Depo-provera

Package leaflet: Information for the patient

DEPO-PROVERA
150 mg/ml, injection suspension
Medroxyprogesterone acetate
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What DEPO-PROVERA is and what it is used for
2. Important information before using DEPO-PROVERA
3. How to use DEPO-PROVERA
4. Possible side effects
5. How to store DEPO-PROVERA
6. Contents of the package and other information

1. What DEPO-PROVERA is and what it is used for

DEPO-PROVERA contains medroxyprogesterone acetate, which is a progestogen affecting the hormonal system.
DEPO-PROVERA is used:

• as an adjunctive and/or palliative treatment in cases of recurrence or metastatic spread of endometrial or kidney cancer;
• in the treatment of recurrent or metastatic breast cancer in postmenopausal women.

2. Information before using DEPO-PROVERA

When not to use DEPO-PROVERA

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• during pregnancy or suspected pregnancy;
• in case of unexplained vaginal bleeding;
• in case of undiagnosed breast changes;
• in case of severe liver insufficiency;
• in case of thrombophlebitis, or current or past thromboembolic disorders, or cerebrovascular disease.

Warnings and precautions
Before starting treatment with DEPO-PROVERA, discuss this with your doctor or pharmacist.
When to exercise special caution when using DEPO-PROVERA

• in case of known hypersensitivity to steroids other than the active ingredient medroxyprogesterone acetate;
• if vaginal bleeding occurs during treatment with DEPO-PROVERA;
• in patients with concomitant diseases such as epilepsy, migraine, asthma, heart or kidney dysfunction, in which weight gain or fluid retention may worsen the medical condition;
• in patients with a history of depression;
• in some patients, symptoms resembling premenstrual depression may occur during treatment with DEPO-PROVERA;
• in some patients receiving DEPO-PROVERA, glucose tolerance may decrease;
• when sending an endometrial biopsy or cervical canal biopsy for histopathological examination, inform the histopathologist (or laboratory) about the use of DEPO-PROVERA;
• treatment with DEPO-PROVERA may reduce the levels of the following hormonal biomarkers: a) steroids in plasma and (or) urine (e.g. cortisol, estrogens, pregnandiol, progesterone, testosterone) b) gonadotropins in plasma and (or) urine (e.g. LH and FSH) c) sex hormone-binding globulin (SHBG);
• DEPO-PROVERA may also cause partial adrenal insufficiency during metyrapone tests;
• if the patient experiences sudden partial or complete vision loss, or develops exophthalmos, diplopia, or migraine, administration of the drug should be discontinued and a thorough ophthalmological examination performed. If papilledema or retinal vascular changes are diagnosed by the physician, treatment should not be continued;
• treatment with DEPO-PROVERA may lead to symptoms resembling Cushing's syndrome, such as obesity, striae, acne, and hypertension;
• if the patient experiences prolonged anovulation with amenorrhea and (or) develops irregular menstrual cycles;
• in patients with a history of thrombotic or thromboembolic disorders;
• due to the possibility of decreased bone mineral density (BMD) in premenopausal women, which may increase the risk of developing osteoporosis later in life.

In a study involving women receiving medroxyprogesterone acetate injections as a contraceptive method, a mean decrease in BMD values was observed.
In adult women, after several years of discontinuing the drug, a partial recovery of BMD to baseline values was observed, whereas complete recovery was observed in younger women.
It is not known whether the use of medroxyprogesterone acetate injections during adolescence and early adulthood—a critical period for bone mass accrual—reduces peak bone mass.
The physician may recommend calcium and vitamin D supplementation and periodic assessment of bone mineral density.

DEPO-PROVERA and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.
Concomitant administration of aminoglutethimide with DEPO-PROVERA may significantly reduce serum concentrations of medroxyprogesterone acetate and reduce the efficacy of DEPO-PROVERA.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Use of DEPO-PROVERA during pregnancy is contraindicated.
Low birth weight has been observed in newborns from unintended pregnancies occurring between the first and second month after DEPO-PROVERA injection, which in turn is associated with an increased risk of neonatal mortality. Data suggest an association between the use of progestogens during the first trimester of pregnancy and developmental abnormalities of the genital system in fetuses of both sexes.
Patients should be informed of the potential risk to the fetus if DEPO-PROVERA is used during pregnancy or if pregnancy occurs while taking the drug.

Breastfeeding
Medroxyprogesterone acetate and its metabolites are excreted in human milk. There are insufficient data to suggest their presence may pose a risk to the infant; however, breastfeeding is not recommended during treatment with this medicine.

Fertility
DEPO-PROVERA administered intramuscularly at doses of 150 mg/ml every 3 months has contraceptive effects. In premenopausal women receiving DEPO-PROVERA for the treatment of kidney or endometrial cancer, irregular bleeding or amenorrhea may occur, and return of fertility (ovulation) may be delayed after discontinuation of treatment.

Driving and operating machinery
The effect of DEPO-PROVERA on the ability to drive and operate machinery has not been studied.

