Contraceptive Update

Brian Halstater, MD Goals and Objectives

At the conclusion of this session, the learner should be better able to: • Describe newer contraceptive methods • Explain risks and benefits of newer contraceptive methods • Interpret the “Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use” ‘New-ish’ Methods • Combined hormonal – Ring (2001) – Patch (2002) – Continuous OCPs (2003) • Long Acting Reversible Contraceptives (LARC) – Progestin IUSs (3) – • Overall Effectiveness

https://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6503.pdf What is being used? Combined Hormonal • Based on idea of using combined hormones in a different delivery system • Ring - 3 weeks at a time • Patch – weekly x 3 weeks • Extended use OCP – either as directed by packs or take single monthly packs continuously without placebo Combined Hormonal

• Contraindications are the same for combined OCPs • Delivery systems are different • Specific side effects are different Contraceptive Ring

https://www.vox.com/2015/2/6/7988229/future-birth-control Contraceptive Ring

• Flexible polymeric ring – 4 mm thick – 54 mm diameter • and ethinyl estradiol • Brand name  NuvaRing (Merck) • 3 weeks in, 1 week out • Comes in a box of 3 rings https://www.vox.com/2015/2/6/7988229/future-birth-control Contraceptive Ring  Insertion Contraceptive Ring - Starting

No • Insert on first day of menses • Alternatively on day 2-5 – Will need to use barrier method for first 7 days of cycle Contraceptive Ring - Starting

Combined OCP • Any day in cycle, including her placebo pills • No later than when she’d start her new pack of pills Contraceptive Ring - Starting

Progestin only method – Minipill, contraceptive implant, Progestin IUS • Minipill  any day, start the day after last pill taken • Implant/ IUS  start on day device is removed • Injectable  when next shot is due NOTE  Barrier method for 1st week Contraceptive Ring - Starting

After (therapeutic or spontaneous) • 1st trimester  within 5 days of event – If > 5 days, as if no prior hormonal contraception • 2nd trimester  No sooner than 4 weeks after event (increased risk of DVT/ PE) Contraceptive Ring - Starting

After delivery • No sooner than 4 weeks after delivery (increased risk of DVT/ PE) • If breastfeeding – another method • When starting, use backup for first 7 days Contraceptive Ring

• Patient should check • Should stay in for 3 continuous weeks

Questions  - Why is it not there? - What does she do if it is not there? Contraceptive Ring Expulsion – What to do? Depends on how long it’s been missing

The magic number is 3

As in 3 hours Contraceptive Ring Expulsion 3 Hours is Branch Point • < 3  rinse and reinsert ASAP – no backup needed • > 3  backup method needed – And it gets complicated as next steps are determined by which week of the cycle she is at. The magic number is 3 • Weeks 1 or 2 • Week 3 Contraceptive Ring Expulsion – Over 3 hours – Next Steps • Weeks 1 or 2  reinsert – Backup method for 7 days Contraceptive Ring Expulsion – Over 3 hours – Next Steps for Week 3 • 1 - Discard ring and • 2 - Either:

– A - New ring, starting new 3 week cycle • Q – what may her bleeding be like? – B - Wait at least 7 days and insert new ring to start new 3 week cycle • Only if the ring was in the vagina for at least a week (i.e. – not a previously expelled ring) Contraceptive Ring The Answer to Your Question Is:

1 week!

The question is: “How long can she leave it in ‘extra’ if she forgets about it?’ Contraceptive Ring

1 week! • ‘Extra time’ – no more than 1 week • Prolonged ring free – if over 1 week, consider and may start new ring with backup for 7 days of ring

• Ring breaks – OK, no reduced efficacy; discard and replace. Contraceptive Ring

• Same CI/ side effects as combined OCP • DVT/ PE risk is the same • Toxic Shock Syndrome reported • Stop if treated for Hep C until 2 weeks after tx • Vaginal irritation/ ulceration reported • Case reports of bladder insertion Contraceptive Ring

• Bleeding – irregular – 3 studies  7.2-11.7% in first year (in US) with European/ S. America less so. • Oligo and amenorrhea – Occasional – About 0.3-3.8% – If 2 missed withdrawal bleeds  R/o pregnancy Contraceptive Ring

• Side effects: – Vaginitis (13.8%), headache (11.2%), mood changes (6.4%), device-related (6.3%) • Discontinued  13% of time – Same as above, with different % • Serious adverse  DVT, anxiety, cholelithiasis and vomiting

https://www.bedsider.org/methods/the_patch • Was Ortho Evra  Xylene is generic • Norelgestromin/ ethinyl estradiol • 5 cm square • Only approved to 90 kg (198 lbs) • Start any time of cycle – 1st 5 days of cycle – no backup – Any other time – barrier method x 7 days Starting Patch

• Any time of cycle • If replacing OCP or ring  start on day the previous method would start – If late start, backup method • Same start as Ring for after or abortion. Contraceptive Patch

• Can be placed anywhere that is clean, dry and not hairy. – Recommended abdomen, back, buttock or outer upper arm • Alternate locations to minimize skin irritation • Same risks as combined oral contraceptives – May be slightly increased risk of DVT/ PE compared with other combined methods Application is Easy Contraceptive Patch – Guidance if Falls Off

