Intrauterine Contraception in Canada

Dr Helen Pymar MD, MPH Associate Professor, Department of Medicine, University of Manitoba April 16, 2015 Speaker Disclosure

 Have given talks for Bayer around Mirena, IUDs  Have been a principal investigator for the University of Manitoba site for IUS study sponsored by Bayer  I use and promote a lot of IUD/IUS in my patients  As a fellow in 1999-2001 I was involved in study of Caya Diaphragm Overview Copper IUD available in Canada Size, copper amounts, cost, coverage Jaydess IUS Emergency contraception IUD now that weight is an issue with Plan B Caya Diaphragm Copper-releasing IUCD  CuT380A (“Paragard”)  FlexiT380+, Liberté TT380 (Standard & “Short”), Mona Lisa 10  CuT380 (no cuffs on T arms)  Liberté UT 380 (Standard & “Short”), Mona Lisa 5  Copper devices with less than 380 mm2 Cu  Flexi T 300, Flexi T 300+, Mona Lisa N  Nova T 200 Paragard- Size- 32 mm horizontally by 36 mm vertically 176 mg copper wire stem, 68.7 mg copper collar on each side Dimensions of IUCs Available in Canada Company, style Length(mm) Width(mm) Bayer, Nova T-200 32 32 Prosan(mm), Flexi-T 300 28 23 Flexi-T 300+ 32 28 Flexi-T 380+ (cuffs on T arm) 32 28 7-Med Industrie, Liberte UT380 Standard 35.4 32 Liberte UT 380 Short 28.4 32 Liberte TT 380 Standard (cuffs) 34 29.9 Liberte TT 380 Short (cuffs) 29.5 23.2 Mona Lisa NV, Mona Lisa 10 (CuT380A,cuffs) 35.85 31.85 Mona Lisa 5 (NT 380, no cuffs NovaT) 31.9 31.8

Mona Lisa N (Flexi T 300) 29 23

References: (all resources accessed 2012 Oct 28, updated Mar 2014) 1. Mirena Product Monograph July 2013 http://www.bayer.ca/files/MIRENA-PM-ENG-15JUL2013-164011.pdf?# 2. Nova T info at manufacturer site http://www.bayer.ca/files/ENG-NOVT%20DEV%201%20PI%2081527628%20130214%20(2).pdf?# 3. Flexi-T Package Insert http://www.trimedic-inc.com/pdf/InsertionInstruction.pdf 4. Liberte info at distributor web site: http://medisafecanada.com/medi_products/liberte-brand-iuds/ 5. Mona Lisa info at distributor web site: http://pacepharma.ca/en/physician-prescribing-information-10.html 380 mm2 300 mm2 200 mm2

Width “LongCopper” - square“Short” mm of surface area 28 to 32 mm 23 to 28 mm 23 to 28 mm 32 mm

FlexiT380+ Size (28 x 32)

T380A Liberte TT380 Liberte TT380 (Cuffs) (30 x 34) Short (23 x 30)

Mona Lisa 10 (32 x 36)

Flexi-T300 Mona Lisa 5 (23 x 28) 380/300/200 (32x32) (No Cuffs) Nova T Mona Lisa N (32X 32) (23 x 29) Liberte UT380 Liberte UT380 (32 x 35) Short Flexi-T300+ (32 x 28) (28 x 32) Websites for the Recommended Copper IUDs

 http://medisafecanada.com/products/liberte- iuds/ For Liberté UT and TT 380  http://www.pacepharma.ca/en/mona-lisa- iuds.html For Mona Lisa 10, and N  http://www.trimedic-inc.com/about_flexi- t_iud.html For Flexi T 380, 300 Uterine size important? Ultrasound study of width normal uterus (n=210, 91 G0)

 Nulliparous women avg 27 mm  Multiparous women avg 32 mm  No relationship to cesarean section or patient age

Benacerraf et al, Obstet Gynecol 2010;116:305-310 3D imaging ultrasound width Uterine size important?- Part 2

Width Ut Embedded(n=29) Nonembedded(n=132) (width±SD ) 25 ± 8 mm 32 ± 10 mm

In USA where all IUDs (Paragard and Mirena) are 32 mm

4 patients with embedded IUD had a uterine width of over 32 mm No information about parity, gravidity in this study

Shipp et al J Ultrasound Med 2010;29:1453-1456 Size of uterus and malposition Show Me The Money!  Nova T- most expensive $177 5 yr  Flexi T 380 $87 10-12 yr  Flexi T 300 $80 5 yr  Mona Lisa 10 $75 10-12 yr  Liberte TT 380- short and standard $74 10-12 yr  Liberte UT 380– short and standard $74 5 yr  Mona Lisa 5 $59 5 yr  Mona Lisa N $59 5 yr Covered by Social Covered by NIHB Assistance 1 every yr Costs Provided by Grand Medicine Pharmacy email April 9, 2015

Pymar Picks for Out of Pocket Patients How Long Can You Leave Your Copper IUD/IUS In the Uterus?  Recommendations based on device type and age at insertion.  Paragard like- inserted age 35 or older good to menopause, and 25 or older good for 12 years  Mirena IUS inserted age 25 or older good for 7 years (some prefer 35 or older)

Wu et al. Contraception 2014;89:495-503 What is the Best Choice?

