Depo-Provera

New Zealand - English - Medsafe (Medicines Safety Authority)

Buy It Now

Active ingredient:
Medroxyprogesterone acetate 150 mg/mL;  
Available from:
Pfizer New Zealand Limited
INN (International Name):
Medroxyprogesterone acetate 150 mg/mL
Dosage:
150 mg/mL
Pharmaceutical form:
Injection (depot)
Composition:
Active: Medroxyprogesterone acetate 150 mg/mL   Excipient: Hydrochloric acid Macrogol 3350 Methyl hydroxybenzoate Polysorbate 80 Propyl hydroxybenzoate Sodium chloride Sodium hydroxide
Units in package:
Syringe, Disposable, 1 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Valdepharm
Therapeutic indications:
Adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal carcinoma
Product summary:
Package - Contents - Shelf Life: Syringe, Disposable - 1 mL - 60 months from date of manufacture stored at or below 25°C - Vial, glass, 1ml - 1 mL - 36 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-0406
Authorization date:
1969-12-31

DEPO-PROVERA

DEPO-PROVERA

®

Medroxyprogesterone acetate 150 mg/mL injection(depot)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about DEPO-PROVERA.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you being treated with

DEPO-PROVERA against the

benefits it is expected to have for

you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What DEPO-

PROVERA is used for

The active ingredient of DEPO-

PROVERA, medroxyprogesterone

acetate, is a chemical similar to the

natural hormone progesterone.

Progesterone is produced by your

ovaries during the second half of

your monthly cycle.

There are several reasons why your

doctor may have prescribed DEPO-

PROVERA for you.

DEPO-PROVERA is used for the

following reasons:

Contraception

DEPO-PROVERA is an injectable

form of contraception. Each injection

protects you from pregnancy for 3

months.

DEPO-PROVERA works by

inhibiting the hormones that are

needed for the release of the eggs

from the ovaries.

Endometriosis

Endometriosis is a condition in

which cells from the lining of the

uterus (womb) grow in places outside

the uterus.

During your period, these cells may

grow and break down in the same

way as those in the lining of the

uterus. This causes pain and

discomfort. DEPO-PROVERA helps

to stop the growth of the cells found

outside the uterus.

Cancer

DEPO-PROVERA is also used in the

treatment of certain types of cancer

including cancer of the breast, kidney

and endometrium (lining of the

uterus). It works by inhibiting the

growth of these types of cancer cells.

DEPO-PROVERA is not a cure for

cancer.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is available only with

a doctor's prescription.

Before treatment with

DEPO-PROVERA

When you must not be given

it

DEPO-PROVERA should not be

given if you have or have had any of

the following medical conditions:

blood clots in your legs

swelling and redness along a vein

(usually extremely tender when

touched)

a stroke

liver problems

unusual or irregular vaginal

bleeding that has not been

diagnosed

blood in your urine that has not

been diagnosed

known or suspected breast cancer

any lumps in your breasts that

have not been diagnosed

any bleeding or discharge from

your nipples

miscarriage

severe, uncontrolled high blood

pressure.

Do not use DEPO-PROVERA if

you have an allergy to any

medicine containing

medroxyprogesterone acetate or

any of the ingredients listed at the

end of this leaflet.

Do not use this medicine if you are

pregnant.

DEPO-PROVERA is not suitable for

use before menstruation (periods)

begins.

Do not breast-feed if you are

taking this medicine.

Do not use this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If you are not sure whether you

should be treated with this

medicine, talk to your doctor.

DEPO-PROVERA

Before treatment with DEPO-

PROVERA

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you are

pregnant or intend to become

pregnant.

Tell your doctor if you are breast-

feeding or plan to breast-feed.

Tell your doctor if you have or

have had any of the following

medical conditions:

blood clots in your legs

clotting disorders

sudden partial or complete loss of

vision

swollen red veins

abnormal menstrual periods

including unusual or irregular

bleeding or spotting

stroke

cancer including breast cancer or

a family history of breast cancer

bone disease or a family history

of bone disease, such as brittle

bones (osteoporosis)

any problems with your breasts

blood pressure problems

epilepsy

migraine

asthma

heart problems

kidney problems

liver problems

diabetes

depression

any condition that may affect

your bone mass e.g., excessive

alcohol intake, smoking,

anorexia, bone disease or long

term treatment with either

corticosteroids or medicines for

epilepsy.

