Depo-SubQ Provera

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Overview

What is Depo-SubQ Provera?

depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), 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 205° and 209°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 17-hydroxy-6α-methylpregn-4-ene-3, 20-dione 17-acetate. The structural formula is as follows:

depo-subQ provera 104 for subcutaneous (SC) injection is available in pre-filled syringes (160 mg/mL), each containing 0.65 mL (104 mg) of medroxyprogesterone acetate sterile aqueous suspension.

Each 0.65 mL contains:

When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

What does Depo-SubQ Provera look like?

What are the available doses of Depo-SubQ Provera?

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What should I talk to my health care provider before I take Depo-SubQ Provera?

Sorry No records found

How should I use Depo-SubQ Provera?

depo-subQ provera 104 is indicated for the prevention of pregnancy in women of child bearing potential.

depo-subQ provera 104 also is indicated for management of endometriosis-associated pain.

In considering use for either indication, the loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use depo-subQ provera 104 long-term (see ).

What interacts with Depo-SubQ Provera?

Known or suspected pregnancy.

Undiagnosed vaginal bleeding.

Known or suspected malignancy of the breast.

Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease.

Significant liver disease.

Known hypersensitivity to medroxyprogesterone acetate or any of its other ingredients.

What are the warnings of Depo-SubQ Provera?

1. Loss of Bone Mineral Density

Use of depo-subQ provera 104 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-subQ provera 104 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 (150 mg medroxyprogesterone acetate IM, DMPA). After discontinuing Depo-Provera CI in adolescents, mean BMD loss at total hip and femoral neck did not fully recover by 60 months (240 weeks) post-treatment. Similarly, in adults, there was only partial recovery of mean BMD at total hip, femoral neck and lumbar spine towards baseline by 24 months post-treatment.

depo-subQ provera 104 should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate. BMD should be evaluated when a woman needs to continue to use depo-subQ provera 104 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-subQ provera 104 in women with osteoporosis risk factors. depo-subQ provera 104 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). Although there are no studies addressing whether calcium and Vitamin D lessen BMD loss in women using depo-subQ provera 104, all patients should have adequate calcium and Vitamin D intake.

BMD Changes in Adult Women after Long-Term Treatment for Contraception

**Table 3. Mean Percent Change from Baseline in BMD in Women Using depo-subQ provera 104**
Time on Treatment	Lumbar Spine	Total Hip	Femoral Neck
N	Mean % Change(95% CI)	N	Mean % Change(95% CI)	N	Mean % Change(95% CI)
1 year	166	-2.7(-3.1 to -2.3)	166	-1.7(-2.1 to -1.3)	166	-1.9(-2.5 to -1.4)
2 year	106	- 4.1(-4.6 to -3.5)	106	-3.5(-4.2 to -2.7)	106	-3.5(-4.3 to -2.6)
Time in Study	Spine	Total Hip	Femoral Neck
	Depo-Provera	Control	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

Bone Mineral Density Changes in Adolescent Females (12–18 years of age)

**Table 5. Mean Percent Change from Baseline in BMD 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 adolescent women

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 adolescent women 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. Subjects treated with Depo-Provera 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. Adolescent women in the untreated cohort gained BMD throughout the trial period (data not shown).

**Table 6: Extent of 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%

BMD Changes in Adult Women after Six Months of Treatment for Endometriosis

In two clinical studies of 573 adult women with endometriosis, the BMD effects of 6 months of depo-subQ provera 104 treatment were compared to 6 months of leuprolide treatment. Subjects were then observed, off therapy, for an additional 12 months (Table 7).

**Table 7. Mean Percent Change from Baseline in BMD after 6 Months on Therapy with depo-subQ provera 104 or Leuprolide and 6 and 12 Months after Stopping Therapy (Studies 268 and 270 Combined)**
	Time of Measurement	Lumbar Spine	Total Hip
	depo-subQ provera 104	Leuprolide	depo-subQ provera 104	Leuprolide
	N	Mean % change	N	Mean % change	N	Mean % change	N	Mean % change
Month 6 of treatment (EOT)	208	-1.20	229	-4.10	207	-0.03	227	-1.83
6 months off treatment	168	-1.06	180	-2.75	169	-0.05	181	-1.59
12 months off treatment	124	-0.54	133	-1.48	125	0.39	134	-1.15

2. Bleeding Irregularities

Most women using depo-subQ provera 104 experienced changes in menstrual bleeding patterns, such as amenorrhea, irregular spotting or bleeding, prolonged spotting or bleeding, and heavy bleeding. As women continued using depo-subQ provera 104, fewer experienced irregular bleeding and more experienced amenorrhea. If abnormal bleeding is persistent or severe, appropriate investigation and treatment should be instituted.

