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«USES Actions MPA (17α-hydroxy-6-α-methylprogesterone acetate) is a progestogen and a derivative of progesterone. MPA induces responses in ...»

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DATA SHEET

®

DEPO-PROVERA

Medroxyprogesterone acetate

150 mg/mL Injection (depot)

PRESENTATION

DEPO-PROVERA 150 mg/mL Injection (depot) is a white, aqueous, suspension containing

medroxyprogesterone acetate (MPA) as the active ingredient.

USES

Actions

MPA (17α-hydroxy-6-α-methylprogesterone acetate) is a progestogen and a derivative of

progesterone.

MPA induces responses in laboratory animals comparable to those caused by progesterone.

It is more potent than progesterone and, when injected as a suspension, has a long duration of action. MPA induces glandular development in the endometrium, maintains pregnancy, delays parturition, inhibits ovulation and suppresses oestrous cycles. It is devoid of androgenic and oestrogenic activity. In selected animal tests it has some adrenal corticoidlike activity and in dogs, increases serum growth hormone levels.

DEPO-PROVERA has prolonged progestational effects when administered by intramuscular (IM) injection.

DEPO-PROVERA suppresses the secretion of pituitary gonadotropins which, in turn, prevents follicular maturation producing long-term anovulation in the reproductive-aged woman. DEPO-PROVERA suppresses the Leydig cell function in the male, i.e., suppresses endogenous testosterone product.

A single dose of 50 mg of parenteral MPA has the equivalent effect of 20 mg of oral progesterone given daily for 10 days in producing an optimal secretory change in an oestrogen-primed endometrium. This steroid also produces typical progestational changes in the cervical mucus (inhibits ferning) increases the viscosity of cervical mucus thereby increasing the difficulty of sperm penetration of the cervical mucus and increases the intermediate cell count in the maturation index of the vaginal epithelium.

Anti-cancer activity of DEPO-PROVERA at pharmacologic doses may be dependent on its effect on the hypopituitary/gonadal axis oestrogen receptors and the metabolism of steroids at the tissue level.

Like progesterone parenteral MPA is thermogenic. Clinically, suppression of adrenocortical function has not been observed at the dose levels employed for ovulation suppression.

However, at the very high dosage levels used in the treatment of certain cancers (500 mg daily or more) corticoid-like activity may manifest.

Version: pfddepoi11214 Supersedes: pfddepoi10714 Page 1 of 15 In chronic toxicity studies in rats and mice, no significant differences between controls and treated groups in relation to clinical signs, mortality rates, development of neoplasms or the development of any other gross or histologic lesions developed. No teratogenic effects were observed in mice and rats. In rabbits, DEPO-PROVERA exhibited a corticoid-like effect on fetal development.

In long-term toxicology studies in monkeys, 2 of the monkeys receiving IM doses of 150 mg/kg every 90 days developed undifferentiated carcinoma of the uterus. No uterine malignancies were found in monkeys receiving 30 mg/kg, 3 mg/kg or placebo every 90 days.

The occurrence of the lesions in these 2 monkeys does not signify that DEPO-PROVERA is carcinogenic in women. The incidence of endometrial carcinoma reported with women on DEPO-PROVERA is considerably less than the random incidence in the general population.

This may be an artifact but it suggests no causal relationship between endometrial cancer and the usage of DEPO-PROVERA. DEPO-PROVERA is used successfully as palliative treatment in endometrial and breast cancer.

Pharmacokinetics Parenteral MPA is a long acting progestational steroid. The 150 mg/mL formulation reaches half its initial concentration in about 27 days. Its long duration of action results from its slow absorption from the injection site.

The principal metabolite of MPA that has been identified is a 6α-methyl-6β,17α,21trihydroxy-4-pregnene-3, 20-dione-17-acetate which is excreted in the urine.

INDICATIONS

DEPO-PROVERA is indicated for:

ovulation suppression.