If you have not told your doctor

about any of the above, tell

him/her before you start treatment

with DEPO-PROVERA.

DEPO-PROVERA is intended to

prevent pregnancy. It will not protect

you from sexually transmitted

diseases such as AIDS (HIV),

Hepatitis B and C, genital herpes,

genital warts, syphilis or gonorrhoea.

Clinical studies suggest if you are

under 35 years of age when you first

start treatment with DEPO-

PROVERA, you may have a slightly

increased risk of developing breast

cancer. This is similar to the risk with

oral contraceptives (the Pill). If you

have any concerns about this, please

discuss them with your doctor.

Using DEPO-PROVERA may result

in a decrease in the amount of

calcium stored in your bones. This

could increase your risk of

developing brittle bones

(osteoporosis), which can lead to

bone breakages in later life. This

affects women of all ages. However,

it can be greater if you are under 18

years old. Your doctor will assess

this risk before giving you DEPO-

PROVERA and if you continue using

DEPO-PROVERA for more than 2

years. If you are under 18 years old,

the amount of calcium in your bones

will start to recover to its original

level once you stop treatment with

DEPO-PROVERA. If you are over

18 years old, the calcium levels in

your bones may only partially

recover to its original level.

Talk to your doctor if you have any

concerns over the risk of

developing osteoporosis.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including:

all prescription medicines

all medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may be affected by

DEPO-PROVERA or may affect

how well it works. You may need

different amounts of your medicines,

or you may need to take different

medicines. Your doctor will advise

you.

Tell your doctor or pharmacist if

you are taking aminoglutethimide,

a medicine used to treat breast

cancer.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while using this

medicine.

How DEPO-PROVERA

is given

DEPO-PROVERA is given as an

injection into the muscle of your

upper arm or buttock. Your doctor or

a trained nurse will give you the

injection.

The dose and the treatment period for

DEPO-PROVERA will depend on

the condition for which you have

been prescribed this medicine.

Contraception

The recommended dose for effective

contraception is 150 mg every three

months.

If you are using DEPO-PROVERA

as a contraception for the first time,

your doctor or trained nurse will

advise you on the changes to expect

when you start treatment.

It is important that you make

arrangements to return to your doctor

every three months, for your

injection, to ensure that pregnancy is

prevented.

If you are using DEPO-PROVERA

as a contraceptive for the first time,

your first injection should be given

during the first 5 days after the start

of your normal monthly period.

If you are using DEPO-PROVERA

as a form of contraception after the

birth of your baby and you are not

breast-feeding, the first injection

should be given within 5 days after

the baby is born.

If you are breast-feeding the first

injection should be given 6 weeks

DEPO-PROVERA

after the baby was born, after your

doctor has checked that you are not

pregnant.

If you are switching from another

form of contraception, then DEPO-

PROVERA should be given in a way

that ensures you have continuous

contraceptive cover. For example,

patients switching from the oral

contraceptive pill should have their

first DEPO-PROVERA injection

within 7 days after taking the last

active pill.

If you miss a scheduled injection,

your doctor will need to check that

you are not pregnant before giving

you another injection.

Endometriosis

The usual dosage is either 50 mg

weekly or 100 mg every two weeks.

Treatment for endometriosis is

usually for at least 6 months.

Endometrial and Renal Cancer

The initial dose range is 500 to 1000

mg per week.

If you respond to treatment and your

condition is stable, a maintenance

dose of 500 mg a week or less may

be possible.

Your doctor will determine how

much you will receive and how long

you should continue to receive the

injections.

Breast Cancer

The usual dosage for breast cancer is

500 mg to 1000 mg daily for 28 days.

If you respond to treatment, a dose of

500 mg twice weekly may be given.

Your doctor will determine how

much you will receive and how long

you should continue to receive the

injections.

