Depo-Provera

medroxyprogesterone acetate · Injection, Suspension · Intramuscular

Prescription (Rx) Progestin

Boxed warning. WARNING: LOSS OF BONE MINERAL DENSITY
• Women who use Depo-Provera Contraceptive Injection (Depo-Provera CI) 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 Depo-Provera CI 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) ] .
• Depo-Provera CI 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 Depo-Provera Contraceptive Injection…

Uses

Depo-Provera CI is indicated for use by females of reproductive potential to prevent pregnancy. Depo-Provera CI is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use: The use of Depo-Provera CI 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) Limitations of Use : The use of Depo-Provera CI 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) ].

Dosage and administration

The recommended dose is 150 mg of Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI 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 Depo‑Provera CI 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 Depo-Provera CI depends on adherence to the dosage schedule of administration. 2.2 Switching from Other Methods of Contraception When switching from other contraceptive methods, Depo-Provera CI 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 Depo-Provera CI on the day after the last active tablet or at the latest, on the day following the final inactive tablet).

Dosage forms and strengths

Sterile Aqueous suspension: 150 mg/mL Prefilled syringes are available packaged with 22-gauge x 1 1/2 inch Terumo® SurGuard™ Needles.
• Vials containing sterile aqueous suspension: 150 mg per mL ( 3 )
• Prefilled syringes: prefilled syringes are available packaged with 22-gauge x 1 1/2 inch Terumo® SurGuard™ Needles. ( 3 )

Contraindications

The use of Depo-Provera CI 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 Depo-Provera CI (medroxyprogesterone acetate) 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 Depo-Provera CI (medroxyprogesterone acetate or any of its other ingredients). ( 4 )
• Significant liver disease. ( 4 )
• Undiagnosed vaginal bleeding. ( 4 )

Warnings and precautions

• Thromboembolic Disorders: Discontinue Depo-Provera CI in patients who develop thrombosis. ( 5.2 )
• Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 )
• Meningioma: Discontinue Depo-Provera CI if meningioma is diagnosed. Monitor patients for signs and symptoms of meningioma. ( 5.4 )
• Ectopic Pregnancy: Consider ectopic pregnancy if a woman using Depo-Provera CI becomes pregnant or complains of severe abdominal pain. ( 5.5 )
• Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. ( 5.6 )
• Liver Function: Discontinue Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI. After discontinuing Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI in women with osteoporosis risk factors. Depo-Provera CI 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 Depo-Provera CI (150 mg). However, Depo-Provera CI has not been causally associated with the induction of thrombotic or thromboembolic disorders. Any patient who develops thrombosis while undergoing therapy with Depo-Provera CI should discontinue treatment unless she has no other acceptable options for birth control. Do not re-administer Depo-Provera CI 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 Depo-Provera CI, 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 Depo-Provera CI from about 72 to about 144 cases per 100,000 women. Figure 1 Cervical Cancer A statistically nonsignificant increase in relative risk (RR) estimates of invasive squamous-cell cervical cancer has been associated with the use of Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI found no overall increased risk of ovarian or liver cancer. 5.4 Meningioma Cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long term use.

Side effects

The following important adverse reactions observed with the use of Depo-Provera CI 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 Pfizer Inc. at 1-800-438-1985 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 Depo-Provera CI, 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 Depo-Provera CI. 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 Depo-Provera CI 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. Table 1. Adverse Reactions that Were Reported by More than 5% of Subjects Body System Body System represented from COSTART medical dictionary. 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 Body System represented from COSTART medical dictionary. 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 Depo-Provera CI. 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 Depo-Provera CI. Table 3. Adverse Reactions Reported during Post-Marketing Experience 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 * 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 Depo‑Provera CI in order to avoid injection site infections [see Dosage and Administration (2.1) ].

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 Depo-Provera CI. ( 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 Depo-Provera CI: (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.