In three contraception trials, 39.0 % of women experienced amenorrhea during month six, and 56.5% experienced amenorrhea during month 12. The changes in menstrual bleeding patterns from the three contraception trials are presented in Figures 3 and 4.

The changes in menstrual patterns in the two endometriosis trials are presented in Figures 5 and 6.

**Figure 3. Percentages of depo-subQ provera 104 Treated Women with Amenorrhea per 30-Day Month in Contraception Studies (ITT Population, N=2053)**
N = Number of subjects in analysis for indicated month
N = Number of subjects with bleeding and/or spotting during indicated month
N = Number of subjects in analysis for indicated month
N = Number of subjects with bleeding and/or spotting during indicated month

3. Cancer Risks

Women who have or have had breast cancer should not use hormonal contraceptives, including depo sub-Q provera 104, because breast cancer may be hormonally sensitive . 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 7. 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 evaluated the recency and duration of use and found a statistically significant 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.

Figure 7. Risk estimates of 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.

The relative rate of invasive squamous-cell cervical cancer in women who ever used Depo-Provera CI (150 mg) 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.

4. Thromboembolic Disorders

Although MPA has not been causally associated with the induction of thrombotic or thromboembolic disorders, there have been rare reports of serious thrombotic events in women using Depo-Provera CI (150 mg). Any patient who develops thrombosis while undergoing therapy with depo-subQ provera 104 should discontinue treatment unless she has no other acceptable options for birth control (see ).

5. Ocular Disorders

Medication should not be re-administered 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. If examination reveals papilledema or retinal vascular lesions, medication should not be re-administered.

6. Ectopic Pregnancy

Healthcare providers should be alert to the possibility of an ectopic pregnancy among women using depo-subQ provera 104 who become pregnant or complain of severe abdominal pain.

7. Anaphylaxis and Anaphylactoid Reaction

Serious anaphylactic reactions have been reported in women using depo-subQ provera 104. If an anaphylactic reaction occurs, appropriate emergency medical treatment should be instituted.

What are the precautions of Depo-SubQ Provera?

1. Physical Examination

It is good medical practice for all women to have annual history and physical examinations, including women using depo-subQ provera 104. The physical examination, however, may be deferred until after initiation of depo-subQ provera 104 if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer should be monitored with particular care.

2. Fluid Retention

Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

3. Weight Gain

Weight gain is a common occurrence in women using depo-subQ provera 104. In three large clinical trials using depo-subQ provera 104, the mean weight gain was 3.5 lb in the first year of use. In a small, two-year study comparing depo-subQ provera 104 to Depo-Provera CI (150 mg), the mean weight gain observed for women using depo-subQ provera 104 (7.5 lb) was similar to the mean weight gain for women using Depo-Provera CI, 150 mg (7.6 lb).

Although there are no data related to weight gain beyond 2 years for depo-subQ provera 104, the data on Depo-Provera CI (150 mg) may be relevant. In a clinical study, after five years, 41 women using Depo-Provera CI (150 mg) had a mean weight gain of 11.2 lb, while 114 women using non-hormonal contraception had a mean weight gain of 6.4 lb.

4. Return to Ovulation and Fertility

Median time to ovulation was 10 months after the last injection
Earliest return to ovulation was 6 months after the last injection
12 women (80%) ovulated within 1 year of the last injection

Return to ovulation is likely to be delayed after stopping therapy. Among 15 women who received multiple doses of depo-subQ provera 104:

However, ovulation has occurred as early as 14 weeks after a single dose of depo-subQ provera 104, and therefore it is important to follow the recommended dosing schedule.

Return to fertility also is likely to be delayed after stopping therapy. Among 28 women using depo-subQ provera 104 for contraception who stopped treatment to become pregnant, 1 became pregnant within 1 year of her last injection. A second woman became pregnant 443 days after her last injection. Seven women were lost to follow-up.

5. Depression

Patients with a history of treatment for clinical depression should be carefully monitored while receiving depo-subQ provera 104.

6. Injection Site Reactions

In 5 clinical studies of depo-subQ provera 104 involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 women treated for up to 2 years), 5% of women reported injection site reactions, and 1% had persistent skin changes, typically described as small areas of induration or atrophy.

In post-marketing experience, injection site reactions such as persistent atrophy of the injection site, dimpling/indentation and injection site lump/nodule have been reported.

7. Carbohydrate/Metabolism

Some patients receiving progestins may exhibit a decrease in glucose tolerance. Diabetic patients should be carefully observed while receiving such therapy.

