"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
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).
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
Use at 1 Year 3
|Typical Use1||Perfect Use2|
|Copper T 380A||0.8||0.6||78|
|Depo-Provera IM 150 mg||0.3||0.3||70|
|Norplant and Norplant-2||0.05||0.05||88|
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.101 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.
Source: Hatcher et al., 1998.
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.
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.
DOSAGE AND ADMINISTRATION
Contraception And Endometriosis Indications
Route of Administration
depo-subQ provera (medroxyprogesterone acetate) 104 must be given by subcutaneous injection into the anterior thigh or abdomen, once every 3 months (12 to 14 weeks). depo-subQ provera (medroxyprogesterone acetate) 104 is not formulated for intramuscular injection. Dosage does not need to be adjusted for body weight. The pre-filled syringe of depo-subQ provera (medroxyprogesterone acetate) 104 must be vigorously shaken just before use to create a uniform suspension.
Ensure that the patient is not pregnant at the time of the first injection. For women who are sexually active and having regular menses, the first injection should be given only during the first 5 days of a normal menstrual period. Women who are breast-feeding may have their first injection during or after their sixth postpartum week.
Second and Subsequent Injections
Dosing is every 12 to 14 weeks. If more than 14 weeks elapse between injections, pregnancy should be ruled out before the next injection.
If Using For Contraception And Switching From Another Method
When switching from other contraceptive methods, depo-subQ provera 104 should be given in a manner that ensures continuous contraceptive coverage. For example, patients switching from combined (estrogen plus progestin) contraceptives should have their first injection of depo-subQ provera (medroxyprogesterone acetate) 104 within 7 days after the last day of using that method (7 days after taking the last active pill, removing the patch or ring). Similarly, contraceptive coverage will be maintained in switching from Depo-Provera CI (150 mg) to depo-subQ provera (medroxyprogesterone acetate) 104, provided the next injection is given within the prescribed dosing period for Depo-Provera CI (150 mg).
If Using For Treatment Of Endometriosis
Treatment for longer than two years is not recommended, due to the impact of long-term depo-subQ provera (medroxyprogesterone acetate) 104 on bone mineral density. If symptoms return after discontinuation of treatment, bone mineral density should be evaluated prior to retreatment.
Instructions for Use of depo-subQ provera (medroxyprogesterone acetate) 104
FOR SUBCUTANEOUS ADMINISTRATION ONLY.
Please read these instructions carefully. It is very important that the entire dose of deposubQ provera 104 is given.
Ensure that the medication is at room temperature. Make sure the following components are available.
depo-subQ provera (medroxyprogesterone acetate) 104, as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
Step 1: Choosing & preparing
Choose the injection area.
- Avoid boney areas and the umbilicus
- The upper thigh & abdomen are preferred injection sites. See shaded areas in diagram
Use an alcohol pad to wipe the skin in the injection area you have chosen.
- Allow the skin to dry
Preferred injection areas:
Step 2: Syringe preparation
Carefully remove the needle and syringe from the packaging.
Hold the syringe firmly by the barrel, with the barrel pointing upward.
- Shake it forcefully for at least 1 minute to thoroughly mix the medication
Hold the syringe barrel firmly.
- Unscrew the protective cap from the tip of the syringe barrel
Hold the syringe barrel firmly.
- Attach the needle to the barrel of the syringe by pushing down firmly with a slight twist
- Move the safety shield away from the needle and toward the syringe barrel. The safety shield will remain in an open 45 to 90 degree position
- While holding the syringe barrel firmly, remove the plastic cover from the needle without twisting, ensuring the needle is still firmly attached to the syringe
- While holding the syringe with the needle pointing upward, gently push in the plunger until the medicine is up to the top of the syringe. There should be no air within the barrel
Step 3: Injecting the dose
Gently grasp and squeeze a large area of skin in the chosen injection area between the thumb and forefinger, pulling it away from the body.
Insert the needle at a 45 degree angle so that most of the needle is in the fatty tissue.
- The plastic hub of the needle should be nearly or almost touching the skin
Inject the medication slowly until the syringe is empty.
- It is important that the entire dose of deposubQ provera 104 is given
- This should take about 5–7 seconds
Step 4: Disposing the needle and syringe
After completing the injection, remove the needle from the skin and activate the safety shield.
Position shield about 40°- 45°. With a firm quick motion, press down against a flat surface until a click is heard or felt.
If uncertain that the safety shield is fully engaged, repeat this step.
Use a clean cotton pad to press lightly on the injection area for a few seconds.
- Do NOT rub the area
Following the administration of each dose, the used syringe should be discarded in a safe and proper manner.
Keep away from children.
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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/27/2009
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