 Copper- 380 “Paragard- like” best

 Size- based on nulliparity, cesarean only, or previous vaginal delivery, acutely retro/anteverted uterus?

 Need to consider cost/coverage by health plan if applicable  The smallest LNG-IUS available  Contraception up to 3 years  Silver ring – Allows it to be distinguished on ultrasound from other uterine devices Jaydess®  Highly effective – Pearl Index (0.33) – Typical use = Perfect use

IUS, intrauterine system Jaydess® Product Monograph, November 21, 2014 LNG-IUS, levonorgestrel-releasing intrauterine system Gemzell-Danielsson et al. Fertil Steril 2012; 97: 616-622 Jaydess® with EvoInserter®

• Few preparatory steps with EvoInserter®: o Simplified loading by pushing the slider forwards to its furthest position o IUS pre-loaded in the correct horizontal orientation in the package o Threads inside handle - handling of threads no longer necessary o Ergonomic design of handle and slider o Double-sided centimeter scale o Not reloadable once IUS fully released IUS, intrauterine system Jaydess® Product Monograph, November 21, 2014 Jaydess®1 Mirena®2 T-frame dimensions 28 × 30 mm 32 × 32 mm (horizontal x vertical) Insertion tube diameter 3.80 mm 4.40 mm

Initial in vivo LNG release rate* 14 μg/day 20 μg/day (24 days after insertion) Maximum duration of use 3 years 5 years Total LNG content 13.5 mg 52 mg Silver ring for differentiation Yes No on ultrasound Inserter EvoInserter® EvoInserter®

*Jaydess® is also known as LNG-IUS 13.5 mg (total content) or LNG-IUS12, which comes from the initial predicted in vitro release rate while Jaydess® was in development. Release rates between Jaydess and Mirena should not be directly compared because they were measured at different time points and using different calculations. LNG-IUS, levonorgestrel-releasing intrauterine system 1. Jaydess® Product Monograph, November 21, 2014 2. Mirena® Product Monograph, October 9, 2014 Emergency Contraception and Weight  Emergency contraceptive pills to carry warnings for reduced effectiveness in women over a certain body weight  Report a Concern  Starting date: March 26, 2014 Posting date: March 26, 2014 Type of communication: Information Update Subcategory: Drugs Source of recall: Health Canada Issue: Important Safety Information Audience: General Public Identification number: RA-38701  Issue  Emergency contraceptive pills, also known as the “morning after” pill, will soon carry new warnings about reduced effectiveness in women weighing over 165 pounds.  Health Canada has asked companies to add new warnings to product packages advising that these pills are less effective in women weighing 165 to 176 pounds (75-80 kg), and are not effective in women over 176 pounds (80 kg). Women who weigh 165 pounds or more are advised to ask a health professional, such as a doctor or pharmacist, for advice on alternative methods of emergency contraception. SOGC Recommendations  Should not discourage pts over BMI 30 from using Plan B if they don’t want IUD  Recent publications from WHO have recommended insertion of copper IUD most effective if done within 5 days of unprotected sex  (Can still go to 7 days)  Future- consider 30 mg Ulipristal Acetate- approx $80

http://sogc.org/wp-content/uploads/2013/01/gui280CPG1209ErevB.pdf NEW Program Copper IUDs for EC

 Working with the Pharmacists  Newsletter  Linking them up with the website at Womens Health Clinic http://womenshealthclinic.org/  Will have OPD and CPU listed on the sites (eventually) for patients to self refer within 7 days  Providers available Monday, Wednesday in CPU 204- 787-1961, and Friday in OPD 204-787-1781 to self-refer Caya Diaphragm  Fits most women  No fitting required  No prescription required  Made of silicone/nylon  Use with Caya diaphragm gel- Containing Water, Lactic acid, Sodium lactate, Cellulose, Sorbic acid  View the Caya Video at: http://www.caya.eu/en/ Overview Copper IUD available in Canada Size, copper amounts, cost, coverage Jaydess IUS Emergency contraception IUD now that weight is an issue with Plan B Caya Diaphragm Giving Thanks!  Wendy V. Norman- Many Slides on Copper IUDs MD, CCFP, FCFP, DTM&H, MHSc  CIHR- Chair, Family Planning Public Health Research, Dept of Family Practice, UBC  Bayer- Jaydess slides  Trimedic for Caya info- Paula Gelbfarb ([email protected])  [email protected]