8. Liver Function

If jaundice or any other liver abnormality develops in any woman receiving depo-subQ provera 104, treatment should be stopped while the cause is determined. Treatment may be resumed when liver function is acceptable and when the healthcare provider has determined that depo-subQ provera 104 did not cause the abnormality.

9. Drug Interactions

No drug-drug interaction studies have been conducted with depo-subQ provera 104. Aminoglutethimide administered concomitantly with depo-subQ provera 104 may significantly decrease the serum concentrations of MPA.

10. Laboratory Tests

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The pathologist should be advised of progestin therapy when relevant specimens are submitted. The physician should be informed that certain endocrine and liver function tests, and blood components may be affected by progestin therapy:

11. Carcinogenesis, Mutagenesis, Impairment of Fertility

See and

12. Pregnancy

Although depo-subQ provera 104 should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy. Neonates exposed to medroxyprogesterone acetate in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development.

13. Nursing Mothers

Although the drug is detectable in the milk of mothers receiving Depo-Provera CI (150 mg), milk composition, quality, and amount are not adversely affected. Neonates and infants exposed to medroxyprogesterone acetate from breast milk have been studied for developmental and behavioral effects through puberty, and no adverse effects have been noted.

14. Pediatric Use

depo-subQ provera 104 is not indicated before menarche. Use of depo-subQ provera 104 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-subQ provera 104 by younger women will reduce peak bone mass and increase the risk for 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.

15. Geriatric Use

depo-subQ provera 104 is intended for use in women with childbearing potential. Studies with depo-subQ provera 104 in geriatric women have not been conducted.

INFORMATION FOR THE PATIENT

See .

What are the side effects of Depo-SubQ Provera?

In five clinical studies of depo-subQ provera 104 involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 treated for up to 2 years), 9% of women discontinued treatment for adverse reactions. Among these 212 women, the most common reasons for discontinuation were:

Adverse reactions reported by 5% or more of all women in these clinical trials included:

Adverse reactions reported by 1% to <5% of all women in these clinical trials included:

General disorders:

Gastrointestinal disorders:

Infections:

Investigations:

Musculoskeletal, connective tissue, and bone disorders:

Nervous system disorders:

Psychiatric disorders:

Reproductive system and breast disorders:

Skin disorders:

Vascular disorders:

Postmarketing Experience

Anaphylactic reaction, anaphylactoid reaction, angioedema, and drug hypersensitivity have been reported with depo-subQ provera 104. There have been rare cases of osteoporosis including osteoporotic fractures reported postmarketing in patients taking DEPO-PROVERA Contraceptive Injection.

The following additional reactions have been reported with Depo-Provera Contraceptive Injection and may occur with use of depo-subQ provera 104:

General disorders:

Blood and lymphatic system disorders:

Cardiac disorders:

Gastrointestinal disorders:

Hepato-biliary disorders:

Infections:

Investigations:

Musculoskeletal, connective tissue, and bone disorders:

Neoplasms:

Nervous system disorders:

Psychiatric disorders:

Reproductive system and breast disorders:

Respiratory disorders:

Skin disorders:

Vascular disorders:

What should I look out for while using Depo-SubQ Provera?

What might happen if I take too much Depo-SubQ Provera?

Sorry No Records found

How should I store and handle Depo-SubQ Provera?

depo-subQ provera 104 for subcutaneous use (medroxyprogesterone acetate injectable suspension 104 mg/0.65 mL) is available as a pre-filled syringe, packaged with a 26-gauge × 3/8 inch Terumo Surguard™ needle in the following presentation:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The pharmacokinetic parameters of medroxyprogesterone acetate (MPA) following a single SC injection of depo-subQ provera 104 are shown in Table 1 and Figure 1.

Non-Clinical Toxicology

No drug-drug interaction studies have been conducted with depo-subQ provera 104. Aminoglutethimide administered concomitantly with depo-subQ provera 104 may significantly decrease the serum concentrations of MPA.

It is good medical practice for all women to have annual history and physical examinations, including women using depo-subQ provera 104. The physical examination, however, may be deferred until after initiation of depo-subQ provera 104 if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer should be monitored with particular care.

In five clinical studies of depo-subQ provera 104 involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 treated for up to 2 years), 9% of women discontinued treatment for adverse reactions. Among these 212 women, the most common reasons for discontinuation were:

Adverse reactions reported by 5% or more of all women in these clinical trials included:

Adverse reactions reported by 1% to <5% of all women in these clinical trials included:

General disorders:

Gastrointestinal disorders:

Infections:

Investigations:

Musculoskeletal, connective tissue, and bone disorders:

Nervous system disorders:

Psychiatric disorders:

Reproductive system and breast disorders:

Skin disorders:

Vascular disorders:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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