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SAYANA PRESS is a brand name for Medroxyprogesterone (also known as Medroxyprogesterone Acetate). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SAYANA PRESS is indicated for long-term female contraception. Each subcutaneous injection prevents ovulation and provides contraception for at least 13 weeks (+/- 1 week). However, it should be taken into consideration that the return to fertility (ovulation) may be delayed for up to one year (see section 4.4). Since…
Verbatim from this product's MHRA label. Tap a section to expand.
SAYANA PRESS may be administered by a healthcare professional (HCP) or when considered appropriate by the HCP, self-injected by the patient, with medical follow up as necessary in accordance with local clinical guidance. Administration of SAYANA PRESS should be initiated under the supervision of a healthcare professional (HCP).
After proper training in injection technique and schedule of administration, patients may self-inject with SAYANA PRESS if their HCP determines that it is appropriate and with medical follow-up as necessary. The SAYANA PRESS single-dose container should be at room temperature.
It must be vigorously shaken just before use to ensure that the dose being given represents a uniform suspension. The contents are completely sealed inside the reservoir of the injector. The injector must be activated before use. The activation process pierces an internal seal so that the medicine can come out through the needle when the reservoir is squeezed.
The liquid does not completely fill the reservoir. There is a small bubble of air above the liquid. The dose is administered as a subcutaneous injection (SC) into the anterior thigh or abdomen. When the injection is being given, the injector must be used with the needle downwards.
This ensures that the full dose of liquid is delivered out through the needle. The medication should be injected slowly for 5-7 seconds. Mixing the medicine • Ensure that the SAYANA PRESS single-dose container is at room temperature.
• Hold the injector firmly by the port. • Shake the injector vigorously for at least 30 seconds to mix the medicine. • The medicine should appear white and uniform. If it is not, discard the injector and use a new one. • If you see liquid leaking out or any other problem, discard the injector and use a new one.
• If there is a delay before injecting, you must repeat the mixing step. Activating the injector • Hold the injector firmly by the port, making sure the needle shield is pointing upwards. Take care not to squeeze the reservoir. • Hold the needle shield with the other hand.
• Push the needle shield firmly towards the port until it will go no further. The injector is now activated. • Pull the needle shield off, and discard it. Please refer to the Instructions for Use included with the Patient Leaflet for full details on preparing and giving an injection Adults First Injection: To provide contraceptive cover in the first cycle of use, an injection of 104 mg SC should be given during the first five days of a normal menstrual cycle.
Events from clinical trials:
The table below provides a listing of adverse drug reactions with frequency based on all-causality data from clinical studies that enrolled 2053 women who received DMPA-SC for contraception. 1%). Adverse reactions are listed according to the following categories.
4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Warnings:
Loss of Bone Mineral Density: Use of depot medroxyprogesterone acetate subcutaneous (DMPA-SC) reduces serum estrogen levels and is associated with significant loss of BMD due to the known effect of estrogen deficiency on the bone remodelling system.
Bone loss is greater with increasing duration of use, however BMD appears to increase after DMPA-SC is discontinued and ovarian estrogen production increases. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion.
e. after menopause. A study to assess the BMD effects of DMPA-IM (Depo-Provera) in adolescent females showed that its use was associated with a statistically significant decline in BMD from baseline. 1). However in some participants, BMD did not fully return to baseline during follow-up and the long-term outcome is not known in this group.
In adolescents, SAYANA PRESS may be used, but only after other methods of contraception have been discussed with the patients and considered to be unsuitable or unacceptable. A large observational study of predominantly adult female contraceptive users showed that use of DMPA-IM did not increase risk for bone fractures.
1 – Relationship of fracture incidence to use of DMPA-IM by women of reproductive age). In women of all ages, careful re-evaluation of the risks and benefits of treatment should be carried out in those who wish to continue use for more than 2 years.
In particular, in women with significant lifestyle and/or medical risk factors for osteoporosis, other methods of contraception should be considered prior to use of SAYANA PRESS. 1. Adequate intake of calcium and Vitamin D, whether from the diet or from supplements, is important for bone health in women of all ages.
Menstrual Irregularities:
1. • SAYANA PRESS is contra-indicated if pregnancy is known or suspected. • SAYANA PRESS is contra-indicated in women with known or suspected malignancy of the breast or genital organs. • SAYANA PRESS is contra-indicated in patients with undiagnosed vaginal bleeding.
• SAYANA PRESS is contra-indicated in patients with severe hepatic impairment. • SAYANA PRESS is contra-indicated in patients with metabolic bone disease. • SAYANA PRESS is contra-indicated in patients with active thromboembolic disease and in patients with current or past history of cerebrovascular disease.
