Sayana-Press overview

 

Prescribing Information and a link to the SPC is available at the bottom of this page.

Sayana®Press delivers precise dosing via a simple, single dose device and has proven efficacy.1,2,3

1. Sayana-Press: A LARC with choices

- Simple device – uses innovative Uniject™ Technology.1
- Easy-to-follow injection instructions – 23 gauge needle attached for subcutaneous injection, no specialised training for HCPs.1,2
- Administration options – HCP administration in clinic or self-administration by women, when considered appropriate by HCP.2*

Guide to self-administering Sayana-Press

2. Efficacy

99% effective in preventing pregnancy if used according to the product recommendations of every 13 weeks (+/-7 days)4.
Two open-label, multi-national, multi-centre, Phase III, 1-year trials were undertaken in order to assess the efficacy and safety of DMPA subcutaneous (DMPA-SC injection)4.


Conducted at 36 sites and involved 722 women in the ITT (Intent-To-Treat) population.

Conducted at 64 sites (including UK sites) and involved 1065 women in the ITT populations.

- A substantial number of overweight or obese women (>26%) took part in the trials. Efficacy was unaffected by body weight and so no dosage adjustments for body weight are required.4
- No pregnancies were observed at 1-year across 16,023 woman-cycles of exposure with DMPA-SC.4
- DMPA-SC was found to be an effective and generally well-tolerated method of contraception with comparable efficacy to DMPA-IM.4
 

3. Precise dosing

Sayana-Press delivers an immediate 13 weeks of contraception.2††

To read the full special warnings and precautions for use for Sayana-Press and see a full list of adverse events, refer to the Summary of Product Characteristics. The benefits of contraceptive options and their risks must be evaluated individually for each woman. If any of the conditions/risk factors mentioned is present, the benefits of Sayana-Press use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. The physician should then decide on whether Sayana-Press use should be discontinued.

*Self-administration should be first performed under the supervision of an HCP following training of the woman in proper injection technique and schedule of administration.

Providing the first injection is given during the first five days of a normal menstrual cycle and subsequent injections are given no later than thirteen weeks and seven days after the previous injection.

††Sayana-Press does not protect against Sexually Transmitted Infections (STIs)

References

1. PATH website: Uniject. Last accessed November 2017.
2. Sayana-Press Summary of Product Characteristics. Available at:
https://www.medicines.org.uk/emc/medicine/27798/SPC/SAYANA+PRESS+104+mg+0.65+ml+suspension+for+injection/ Last accessed September 2020.
3. Public Assessment Report. Mutual Recognition Procedure. Sayana® Press 104 mg/0.65 ml suspension for injection.
PL 000057/1093; UK/H/0960/002/DC. Available at:
http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con126147.pdf  Last accessed September 2020.
4. Jain J, et al. Contraceptive efficacy and safety of DMPA-SC. Contraception 2004;70:269-275.

Prescribing Information:

Sayana-Press:
Legal Category: POM  Basic NHS Price : £6.90

Depo-Provera (Medroxyprogesterone acetate): 
Legal Category: POM  Basic NHS Price : £6.01

PP-SAY-GBR-0185.  September 2020