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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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The overall RR of breast cancer associated with the use of DEPO-PROVERA appears to be 1.2 (95% CI 0.96-1.52). However, an increased RR of 2.19 (95% CI 1.23-3.89) has been associated with use of DEPO-PROVERA in women whose first exposure to the drug was within the previous 4 years and were under 35 years of age. The RR increases in women aged between 25 and 34 years of age (RR of 2 (95% CI 1.0-3.8) and rises to 4.6 (95% CI 1.4in women aged less than 25 years with more than 2 years exposure to DEPOPROVERA. The risk of breast cancer was comparable in similar groups of women who used either DEPO-PROVERA or an oral contraceptive.

The Australian Institute of Health & Welfare report, between 1983 to 1985, an average incidence rate for breast cancer of 20.97/100,000 in Australian women, aged 30 to 34 years.

A RR of 2.19 increases the possible risk from 20.

97 to 45.92 cases per 100,000 women. The attributable risk, therefore, is 24.95 per 100,000 women per year.

The overall, non-significant, relative rate of invasive squamous cell cervical cancer in women who ever used DEPO-PROVERA was estimated at 1.11 (95% CI 0.95-1.28). A statistically insignificant increase in RR estimates of invasive squamous cell cervical cancer has been associated with the use of DEPO-PROVERA in women who were first exposed before the age of 35 years (RR 1.22 to 1.28 and 95% CI 0.93-1.70). No trends in risk with duration of use or times since initial or most recent exposure were observed.

Additional precautions for oncology patients.

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Some patients receiving high dose MPA, used in the treatment of cancer, may exhibit suppressed adrenal function. MPA may decrease ACTH and hydrocortisone blood levels.

Animal studies show that MPA possesses adrenocorticoid activity.

Accidental pregnancies Infants from unintentional pregnancies that occur 1 to 2 months after injection of DEPOPROVERA may be at increased risk of low birth weight, which in turn, is associated with an increased risk of neonatal death. Because there is a low incidence of pregnancies in women on MPA, the attributable risk is low. There is no definitive information for the other formulations of MPA.

A significant increase in polysyndactyly and chromosomal anomalies was observed among infants of DEPO-PROVERA users, the former being most pronounced in women under 30 years of age. The unrelated nature of these defects, the lack of confirmation from other studies, the distant preconceptual exposure to DEPO-PROVERA, and the chance effects due to multiple statistical comparisons, make a causal association unlikely.

Ectopic pregnancy As with all forms of hormonal contraception, health-care providers should be alert to the possibility of an ectopic pregnancy among women using DEPO-PROVERA who become pregnant or complain of severe abdominal pain.

Sexually transmitted diseases DEPO-PROVERA 150 mg/mL is intended to prevent pregnancy. Patients should be counselled that DEPO-PROVERA does not protect against HIV infections (AIDS) or other sexually transmitted diseases. The woman should be advised that additional measures are needed to prevent the transmission of sexually transmitted diseases.

In all situations where cessation of therapy is warranted, the physician should be aware of the slow elimination of the depot formulation Anaphylactic and anaphylactoid reactions Anaphylactic and anaphylactoid reactions have occasionally been reported in patients treated with IM MPA.

Precautions Physical examination A complete medical and family history should be taken before the initiation of any hormone therapy. The pre-treatment and periodic physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology (Papanicolaou smear).

Fluid retention DEPO-PROVERA may cause some degree of fluid retention, therefore, caution should be exercised in treating any patient with a pre-existing medical condition that might be adversely affected by fluid retention, such as epilepsy, migraine, asthma, or cardiac or renal dysfunction.

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Carbohydrate metabolism Some patients receiving DEPO-PROVERA may exhibit a decreased glucose tolerance. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving such therapy.

CNS disorders and convulsions Patients with a history of treatment for clinical depression should be carefully monitored while receiving DEPO-PROVERA therapy and the drug discontinued if the depression recurs to a serious degree.

