MEDROXYPROGESTERONE ACETATE- medroxyprogesterone acetate injection, suspension
A-S Medication Solutions
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use MEDROXYPROGESTERONE ACETATE (MPA) Injectable Suspension, USP safely and effectively. See full prescribing information for MPA INJECTABLE SUSPENSION, USP.
MEDROXYPROGESTERONE ACETATE (MPA) Injectable Suspension, USP, for intramuscular use
Initial U.S. Approval: 1959
WARNING: LOSS OF BONE MINERAL DENSITY
See full prescribing information for complete boxed warning.
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP is a progestin indicated for use by females of reproductive potential to prevent pregnancy. (1)
Limitations of Use:
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
WARNINGS AND PRECAUTIONS
Most common adverse reactions (incidence >5%) are: menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 MPA Injectable Suspension, USP. (7.1)
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
FULL PRESCRIBING INFORMATION: CONTENTS*
14.3 Bone Mineral Density Changes in Adolescent Females (12 to 18 Years of Age) Treated with MPA Injectable Suspension, USP
Both the 1 mL vial and the 1 mL prefilled syringe of MPA 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 MPA Injectable Suspension, USP 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 MPA Injectable Suspension, USP 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; 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 MPA Injectable Suspension, USP depends on adherence to the dosage schedule of administration.
When switching from other contraceptive methods, MPA Injectable Suspension, USP 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 MPA Injectable Suspension, USP on the day after the last active tablet or at the latest, on the day following the final inactive tablet).
Sterile Aqueous suspension: 150mg/ml
Prefilled syringes are available packaged with 22-gauge × 1 1/2 inch Terumo® SurGuard™ Needles.
The use of MPA Injectable Suspension, USP is contraindicated in the following conditions:
Use of MPA Injectable Suspension, USP 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 MPA Injectable Suspension, USP 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 MPA Injectable Suspension, USP. After discontinuing MPA Injectable Suspension, USP 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 MPA Injectable Suspension, USP 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 MPA 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 MPA Injectable Suspension, USP in women with osteoporosis risk factors. MPA 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).
There have been reports of serious thrombotic events in women using MPA Injectable Suspension, USP (150 mg). However, MPA Injectable Suspension, USP has not been causally associated with the induction of thrombotic or thromboembolic disorders. Any patient who develops thrombosis while undergoing therapy with MPA Injectable Suspension, USP should discontinue treatment unless she has no other acceptable options for birth control.
Do not re-administer MPA Injectable Suspension, USP 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.
Women who have or have had a history of breast cancer should not use hormonal contraceptives, including MPA Injectable Suspension, USP, 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 study1 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 study2.
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 MPA Injectable Suspension, USP from about 72 to about 144 cases per 100,000 women.
A statistically nonsignificant increase in RR estimates of invasive squamous-cell cervical cancer has been associated with the use of MPA 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 MPA 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.
Be alert to the possibility of an ectopic pregnancy among women using MPA Injectable Suspension, USP who become pregnant or complain of severe abdominal pain.
Anaphylaxis and anaphylactoid reaction have been reported with the use of MPA Injectable Suspension, USP. Institute emergency medical treatment if an anaphylactic reaction occurs.
Injection site reactions have been reported with use of MPA Injectable Suspension, USP [see Adverse Reactions (6.2)]. Persistent injection site reactions may occur after administration of MPA Injectable Suspension, USP due to inadvertent subcutaneous administration or release of the drug into the subcutaneous space while removing the needle [see Dosage and Administration (2.1)].
Discontinue MPA Injectable Suspension, USP 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 MPA Injectable Suspension, USP causation has been excluded.
There have been a few reported cases of convulsions in patients who were treated with MPA Injectable Suspension, USP. Association with drug use or pre-existing conditions is not clear.
Monitor patients who have a history of depression and do not re-administer MPA Injectable Suspension, USP if depression recurs.
Most women using MPA Injectable Suspension, USP 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 MPA Injectable Suspension, USP, fewer experience irregular bleeding and more experience amenorrhea. In clinical studies of MPA Injectable Suspension, USP, by month 12 amenorrhea was reported by 55% of women, and by month 24, amenorrhea was reported by 68% of women using MPA Injectable Suspension, USP.
Women tend to gain weight while on therapy with MPA Injectable Suspension, USP. From an initial average body weight of 136 lb, women who completed 1 year of therapy with MPA Injectable Suspension, USP 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.
A decrease in glucose tolerance has been observed in some patients on MPA Injectable Suspension, USP treatment. Monitor diabetic patients carefully while receiving MPA Injectable Suspension, USP.
Detectable amounts of drug have been identified in the milk of mothers receiving MPA Injectable Suspension, USP. In nursing mothers treated with MPA 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.
