Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Medroxyprogesterone
laboratory: Pfizer Holding France
Box of 1 Bottle of 3.3 ml
All forms
Indication
Hormonal treatment of certain hormone-dependent cancers:
· Breast carcinomas;
· Adenocarcinomas of the endometrium in menopausal women.
This hormone therapy is especially used when metastases appear in the soft parts and bone level. It is especially effective when the tumor or its metastases contain estrogen and progesterone receptors.
Dosage DEPO-PRODASONE 500 mg Suspension for injection Box of 1 vial of 3.3 ml
Administration mode
· This medication should be administered intramuscularly deep.
· Do not inject intravenously.
· Shake the bottle well before use.
· A strict asepsis should be observed.
Dosage
· The dosage varies according to the nature and stage of the tumor:
o In the case of metastasized breast cancer: 500 mg per day as an attack treatment for 4 weeks, then 500 mg twice a week in maintenance treatment.
o in case of endometrial cancer: 500 to 1000 mg per week.
Hepatic insufficiency :
No clinical studies have evaluated the impact of hepatic impairment on the pharmacokinetics of medroxyprogesterone acetate. However, medroxyprogesterone acetate, which is almost exclusively eliminated by hepatic metabolism, is reported to be weakly metabolized in patients with severe hepatic impairment (see section 4.3 ).
Renal failure :
No clinical studies have evaluated the impact of renal impairment on the pharmacokinetics of medroxyprogesterone acetate.
However, since medroxyprogesterone acetate is almost exclusively eliminated by hepatic metabolism, no dose adjustment should be required in patients with renal impairment.
Against indications
This medicine is contraindicated in the following situations:
· Hypersensitivity to the active substance or to any of the excipients,
· History or history of venous thromboembolic events (phlebitis, pulmonary embolism),
· Arterial thromboembolic events or antecedents (particularly myocardial infarction, cerebrovascular accident),
· Severe liver test abnormalities, severe liver injury,
· Undiagnosed genital haemorrhage,
· Association with St. John's Wort (see section Interactions with other medicinal products and other forms of interaction ).
Depo-Prodasone side effects
The reported adverse effects are presented in the table below:
System | Side effects |
Immune system disorders | Hypersensitivity reactions related to the presence of propyl and methyl parahydroxybenzoate, possibly delayed and exceptionally, bronchospasm |
Endocrine disorders | Corticosteroid-like effects (Cushing syndrome type) |
Metabolism and nutrition disorders | Weight change, Aggravation of diabetes, edema / fluid retention |
Psychiatric disorders | Depression, Nervousness, Confusion, Libido Modification, Insomnia |
Nervous system disorders | Dizziness, Headache, Loss of concentration, Somnolence, Cerebral infarction, Adrenergic-like effects (fine hand tremor, sweating, night cramps in the calves) |
Eye disorders | Vision Disorders, Diabetic Cataract, Retinal Thrombosis |
Heart conditions | Myocardial infarction, Congestive heart failure, Palpitations, Tachycardia |
Vascular disorders | Augmentation of functional symptoms related to venous insufficiency of the lower extremities, Thromboembolic disorders, Thrombophlebitis |
Respiratory, thoracic and mediastinal disorders | Pulmonary embolism |
Gastrointestinal disorders | Constipation, Diarrhea, Dry mouth, Nausea, Vomiting |
Hepatobiliary disorders | Hepatic involvement including cholestatic |
Skin and subcutaneous tissue disorders | Acne, Alopecia, Hirsutism, Pruritus, Eruption, Urticaria, Chloasma |
Renal and urinary disorders | glycosuria |
Disorders of reproductive organs and breast | Menstrual cycle disorder (irregularity, increased or decreased bleeding), Amenorrhea, Prolonged anovulation, Cervical erosions, Disturbance of cervical (cervico-vaginal) secretions, Galactorrhea, Mastodynia |
General disorders and administration site conditions | Fatigue, Injection site reaction, Malaise, Fever |
investigations | Appetite change, Abnormal liver function tests, Decreased glucose tolerance, Increased blood pressure, Decreased biological markers of endocrine activity: plasma and urinary steroids, plasma and urinary gonadotropins, hormone-binding proteins Decreased blood levels of ACTH and hydrocortisol |
During post-marketing surveillance, rare cases of osteoporosis including osteoporotic fractures have been reported.
