer [see Warnings and Precautions (5.3) ] Anaphylaxis and Anaphylactoid Reactions [see Warnings and Precautions (5.6) ] Bleeding Irregularities [see Warnings and Precautions (5.11) ] Weight Gain [see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence >5%): menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lb at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Clinical trials are conducted under widely varying conditions; therefore, adverse reaction rates observed in the clinical studies 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. In the two clinical trials with medroxyprogesterone acetate injectable suspension, 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. The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg medroxyprogesterone acetate injectable suspension every 3-months (90 days). The median study duration was 13 months with a range of 1 to 84 months. Fifty-eight percent of patients remained in the study after 13 months and 34% after 24 months. Table 1. Adverse Reactions that Were Reported by More than 5% of Subjects * Body System represented from COSTART medical dictionary. Body System* Adverse Reactions [Incidence (%)] Body as a Whole Headache (16.5%) Abdominal pain/discomfort (11.2%) Metabolic/Nutritional Increased weight >10 lb at 24 months (37.7%) Nervous Nervousness (10.8%) Dizziness (5.6%) Libido decreased (5.5%) Reproductive (Urogenital*) Menstrual irregularities: bleeding (57.3% at 12 months, 32.1% at 24 months) amenorrhea (55% at 12 months, 68% at 24 months) Table 2. Adverse Reactions that Were Reported by between 1 and 5% of Subjects * Body System represented from COSTART medical dictionary. Body System* Adverse Reactions [Incidence (%)] Body as a Whole Asthenia/fatigue (4.2%) Backache (2.2%) Dysmenorrhea (1.7%) Hot flashes (1.0%) Digestive Nausea (3.3%) Bloating (2.3%) Metabolic/Nutritional Edema (2.2%) Musculoskeletal Leg cramps (3.7%) Arthralgia (1.0%) Nervous Depression (1.5%) Insomnia (1.0%) Skin and Appendages Acne (1.2%) No hair growth/alopecia (1.1%) Rash (1.1%) Reproductive (Urogenital*) Leukorrhea (2.9%) Breast pain (2.8%) Vaginitis (1.2%) Adverse reactions leading to study discontinuation in ≥2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%). 6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of medroxyprogesterone acetate injectable suspension. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking medroxyprogesterone acetate injectable suspension. Table 3. Adverse Reactions Reported during Post-Marketing Experience * Body System represented from COSTART medical dictionary. † Injection site abscess and injection site infections have been reported; therefore, strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration (2.1) ] . Body System* Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess † , Injection site infection † , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma, Melasma, Chloasma Reproductive (Urogenital*) Lack of return to fertility, Unexpected pregnancy, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Increased libido, Uterine hyperplasia, Vaginal cysts, Genitourinary infections, Dyspareunia
Drug Interactions
Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with medroxyprogesterone acetate injectable suspension. ( 7.1 ) 7.1 Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors : Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors. Antibiotics : There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. 7.2 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: (a) Plasma and urinary steroid levels are decreased (e.g., 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. T 3 -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.
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