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 CayaDiaphragm

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

(mm)

Company, style Length(mm) Width(mm)

Bayer, Nova T-200 32 32

Prosan, 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 “Long”

28 to 32 mm

“Short”

23 to 28 mm 23 to 28 mm 32 mm

T380A

(Cuffs)

FlexiT380+

(28 x 32)

Liberte TT380

(30 x 34)

Liberte TT380

Short

(23 x 30)

Mona Lisa 10

(32 x 36)

380/300/200

(No Cuffs)

Mona Lisa 5

(32x32)

Flexi-T300

(23 x 28)

Mona Lisa N

(23 x 29)

Nova T

(32X 32)

Liberte UT380

(32 x 35)

Liberte UT380

Short

(32 x 28)

Flexi-T300+

(28 x 32)

Copper - square mm of surface area

Siz

e

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 mmNo 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

Costs Provided by Grand Medicine Pharmacy email April 9, 2015

Covered by NIHB 1 every yr

Covered by Social Assistance

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

Highly effective

– Pearl Index (0.33)

– Typical use = Perfect use

Jaydess® Product Monograph, November 21, 2014

Gemzell-Danielsson et al. Fertil Steril 2012; 97: 616-622

Jaydess®

IUS, intrauterine system

LNG-IUS, levonorgestrel-releasing intrauterine system

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 releasedJaydess® Product Monograph, November 21, 2014IUS, intrauterine system

Jaydess®1 Mirena®2

T-frame dimensions

(horizontal x vertical)28 × 30 mm 32 × 32 mm

Insertion tube diameter 3.80 mm 4.40 mm

Initial in vivo LNG release rate* 14 μg/day

(24 days after insertion)

20 μg/day

Maximum duration of use 3 years 5 years

Total LNG content 13.5 mg 52 mg

Silver ring for differentiation

on ultrasound

Yes No

Inserter EvoInserter® EvoInserter®

1. Jaydess® Product Monograph, November 21, 2014

2. Mirena® Product Monograph, October 9, 2014

*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

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, Sorbicacid

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, Deptof Family Practice, UBC

Bayer- Jaydess slides

Trimedic for Caya info- Paula Gelbfarb(paula@trimedic-inc.com)

hpymar@hsc.mb.ca