Because progestational drugs including MPA Injectable Suspension, USP 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.
Return to ovulation and fertility is likely to be delayed after stopping MPA Injectable Suspension, USP. In a large US study of women who discontinued use of MPA Injectable Suspension, USP 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 MPA Injectable Suspension, USP to become pregnant and who were lost to follow-up or changed their mind.
Patients should be counseled that MPA Injectable Suspension, USP does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Although MPA Injectable Suspension, USP should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to MPA injections in early pregnancy. Neonates exposed to MPA in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development.
A woman who is taking hormonal contraceptive should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
The use of MPA Injectable Suspension, USP may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. [See Drug Interactions (7.2).]
The following important adverse reactions observed with the use of MPA Injectable Suspension, USP are discussed in greater detail in the Warnings and Precautions section (5):
Because clinical trials are conducted under widely varying conditions, 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 MPA 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 MPA Injectable Suspension, USP. 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 MPA Injectable Suspension, USP every 3-months (90 days). The median study duration was 13 months with a range of 1–84 months. Fifty eight percent of patients remained in the study after 13 months and 34% after 24 months.
|Body System*||Adverse Reactions [Incidence (%)]|
|Body as a Whole||Headache (16.5%)
Abdominal pain/discomfort (11.2%)
|Metabolic/Nutritional||Increased weight >10lbs at 24 months (37.7%)|
Libido decreased (5.5%)
(bleeding (57.3% at 12 months, 32.1% at 24 months) amenorrhea (55% at 12 months, 68% at 24 months)
|Body System*||Adverse Reactions [Incidence (%)]|
|Body as a Whole||Asthenia/fatigue (4.2%)
Hot flashes (1.0%)
|Musculoskeletal||Leg cramps (3.7%)
|Skin and Appendages||Acne (1.2%)
No hair growth/alopecia (1.1%)
Breast pain (2.8%)
Adverse reactions leading to study discontinuation in ≥2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%)
The following adverse reactions have been identified during post approval use of MPA Injectable Suspension, USP. 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 MPA Injectable Suspension, USP.
|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|
|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|
|Urogenital||Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia|
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:
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.
The pathologist should be advised of progestin therapy when relevant specimens are submitted.
The following laboratory tests may be affected by progestins including MPA Injectable Suspension, USP:
Detectable amounts of drug have been identified in the milk of mothers receiving MPA Injectable Suspension, USP. [See Warnings and Precautions (5.13).]
MPA Injectable Suspension, USP is not indicated before menarche. Use of MPA 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 MPA 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.
This product has not been studied in post-menopausal women and is not indicated in this population.
The effect of renal impairment on MPA Injectable Suspension, USP pharmacokinetics has not been studied.
The effect of hepatic impairment on MPA Injectable Suspension, USP pharmacokinetics has not been studied. MPA Injectable Suspension, USP should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur. [See Contraindications (4) and Warnings and Precautions (5.7).]
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:
MPA Injectable Suspension, USP for IM injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL.
For MPA Injectable Suspension, USP vials, 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|
|Water for injection||quantity sufficient|
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
For MPA Injectable Suspension, USP prefilled syringes, each mL of sterile aqueous suspension contains:
|Medroxyprogesterone acetate||150 mg|
|Polyethylene glycol 3350||28.5 mg|
|Polysorbate 80||2.37 mg|
|Sodium chloride||8.56 mg|
|Water for injection||quantity sufficient|
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
MPA Injectable Suspension, USP inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. These actions contribute to its contraceptive effect.
No specific pharmacodynamic studies were conducted with MPA Injectable Suspension, USP.
Following a single 150 mg IM dose of MPA Injectable Suspension, USP in eight women between the ages of 28 and 36 years old, 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.
Plasma protein binding of medroxyprogesterone acetate averages 86%. Medroxyprogesterone acetate binding occurs primarily to serum albumin. No binding of medroxyprogesterone acetate occurs with sex-hormone-binding globulin (SHBG).
Medroxyprogesterone acetate is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.
The concentrations of medroxyprogesterone acetate 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 MPA Injectable Suspension, USP is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.
In five clinical studies using MPA Injectable Suspension, USP, the 12-month failure rate for the group of women treated with MPA Injectable Suspension, USP was zero (no pregnancies reported) to 0.7 by Life-Table method. The effectiveness of MPA Injectable Suspension, USP is dependent on the patient returning every 3 months (13 weeks) for reinjection.
In a controlled, clinical study, adult women using MPA Injectable Suspension, USP (150mg) for up to 5 years showed spine and hip bone mineral density (BMD) mean decreases of 5–6%, compared to no significant change in BMD in the control group. The decline in BMD was more pronounced during the first two years of use, with smaller declines in subsequent years. Mean changes in lumbar spine BMD of -2.86%, -4.11%, -4.89%, -4.93% and -5.38% after 1, 2, 3, 4, and 5 years, respectively, were observed. Mean decreases in BMD of the total hip and femoral neck were similar.
