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| Product NDC Code | 0009-7376 | ||||
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| Drug Name | Depo-provera |
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| Type | Brand | ||||
| Pharm Class | Progesterone Congeners [CS], Progestin [EPC] |
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| Route | INTRAMUSCULAR | ||||
| Dosage Form | INJECTION, SUSPENSION | ||||
| RxCUI drug identifier | 1000126, 1000128, 1000153, 1000154 |
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| Application Number | NDA020246 | ||||
| Labeler Name | Pharmacia & Upjohn Company LLC | ||||
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| Check if available Online | Get Medication Prices online with Discount |
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS 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 (5.5) ] • Bleeding Irregularities [see Warnings and Precautions (5.10) ] • Weight Gain [see Warnings and Precautions (5.11) ] 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* 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) * Body System represented from COSTART medical dictionary. Table 2. Adverse Reactions that Were Reported by between 1 and 5% of Subjects 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%) * Body System represented from COSTART medical dictionary. Adverse reactions leading to study discontinuation in ≥2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%). 6.2 Postmarketing 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) ].
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Depo-Provera Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 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. 12.2 Pharmacodynamics No specific pharmacodynamic studies were conducted with Depo-Provera CI. 12.3 Pharmacokinetics Absorption Following a single 150 mg IM dose of Depo-Provera CI 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. Distribution Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG). Elimination Metabolism MPA 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. Excretion 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 Depo-Provera CI is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates. Specific Populations The effect of hepatic and/or renal impairment on the pharmacokinetics of Depo-Provera CI is unknown.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.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.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics No specific pharmacodynamic studies were conducted with Depo-Provera CI.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Absorption Following a single 150 mg IM dose of Depo-Provera CI 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. Distribution Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG). Elimination Metabolism MPA 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. Excretion 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 Depo-Provera CI is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates. Specific Populations The effect of hepatic and/or renal impairment on the pharmacokinetics of Depo-Provera CI is unknown.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 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 (5.5) ] . • Significant liver disease [see Warnings and Precautions (5.7) ] . • Undiagnosed vaginal bleeding [see Warnings and Precautions (5.10) ] . • 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 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 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
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 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
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 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 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE 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) ].
Spl product data elements
Usually a list of ingredients in a drug product.Depo-Provera medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE POLYETHYLENE GLYCOL 3350 POLYSORBATE 80 SODIUM CHLORIDE METHYLPARABEN PROPYLPARABEN WATER SODIUM HYDROXIDE HYDROCHLORIC ACID Depo-Provera medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE POLYETHYLENE GLYCOL 3350 POLYSORBATE 80 SODIUM CHLORIDE METHYLPARABEN PROPYLPARABEN WATER SODIUM HYDROXIDE HYDROCHLORIC ACID
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility [see Warnings and Precautions (5.3 , 5.14 ) and Use in Specific Populations (8.3) ] .
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility [see Warnings and Precautions (5.3 , 5.14 ) and Use in Specific Populations (8.3) ] .
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 150 mg/mL Vial Label NDC 0009-0746-30 Rx only Depo-Provera ® Contraceptive Injection medroxy PROGESTER one acetate injectable suspension, USP 150 mg/mL PRINCIPAL DISPLAY PANEL - 150 mg/mL Vial Label
PRINCIPAL DISPLAY PANEL - 150 mg/mL Vial Carton Pfizer NDC 0009-0746-30 Rx only Depo-Provera ® Contraceptive Injection medroxy PROGESTER one acetate injectable suspension, USP 150 mg/mL 1 mL Single-Dose Vial For intramuscular use only PRINCIPAL DISPLAY PANEL - 150 mg/mL Vial Carton
PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label Pfizer NDC 0009-7376-11 Rx only Depo-Provera ® Contraceptive Injection 150 mg per mL medroxyprogesterone acetate injectable suspension, USP Intramuscular use only 1 mL Single Dose Syringe Shake vigorously before use Pfizer Inc, NY, NY 10017 819 361 101 LOT/EXP: 8Q2671 Principal Display Panel - 1 mL Syringe Label
PRINCIPAL DISPLAY PANEL - 1 mL Syringe Carton - NDC 0009-7376-11 NDC 0009-7376-11 Pfizer Depo-Provera ® Contraceptive Injection (medroxyprogesterone acetate) injectable suspension, USP 150 mg per mL Intramuscular use only Single Use Syringe Rx only 1 mL Prefilled Syringe PRINCIPAL DISPLAY PANEL - 1 mL Syringe Carton - NDC 0009-7376-11
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Contraindications, Pregnancy (4) Removed 04/2024
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.LAB-0149-21.0 logo
Depo-Provera: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING 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 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.
