INDICATIONS AND USAGE
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.
Contraception Studies
In three clinical studies, no pregnancies were detected among 2,042 women using depo-subQ 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
|
| |
% of Women Experiencing an Unintended Pregnancy within
the First Year of Use
|
% of Women Continuing Use at 1 Year3
|
| Method |
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
|
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
|
0.1
|
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.i |
| 1Among 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.
|
| 2Among 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. |
| 3Among couples attempting to avoid pregnancy, the
percentage who continue to use a method for 1 year. |
| 4The 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. |
| 5Foams, 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. |
| 7With spermicidal cream or jelly. |
| 8Without spermicides. |
| 9The 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). |
| 10However, 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 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 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 104 and 138 on leuprolide). Study 270 was conducted in South America, Europe and Asia, and enrolled 299 subjects (153 on depo-subQ 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 ³1 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 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 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 subQ provera 104 must be given by subcutaneous injection into the anterior thigh or abdomen, once every 3 months (12 to 14 weeks). depo-subQ provera 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 104 must be vigorously shaken just before use to create a uniform suspension.
First Injection
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 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 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 104 on bone mineral density. If symptoms return after discontinuation of treatment, bone mineral density should be evaluated prior to retreatment.
Instructions for Administration of depo-subQ provera 104 for Subcutaneous Use
Getting ready
Ensure that the medication is at room temperature. Make sure the following
components (Diagrams 1, 2, and 3) are available.
depo-subQ provera 104, as with other parenteral drug products, should be
inspected visually for particulate matter and discoloration prior to administration.
Step 1: Choosing and preparing the injection area.
Choose the injection area. Avoid boney areas and the umbilicus. See shaded areas (Diagram 4).
Upper thigh & Abdomen
Diagram 4