• Since loss of bone mineral density (BMD) may occur in pre-menopausal women who use DEPO-PROVERA, particularly if treated long-term (greater than 2 years), women should be assessed for risk factors for low BMD including a review of their medical history, to determine the risk of developing osteoporosis. This should be conducted before the commencement of treatment. A careful re-evaluation of the risks and benefits of treatment beyond 2 years should be carried out in those patients who need to remain on DEPOPROVERA.

Women under the age of 18 years may be at risk of failing to achieve their predicted peak BMD (see WARNINGS AND PRECAUTIONS).

the treatment of endometriosis.

• adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or • renal carcinoma.

the treatment of hormonally-dependent recurrent breast cancer in post-menopausal • women.

–  –  –

Ovulation suppression DEPO-PROVERA should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension. The IM suspension is not formulated for subcutaneous injection.





The recommended dose is 150 mg of DEPO-PROVERA every 3 months administered by IM injection in the gluteal or deltoid muscle. The initial injection should be given during the first 5 days after the onset of a normal menstrual period; within 5 days post-partum if not breastfeeding; or if exclusively breast-feeding at or after 6 weeks post-partum.

It is recommended that physicians or others directly responsible for these patients advise them at the beginning of treatment that their menstrual cycle may be disrupted, that irregular and unpredictable bleeding or spotting are produced, but that this usually decreases to the point of amenorrhoea as treatment with DEPO-PROVERA continues without other therapy being required.

Routine or long-term cyclic use of supplemental oestrogens with DEPO-PROVERA is not recommended. Excessive or prolonged bleeding which becomes troublesome to the patient can usually be controlled by the administration of oral or parenteral oestrogens in the equivalent of 0.05 mg to 0.1 mg ethinyloestradiol daily for 7 to 21 days. This therapy can be continued for 1 to 2 cycles, but should not be considered for long-term administration.

Based on limited experience, some investigators favour the use of a second injection of DEPO-PROVERA before 90 days to control troublesome bleeding. The third and subsequent injections should be administered at separate 90 day intervals.

If abnormal bleeding persists, appropriate investigation should be instituted to rule out the possibility of organic pathology. Uterine curettage may be required on rare occasions.

Endometriosis The recommended dose of DEPO-PROVERA given intramuscularly is 50 mg weekly or 100 mg every 2 weeks for at least 6 months.

Endometrial and renal carcinoma Doses of 500 mg to 1000 mg of DEPO-PROVERA intramuscularly per week are recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilised, it may be possible to maintain improvement with 500 mg per week or less. DEPO-PROVERA is not recommended as primary therapy, but as adjunctive and palliative treatment in advanced inoperable cases including those with recurrent or metastatic disease.

Breast cancer The recommended dosage schedule is DEPO-PROVERA 500 mg to 1000 mg per day intramuscularly for 28 days. The patient should then be placed on a maintenance schedule of 500 mg twice weekly as long as she is responding to treatment. Response to hormonal therapy (DEPO-PROVERA) for breast cancer may not be evident until 8 to 10 weeks of therapy. Treatment with DEPO-PROVERA should be terminated should rapid progression of disease occur at any time during therapy.

–  –  –

BMD should also be evaluated when considering continuing DEPO-PROVERA for contraception or treatment of endometriosis beyond 2 years. An evaluation of BMD may also be appropriate in some patients who use DEPO-PROVERA long-term for oncology indications.

CONTRAINDICATIONS

DEPO PROVERA is contraindicated in patients with:

thrombophlebitis, thromboembolic disorders, cerebral apoplexy or patients with a past • history of these conditions known or suspected pregnancy (see WARNINGS AND PRECAUTIONS, Precautions, • Use in pregnancy) missed abortion • undiagnosed vaginal bleeding • known or suspected malignancy of the breast (when used for ovulation suppression or • gynaecology indications) undiagnosed breast pathology • undiagnosed urinary tract bleeding • severe uncontrolled hypertension • severe liver dysfunction • known hypersensitivity to MPA or any component of the injection (see FURTHER • INFORMATION, Excipients).