DEPO-PROVERA contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)
This medicine may cause allergic reactions (including delayed-type reactions).

DEPO-PROVERA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning it is considered "sodium-free".

3. How to use DEPO-PROVERA

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Endometrial and renal cancer: at the beginning of treatment, doses of 400 mg to 1000 mg of medroxyprogesterone acetate per week administered intramuscularly are recommended. If improvement occurs within a few weeks or months and the patient's condition appears stable, a maintenance dose of 400 mg monthly may be considered.
Breast cancer: the recommended initial dose is 500 mg to 1000 mg of medroxyprogesterone acetate per day administered intramuscularly for 28 days. Subsequently, maintenance doses of 500 mg twice a week should be administered for as long as the patient responds to treatment.
Taking more DEPO-PROVERA than prescribed
Do not take more medicine than prescribed by your doctor. If you have taken more DEPO-PROVERA than recommended, contact your doctor immediately.
Missing a dose of DEPO-PROVERA
If a patient forgets to take DEPO-PROVERA, they should take it as soon as possible, unless it is almost time for the next dose. In that case, the next dose should be taken at the scheduled time.
Stopping DEPO-PROVERA treatment
The decision to discontinue treatment should be made by the doctor. Do not stop treatment without consulting your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common (may occur in up to 1 in 10 people):

• Changes in body weight, increased appetite
• Insomnia
• Headache, dizziness, tremor
• Vomiting, constipation, nausea
• Excessive sweating
• Erectile dysfunction
• Swelling, fluid retention, fatigue, injection site reactions

Uncommon (may occur in up to 1 in 100 people):

• Angioedema (a skin and mucous membrane disorder characterized by localized swelling)
• Corticosteroid-like effects (a group of drugs with anti-inflammatory, antiallergic and immunosuppressive action), e.g. as seen in Cushing's syndrome
  • A cluster of symptoms associated with elevated cortisol levels in the blood
• Worsening of diabetes, hypercalcaemia (increased calcium levels in the blood)
• Depression, euphoria, changes in sexual drive
• Congestive heart failure
• Thrombophlebitis
• Pulmonary embolism
• Diarrhea, dryness of the oral mucosa
• Acne, excessive hair growth
• Muscle cramps
• Abnormal uterine bleeding (irregular, excessively heavy, too light, menstrual spotting), breast tenderness
• Pain or tenderness at the injection site

Rare (may occur in up to 1 in 1,000 people):

• Hypersensitivity to the medicine
• Restlessness
• Stroke, somnolence
• Myocardial infarction
• Embolism and thromboembolic disorders
• Jaundice
• Alopecia, rash
• Malaise, fever
• Decreased glucose tolerance (prediabetic state), increased blood pressure

Frequency not known (cannot be estimated from available data):

• Anaphylactic reaction (sudden, severe allergic or non-allergic reaction which may be fatal), anaphylactoid reaction (sudden systemic reaction mimicking anaphylaxis but not an allergic reaction)
• Prolonged anovulatory period
• Confusion
• Attention disorders, effects similar to those related to sympathetic nervous system activation (part of the autonomic nervous system)
• Embolism and thrombosis of retinal vessels, diabetic cataract, visual disturbances
• Tachycardia, palpitations
• Atrophy or impairment of adipose tissue structure (acquired lipodystrophy), urticaria, pruritus
• Osteoporosis, including osteoporotic fractures
• Glucosuria
• Amenorrhea, cervical erosion, cervical discharge, galactorrhea, vaginal discharge, breast tenderness to pressure
• Persistent depression at injection site, nodule at injection site
• Abnormal liver function tests, increased white blood cell count, increased platelet count

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or the representative of the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store DEPO-PROVERA

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the container after: EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What DEPO-PROVERA contains

• The active substance is medroxyprogesterone acetate. 1 ml of suspension contains 150 mg of medroxyprogesterone acetate (Medroxyprogesteroni acetas).
• The other ingredients are: sodium chloride (see section 2 "DEPO-PROVERA contains sodium"), methyl parahydroxybenzoate (E 218) [see section 2 "DEPO-PROVERA contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)"], propyl parahydroxybenzoate (E 216) [see section 2 "DEPO-PROVERA contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)"], polysorbate 80,
  macrogol 3350, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.
  What DEPO-PROVERA looks like and contents of the pack
  White-colored suspension.
  Vials made of colourless glass in cardboard boxes. The vials contain either 3.3 ml or 6.7 ml of suspension.
  Marketing Authorisation Holder:
  Pfizer Europe MA EEIG
  Boulevard de la Plaine 17
  1050 Bruxelles
  Belgium
  Manufacturer:
  Pfizer Manufacturing Belgium NV
  Rijksweg 12
  2870 Puurs
  Belgium
  For more detailed information about this medicinal product, please contact
  the local representative of the Marketing Authorisation Holder:
  Pfizer Polska Sp. z o.o.
  tel. 22 335 61 00