Weight changes There was a tendency for women to gain weight while on therapy with MPA. From an initial average body weight of 61.8 kg women who completed 1 year of therapy with DEPOPROVERA gained an average of 2.45 kg. Women who completed 2 years of therapy gained an average of 3.68 kg. Women who completed 4 years gained an average of 6.3 kg. Women who completed 6 years gained an average of 7.5 kg. Two per cent of women withdrew from a large-scale clinical trial because of excessive weight gain.

Return of fertility DEPO-PROVERA (150 mg IM injection) has a prolonged contraceptive effect. In a large US study of women who discontinued use of DEPO-PROVERA to become pregnant, data are available for 61% of them. Based on Life-Table analysis of these data, it is expected that 65% of women who do become pregnant may conceive within 12 months. 83% may conceive within 15 months, and 93% may conceive within 18 months from the last injection.





The median time to conception for those who do conceive is 10 months following the last injection with a range of 4 to 31 months, and is unrelated to the duration of use. No data are available for 39% of the patients who discontinued DEPO-PROVERA and were lost to follow-up or changed their mind.

Liver function Certain endocrine and possible liver function tests may be affected by treatment with DEPOPROVERA. Therefore, if such tests are abnormal in a patient taking DEPO-PROVERA, it is recommended that they be repeated after the drug has been withdrawn. If jaundice develops, consideration should be given to not readminister the drug.

Patient age The age of the patient constitutes no absolute limiting factor, although treatment with progestogens may mask the onset of the climacteric.

Pathology tests The pathologist (laboratory) should be informed of the patient’s use of DEPO-PROVERA if endometrial or endocervical tissue is submitted for examination.

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General Because of the prolonged action and the resulting difficulty in predicting the time of withdrawal bleeding following injection, DEPO-PROVERA is not recommended for treatment for secondary amenorrhoea or dysfunctional uterine bleeding. In these conditions, oral therapy is recommended.

Use in pregnancy: Category D

DEPO-PROVERA IS NOT TO BE USED AS A TEST FOR PREGNANCY OR

WHERE PREGNANCY IS SUSPECTED.

DEPO-PROVERA is contraindicated in women who are pregnant.

Studies in animals have shown that progestogens, including MPA, may have an adverse effect on the developing fetus, including teratogenicity and fetotoxicity.

In addition, other animal studies have shown that high doses of progestogens can cause masculinisation of the female fetus.

Some reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses.

The risk of hypospadias (5 to 8 per 1000 male births in the general population) may be approximately doubled with exposure to these drugs. There are insufficient data to quantify the risks to female fetuses, but because some of these drugs induce mild virilisation of the external genitalia of the female fetus and because of the increased association of hypospadias in the male fetus, it is prudent to avoid use of these drugs during the first trimester of pregnancy.

Children exposed to MPA in utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development.

If DEPO-PROVERA is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus.

To ensure that DEPO-PROVERA is not administered inadvertently to a pregnant woman, it is

important that the first injection only be given:

during the first 5 days after the onset of a normal menstrual period • within 5 days post-partum if not breast feeding and • if breast feeding, at the sixth week post-partum, after having excluded pregnancy.

• When switching from other contraceptive methods, MPA IM should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g., patients switching from oral contraceptives should have their first injection of MPA within 7 days after taking their last active pill).

Use in lactation MPA and its metabolites are excreted in breast milk. In mothers who are breastfeeding and who are treated with DEPO-PROVERA, milk composition, quality and amount are not adversely affected. Infants exposed to medroxyprogesterone via breast milk have been

–  –  –

Paediatric use DEPO-PROVERA is not indicated before menarche. Data are available in adolescent females (12 to 18 years) (see FURTHER INFORMATION, Clinical trial data). Other than concerns about loss of BMD, the safety and effectiveness of DEPO-PROVERA are expected to be the same for postmenarcheal adolescent and adult females.

Use in hepatic insufficiency No clinical studies have evaluated the effect of hepatic disease on the pharmacokinetics of MPA. However, MPA is almost exclusively eliminated by hepatic metabolism and steroid hormones may be poorly metabolised in patients with severe liver insufficiency (see

CONTRAINDICATIONS).

