First self-administered injectable contraceptive approved for use in the UK
Women will be able to self-inject Sayana Press, a long-acting contraceptive, which provides contraception for three months.
Women in the UK will be able to self-administer an injectable contraceptive for the first time after the Medicines and Healthcare Products Regulatory Agency (MHRA) approved new labelling for Sayana Press (medroxyprogesterone acetate; Pfizer).
The updated Sayana Press label adds that healthcare professionals can consider the option of self-injection by women when appropriate, instead of them having to attend a clinic or GP surgery to receive the injection.
Sayana Press is a long-acting, reversible, contraceptive supplied as a prefilled syringe, which prevents ovulation and provides contraception for at least 13 weeks. It was approved for use as a contraceptive by the MHRA in 2011.
“With this revised label, following consent from a healthcare professional and with proper training, UK women will now have the opportunity to administer Sayana Press outside of a clinical setting,” says Salomon Azoulay, senior vice president and chief medical officer, Pfizer Global Established Pharma Business. “This is an exciting milestone for women in the UK.”
Diana Mansour, a spokesperson for the Faculty of Sexual and Reproductive Healthcare, welcomed the licence extension. “After initial injection from a healthcare professional, the contraceptive can be self-injected by the patient every 13 weeks, if they are comfortable doing so,” she says.
“Pilot studies have shown that self-administration of Sayana Press is easy and acceptable with approximately 50% of current users of injectable contraceptives interested in trying this new approach.”
Doctors will now be able to discuss self-administered Sayana Press as a contraceptive option. Mansour adds: “Women choosing to self-administer the injection need to be motivated and to remember when the next injection is due. Many women like injectable contraceptives because over 60% get no periods and period pain is also improved.” An injection is also discreet and eliminates the need to take a daily contraceptive pill regimen.
Sayana Press should not be used in women with known or suspected malignancy of the breast or genital organs, metabolic bone disease, active thromboembolic disease, and in women with current or past history of cerebrovascular disease. Its use is also associated with significant loss of bone mineral density. The most common adverse events with its use are amenorrhea, heavy intermenstrual bleeding, weight gain and headache.
This new method of administration has also been approved in Austria, Belgium, Ireland and the Netherlands, and approval is pending in Hungary.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20069447
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