If you use too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone 0800 POISON or 0800

764 766) for advice, or go to

Accident and Emergency at the

nearest hospital, if you think that

you or anyone else may have been

given too much DEPO-PROVERA.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Overdose is unlikely as treatment

will be given by your doctor or a

health professional. Ask your doctor

or pharmacist if you have any

concerns.

While you are being

treated with DEPO-

PROVERA

Things you must do

If you become pregnant while

using DEPO-PROVERA, tell your

doctor.

If you have a sudden partial or

complete loss of vision or sudden

onset of double vision or migraine

while you are using DEPO-

PROVERA, tell your doctor

immediately.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are being treated with DEPO-

PROVERA.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are are being treated with

DEPO-PROVERA, particularly if

you are about to have any

pathology tests (e.g., blood or urine

tests).

DEPO-PROVERA may interfere

with the results.

Do not use DEPO-PROVERA to

treat any other complaints unless

your doctor tells you to.

Do not give your medicine to anyone

else, even if they have the same

condition as you.

Do not stop using your medicine or

lower the dosage without checking

with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

DEPO-PROVERA affects you.

DEPO-PROVERA generally does

not cause any problems with your

ability to drive a car or operate

machinery. However, DEPO-

PROVERA may cause dizziness,

drowsiness or fatigue in some people.

Make sure you know how DEPO-

PROVERA affects you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well during or after treatment with

DEPO-PROVERA.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. However, you

may need medical treatment if you

get certain side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Most women using DEPO-

PROVERA for contraception

experience changes in their normal

monthly period. This includes

irregular or unpredictable bleeding or

spotting, or rarely, heavy or

continuous bleeding. If abnormal

bleeding continues or is severe, see

your doctor immediately.

With continued use of DEPO-

PROVERA, it is usual for vaginal

bleeding to decrease. Your periods

may stop completely.

When you stop treatment with

DEPO-PROVERA, your periods will

return. However, this may take up to

18 months. Most women find that it

takes about 10 months after their last

injection to become pregnant. The

length of time that you use DEPO-

PROVERA does not affect the time it

takes for you to become pregnant. If

you do not wish to become pregnant

after you stop treatment with DEPO-

PROVERA, you or your partner

DEPO-PROVERA

should use another form of

contraception.

A reduction in the amount of calcium

stored in your bones leading to brittle

bones (osteoporosis) or fractures may

occur. Talk to your doctor if you

have any concerns over the risk of

developing osteoporosis.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

nervousness

euphoria

loss of concentration

trouble sleeping

drowsiness or sleepiness

fatigue

depression

dizziness

headache

tremor or shaking

hives, rash or itching

acne

excessive hair growth

unusual hair loss or thinning

sweating

nausea

vomiting

diarrhoea

constipation

dry mouth

breast tenderness, pain or

secretions

changes in vaginal secretions

irregular vaginal bleeding or

spotting

lack of menstrual periods

weight changes (increase or

decrease)

high fever

abdominal pain, bloating or

discomfort

decreased libido or the inability to

climax

backache

leg cramps

joint pain

pelvic pain

pain and inflammation of the

vagina

swelling or puffiness

change in facial shape (round

appearance)

fluid retention

hot flushes

change in appetite

generally feeling unwell

impotence (in men being treated

for cancer).

Tell your doctor as soon as possible

if you notice the following:

confusion

yellowing of the skin and eyes

abnormal liver function test

changes in body fat (e.g., an

increased amount of fat in the

upper back, neck, breast, and

trunk, and loss of fat from the

legs, arms, and face

pain, tenderness, lump,

indentation, thinning of the skin,

inflammation or abscess

formation at the injection site.

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital, if you notice

any of the following:

sudden signs of allergy such as

rash, itching or hives on the skin,

swelling of the face, lips, tongue

or other parts of the body,

shortness of breath, wheezing or

trouble breathing

sharp chest pain or coughing up

blood

weakness or numbness in your

arms or legs

fainting

severe headaches or changes in

speech or vision, loss of

coordination, slurred speech,

shortness of breath, chest pain,

numbness heat or painful

swelling in the arms or

legsswollen or tender veins

sudden, painless loss of vision in

one eye as a result of blood clots

in the retina at the back of the eye

sudden onset of migraine

severe abdominal pain

increase in heart rate

abnormal heart beat

seizures

vision problems.