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.Patient Information Depo-Provera ® ( DEP-po pro-VAIR-ah ) CI (medroxyprogesterone acetate injectable suspension) Contraceptive Injection Read this Patient Information carefully before you decide if Depo-Provera CI is right for you. This information does not take the place of talking with your gynecologist or other healthcare professional who specializes in women's health. If you have any questions about Depo-Provera CI, ask your healthcare professional. 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 Depo-Provera CI? Depo-Provera CI can cause serious side effects, including: • Use of Depo-Provera CI may cause you to lose calcium stored in your bone and decrease your bone mass. The longer you use Depo-Provera CI, the greater your loss of calcium from your bones. Your bones may not recover completely when you stop using Depo-Provera CI. • If you use Depo-Provera CI continuously for a long time (for more than 2 years), it may increase the risk of weak, porous bones (osteoporosis) that could increase the risk of broken bones, especially after menopause. • You should not use Depo-Provera CI for more than two years unless you cannot use other birth control methods. • It is not known if your risk of developing osteoporosis is greater if you are a teenager or young adult when you start to use Depo-Provera CI (see "What are the possible side effects of Depo-Provera CI?"). Depo-Provera CI is intended to prevent pregnancy. Depo-Provera CI does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). What is Depo-Provera CI? Depo-Provera CI is a progestin hormone birth control method that is given by injection (a shot) to prevent pregnancy. How well does Depo-Provera CI work? Your chance of getting pregnant depends on how well you follow the directions for taking your Depo-Provera CI. 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 Depo-Provera CI. 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 Depo-Provera CI? • Depo-Provera CI is given by your healthcare professional as a shot into your muscle (intramuscular injection). The shot is given in your buttock or upper arm 1 time every 3 months. At the end of the 3 months, you will need to return to your healthcare professional for your next injection in order to continue your protection against pregnancy . • To make sure that you are not pregnant before you take Depo-Provera CI, the first injection should be given only: o during the first 5 days of a normal menstrual period, or o within the first 5 days after giving birth, if you are not breastfeeding , or o at the 6th week after giving birth, if you are feeding your baby only breastmilk. • Depo-Provera CI may be given at other times than those listed above, but you will likely need to have a pregnancy test first to show that you are not pregnant. • During treatment with Depo-Provera CI, you should see your healthcare professional every year for a blood pressure check and other healthcare needs. Who Should Not Use Depo-Provera CI? Do not use Depo-Provera CI if you: • have bleeding from your vagina that has not been explained • have breast cancer now or in the past, or think you have breast cancer • have had a stroke • ever had blood clots in your arms, legs or lungs • have problems with your liver or liver disease • are allergic to medroxyprogesterone acetate or any of the other ingredients in Depo-Provera CI. See the end of this leaflet for a complete list of ingredients in Depo-Provera CI. What should I tell my healthcare professional before taking Depo-Provera CI? Before taking Depo-Provera CI, tell your healthcare professional if you have: • risk factors for weak bones (osteoporosis) such as bone disease, use alcohol or smoke regularly, anorexia nervosa, or a strong family history of osteoporosis • irregular or lighter than usual menstrual periods • breast cancer now or in the past, or think you have breast cancer • a family history of breast cancer • an abnormal mammogram (breast X-ray), lumps in your breasts, or bleeding from your nipples • kidney problems • high blood pressure • had a stroke • had blood clots in your arms, legs or lungs • migraine headaches • asthma • epilepsy (convulsions or seizures) • diabetes • depression or a history of depression • any other medical conditions If you are breastfeeding or plan to breastfeed, Depo-Provera CI can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you take Depo-Provera CI. Tell your healthcare professional about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Depo-Provera CI 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 Depo-Provera CI. Some medicines may make Depo-Provera CI less effective at preventing pregnancy, including those listed below. Especially tell your healthcare professional if you take: • medicine to help you sleep • bosentan • medicine for seizures • griseofulvin • an antibiotic • medicine for HIV (AIDS) • St. John's wort Know the medicines you take. Keep a list of your medicines with you to show your healthcare professional or pharmacist before you first start taking Depo-Provera CI or when you get a new medicine. Follow your healthcare professional's instructions about using a back-up method of birth control if you are taking medicines that may make Depo-Provera CI less effective. What are the possible side effects of Depo-Provera CI? Depo-Provera CI can cause serious side effects, including: • Effect on the bones: See "What is the most important information I should know about Depo-Provera CI?". Teenage years are the most important years to gain bone strength. The