What are the indications and usage of Deviry (medroxyprogesterone)?

Deviry (Medroxyprogesterone Acetate): Indications and Usage

FDA-Approved Indications

Medroxyprogesterone acetate tablets are FDA-approved for three specific indications: treatment of secondary amenorrhea, treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology (such as fibroids or uterine cancer), and prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg. 1

Primary Treatment Indications

• Secondary amenorrhea: Medroxyprogesterone acetate is administered at 5-10 mg daily for 5-10 days to treat absent menstrual periods in non-pregnant women with a uterus who have stopped having regular menstrual periods due to a drop in progesterone levels 1

• Abnormal uterine bleeding: For women with irregular menstrual bleeding or abnormal uterine bleeding due to hormonal imbalance, medroxyprogesterone acetate is given at 5-10 mg daily for 5-10 days 1

• Endometrial protection: In postmenopausal women with a uterus who are receiving estrogen therapy, medroxyprogesterone acetate reduces the chance of developing endometrial hyperplasia and uterine cancer 1

Additional Clinical Applications Based on Guidelines

Contraception

• Injectable depot medroxyprogesterone acetate (DMPA) can be considered for contraception in patients willing to use injectable contraception, particularly when other methods are contraindicated 2

• DMPA-SC (subcutaneous formulation) should be made available as an additional approach to deliver injectable contraception, with both self-administered and provider-administered options available 3

• DMPA is highly effective with pregnancy rates equivalent between self-administered and provider-administered formulations 4

Menorrhagia Management

• DMPA injectable can be considered as a treatment option for menorrhagia (heavy menstrual bleeding) if the patient is willing to use injectable contraception 2

• In perimenopausal women with uterine fibroids and abnormal uterine bleeding, DMPA 150 mg monthly showed 72.4% efficacy in controlling bleeding, allowing many cases to avoid hysterectomy 5

• NSAIDs for 5-7 days should be used concurrently for heavy or prolonged bleeding that may occur with DMPA 2

Hormone Replacement Therapy Component

• Medroxyprogesterone acetate (MPA) is the only progestin with demonstrated full effectiveness in inducing secretory endometrium when combined with a full replacement dose of estrogen, making it a first-choice progestin in hormone replacement therapy despite concerns about cardiovascular effects 3

• MPA 10 mg daily for 12-14 days every 28 days can be combined with transdermal 17β-estradiol in women with premature ovarian insufficiency who require hormone replacement 3

• MPA is particularly useful when micronized progesterone is unavailable or when definitive endometrial protection is the priority 3

Endometriosis Treatment

• Oral medroxyprogesterone acetate at 30-50 mg daily for 90-120 days is effective in managing minimal to moderate endometriosis, with improvement or remission occurring in all treated cases and a 90% pregnancy rate in women with fertile partners 6, 7

• The mechanism involves inducing pseudodecidualized reaction and atrophic changes in both the endometrium and ectopic implants, while suppressing ovulation 7

Preterm Birth Prevention

• 17-hydroxyprogesterone caproate (17P), a related progestogen compound, is used for prevention of recurrent preterm birth in singleton gestations with prior preterm birth, though this is a different formulation than standard medroxyprogesterone acetate 3

• Vaginal progesterone (not medroxyprogesterone acetate) is preferred for women with short cervical length and no prior preterm birth 3

Dosing Algorithms by Indication

For Secondary Amenorrhea or Abnormal Uterine Bleeding

• Start with 5 mg daily for 5-10 days 1
• If inadequate response, increase to 10 mg daily for 5-10 days 1
• Withdrawal bleeding typically occurs 3-7 days after completing the course 1

For Endometrial Protection in Postmenopausal Women

• Administer medroxyprogesterone acetate cyclically (12-14 days per month) or continuously in combination with estrogen 1
• The specific dose should be determined based on the estrogen dose being used 3

For Contraception (DMPA Injectable)

• DMPA-IM: 150 mg intramuscularly every 12-13 weeks 3, 8
• DMPA-SC: 104 mg subcutaneously every 12-13 weeks 3
• For adolescents, schedule follow-up visits every 11-12 weeks to allow for missed or delayed visits 4

Critical Safety Considerations and Contraindications

Absolute Contraindications

• Current or history of unusual vaginal bleeding of unknown cause 1
• Known or suspected pregnancy (may increase risk of minor birth defects if used in first 4 months) 1
• Current or history of certain cancers, particularly breast cancer 1
• Active or history of thromboembolic disorders or stroke 1
• Current or history of liver disease 1
• Known hypersensitivity to medroxyprogesterone acetate 1

Major Safety Warnings

Thromboembolic risk is the most serious adverse effect, with approximately 1 in 6 patients developing thromboembolic phenomena and 1 in 23 patients at risk of treatment-related death based on meta-analysis data. 4

• All patients using medroxyprogesterone acetate must be monitored carefully for signs of thromboembolism 4

• Weight gain is common and predictable: weight gain at 6 months is a strong predictor of excessive future weight gain with continued DMPA use 4

• Monitor weight regularly, especially during the first 6 months, and consider alternative contraceptive methods if significant weight gain occurs 4

• Irregular vaginal bleeding is extremely common, including breakthrough bleeding and amenorrhea 4

• Provide thorough pre-treatment counseling about expected menstrual changes to improve continuation rates 4

Bone Health Considerations

• Ensure adequate calcium and vitamin D supplementation for women using DMPA long-term 4
• This is particularly important given the suppression of estradiol levels to early-to-mid follicular phase range (mean approximately 50 pg/mL) 8

Common Clinical Pitfalls to Avoid

• Do not use medroxyprogesterone acetate as a pregnancy test 1
• Do not fail to rule out organic pathology (fibroids, uterine cancer) before treating abnormal uterine bleeding 1
• Do not overlook the importance of pre-treatment counseling about bleeding patterns and weight changes, which significantly impacts continuation rates 4
• Do not fail to monitor weight, especially during the first 6 months of DMPA use 4
• Do not ignore the need for calcium and vitamin D supplementation in long-term DMPA users 4
• Do not use in combination with estrogens to prevent heart disease, heart attacks, strokes, or dementia, as this may increase risks 1

Follow-Up Recommendations

• Discuss with patients every 3-6 months whether they still need treatment with medroxyprogesterone acetate 1
• Start at the lowest effective dose and adjust based on response 1
• For DMPA users, schedule visits every 11-13 weeks for reinjection 3, 4
• Monitor for thromboembolic signs and symptoms at each visit 4
• Assess weight changes and discuss lifestyle modifications as needed 4