These may be signs of a serious side

effect. You may need urgent medical

attention. Serious side effects are

rare.

Some side effects (e.g, increase in

blood pressure, increases in white

blood cells and blood platelet count,

osteoporosis) can only be found

when your doctor does tests from

time to time to check your progress.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

After treatment with

DEPO-PROVERA

Storage

Normally you should take your

DEPO-PROVERA straight from the

pharmacy to your doctor.

If, for any reason you take your

DEPO-PROVERA home, always

ensure that it is stored in a place

where children cannot reach it.

It is important to store your DEPO-

PROVERA in a safe place that is

cool and dry (below 25°C).

Do not leave your DEPO-

PROVERA in a car.

Do not store DEPO-PROVERA or

any other medicine in the

bathroom or near a sink.

DEPO-PROVERA

Disposal

If the DEPO-PROVERA has

passed its expiry date, return it to

your pharmacist.

Product description

What it looks like

DEPO-PROVERA is a white cloudy

liquid.

DEPO-PROVERA is available as a 1

mL disposable syringe.

Ingredients

Each syringe of DEPO-PROVERA

contains medroxyprogesterone

acetate as active ingredient.

It also contains:

macrogol 3350

polysorbate 80

sodium chloride

methyl hydroxybenzoate

propyl hydroxybenzoate

Water for Injections.

This medicine does not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Supplier

DEPO-PROVERA is supplied in

New Zealand by:

Pfizer New Zealand Limited

PO Box 3998

Auckland, New Zealand

Toll Free Number: 0800 736 363.

Date of preparation

This leaflet was prepared in

November 2016.

Registered Trademark.

© Pfizer Australia Pty Ltd 2016.

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NEW ZEALAND DATA SHEET

1. PRODUCT NAME

DEPO-PROVERA

150 mg/mL Injection (depot)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 mL vial contains 150 mg/mL Medroxyprogesterone acetate

Each 1 mL disposable syringe contains 150 mg/mL Medroxyprogesterone acetate

Excipients with known effects:

Sodium

Methyl hydroxybenzoate,

Propyl hydroxybenzoate,

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

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

medroxyprogesterone acetate (MPA) as the active ingredient.

4. CLINICAL PARTICULARS

4.1 Therapeutic 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 DEPO-PROVERA.

Women under the age of 18 years may be at risk of failing to achieve their predicted peak BMD

(see section 4.4).

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.

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4.2 Dose and method of administration

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 breast-

feeding; 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 estrogens 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 estrogens in the equivalent

of 0.05 mg to 0.1 mg ethinylestradiol 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

500 mg

1000 mg

DEPO-PROVERA

intramuscularly

week

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

recommended

dosage

schedule

DEPO-PROVERA

500 mg

to 1000 mg

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.

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Women should be assessed for risk factors for low BMD when treated for ovulation

suppression or endometriosis. If these are found to be present, a full risk-benefit evaluation

should be undertaken by the prescriber to determine the appropriateness of using DEPO-

PROVERA. In women with significant lifestyle and /or medical risk factors for osteoporosis,

other methods of contraception should be considered prior to use of DEPO-PROVERA.

should

also

evaluated

when

considering

continuing

DEPO-PROVERA

contraception or treatment of endometriosis beyond 2 years. An evaluation of BMD may also

appropriate

some

patients

DEPO-PROVERA

long-term

oncology

indications.

Paediatric population

DEPO-PROVERA is not indicated before menarche. Data are available in adolescent females

(12 to 18 years) (see section 5.1, Clinical trial data). 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 section

4.3).

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.

4.3 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 section 4.4)

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 section 6.1).

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4.4 Special warnings and precautions for use

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

examination reveals papilloedema or retinal vascular lesions, medication should not be

readministered.

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 estrogen levels in premenopausal women and is

associated with a statistically significant loss of BMD as bone metabolism accommodates to a

lower estrogen level. Decreases in serum estrogen 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.