After stopping use of MPA Injectable Suspension, USP , there was partial recovery of BMD toward baseline values during the 2-year post-therapy period. Longer duration of treatment was associated with less complete recovery during this 2-year period following the last injection. Table 4 shows the change in BMD in women after 5 years of treatment with MPA Injectable Suspension, USP and in women in a control group, as well as the extent of recovery of BMD for the subset of the women for whom 2-year post treatment data were available.
|Time in Study||Spine||Total Hip||Femoral Neck|
|Medroxy-progesterone Acetate*||Control†||Medroxy-progesterone Acetate*||Control†||Medroxy-progesterone Acetate*||Control†|
The impact of MPA Injectable Suspension, USP (150 mg) use for up to 240 weeks (4.6 years) was evaluated in an open-label non-randomized clinical study in 389 adolescent females (12 to 18 years of age). Use of MPA Injectable Suspension, USP was associated with a significant decline from baseline in BMD.
Partway through the trial, drug administration was stopped (at 120 weeks). The mean number of injections per MPA Injectable Suspension, USP user was 9.3. Table 5 summarizes the study findings. The decline in BMD at total hip and femoral neck was greater with longer duration of use. The mean decrease in BMD at 240 weeks was more pronounced at total hip (-6.4%) and femoral neck (-5.4%) compared to lumbar spine (-2.1%).
Adolescents in the untreated cohort had an increase in BMD during the period of growth following menarche. However, the two cohorts were not matched at baseline for age, gynecologic age, race, BMD and other factors that influence the rate of acquisition of BMD.
|Duration of Treatment||MPA Injectable Suspension, USP|
(150 mg IM)
|Unmatched, Untreated Cohort|
|N||Mean % Change||N||Mean % Change|
|Total Hip BMD|
|Week 60 (1.2 years)||113||-2.75||166||1.22|
|Week 120 (2.3 years)||73||-5.40||109||2.19|
|Week 240 (4.6 years)||28||-6.40||84||1.71|
|Femoral Neck BMD|
|Lumbar Spine BMD|
BMD Recovery Post-Treatment in Adolescents
Longer duration of treatment and smoking were associated with less recovery of BMD following the last injection of MPA Injectable Suspension, USP. Table 6 shows the extent of recovery of BMD up to 60 months post-treatment for adolescents who received MPA Injectable Suspension, USP for two years or less compared to more than two years. Post-treatment follow-up showed that, in women treated for more than two years, only lumbar spine BMD recovered to baseline levels after treatment was discontinued. Adolescents treated with MPA Injectable Suspension, USP for more than two years did not recover to their baseline BMD level at femoral neck and total hip even up to 60 months post-treatment. Adolescents in the untreated cohort gained BMD throughout the trial period (data not shown) [see Warnings and Precautions (5.1)].
|Duration of Treatment||2 years or less||More than 2 years|
|N||Mean % Change from baseline||N||Mean % Change from baseline|
|Total Hip BMD|
|End of Treatment||49||-1.5%||49||-6.2%|
|12 M post-treatment||33||-1.4%||24||-4.6%|
|24 M post-treatment||18||0.3%||17||-3.6%|
|36 M post-treatment||12||2.1%||11||-4.6%|
|48 M post-treatment||10||1.3%||9||-2.5%|
|60 M post-treatment||3||0.2%||2||-1.0%|
|Femoral Neck BMD|
|End of Treatment||49||-1.6%||49||-5.8%|
|12 M post-treatment||33||-1.4%||24||-4.3%|
|24 M post-treatment||18||0.5%||17||-3.8%|
|36 M post-treatment||12||1.2%||11||-3.8%|
|48 M post-treatment||10||2.0%||9||-1.7%|
|60 M post-treatment||3||1.0%||2||-1.9%|
|Lumbar Spine BMD|
|End of Treatment||49||-0.9%||49||-3.5%|
|12 M post-treatment||33||0.4%||23||-1.1%|
|24 M post-treatment||18||2.6%||17||1.9%|
|36 M post-treatment||12||2.4%||11||0.6%|
|48 M post-treatment||10||6.5%||9||3.5%|
|60 M post-treatment||3||6.2%||2||5.7%|
A retrospective cohort study to assess the association between MPA Injectable Suspension, USP and the incidence of bone fractures was conducted in 312,395 female contraceptive users in the UK. The incidence rates of fracture were compared between MPA Injectable Suspension, USP users and contraceptive users who had no recorded use of MPA Injectable Suspension, USP. The Incident Rate Ratio (IRR) for any fracture during the follow-up period (mean=5.5 years) was 1.41 (95% CI 1.35, 1.47). It is not known if this is due to MPA Injectable Suspension, USP use or to other related lifestyle factors that have a bearing on fracture rate.
