OF SEXUAL &REPRODUCTIVE HEALTHCARE

1 Faculty of SEXUAL &Reproductive HealthcareClinical GuidanceFACULTYOF SEXUAL &REPRODUCTIVEHEALTHCAREP rogestogen-only InjectableContraceptionClinical Effectiveness Unit December 2014 (Amended October 2020)Published by th e Faculty of SEXUAL & Reproductive HealthcareRegistered in England No. 2804213 and Registered Charity No. 1019969 First published in 2014 (Amended October 2020)Copyright Faculty of SEXUAL & Reproductive HEALTHCARE 2014 Permission granted to reproduce fo r personal an d educational use only. Commercial copying, hiring an d lending ar e reference numberTitleAuthor/publisherPublication dateDescription/descriptorsCross referencesSuperseded documentsUpdate/amendment levelReview date02/FSRH/Injectable/2014 Progestogen-only Injectable ContraceptionFaculty of SEXUAL & Reproductive HEALTHCARE (FSRH)December 2014 (Amended October 2020)

2 Injectable contraception, progestogen-only contraception, long-acting reversible contraception, LARC, method-specific guidanceUnited Kingdom Medical Eligibility Criteria (UKMEC)FSRH New Product Review: Subcutaneous Depot Medroxyprogesterone AcetateFSRH CEU Guidance Progestogen-only Injectable Contraception 2008 Full amendment including changes to recommendations and practiceDecember 2019 DETAILS OF CHANGES TO ORIGINAL GUIDANCE DOCUMENTS ince this set of guidelines was first published, the following changes have been made March 2015 - Amendments made to the document are to CPD questions 3 and 5.

3 February 2019 - Box 1 and Tables 2-4 updated to reflect updates to other FSRH guidance. April 2019 - Section 7, 8, and has been updated to reflect updates to other FSRH guidanceJune 2020 - Section 7 has been updated to include advice that (in case of anaphylactic reaction) another competent adult should be present when Sayana Press is self-administered. Note that the risk of anaphylaxis is extremely 2020 - Section has been updated to align with UKMEC 2016 regarding antiphospholipid OF RECOMMENDATIONSE vidence based on randomised controlled trialsEvidence based on other robust experimental or observational studiesEvidence is limited but the advice relies on expert opinion and has theendorsement of respected authoritiesGood Practice Point where no evidence exists but where best practice is basedon the clinical experience of the guideline groupABC NICE has

4 Accredited the process used by the Faculty of SEXUAL & Reproductive HEALTHCARE to produce its Progestogen-only Injectable Contraception guidance. Accreditation is valid until May 2021. More information on accreditation can be viewed full details on our accreditation of RecommendationsIFCA bbreviations Usedii Summary of Key Recommendations iii1 Purpose and Scope 12 Background 13 What is the Mode of Action of the Progestogen-only Injectable and How Effective is it? 24 Who is Eligible to Use the Progestogen-only Injectable?

5 25 Non-contraceptive Benefits, health Concerns and Side Effects Associated with Use of the Progestogen-only Non-contraceptive health concerns Side effects 86 How Long Can Women Use Progestogen-only Injectable Contraceptives? 117 How Should Progestogen-only Injectables be Administered? What clinical assessment and documentation is required? 128 When in the Menstrual Cycle Can Progestogen-only Injectable Contraceptives be Started? Switching from another method When should repeat injections be administered?

6 139 What Advice Should be Given Regarding Exposure to Progestogen-only Injectable Contraception in Pregnancy? 1510 Are there Any Factors that Would Affect the Efficacy of Progestogen-only Injectables? Drug interactions Weight 1611 Other Considerations Return of fertility Emergency contraception Sexually transmitted infections and testing 1712 How Should Common Problems Associated with DMPA Use be Managed? Problematic bleeding Injectable contraception and women with epilepsy , a learning disability, or HIV 18 References 20 Appendix 1.

7 Development of CEU Guidance 27 Questions for Continuing Professional Development 28 Auditable Outcomes for Progestogen-only Injectable Contraception 30 Comments and Feedback on Published Guidance IBCCEU GUIDANCE FSRH 2014iCEU GUIDANCEii FSRH 2014 ABBREVIATIONS USEDBMD bone mineral densityBMIbody mass indexCEUC linical Effectiveness UnitCHCcombined hormonal contraception/contraceptiveCIconfidence intervalCINcervical intraepithelial neoplasiaCOCcombined oral contraception/contraceptiveCu-IUDcopper intrauterine deviceDMPA depot medroxyprogesterone acetateECemergency contraceptionFSRHF aculty of SEXUAL & Reproductive HealthcareHIVhuman immunodeficiency virusHPVhuman papillomavirusIMintramuscularIUDintraute rine deviceLARC long-acting reversible contraception/contraceptiveLNGlevonorges trelLNG-IUSlevonorgestrel intrauterine systemMHRAM edicines and HEALTHCARE Products Regulatory AgencyMImyocardial infarctionNET-ENnorethisterone enantateNICEN ational Institute for health and Care ExcellenceORodds ratioRCTrandomised controlled

8 TrialRRrelative riskSCsubcutaneousSPCS ummary of Product CharacteristicsSTIsexually transmitted infectionUKMECUK Medical Eligibility Criteria for Contraceptive UseUPAulipristal acetateUPSI unprotected SEXUAL intercourseVTEvenous thromboembolismWHOW orld health OrganizationWHOMECW orld health organization Medical Eligibility Criteria for Contraceptive UseSUMMARY OF KEY RECOMMENDATIONSWhen administered at the recommended dosing interval the failure rate ofprogestogen-only injectable contraception is approximately in the first year of typical use the failure rate is approximately 6%.

9 health professionals should be familiar with the most up-to-date UK Medical EligibilityCriteria for progestogen-only injectable or reduced bleeding is common in progestogen-only injectable usersand may benefit women with menstrual medroxyprogesterone acetate (DMPA) use may reduce pain associated should be advised about changes in bleeding of DMPA is not associated with an increased risk of ovarian or endometrial cancerand may offer some is a contraceptive option for women with sickle cell disease and may reduce theseverity of sickle crisis injectable use is associated with a small loss of bone mineral density,which is usually recovered after discontinuation.

10 In women aged under 18 years progestogen-only injectable contraception can beused after consideration of alternative using DMPA who wish to continue use should be reviewed every 2 years toassess individual situations, and to discuss the benefits and potential are generally advised to switch to another method at age 50 years. If a womandoes not wish to stop using DMPA, consideration may be given to continuation,providing the benefits and risks have been assessed and the woman informed of thepotential is possibly a weak association between current use of DMPA and breast increased risk is likely to be small and reduce with time after causal association between DMPA and venous thrombosis has not beendemonstrated in the small number of studies that have investigated this the limited evidence available it is not possible to confirm or exclude anassociation between progestogen-only injectable use and