DEPO-PROVERA STERILE AQUEOUS SUSPENSION 50 mg/ml

INJECTION

**4.2 Posology and method of administration** Injectable suspensions should be shaken well before use. **_Contraception_** _Contraception (Ovulation Suppression)_ MPA intramuscular injectable suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension. _Intramuscular (IM)_ The recommended dose is 150 mg of MPA injectable suspension every 12–13 weeks (3 months) administered by intramuscular injection in the gluteal or deltoid muscle. _First injection_ The initial IM 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. _Second and subsequent injections_ If the time interval between IM injections is greater than 13 weeks, pregnancy should be ruled out before administering the next IM injection. _Switching from other methods of contraception_ 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. _**Gynecology**_ Use of combined estrogen/progestin therapy in post-menopausal women should be limited to the lowest effective dose and shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically evaluated (see **Section 4.4 Special warnings and precautions for use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Periodic check-ups are recommended of a frequency and nature adapted to the individual woman (see **Section 4.4 Special warnings and precautions for use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestin in a woman without an intact uterus. _Endometriosis_ Injectable MPA given intramuscularly 50 mg weekly or 100 mg every 2 weeks for at least 6 months. _Menopausal Vasomotor Symptoms_ Injectable MPA given intramuscularly 150 mg every 12 weeks. **_Oncology_** _Endometrial and Renal Carcinoma_ Injectable MPA 400 mg to 1,000 mg intramuscularly per week is recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month. _Breast Cancer_ Injectable MPA 500 mg/day intramuscularly for 28 days. The patient should then be placed on a maintenance schedule of 500 mg twice weekly as long as she responds to treatment. _**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 metabolized in patients with severe liver insufficiency (see **Section 4.3 Contraindications**). _**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.