Pancrex V

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Pancreatin

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• United Kingdom

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Promonta

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Montelukast

Montelukast is reported as an ingredient of Promonta in the following countries:

• Poland

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Depo-SubQ Provera 104

medroxyprogesterone acetate

Dosage Form: injection, suspension
Depo-SubQ Provera 104®

medroxyprogesterone acetate injectable suspension

104 mg/0.65 mL

Physician Information

WARNING: LOSS OF BONE MINERAL DENSITY

Women who use Depo-SubQ Provera 104 may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.

It is unknown if use of Depo-SubQ Provera 104 during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.

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 (see WARNINGS, section 1).

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Depo-SubQ Provera 104 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-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:

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.

Depo-SubQ Provera 104 - Clinical Pharmacology

Depo-SubQ Provera 104 (medroxyprogesterone acetate injectable suspension), when administered at 104 mg/0.65 mL to women every 3 months (12 to 14 weeks), inhibits the secretion of gonadotropins, which prevents follicular maturation and ovulation and causes endometrial thinning. These actions produce its contraceptive effect.

Supression of serum estradiol concentrations and a possible direct action of Depo-SubQ Provera 104 on the lesions of endometriosis are likely to be responsible for the therapeutic effect on endometriosis-associated pain.

Pharmacokinetics

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.

Table 1. Pharmacokinetic Parameters of MPA after a Single SC Injection of Depo-SubQ Provera 104 in Healthy Women (n = 42)

	Cmax (ng/mL)	Tmax (day)	C91 (ng/mL)	AUC0–91 (ng∙day/mL)	AUC0–∞ (ng∙day/mL)	t½ (day)
Cmax = peak serum concentration; Tmax = time when Cmax is observed; C91 = serum concentration at 91 days; AUC0–91 and AUC0–∞ = area under the concentration-time curve over 91 days or infinity, respectively; t½ = terminal half-life
Mean	1.56	8.8	0.402	66.98	92.84	43
Min	0.53	2.0	0.133	20.63	31.36	16
Max	3.08	80.0	0.733	139.79	162.29	114

Absorption

Following a single SC injection of Depo-SubQ Provera 104, serum MPA concentrations reach ≥ 0.2 ng/mL within 24 hours. The mean Tmax is attained approximately 1 week after injection.

In a study to assess accumulation and the achievement of steady state following multiple SC administrations, trough concentrations of MPA were determined after 6, 12, and 24 months, and in a subset of 8 subjects, bi-weekly concentrations were determined within one dosing interval in the second year of administration. The mean (SD) MPA trough concentrations were 0.67 (0.36) ng/mL (n=157), 0.79 (0.36) ng/mL (n=144), and 0.87 (0.33) ng/mL (n=106) at 6, 12 and 24 months, respectively.

Effect of Injection Site

Depo-SubQ Provera 104 was administered into the anterior thigh or the abdomen to evaluate effects on the MPA concentration-time profile. MPA trough concentrations (Cmin; Day 91) were similar for the two injection locations.

Distribution

Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin. No binding of MPA occurs with sex-hormone-binding globulin (SHBG).

Metabolism

MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion

Residual MPA concentrations at the end of the first dosing interval (12 to 14 weeks) of Depo-SubQ Provera 104 are generally below 0.5 ng/mL, consistent with its apparent terminal half-life of ~40 days after SC administration. Most MPA metabolites are excreted in the urine as glucuronide conjugates with only small amounts excreted as sulfates.

Linearity/Non-Linearity

Following a single SC administration of doses ranging from 50 to 150 mg, the AUC and Cmin (Day 91) increased with higher doses of Depo-SubQ Provera 104, but there was considerable overlap across dose levels. Serum MPA concentrations at Day 91 increased in a dose proportional manner but Cmax did not appear to increase proportionally with increasing dose. The AUC data were suggestive of dose linearity.

Special Populations

Race

There were no significant differences in the pharmacokinetics and/or pharmacodynamics of MPA after SC administration of Depo-SubQ Provera 104 in African-American and Caucasian women. The pharmacokinetics/pharmacodynamics of Depo-SubQ Provera 104 were evaluated in Asian women in a separate study and also found to be similar to African-American and Caucasian women.

Effect of Body Weight

Although total MPA exposure was lower in obese women, no dosage adjustment of Depo-SubQ Provera 104 is necessary based on body weight. The effect of body weight on the pharmacokinetics of MPA following a single dose was assessed in a subset of women (n = 42, body mass index [BMI] ranged from 18.2 to 46.7 kg/m2). The AUC0–91 values for MPA were 71.6, 67.9, and 46.3 ng·day/mL in women with BMI categories of ≤ 28 kg/m2, >28–38 kg/m2, and >38 kg/m2, respectively. The mean MPA Cmax was 1.74 ng/mL in women with BMI ≤ 28 kg/m2, 1.53 ng/mL in women with BMI >28–38 kg/m2, and 1.02 ng/mL in women with BMI > 38 kg/m2, respectively. The MPA trough (Cmin) concentrations had a tendency to be lower in women with BMI >38 kg/m2.