Under 24 hours Over 24 hours • Reapply • New patch – If still sticky • Starts new cycle – New patch if not – New week 1 • No backup needed • Backup needed for 7 days Contraceptive Patch – Forget to Change Between Weeks 1-2, 2-3

< 48 hours > 48 hours • Reapply • New patch – If still sticky • Starts new cycle – New patch if not – New week 1 • No backup needed • Backup needed for 7 days • Consider Virtually the same as if Patch falls emergency off and under/ over 24 hours contraception Contraceptive Patch – Forget to Remove after Week 3 • Take off as soon as remember • Start new cycle of patches on normal start day • If > 7 days late, start new cycle of patches and backup for 7 days

If forget new week 1 start, same as if fell off with new start day of cycles Contraceptive Patch - Other

• If want to change day of week to change patch, do so during 3rd patch week (end early) • May use steroid cream if skin irritation (careful for adhesion) • Patch must entirely adhere – new patch if not completely adherent. Continuous OCPs

https://wellcomeimages.org/indexplus/image/L0059976.html • May use back to back cycles of OCPs or a prescription for extended use OCPs (monophasic only) • Technically – Extended use  12 weeks on OCP – Continuous use  no breaks • Ring/ Patch can do this too, not FDA approved Continuous OCPs

• Ethinylestradiol/ (30/150)  4 menses a year – 84 + 7 – Many generics (Seasonale) – 84 + 7 – Many generics (Seasonique) • Ethinylestradiol/ levonorgestrel (20/90) – no menses – 90 – Amethyst (was Lybrel) Continuous OCPs

• Benefits – Fewer menses and related symptoms • Cons – Cost – Spotting/ breakthrough bleeding • Tends to get lighter and less frequent over time LARC – Hormonal IUS

4 Progestin IUSs • Mirena – up to 5 (?6) years (2001) • Kyleena – up to 5 years (2016) • Liletta – up to 3 (?5) years (2015) • Skyla – up to 3 years (2013)

https://www.mirena-us.com/ https://hcp.kyleena-us.com/ https://www.liletta.com/about/what-it- http://www.skyla-us.com/see-skyla-up-close.php looks-like LARC – Hormonal IUS

Mechanism of action - Thicken cervical mucous - Prevention of - Thinning endometrial lining LARC – Hormonal IUS Insertion Timing Not on hormonal contraception: • 1st week of menses; no backup needed • Other time in cycle  backup needed

On hormonal contraception • Any time in cycle • If on active part, continue for at least 7 days or finish treatment cycle • If on continuous – 7 day overlap LARC – Hormonal IUS Insertion Timing If implant or IUS • Same day If injection • No later than 13 weeks after last dose After abortion • 1st trimester – same day • 2nd trimester – at least 6 weeks After childbirth – at least 6 weeks* LARC – IUS Threads

Mirena Liletta • Brown • Blue

Skyla Kyleena • Brown • Blue

Data from prescribing information for each IUS LARC – Hormonal IUS

Most common reason for discontinuation: - Increased bleeding - Pelvic pain - Expulsion of IUS - Dysmenorrhea Serious risks – ectopic, depression, uterine perforation LARC - Implant

• Etonogestrol (Nexplanon) • Precursor was Implanon • Single radiopaque rod – 4 cm long, 2 mm diameter • Lasts 3 years • Implanted subdermally in inner lower side of upper non-dominant arm • Special applicator with rod pre- loaded

Both images from https://www.nexplanon.com/ Nexplanon – timing/ backup?

• If no contraception – insert during first 5 of menses – Any other time  backup for 7 days • Combined hormonal pills, patch, ring – Insert no later than on last day of active medicine (different than IUS) – If not  BU for 7 days

Need certificate training from the manufacturer Nexplanon – timing/ backup?

• Progestin only, no backup needed if: – Injection – insert when next shot is due – Pill – any day of pill packet within 24 hours of last pill taken – IUS – same day as removal – Nexplanon – same day as removal • If any other time – 7 days of backup Nexplanon – timing/ backup?

• Abortion (therapeutic or spontaneous), depends on trimester: – 1st  within 5 days of event – 2nd  between days 21-28 after event • If not, 7 days of backup • Postpartum, depends on breastfeeding: – No breastfeeding  21-28 days • Backup for 7 days if later than this interval – Yes breastfeeding  After 4 weeks • Backup for 7 days is recommended Nexplanon

• Bleeding (most common reason to discontinue ~ 11%) – > 3/ 10  irregular menses/ spotting – > 2/ 10  Amenorrhea – > 2/ 10  More/ prolonged bleeding MEC Introduction

• 45% of in US are unintended • 2010 CDC published the first US Medical Eligibility Criteria for Contraceptive Use (US MEC) • Goal of recommendations to provide guidelines to address potential medical barriers to contraceptive use Contraceptive Categories for Medical Eligibility A condition: 1 – for which there is no restriction for the use of the contraceptive method 2 – for which the advantages of using the method generally outweigh the theoretical or proven risks 3 – for which the theoretical or proven risks usually outweigh the advantages of using the method 4 – that represents an unacceptable health risk if the contraceptive method is used 2017 MEC Summary Chart