decrease in calcium in your bones is of most concern if you are a teenager or have the following problems: • bone disease • an eating disorder (anorexia nervosa) • a strong family history of osteoporosis • you take a drug that can lower the amount of calcium in your bones (drugs for epilepsy or steroid drugs) • you drink a lot of alcohol (more than 2 drinks a day) • you smoke If you need a birth control method for more than 2 years, your healthcare professional may switch you to another birth control method instead of using Depo-Provera CI. If you continue using Depo-Provera CI, your healthcare professional may ask you to have a bone test, especially if you have other risks for weak bones. When Depo-Provera CI is stopped, your bones may start to regain calcium. However, in a study of teenage girls who used Depo-Provera CI for more than 2 years, their hip bones did not completely recover by 5 years after they stopped using Depo-Provera CI. Taking calcium and Vitamin D and exercising daily may lessen the loss of calcium from your bones. • possible increased risk of breast cancer. Women who use Depo-Provera CI may have a slightly increased risk of breast cancer compared to non-users. • blood clots in your arms, legs, lungs, and eyes • stroke • a pregnancy outside of your uterus (ectopic pregnancy). Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death. • allergic reactions. Severe allergic reactions have been reported in some women using Depo-Provera CI. • loss of vision or other eye problems • migraine headaches • depression • convulsions or seizures • liver problems Call your healthcare professional right away if you have: • sharp chest pain, coughing up blood, or sudden shortness of breath (indicating a possible clot in the lung) • sudden severe headache or vomiting, dizziness or fainting, problems with your eyesight or speech, weakness, or numbness in an arm or leg (indicating a possible stroke) • severe pain or swelling in the calf (indicating a possible clot in the leg) • sudden blindness, partial or complete (indicating a possible clot in the blood vessels of the eye) • unusually heavy vaginal bleeding • severe pain or tenderness in the lower abdominal area • persistent pain, pus, or bleeding at the injection site • yellowing of the eyes or skin • hives • difficulty breathing • swelling of the face, mouth, tongue or neck The most common side effects of Depo-Provera CI include: • irregular vaginal bleeding, such as lighter or heavier menstrual bleeding, or continued spotting • weight gain. You may experience weight gain while you are using Depo-Provera CI. About two-thirds of the women who used Depo-Provera CI in the clinical trials reported a weight gain of about 5 pounds during the first year of use. You may continue to gain weight after the first year. Women who used Depo-Provera CI for 2 years gained an average of 8 pounds over those 2 years. • abdominal pain • headache • weakness • tiredness • nervousness • dizziness Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Depo-Provera CI. For more information, ask your healthcare professional 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 Depo-Provera CI? • Pregnancy . When you take Depo-Provera CI every 3 months, your chance of getting pregnant is very low. You could miss a period or have a light period and not be pregnant. If you miss 1 or 2 periods and think you might be pregnant, see your healthcare professional as soon as possible. You should not use Depo-Provera CI if you are pregnant. However, Depo-Provera CI taken by accident during pregnancy does not seem to cause birth defects. • Nursing Mothers . Although Depo-Provera CI can be passed to the nursing baby in the breast milk, no harmful effects on babies have been found. Depo-Provera CI does not stop the breasts from producing milk, so it can be used by nursing mothers. However, to minimize the amount of Depo-Provera CI that is passed to the baby in the first weeks after birth, you should wait until your baby is 6 weeks old before you start using Depo-Provera CI for birth control. How will Depo-Provera CI change my periods? • Change in normal menstrual cycle . The side effect reported most frequently by women who use Depo-Provera CI for birth controls is a change in their normal menstrual cycle. During the first year of using Depo-Provera CI, you might have one or more of the following changes: o irregular or unpredictable bleeding or spotting o an increase or decrease in menstrual bleeding o no bleeding at all . In clinical studies of Depo-Provera CI, 55% of women reported no menstrual bleeding (amenorrhea) after one year of use and 68% of women reported no menstrual bleeding after two years of use. • Missed period . During the time you are using Depo-Provera CI for birth controls, you may skip a period, or your periods may stop completely. If you have been receiving your shot of Depo-Provera CI regularly every 3 months, then you are probably not pregnant. However, if you think that you may be pregnant, see your healthcare professional. Unusually heavy or continuous bleeding is not a usual effect of Depo-Provera CI and if this happens you should see your healthcare professional right away. With continued use of Depo-Provera CI, bleeding usually decreases and many women stop having periods completely. When you stop using Depo-Provera CI your menstrual period will usually, in time, return to its normal cycle. What if I want to become pregnant? Because Depo-Provera CI 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 Depo-Provera CI get pregnant within 18 months after their last shot. The length of time you use Depo-Provera CI has no effect on how long it takes you to become pregnant after you stop using it. General Information about Depo-Provera CI Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. This leaflet summarizes the most important information about Depo-Provera CI. If you would like more information, talk with your healthcare professional. You can ask your healthcare professional for information about Depo-Provera CI that is written for healthcare professionals. What are the ingredients in Depo-Provera CI? 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. This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com . LAB-0148-14.0 Revised July 2024 Chart logo
