Depo-SubQ Provera

Name: Depo-SubQ Provera

Description

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-4ene-3,20-dione 17-acetate. The structural formula is as follows:

depo-subQ provera (medroxyprogesterone acetate) 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:

Medroxyprogesterone acetate 104 mg
Methylparaben 1.040 mg
Propylparaben 0.098 mg
Sodium Chloride 5.200 mg
Polyethylene Glycol 18.688 mg
Polysorbate 80 1.950 mg
Monobasic Sodium Phosphate. H2O 0.451 mg
Dibasic Sodium Phosphate . 12H2O 0.382 mg
Methionine 0.975 mg
Povidone 3.250 mg
Water for Injection qs

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

Indications

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

depo-subQ provera (medroxyprogesterone acetate) 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 WARNINGS).

Contraception Studies

In three clinical studies, no pregnancies were detected among 2,042 women using deposubQ provera 104 for up to 1 year. The Pearl Index pregnancy rate in women who were less than 36 years old at baseline, based on cycles in which they used no other contraceptive methods, was 0 pregnancies per 100 women-years of use (upper 95% confidence interval = 0.25).

Pregnancy rates for various contraceptive methods are typically reported for only the first year of use and are shown in Table 2.

Table 2 : Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year: United States

Method % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women
Continuing
Use at 1 Year 3
Typical Use1 Perfect Use2
Chance4 85 85  
Spermicides5 26 6 40
Periodic Abstinence 25   63
  Calendar   9  
  Ovulation Method   3  
  Symptothermal6   2  
  Post-ovulation   1  
Cap7  
  Parous Women 40 26 42
  Nulliparous Women 20 9 56
Sponge      
  Parous Women 40 20 42
  Nulliparous Women 20 9 56
Diaphragm7 20 6 56
Withdrawal 19 4  
Condom8  
  Female (Reality) 21 5 56
  Male 14 3 61
Pill 5   71
  Progestin only   0.5  
  Combined   0.1  
IUD  
  Progesterone T 2.0 1.5 81
  Copper T 380A 0.8 0.6 78
  LNg 20 0.1 0.1 81
Depo-Provera IM 150 mg 0.3 0.3 70
Norplant and Norplant-2 0.05 0.05 88
Female Sterilization 0.5 0.5 100
Male Sterilization 0.15 0.10 100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10
Source: Hatcher et al., 1998.
1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year.
4 The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentages who would become pregnant within 1 year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5 Foams, creams, gels, vaginal suppositories, and vaginal film.
6Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7 With spermicidal cream or jelly.
8 Without spermicides.
9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 4 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

Endometriosis Studies

The efficacy of depo-subQ provera (medroxyprogesterone acetate) 104 in the reduction of endometriosis-associated pain in women with the signs and symptoms of endometriosis was demonstrated in two active comparator-controlled studies. Each study assessed reduction in endometriosis-associated pain over 6 months of treatment and recurrence of symptoms for 12-months post treatment. Subjects treated with depo-subQ provera (medroxyprogesterone acetate) 104 for 6 months received a 104 mg dose every 3 months (2 injections), while women treated with leuprolide microspheres for 6 months received a dose of 11.25 mg every 3 months (2 injections) or 3.75 mg every month (6 injections). Study 268 was conducted in the U.S. and Canada and enrolled 274 subjects (136 on depo-subQ provera (medroxyprogesterone acetate) 104 and 138 on leuprolide). Study 270 was conducted in South America, Europe and Asia, and enrolled 299 subjects (153 on deposubQ provera 104 and 146 on leuprolide).

Reduction in pain was evaluated using a modified Biberoglu and Behrman scale that consisted of three patient-reported symptoms (dysmenorrhea, dyspareunia, and pelvic pain not related to menses) and two signs assessed during pelvic examination (pelvic tenderness and induration). For each category, a favorable response was defined as improvement of at least 1 unit (severity was assessed on a scale of 0 to 3) relative to baseline score (Figure 2).

Figure 2 : Percentages of Responders at End of Treatment (Month 6 or Last Assessment if Earlier) in Studies 268 & 270

Favorable Response = reduction in severity of symptom or sign of ≥ 1 point on a scale of 0 to 3, as compared to baseline

Additionally, scores from each of the five categories were combined, with the total (composite score) considered a global measurement of overall disease improvement. For subjects with baseline scores for each of the 5 categories, a mean decrease of 4 points relative to baseline was considered a clinically meaningful improvement. Across both studies, for both treatment groups, the mean changes in the composite score met the protocol-defined criterion for improvement.

In the clinical trials, treatment with depo-subQ provera (medroxyprogesterone acetate) 104 was limited to six months. Data on the persistence of benefit with longer treatment are not available.

Subjects recorded daily the occurrence and severity of hot flushes. Of the depo-subQ provera (medroxyprogesterone acetate) 104 users, 28.6% reported experiencing moderate or severe hot flushes at baseline, 36.2% at month 3, and 26.7% at month 6. Of the leuprolide users, 32.8% reported experiencing moderate or severe hot flushes at baseline, 74.2% at month 3, and 68.5% at month 6.

How supplied

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 26gauge x 3/8 inch Terumo® Surguard™ needle in the following presentation:

NDC 0009-4709-13 0.65 mL single-use, disposable syringe

Store at controlled room temperature 20°to 25°C (68°to 77°F) [see USP].

Distributed By: Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised June 2009.

Manufacturer

  • Pharmacia and Upjohn Company

depo-subQ provera Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of depo-subQ provera, there are no specific foods that you must exclude from your diet when receiving this medication.

 

depo-subQ provera and Lactation

Tell your healthcare provider if you are breastfeeding. 

When nursing a baby, wait at least 6 weeks after your baby is born to start depo-subQ provera. You can use depo-subQ provera if you are nursing.

  • It does not lower the amount of milk you can make.
  • It can pass through breast milk into your baby, but it is not harmful.

depo-subQ provera Overdose

Depo-subQ provera is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention. 

What is medroxyprogesterone (depo-provera, depo-provera contraceptive, depo-subq provera 104)?

Medroxyprogesterone is a form of progesterone, a female hormone that prevents ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Medroxyprogesterone is used as contraception to prevent pregnancy. It is also used to reduce pain caused by endometriosis.

Medroxyprogesterone is also used to ease pain and other symptoms in women with metastatic uterine or kidney cancer. This medication is not a cure for these conditions.

Medroxyprogesterone may also be used for purposes not listed in this medication guide.

What happens if i miss a dose (depo-provera, depo-provera contraceptive, depo-subq provera 104)?

Call your doctor for instructions if you miss a dose of this medication.

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