Bone loss may be greater with increasing duration of use and may not be completely reversible

in some women. It is unknown if use of DEPO-PROVERA during adolescence and early

adulthood, a critical period of bone accretion, will reduce peak bone mass. In both adult and

adolescent females, the decrease in BMD during treatment appears to be substantially

reversible after DEPO-PROVERA is discontinued and ovarian estrogen production increases.

After discontinuing Depo-Provera injection in adolescents, full recovery of mean BMD

required 1.2 years at the lumbar spine, 4.6 years at the total hip and 4.6 years at the femoral

neck (see section 5.1, Clinical trial data).

In adults, BMD was observed for a period of 2 years after DEPO-PROVERA injection was

discontinued and partial recovery of mean BMD towards baseline was observed at total hip,

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femoral neck and lumbar spine (see section 5.1, Clinical trial data). A large observational

study of female contraceptive users showed that use of Depo-Provera injection has no effect

on a woman’s risk for osteoporotic or non-osteoporotic fractures (see

section 5.1, Clinical trial

data).

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 section 5.1, Clinical trial data).

Other

contraceptive

methods

endometriotic

treatments

should

considered

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

low body mass index or eating disorder, e.g., anorexia nervosa or bulimia

metabolic bone disease

strong family history of osteoporosis.

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

every

3 months,

contraception,

demonstrated

significant decreases in BMD (see section 5.1, Clinical trial data). Decreases in serum estrogen

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 DEPO-PROVERA

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.

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

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between 25 and 34 years of age (RR of 2 (95% CI 1.0-3.8) and rises to 4.6 (95% CI 1.4-15.1))

in women aged less than 25 years with more than 2 years exposure to DEPO-PROVERA.

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.

MPA may produce cushingoid symptoms.

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 DEPO-

PROVERA 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 infections

DEPO-PROVERA

150 mg/mL

intended

prevent

pregnancy.

Women

should

counselled that DEPO-PROVERA does not protect against sexually transmitted infections

(STIs) including HIV infections (AIDS) but equally, DMPA is a sterile injection and, used as

directed, will not expose them to sexually transmitted infections. Safer sex practices including

correct and consistent use of condoms reduce the transmission of STIs through sexual contact,

including HIV.

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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.

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

blood

pressure,

breasts,

abdomen

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.

Breakthrough bleeding

Unexpected vaginal bleeding during therapy with DEPO-PROVERA should be investigated.

Breakthrough bleeding is likely to occur in patients being treated for endometriosis. No other

hormonal intervention is recommended for managing this bleeding. Non-functional causes

should also be borne in mind and in cases of undiagnosed vaginal bleeding, adequate diagnostic

measures are indicated.

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 DEPO-

PROVERA 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

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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 DEPO-

PROVERA. 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.

IM administration

Gluteal infiltration and abscess formation may occur with IM administration.

General

Because of the prolonged action and the resulting difficulty in predicting the time of withdrawal

bleeding

following

injection,

DEPO-PROVERA

recommended

treatment

secondary amenorrhoea or dysfunctional uterine bleeding. In these conditions, oral therapy is

recommended.

4.5 Interaction with other medicines and other forms of interaction

Aminoglutethimide administered concomitantly with high doses of MPA may significantly

depress the serum concentrations of MPA. Users of DEPO-PROVERA should be warned of

the possibility of decreased efficacy with the use of aminoglutethimide or any related drugs.

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 co-

administration of MPA with CYP3A4 inhibitors may increase MPA levels.

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, estrogen, pregnanediol, progesterone,

testosterone)

plasma/urinary gonadotrophins (e.g., LH and FSH)

sex hormone-binding-globulin.

glucose tolerance test

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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.

4.6 Fertility, pregnancy and lactation

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

their

health

including

their

physical,

intellectual,

sexual

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).

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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 studied

for developmental and behavioural effects through puberty and there is no evidence to suggest

that this presents any hazard to the nursing child.

4.7 Effects on ability to drive and use machines

The effect of medroxyprogesterone acetate on the ability to drive and use machinery has not

been systematically evaluated.

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