Hepatic Insufficiency

No clinical studies have evaluated the effect of hepatic disease on the disposition of Depo-SubQ Provera 104. However, steroid hormones may be poorly metabolized in patients with severe liver dysfunction (see CONTRAINDICATIONS).

Renal Insufficiency

No clinical studies have evaluated the effect of renal disease on the pharmacokinetics of Depo-SubQ Provera 104.

Drug-Drug Interactions

See PRECAUTIONS, section 9

Indications and Usage for Depo-SubQ Provera 104

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 WARNINGS, section 1).

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 Year*
Method	Typical Use†	Perfect Use‡
Source: Hatcher et al., 1998.i
* Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. † 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. ‡ 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. § 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. ¶ Foams, creams, gels, vaginal suppositories, and vaginal film. # Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. Þ With spermicidal cream or jelly. ß Without spermicides. à 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). è 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.
Chance§	85	85
Spermicides¶	26	6	40
Periodic Abstinence	25		63
Calendar		9
Ovulation Method		3
Symptothermal#		2
Post-ovulation		1
CapÞ
Parous Women	40	26	42
Nulliparous Women	20	9	56
Sponge
Parous Women	40	20	42
Nulliparous Women	20	9	56
DiaphragmÞ	20	6	56
Withdrawal	19	4
Condomß
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%.à Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.è

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).

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 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.

Contraindications

1. Known or suspected pregnancy.


2. Undiagnosed vaginal bleeding.


3. Known or suspected malignancy of breast.


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


5. Significant liver disease.


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

Warnings

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 (150mg 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

A study comparing changes in BMD in women using Depo-SubQ Provera 104 with women using Depo-Provera Contraceptive Injection (Depo-Provera CI, 150 mg) showed no significant differences in BMD loss between the two groups after two years of treatment. Mean percent changes in BMD in the Depo-SubQ Provera 104 group are listed in Table 3.

Table 3. Mean Percent Change from Baseline in BMD in Women Using Depo-SubQ Provera 104

	Lumbar Spine		Total Hip		Femoral Neck
Time on Treatment	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)

In another controlled clinical study, adult women using Depo-Provera CI (150 mg) for up to 5 years showed spine and hip BMD mean decreases of 5–6%, compared to no significant change in BMD in the control group. The decline in BMD was more pronounced during the first two years of use, with smaller declines in subsequent years. Mean changes in lumbar spine BMD of –2.86%, -4.11%, -4.89%, -4.93% and –5.38% after 1, 2, 3, 4 and 5 years,-respectively, were observed. Mean decreases in BMD of the total hip and femoral neck were similar.

After stopping use of Depo-Provera CI (150 mg) there was partial recovery of BMD toward baseline values during the 2-year post-therapy period. Longer duration of treatment was associated with less complete recovery during this 2-year period following the last injection. Table 4 shows the change in BMD in women after 5 years of treatment with Depo-Provera CI and in women in a control group, as well as the extent of recovery of BMD for the subset of the women for whom 2-year post treatment data were available.

Table 4. Mean Percent Change from Baseline in BMD in Adults by Skeletal Site and Cohort (5 Years of Treatment and 2 Years of Follow-Up)

Time in Study	Spine		Total Hip		Femoral Neck
	Depo-Provera *	Control†	Depo-Provera *	Control†	Depo-Provera *	Control†
* The treatment group consisted of women who received Depo-Provera CI (150 mg) for 5 years and were then followed for 2 years post-use (total time in study of 7 years). † The control group consisted of women who did not use hormonal contraception and were followed for 7 years.
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)

The impact of Depo-Provera CI (150 mg) use for up to 240 weeks (4.6 years) was evaluated in an open-label non-randomized clinical study in 389 adolescent females (12–18 years). Use of Depo-Provera CI was associated with a significant decline from baseline in BMD.

Partway through the trial, drug administration was stopped (at 120 weeks). The mean number of injections per Depo-Provera CI user was 9.3. The decline in BMD at total hip and femoral neck was greater with longer duration of use (see Table 5). The mean decrease in BMD at 240 weeks was more pronounced at total hip (-6.4%) and femoral neck (-5.4%) compared to lumbar spine (-2.1%).

In general, adolescents increase bone density during the period of growth following menarche, as seen in the untreated cohort. However, the two cohorts were not matched at baseline for age, gynecologic age, race, BMD and other factors that influence the rate of acquisition of bone mineral density.

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
EOT = End of Treatment
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.

 

N = Number of subjects in analysis for indicated month

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 with bleeding and/or spotting during indicated month

Figure 4. Mean (25th, 75th Percentiles) Number of Bleeding and/or Spotting Days in the Subgroup of Women with Bleeding and/or Spotting by Month for Women Treated with Depo-SubQ Provera 104 in Contraception Studies

The changes in men

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