P1 Left Column 2017 MEC Summary Chart

P1 Right Column 2017 MEC Summary Chart

P2 Left Column 2017 MEC Summary Chart

P2 Right Column Case #1

• 18 year old high school senior • Mom with history of Breast Cancer • Smoker • Mild-moderated dysmenorrhea • Nullip • Thinking about becoming sexually active • PE with blood pressure in the low 140’s systolic 18 yo, mom with Breast Cancer, some dysmorrhea, tobacco, elevated BP Case #2

• 34 year old PhD student in economics • Type I Diabetes since age 10 • No diabetic complications • Nullip 32 yo with Diabetes Type I Case #3

• 40 year old G2P2 • On triphasic OCP when not pregnant or breast feeding • Return visit • Reports recurrent sinus headaches 40 yo Multip, recurrent headaches on CHC Case #4

• 23 year old G2P1 • Pregnancy complicated by gestational DM and DVT without PE • Delivered a year ago, normal glucose and workup for DVT was negative 23 yo with h/o GDM and DVT provoked by pregnancy Case #5 Taken directly from the CDC MEC Slide Deck • 28 yo G1P0 is pregnant and is being counseled for post partum family planning. She is not planning on breastfeeding. What options are available to her postpartum? A – IUD (copper or levonorgestrel) B – Progestin-only methods (pill, injectable, implant) C – Combined hormonal (pill, patch, ring) 28 yo Pregnant Woman for Post- Partum Contraception Counseling 28 yo Pregnant Woman for Post- Partum Contraception Counseling

• 28 yo G1P0 is pregnant is not planning on breastfeeding. What options are available to her postpartum? A – IUD (copper or levonorgestrel) B – Progestin-only methods (pill, injectable, implant) C – Combined hormonal (pill, patch, ring) Wait 21-42 days depending on VTE risk factors There’s an APP for that! New Case 23 yo Medical Student using for contraception • Healthy • No medical issues • broke • LMP was 3 weeks ago

What do you recommend? What do you need to know? Emergency Contraception

• Copper IUD (most effective) • Oral medications (2 options) – Levonorgestrel • Was Plan B 75 mg x2 doses 12 hours apart • Now is Plan B One step 1.5 mg x 1 – Ulipristal • Ella 30 mg x 1 Copper IUD

• More effective than oral (Failure rate <0.1%) • When can be put in? – 5 days from event • Need to exclude pregnancy and cervicitis (physical exam and urine HCG) Copper IUD

Cons: Pros: • Provider inserted • Effective (5 days from • Contraception that event) is long lasting (10- • Heavier menses 12 years) beyond • Insertion the initial event discomfort • Menstrual cramps • Cost Levonorgesterel

• Take asap (before 72 hours, up to 120 hours after event) • OTC (or behind the counter) • Safe if does not work • Suppression of ovulation by LH suppression • Failure rate 0.3-2.6% Ulipristal

• Take same as Levonorgesterel – asap, up to 120 hours after event • Rx only • Safe if does not work • Works differently than Levonorgesterel – Delays ovulation by delaying/ preventing follicular rupture • Wait at least 5 days to start new BC • Failure rate is under 2% Oral – weight considerations

If BMI > 26 or weight > 75 kg (165 lbs)

Levonorgesterel is less effective - Use Ulipristal - If unavailable, OK to double the Levonorgesterel to 3 mg. References/ For More Reading

• Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep 2016;65(No. RR-3):1–104. DOI: http://dx.doi.org/10.15585/mmwr.rr6503a1 • Tepper NK, Krashin JW, Curtis KM, Cox S, Whiteman MK. Update to CDC’s U.S. Medical Eligibility Criteria for Contraceptive Use, 2016: Revised Recommendations for the Use of Hormonal Contraception Among Women at High Risk for HIV Infection. MMWR Morb Mortal Wkly Rep 2017;66:990– 994. DOI: http://dx.doi.org/10.15585/mmwr.mm6637a6 • https://www.cdc.gov/reproductivehealth/contraceptio n/pdf/summary-chart-us-medical-eligibility- criteria_508tagged.pdf References/ For More Reading

• https://www.nuvaring.com/ • http://www.arhp.org/ • https://www.plannedparenthood.org/le arn/birth-control • https://www.bedsider.org/ • https://www.ncbi.nlm.nih.gov/pmc/arti cles/PMC2621397/ • https://www.fphandbook.org/ • https://www.nexplanon.com/ Podcasts that work for providers/ patients Podcasts that work for providers/ patients Nexplanon insertion Nexplanon insertion Nexplanon insertion Nexplanon insertion Nexplanon insertion Nexplanon insertion Nexplanon insertion Nexplanon insertion Nexplanon insertion Nexplanon insertion Nexplanon insertion LARC – Hormonal IUS Sample Insertion Video (animation) https://www.youtube.com/watch?v=Kr TBU_5LXc8