Use in specific populations

• Pregnancy: Discontinue if pregnancy occurs. ( 8.1 )
• Lactation: Detectable amounts of drug have been identified in the milk of mothers receiving Depo-Provera CI. ( 8.2 )
• Pediatric Patients: Depo-Provera CI is not indicated before menarche. ( 8.4 ) 8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, Depo-Provera CI should be discontinued during pregnancy. Epidemiologic studies and meta‑analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to progestins before conception or during early pregnancy. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary Although medroxyprogesterone acetate is detectable in the milk of mothers receiving Depo-Provera CI, milk composition, quality, and amount do not appear to be adversely affected. Effects on milk production and lactation initiation/duration remain unclear when administered before 6 weeks after delivery, therefore, in mothers who exclusively breastfeed, initiate Depo-Provera CI during or after the sixth post-partum week [see Dosage and Administration (2.1) ] . No adverse effects in breastfed infants would be expected with maternal use of progestins. Neonates and infants exposed to medroxyprogesterone acetate from breast milk have been studied and no adverse effects have been noted. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Depo-Provera CI and any potential adverse effects on the breastfed child from Depo-Provera CI or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Depo-Provera CI is indicated for the prevention of pregnancy and would therefore be expected to impair female fertility until cessation of treatment. Women may experience a delay in return to ovulation and fertility (conception) following discontinuation of Depo-Provera CI [see Warnings and Precautions (5.15) ] . 8.4 Pediatric Use Depo-Provera CI is not indicated before menarche. Use of Depo-Provera CI 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 Depo-Provera CI 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. 8.5 Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population.

Pregnancy

8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, Depo-Provera CI should be discontinued during pregnancy. Epidemiologic studies and meta‑analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to progestins before conception or during early pregnancy. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Pediatric use

8.4 Pediatric Use Depo-Provera CI is not indicated before menarche. Use of Depo-Provera CI 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 Depo-Provera CI 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.

Geriatric use

8.5 Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population.

Description

Depo-Provera CI 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: Depo-Provera CI for IM injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL. For Depo-Provera CI 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 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. For Depo-Provera CI 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 Methylparaben 1.35 mg Propylparaben 0.147 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both. chemical structure

Mechanism of action

12.1 Mechanism of Action Depo-Provera CI (medroxyprogesterone acetate [MPA]) 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.

How supplied

Depo-Provera CI is supplied in the following strengths and package configurations: Package Configuration Strength NDC Depo-Provera CI (medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) 1 mL vial 150 mg/mL NDC 0009-0746-30 25 × 1 mL vials 150 mg/mL NDC 0009-0746-35 Depo-Provera CI prefilled syringes packaged with 22 gauge × 1 1/2 inch Terumo® SurGuard™ Needles 1 mL prefilled syringe 150 mg/mL NDC 0009-7376-11 Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Storage

Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Patient information

Advise the patient to read the FDA‑approved patient labeling (Patient Information).
• Advise patients 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 Depo-Provera CI continues, without other therapy being required.
• Counsel patients about the possible increased risk of breast cancer in women who use Depo-Provera CI [see Warnings and Precautions (5.3) ].
• Counsel patients with a history of meningioma about the possible risk of worsening meningioma [see Warnings and Precautions (5.4) ] .
• Counsel patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted infections.
• Counsel patients on Warnings and Precautions associated with use of Depo-Provera CI.
• Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with Depo-Provera CI. This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com . To contact Pfizer’s Medical Information Department please visit www.pfizermedinfo.com or call 1‑800‑438‑1985.

Label text from the FDA structured product label by Pharmacia & Upjohn Company LLC (revised Aug 25, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Medroxyprogesterone Acetate in 2 products

Depo-Provera NDC products (2)

NDC	Strength & form	Labeler	Type
0009-0746	Medroxyprogesterone Acetate 150 mg/mL Injection, Suspension	Pharmacia & Upjohn Company LLC	NDA
0009-7376	Medroxyprogesterone Acetate 150 mg/mL Injection, Suspension	Pharmacia & Upjohn Company LLC	NDA

Frequently asked questions

What is Depo-Provera used for?

What are the side effects of Depo-Provera?

Who makes Depo-Provera?

Depo-Provera is listed by 1 labeler in the FDA NDC directory, including Pharmacia & Upjohn Company LLC.