FDA

Medroxyprogesterone Acetate

Approved 7 Jun 2023InjectionInjectable

The FDA lists this product in 20 strengths and forms.

Indications

Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e. longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] . Medroxyprogesterone acetate injectable suspension is a progestin indicated for use by females of reproductive potential to prevent pregnancy.

(1) Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. (1 , 5.1)

Contraindications

The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: Active thrombophlebitis, or current or history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2) ] . Known or suspected malignancy of breast [see Warnings and Precautions (5.3) ] . Known hypersensitivity to medroxyprogesterone acetate injectable suspension (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 medroxyprogesterone acetate injectable suspension (medroxyprogesterone acetate or any of its other ingredients).

(4) Significant liver disease. (4) Undiagnosed vaginal bleeding. (4)

Warnings and precautions

Thromboembolic Disorders: Discontinue medroxyprogesterone acetate in patients who develop thrombosis. (5.2) Cancer Risks: Monitor women with a strong family history of breast cancer carefully. (5.3) Meningioma: Discontinue medroxyprogesterone acetate if meningioma is diagnosed. Monitor patients for signs and symptoms of meningioma. ( 5.4 ) Ectopic Pregnancy: Consider ectopic pregnancy if a woman using medroxyprogesterone acetate becomes pregnant or complains of severe abdominal pain.

Indications

Contraindications

(4) Significant liver disease. (4) Undiagnosed vaginal bleeding. (4)

Warnings and precautions

Interactions

Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with medroxyprogesterone acetate. (7.1)

7.1Changes 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.

7.2Laboratory Test Interactions

The pathologist should be advised of progestin therapy when relevant specimens are submitted. The following laboratory tests may be affected by progestins including medroxyprogesterone acetate: (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.

Adverse reactions

The following important adverse reactions observed with the use of medroxyprogesterone acetate 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 Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience

Clinical trials are conducted under widely varying conditions, therefore, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the two clinical trials with medroxyprogesterone acetate, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of medroxyprogesterone acetate.

The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg medroxyprogesterone acetate every 3-months (90 days). The median study duration was 13 months with a range of 1 to 84 months. Fifty-eight percent of patients remained in the study after 13 months and 34% after 24 months. Table 1: Adverse Reactions that Were Reported by More than 5% of Subjects Body System * 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%).

6.2Post-Marketing Experience

The following adverse reactions have been identified during post approval use of medroxyprogesterone acetate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking medroxyprogesterone acetate.

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 medroxyprogesterone acetate in order to avoid injection site infections [see Dosage and Administration (2.1) ].

Medroxyprogesterone Acetate

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Medroxyprogesterone Acetate

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Loss of Bone Mineral Density Use

5.2Thromboembolic Disorders

5.3Cancer Risks Breast Cancer

5.4Meningioma Cases

5.5Ectopic Pregnancy

5.6Anaphylaxis and Anaphylactoid Reaction Anaphylaxis

5.7Injection Site Reactions

5.8Liver Function

5.9Convulsions

5.10Depression

5.11Bleeding Irregularities

Interactions

7.1Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products If

7.2Laboratory Test Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Post-Marketing Experience

Composition

Strengths and forms

Official product information

At a glance