Use in renal insufficiency No clinical studies have evaluated the effect of renal disease on the pharmacokinetics of MPA. However, since MPA is almost exclusively eliminated by hepatic metabolism, no dosage adjustment should be necessary in women with renal insufficiency.

Effects on laboratory tests The physician/laboratory should be informed that the use of DEPO-PROVERA may decrease

the levels of the following endocrine biomarkers or affect the following laboratory tests:

plasma/urinary steroids (e.g., cortisol, oestrogen, pregnanediol, progesterone, • testosterone) plasma/urinary gonadotrophins (e.g., LH and FSH) • sex hormone-binding-globulin.

• glucose tolerance test • metyrapone test - the use of DEPO-PROVERA may also cause partial adrenal • insufficiency (decrease in pituitary-adrenal axis response) during metyrapone testing.

Thus, the ability of adrenal cortex to respond to ACTH should be demonstrated before metyrapone is administered.

coagulation test values for prothrombin (Factor II) and Factors VII, VIII, IX and X may • increase.

–  –  –

In a clinical trial conducted using DEPO-PROVERA for contraception, over 3,900 women (who were treated for up to 7 years) reported the following adverse reactions, which may or may not be related to the use of DEPO-PROVERA. The following adverse reactions were

reported by more than 5% of subjects:

menstrual irregularities (bleeding &/or amenorrhoea) • abdominal pain or discomfort • dizziness • weight changes •

–  –  –

Events reported by fewer than 1% of subjects included galactorrhoea, melasma, chloasma, convulsions, changes in appetite, gastrointestinal disturbances, jaundice, genitourinary infections, vaginal cysts, dyspareunia, paraesthesia, chest pain, pulmonary embolus, allergic reactions, anaemia, drowsiness, syncope, dyspnoea and asthma, tachycardia, fever, excessive, sweating and body odour, dry skin, chills, increased libido, excessive thirst, hoarseness, pain at injection site, blood dyscrasia, rectal bleeding, changes in breast size, breast lumps or nipple bleeding, axillary swelling, breast cancer, prevention of lactation, sensation of pregnancy, lack of return to fertility, paralysis, facial palsy, scleroderma, osteoporosis, uterine hyperplasia, cervical cancer, varicose veins, dysmenorrhoea, hirsutism, accidental pregnancy, thrombophlebitis, deep vein thrombosis.

Post-marketing experience In post-marketing experience, there have been reports of anaphylactic responses, thromboembolic events and rare cases of osteoporosis including osteoporotic fractures reported in patients taking DEPO-PROVERA.

There have been post-marketing reports of erectile dysfunction in association with use of MPA in oncology treatments.

–  –  –

MPA is metabolised in vitro primarily by hydroxylation via the CYP3A4. While specific drug-drug interaction studies evaluating the clinical effect of CYP3A4 inhibitors or inducers on MPA have not been conducted or reported in the literature, physicians should consider that interactions could occur which may result in compromised efficacy. Co-administration of MPA with CYP3A4 inducers may result in decreased systemic levels of MPA whilst coadministration of MPA with CYP3A4 inhibitors may increase MPA levels.

OVERDOSAGE

No serious medical effects have been reported in association with overdosage of DEPO-PROVERA.

Oral doses up to 3 g per day have been well tolerated. Patients receiving pharmacological doses of MPA for treatments of neoplasms (400 mg/day or greater) may occasionally exhibit effects resembling those of glucocorticoid excess.

As with the management of any overdosage, the physician should carefully observe the patient for the potential side effects. Overdose treatment is symptomatic and supportive.

Contact the National Poisons Centre on 0800 764 766 for advice on the management of an overdose.

PHARMACEUTICAL PRECAUTIONS

Storage Syringe: Store at or below 25°C.

Vial: Store below 30°C.

MEDICINE CLASSIFICATION

Prescription Medicine.

PACKAGE QUANTITIES

150 mg/mL - 1 mL disposable syringe.

150 mg/mL - 1 mL vial.

–  –  –



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