In the study, when cumulative exposure to MPA Injectable Suspension, USP was calculated, the fracture rate in users who received fewer than 8 injections was higher than that in women who received 8 or more injections. However, it is not clear that cumulative exposure, which may include periods of intermittent use separated by periods of non-use, is a useful measure of risk, as compared to exposure measures based on continuous use.
There were very few osteoporotic fractures (fracture sites known to be related to low BMD) in the study overall, and the incidence of osteoporotic fractures was not found to be higher in MPA Injectable Suspension, USP users compared to non-users.
Importantly, this study could not determine whether use of MPA Injectable Suspension, USP has an effect on fracture rate later in life.
NDC: 50090-5619-0 1 mL in a VIAL / 1 in a CARTON
"See FDA-approved patient labeling (Patient Information)."
Medroxyprogesterone Acetate Injectable Suspension, USP
Read this Patient Information carefully before you decide if Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP is right for you. This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in women's health. If you have any questions about MPA Injectable Suspension, USP, ask your healthcare provider. You should also learn about other birth control methods to choose the one that is best for you.
What is the most important information I should know about MPA Injectable Suspension, USP?
MPA Injectable Suspension, USP can cause serious side effects, including:
MPA Injectable Suspension, USP is intended to prevent pregnancy. MPA Injectable Suspension, USP does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs).
What is MPA Injectable Suspension, USP?
MPA Injectable Suspension, USP is a progestin hormone birth control method that is given by injection (a shot) to prevent pregnancy.
How well does MPA Injectable Suspension, USP work?
Your chance of getting pregnant depends on how well you follow the directions for taking your MPA Injectable Suspension, USP. The more carefully you follow the directions (such as returning every 3 months for your next injection), the less chance you have of getting pregnant.
In clinical studies, about 1 out of 100 women got pregnant during the first year that they used MPA Injectable Suspension, USP.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
How should I take MPA Injectable Suspension, USP?
Who Should Not Use MPA Injectable Suspension, USP?
Do not use MPA Injectable Suspension, USP if you:
What should I tell my healthcare provider before taking MPA Injectable Suspension, USP?
Before taking MPA Injectable Suspension, USP, tell your healthcare provider if you have:
If you are breastfeeding or plan to breastfeed, MPA Injectable Suspension, USP can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take MPA Injectable Suspension, USP.
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
MPA Injectable Suspension, USP and certain other medicines may affect each other, causing serious side effects. Sometimes the doses of other medicines may need to be changed while you are taking MPA Injectable Suspension, USP.
Some medicines may make MPA Injectable Suspension, USP less effective at preventing pregnancy, including those listed below.
Especially tell your healthcare provider if you take:
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider or pharmacist before you first start taking MPA Injectable Suspension, USP or when you get a new medicine.
Follow your healthcare provider's instructions about using a back-up method of birth control if you are taking medicines that may make MPA Injectable Suspension, USP less effective.
What are the possible side effects of MPA Injectable Suspension, USP?
MPA Injectable Suspension, USP can cause serious side effects, including:
Call your healthcare provider right away if you have:
The most common side effects of MPA Injectable Suspension, USP include:
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of MPA Injectable Suspension, USP. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.
What other information should I know before choosing MPA Injectable Suspension, USP?
How will MPA Injectable Suspension, USP change my periods?
Unusually heavy or continuous bleeding is not a usual effect of MPA Injectable Suspension, USP and if this happens you should see your healthcare provider right away.
With continued use of MPA Injectable Suspension, USP, bleeding usually decreases and many women stop having periods completely. When you stop using MPA Injectable Suspension, USP your menstrual period will usually, in time, return to its normal cycle.
What if I want to become pregnant?
Because MPA Injectable Suspension, USP is a long-acting birth control method, it takes some time after your last shot for its effect to wear off. Most women who try to get pregnant after using MPA Injectable Suspension, USP get pregnant within 18 months after their last shot. The length of time you use MPA Injectable Suspension, USP has no effect on how long it takes you to become pregnant after you stop using it.
General Information about MPA Injectable Suspension, USP
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. This leaflet summarizes the most important information about MPA Injectable Suspension, USP. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about MPA Injectable Suspension, USP that is written for healthcare providers.
What are the ingredients in MPA Injectable Suspension, USP?
Active ingredient: medroxyprogesterone acetate
Inactive ingredients: polyethylene glycol 3350, polysorbate 80, sodium chloride, methylparaben, propylparaben, and water for injection. When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Mason, OH 45040 USA
Revised: August 2021
medroxyprogesterone acetate injection, suspension
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