WARNINGS AND PRECAUTIONS

Warnings Thromboembolic disorders DEPO-PROVERA has not been causally associated with the induction of thrombotic or thromboembolic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis), however, MPA is not recommended in any patient with a history of venous thromboembolism (VTE). The physician should be alert to the earliest manifestations of thrombotic or thromboembolic disorders. Should any of these occur or be suspected, the drug should be discontinued immediately.

Ocular disorders Medication should not be readministered 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

–  –  –

Bleeding irregularities Most women using DEPO-PROVERA experience disruption of menstrual bleeding patterns following the administration of either a single or multiple doses of MPA (e.g., irregular or unpredictable bleeding/spotting, rarely, heavy or continuous bleeding). If unexpected vaginal bleeding occurs or abnormal bleeding persists or is severe, appropriate investigations should be instituted to rule out the possibility of organic pathology and appropriate treatment should be instituted when necessary.

As women continue using DEPO-PROVERA fewer experience irregular bleeding and more experience amenorrhoea. By month 12, amenorrhoea was reported by 57% of women, and by month 24, amenorrhoea was reported by 68% of women using DEPO-PROVERA.

Infertility and anovulation with amenorrhoea and/or erratic menstrual patterns may persist for periods of up to 18 months and occasionally longer following either single or multiple injections of DEPO-PROVERA.

Loss of BMD Contraception and endometriosis Use of DEPO-PROVERA reduces serum oestrogen levels and is associated with significant loss of BMD as bone metabolism accommodates to a lower oestrogen level. Decreases in serum oestrogen due to DEPO-PROVERA may result in a decrease in BMD in a premenopausal woman and may increase her risk for developing osteoporosis later in life.

This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of DEPO-PROVERA by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. In both adult and adolescent females, the decrease in BMD during treatment appears to be substantially reversible after DEPO-PROVERA is discontinued and ovarian oestrogen production increases. A study to assess the reversibility of loss of BMD in adolescent females is ongoing.

DEPO-PROVERA should only be used as a long-term (e.g., longer than 2 years) contraceptive method or treatment for endometriosis if other contraceptive methods or endometriotic treatments are inadequate. BMD should be evaluated when a female needs to continue to use DEPO-PROVERA long term. In adolescent females, interpretation of BMD results should take into account patient age and skeletal maturity. Since loss of BMD may occur in pre-menopausal women who use DEPO-PROVERA long-term (greater than 2 years) a risk/benefit assessment, which also takes into consideration the decrease in BMD that occurs during pregnancy and/or lactation, should be considered (see FURTHER INFORMATION, Clinical trial data).

Other contraceptive methods or endometriotic treatments should be considered in the risk/benefit analysis for the use of DEPO-PROVERA in women with osteoporotic risk factors

such as:

chronic alcohol and/or tobacco use • chronic use of drugs that can reduce bone mass, e.g., anticonvulsants or corticosteroids •

–  –  –

Oncology There are no studies on the BMD effects of high doses of parenteral DEPO-PROVERA for oncology use.

However, 2 clinical studies of adult women of childbearing potential and of adolescent females given DEPO-PROVERA 150 mg IM every 3 months, for contraception, demonstrated significant decreases in BMD (see FURTHER INFORMATION, Clinical trial data). Decreases in serum oestrogen due to DEPO-PROVERA may result in a decrease in BMD in a pre-menopausal woman and may increase her risk for developing osteoporosis later in life.

An evaluation of BMD may be appropriate in some cancer patients who use DEPOPROVERA long term.

It is recommended that all patients have adequate calcium and vitamin D intake.

Cancer risks Long-term case-controlled surveillance of users of DEPO-PROVERA found slight or no increased overall risk of breast cancer and no overall increased risk of ovarian, liver, or cervical cancer. There was a prolonged effect of reducing the risk of endometrial cancer in the population of users, with a relative risk (RR) of 0.21 (95% Confidence Interval [CI] of 0.06-0.79). This protective effect lasts for at least 8 years after the cessation of DEPO-PROVERA use.



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