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES 14.1 Contraception In five clinical studies using Depo-Provera CI, the 12-month failure rate for the group of women treated with Depo-Provera CI was zero (no pregnancies reported) to 0.7 by Life-Table method. The effectiveness of Depo‑Provera CI is dependent on the patient returning every 3 months (13 weeks) for reinjection. 14.2 Bone Mineral Density Changes in Women Treated with DepoProvera CI In a controlled, clinical study, adult women using Depo-Provera CI (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 Depo-Provera CI, 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 Depo-Provera CI 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. Table 4. Mean Percent Change from Baseline in BMD in Adults by Skeletal Site and Cohort (5 Years of Treatment and 2 Years of Follow-Up) Time in Study Spine Total Hip Femoral Neck Depo-Provera The treatment group consisted of women who received Depo-Provera CI for 5 years and were then followed for 2 years post‑use (total time in study of 7 years). Control The control group consisted of women who did not use hormonal contraception and were followed for 7 years. Depo-Provera Control Depo-Provera Control 5 years -5.38% n=33 0.43% n=105 -5.16% n=21 0.19% n=65 -6.12% n=34 -0.27% n=106 7 years -3.13% n=12 0.53% n=60 -1.34% n=7 0.94% n=39 -5.38% n=13 -0.11% n=63 14.3 Bone Mineral Density Changes in Adolescent Females (12 to 18 Years of Age) Treated with DepoProvera CI The impact of Depo-Provera CI (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 Depo-Provera CI 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 Depo-Provera CI 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. Table 5. BMD Mean Percent Change from Baseline in Adolescents Receiving ≥4 Injections per 60‑week Period, by Skeletal Site and Cohort Duration of Treatment Depo-Provera CI (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 Week 60 113 -2.96 166 1.75 Week 120 73 -5.30 108 2.83 Week 240 28 -5.40 84 1.94 Lumbar Spine BMD Week 60 114 -2.47 167 3.39 Week 120 73 -2.74 109 5.28 Week 240 27 -2.11 84 6.40 BMD Recovery Post-Treatment in Adolescents Longer duration of treatment and smoking were associated with less recovery of BMD following the last injection of Depo-Provera CI. Table 6 shows the extent of recovery of BMD up to 60 months post-treatment for adolescents who received Depo-Provera CI 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 Depo-Provera CI 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) ] . Table 6. BMD Recovery (Months Post-Treatment) in Adolescents by Years of Depo‑Provera CI Use (2 Years or Less vs. More than 2 Years) 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% 14.4 Bone Fracture Incidence in Women Treated with DepoProvera CI A retrospective cohort study to assess the association between Depo-Provera CI injection 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 Depo-Provera CI users and contraceptive users who had no recorded use of Depo-Provera CI. 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 Depo-Provera CI use or to other related lifestyle factors that have a bearing on fracture rate. In the study, when cumulative exposure to Depo-Provera CI 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 Depo-Provera CI users compared to non-users. Importantly, this study could not determine whether use of Depo-Provera CI has an effect on fracture rate later in life.
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.15 REFERENCES 1. Li CI, Beaber EF, Tang, MCT et al. Effect of Depo-Medroxyprogesterone Acetate on Breast Cancer Risk among Women 20 to 44 years of Age. Cancer Research 2012;72:2028–2035. 2. Paul C, Skegg DCG, Spears GFS. Depot medroxyprogesterone (Depo-Provera) and risk of breast cancer. Br Med J 1989; 299:759–62.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.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.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)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.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 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 (5.14) ] . 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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING 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 and handling
Information about safe storage and handling of the drug product.Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Boxed warning
Information about contraindications or serious warnings, particularly those that may lead to death or serious injury.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 (Depo-Provera CI) 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 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. ( 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. ( 1 , 5.1 )
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API