Depo-Provera ® suspension for injection is used for the following indications:
contraception; gynecology: treatment of endometriosis; treatment of vasomotor symptoms during menopause; oncology: recurrent and/or metastatic breast cancer; recurrent and/or metastatic endometrial cancer; recurrent and/or metastatic kidney cancer; metastatic prostate cancer.
Composition
The active substance is medroxyprogesterone acetate (1 vial contains 500 mg of medroxyprogesterone acetate; 1 ml of suspension contains 150 mg of medroxyprogesterone acetate).
Excipients: polysorbate 80, methylparaben (E 218), propylparaben (E 216), polyethylene glycol 3350, sodium chloride, sodium hydroxide, concentrated hydrochloric acid, water for injections.
Contraindication
The use of medroxyprogesterone acetate is contraindicated in patients with the following conditions:
established or suspected pregnancy; undiagnosed vaginal bleeding; severe liver dysfunction; known hypersensitivity to the active substance (medroxyprogesterone acetate) or other components of the drug; active thrombophlebitis, the presence of thromboembolic disorders now or in history, cerebrovascular diseases.
Additional contraindication for use of the drug in gynecology: known or suspected malignant neoplasm of the breast.
Additional contraindication when using the drug for contraceptive purposes: known or suspected hormone-dependent malignant neoplasm of the breast or genital organs.
Method of application
The suspension for injection must be shaken well before use.
Contraception
Immediately before use, the suspension for injection should be shaken vigorously to ensure that the dose is administered as a homogeneous suspension.
Intramuscular use. The recommended dose of the suspension for injection is 150 mg once every 3 months (12-13 weeks). The drug is administered intramuscularly into the gluteal or deltoid muscle. The suspension for injection is not intended for subcutaneous administration.
First injection. The initial intramuscular injection should be given within the first 5 days after the start of the normal menstrual cycle, within the first 5 days after delivery if the patient is not breastfeeding, or 6 weeks postpartum or later if the patient is breastfeeding.
Second and subsequent injections: If the interval between intramuscular injections is more than 13 weeks, pregnancy should be excluded before the next injection.
Switching from other methods of contraception. When switching from other methods of contraception, intramuscular injection of the drug should be carried out in such a way as to ensure continuous contraception based on the mechanism of action of both methods (for example, patients switching from oral contraceptives should have the first injection of the drug within 7 days after taking the last tablet with the active substance).
Gynecology
In the case of combined estrogen/progestin therapy for the treatment of postmenopausal women, the drug should be used at the lowest effective dose and for the shortest possible period, taking into account the treatment goals and risks to the health of the individual patient; the appropriateness of such therapy should be periodically assessed.
It is recommended to conduct periodic examinations, the frequency and nature of which should be selected for each woman individually.
It is not recommended to add progestin to the treatment regimen for women without an intact uterus, except in cases where endometriosis has been previously diagnosed.
Endometriosis. Injections of the drug are administered intramuscularly at a dose of 50 mg once a week or at a dose of 100 mg once every two weeks for at least 6 months.
Vasomotor symptoms during menopause. The drug is injected intramuscularly at a dose of 150 mg every 12 weeks.
Oncology
Recurrent and/or metastatic breast cancer. The initial dose of medroxyprogesterone acetate is 500-1000 mg/day intramuscularly for 28 days. The patient should then be switched to a maintenance dose schedule of 500 mg twice weekly until a response is observed.
Recurrent and/or metastatic endometrial or renal cancer. The recommended initial dose is 400-1000 mg per week intramuscularly. If improvement is observed within several weeks or months and the disease has stabilized, maintenance of improvement may be possible with a lower dose of 400 mg once monthly.
Metastatic prostate cancer. The initial dose is 500 mg twice a week for 3 months. The maintenance dose is 500 mg once a week.
Application features
Children
The drug is not indicated for use before the onset of the menstrual period.
Overdose
Treatment of overdose should be symptomatic and supportive.
Side effects
Contraception
The most commonly reported adverse reactions (> 5%) were weight gain (69%), weight loss (25%), headache (16%), nervousness (11%), abdominal pain or discomfort (11%), dizziness (6%), and decreased libido (6%).
Gynecology
The most commonly reported adverse reactions (>5%) were abnormal uterine bleeding (19%), headache (12%), and nausea (10%).
Metabolism and nutrition disorders: often - change in body weight.
Mental disorders: often - insomnia.
From the nervous system: often - headache, dizziness, tremor.
Gastrointestinal: often - nausea, constipation, vomiting.
Skin and subcutaneous tissue disorders: often - hyperhidrosis.
From the reproductive system and mammary glands: often - erectile dysfunction.
Storage conditions
Store at a temperature not exceeding 25 °C, out of the reach of children. Do not freeze.
Shelf life - 5 years.