• SAYANA PRESS is contra-indicated in patients with meningioma or history of meningioma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Medroxyprogesterone in United Kingdom.
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If the injection is carried out according to these instructions, no additional contraceptive measure is required. g. barrier) are required. If the interval from the preceding injection is greater than 14 weeks (13 weeks plus 7 days) for any reason, then pregnancy should be excluded before the next injection is given.
The efficacy of SAYANA PRESS depends on adherence to the recommended dosage schedule of administration. Women should be re-evaluated periodically as clinically appropriate at least every year to determine if SAYANA PRESS is still the best option for them.
Post Partum:
If the patient is not breast-feeding, the injection should be given within 5 days post partum (to increase assurance that the patient is not pregnant). If the injection is to be given at another time then the pregnancy should be excluded.
6). There is evidence that women prescribed SAYANA PRESS in the immediate puerperium can experience prolonged and heavy bleeding. Because of this, the drug should be used with caution in the puerperium. Women who are considering use of the product immediately following delivery or termination should be advised that the risk of heavy or prolonged bleeding may be increased.
Doctors are reminded that in the non breast-feeding, post partum patient, ovulation may occur as early as week 4. g. patients switching from oral contraceptives should have their first injection of SAYANA PRESS within 7 days after their last active pill).
Hepatic impairment:
The effect of hepatic disease on the pharmacokinetics of SAYANA PRESS is unknown. 3).
Renal impairment:
The effect of renal disease on the pharmacokinetics of SAYANA PRESS is unknown. No dosage adjustment should be necessary in women with renal insufficiency, since SAYANA PRESS is almost exclusively eliminated by hepatic metabolism. 1).
1). Other than concerns about loss of BMD, the safety and effectiveness of SAYANA PRESS is expected to be the same for adolescents after menarche and adult females.
Most women using DMPA subcutaneous injection experienced alteration of menstrual bleeding patterns. Patients should be appropriately counselled concerning the likelihood of menstrual disturbance and the potential delay in return to ovulation.
As women continued using DMPA subcutaneous injection, fewer experienced irregular bleeding and more experienced amenorrhea. After receiving the fourth dose, 39% of women experienced amenorrhea during month 6. 5% of women experienced amenorrhea.
The changes in menstrual patterns from the three contraception trials are presented in Figures 1 and 2. Figure 1 shows the increase in the percentage of women experiencing amenorrhea over the 12 month study. Figure 2 presents the percentage of women experiencing spotting only, bleeding only, and bleeding and spotting over the same time period.
In addition to amenorrhea, altered bleeding patterns included intermenstrual bleeding, menorrhagia and metrorrhagia. If abnormal bleeding associated with DMPA subcutaneous injection persists or is severe, appropriate investigation and treatment should be instituted.
Figure 1. 5 0 10 20 30 40 50 60 70 80 90 100 1 Ns:1831 2 1854 3 1840 4 1729 5 1717 6 1689 7 1544 8 1550 9 1520 10 1413 11 1404 12 1273 Month Percent Amenorrhea Figure 2. Percent of DMPA subcutaneous injection -Treated Women with Bleeding and/or Spotting per 30-Day Month Contraception Studies (ITT Population, N=2053) Cancer Risks: Long-term case-controlled surveillance of DMPA-IM 150 mg users found no overall increased risk of ovarian, liver, or cervical cancer and a prolonged, protective effect of reducing the risk of endometrial cancer in the population of users.
Breast cancer is rare among women under 40 years of age whether or not they use hormonal contraceptives. Results from some epidemiological studies suggest a small difference in the risk of having the disease in current and recent users compared with never-users.
Any excess risk in current and recent DMPA users is small in relation to the overall risk of breast cancer, particularly in young women (see below), and is not apparent after 10 years since last use. Duration of use does not seem to be important.
Possible number of additional cases of breast cancer diagnosed up to 10 years after stopping injectable progestogens* Age at last use of DMPA No of cases per 10,000 women who are never-users Possible additional cases per 10,000 DMPA users 20 Less than 1 Much less than 1 30 44 2-3 40 160 10 *based on use for 5 years” Meningioma Cases of meningioma (single and multiple) have been reported in patients treated with medroxyprogesterone acetate for a prolonged time (several years).
If a patient is diagnosed with meningioma, medroxyprogesterone acetate must be stopped, as a precautionary measure. In some cases, shrinkage of meningioma was observed after treatment discontinuation of depot medroxyprogesterone acetate.
0 10 20 30 40 50 60 70 80 90 100 1 Ns:1831 2 1854 3 1840 4 1729 5 1717 6 1689 7 1544 8 1550 9 1520 10 1413 11 1404 12 1273 Month Percent Spotting Only Bleeding Only Bleeding and Spotting Thromboembolic Disorders Although MPA […]