Most Recent Modification:

MARCH 2023

The iPLEDGE REMS

Contraception Counseling
Guide

Guide for counselors regarding effective

forms of contraception.
This guide contains the Contraception
Referral Form and the faxable Reimbursement
Form
 TABLE OF CONTENTS

Contraception counseling for isotretinoin patients ................................... 3

Counseling goals ................................................................................... 6

Contraception requirements .................................................................... 7

Unacceptable forms of contraception .......................................................8

Emergency contraception ....................................................................... 9

Abstinence ............................................................................................ 9

Reporting a pregnancy ....................................................................... 10

Contraception referral form ................................................................ 11*

Reimbursement referral form .............................................................. 11*

*Located inside back cover pocket.

WARNING
Isotretinoin must not be used by patients who are or may become
pregnant. There is an extremely high risk that life-threatening birth
CAUSES
BIRTH DEFECTS
defects will result if pregnancy occurs while taking isotretinoin in any
amount, even for a short period of time. Potentially any fetus exposed
during pregnancy can be affected. There are no accurate means of
determining whether an exposed fetus has been affected.
IMPORTANT NOTICE
DO NOT GET
Use only isotretinoin products approved by the US Food and Drug
PREGNANT Administration.
Obtain your isotretinoin prescriptions only from pharmacies that are
licensed in the United States and are enrolled with and activated in
the iPLEDGE REMS.

2
Contraception Counseling For Isotretinoin Patients
Isotretinoin is used to treat severe recalcitrant nodular acne in non-pregnant patients 12 years of
age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of
significant adverse reactions associated with its use, isotretinoin is reserved for patients with
severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
Isotretinoin is a known human teratogen; over one-third of all babies exposed to isotretinoin in
utero and carried to term have major birth defects.
What Is The iPLEDGE® REMS?
To avoid serious risks to unborn babies, the Food and Drug Administration (FDA) has
required a special program called a Risk Evaluation and Mitigation Strategy (REMS) for
isotretinoin. The iPLEDGE REMS is a, shared (includes multiple manufacturers) system
with requirements for prescribers, pharmacies, and patients. The iPLEDGE REMS also
includes a pregnancy registry for patients who get pregnant.
The goal of the iPLEDGE REMS is to
• prevent pregnancies in patients taking isotretinoin and to
• prevent pregnant patients from taking isotretinoin
Only enrolled and activated prescribers can prescribe isotretinoin, and only enrolled and
activated pharmacies can dispense isotretinoin. In order to receive isotretinoin, all patients
must be enrolled in the iPLEDGE REMS and agree to follow the requirements.

www.ipledgeprogram.com

1-866-495-0654

3
 Your Role
This patient is being referred to you because the patient has asked for counseling to help the
patient decide which contraceptive forms are best for this patient, and that will enable to
comply with the contraception requirements of the iPLEDGE® REMS.
The patient must:
• Select and commit to using 2 forms of effective contraception simultaneously
• One form must be a primary form unless the patient commits to continuous
abstinence from having any sexual contact (penis-vaginal) with a partner that could
result in pregnancy
• Have undergone a hysterectomy or bilateral oophorectomy
• Have been medically confirmed to be post-menopausal

Isotretinoin is not recommended for patients who can become pregnant, who cannot
commit to not having any sexual contact (penis-vaginal) with a partner that could result
in pregnancy, whom you believe will not be able to maintain abstinence, or will not use
contraception, as the program requires.

Please read this Contraception Counseling Guide completely before you begin your
counseling session. This provides an overview of the counseling goals for the patient and the
contraception requirements of the iPLEDGE REMS. It does not contain detailed information
on the various forms of contraception.
The patient received an iPLEDGE REMS Guide for Patients who can get Pregnant
which lists the approved primary and secondary forms of birth control required for the
iPLEDGE REMS (www.ipledgeprogram.com).

CAUSES
BIRTH DEFECTS

DO NOT GET
PREGNANT

4
 iPLEDGE REMS Approved Forms of Contraception
Choose 1 Primary + 1 Secondary Birth Control Form
Primary Form How
Birth Control How to Use it Well it Benefits† Risks†
(Choose One)* Works

Hormonal Implant Placed under the skin of >99%1 • Nothing to do or remember • Irregular Periods
the arm by a clinician. • Light or no periods
Works for 3 years.1 • May decrease acne
‡ • No increased risk of clots

Hormonal IUD Placed in the uterus by the >99%1 • Light or no periods • Irregular Periods
clinician. Self-check • No increased risk of clots
monthly.
Works for 5 years.1,4,3

Non-Hormonal IUD Placed in the uterus by the >99%1 • No hormones • May cause heavier
clinician. Self-check • Periods remain regular periods and cramping
monthly. Works for 10 • Effective immediately
year.4 • No increased risk of clots

Tubal Sterilization A surgical procedure to >99%5 • It is a virtually permanent method • If you want to have a
close the tubes between of birth control child later, it is very
the uterus and the ovaries. • Nothing to do or remember difficult to re-open the
tubes

Male Vasectomy A surgical procedure >99%5 • It is a virtually permanent form • If you want to have a
that closes off the tubes of birth control child later, it is very
that carry a partner’s • Nothing to do or remember difficult to re-open the
sperm. tubes

Hormonal Shot Given every 3 months by >97%1 • Light or no periods • Irregular Periods
a clinician. • No increased risk of clots • May cause weight gain

Vaginal Ring You place it in the 92%1 • Lighter periods • Blood clots
vagina. Replace • May decrease acne
monthly.

Hormonal Patch You place it on the 92%1 • Lighter periods • Blood clots
skin. Replace • May decrease acne
weekly.

Birth Control Pill Swallow at the same 92%1 • Lighter periods • Blood clots
(Combination Type) time daily. • May decrease acne

Secondary Form of Birth

How to Use it Benefits Risks
Control (Choose One)

Male Latex Partner must be willing to use each and • Protects from STIs (Sexually • Allergic Reactions
Condoms (with or every time you have sex. Transmitted Infections) and
without spermicide) HIV/AIDS

Cervical Cap, Diaphragm Place in the vagina before you • You are in control of its use • Allergic Reactions
(must be used with spermicide). have sex.
Vaginal Sponge
*Consult your doctor if you are considering choosing 2 primary forms of birth control rather than a primary and secondary form.
\
Benefits and Risks are not inclusive. Please review the Full Prescribing Information for the products listed.
All pictograms from FDA website www.fda.gov/downloads/forconsumers/byaudience/forwomen/freepublications/ucm356451.pdf. Accessed January 20, 2016.
‡ References 1. Werner CA, Papic MJ, Ferris LK, Schwartz EB. Promoting the safe use of isotretinoin by increasing contraceptive knowledge. JAMA Dermatol. 2015;151(4):389-3932. Skyla®
Prescribing Information, Bayer HealthCare Pharmaceuticals Inc., February 2018. 3. Liletta® Prescribing Information, Actavis Pharma, Inc., August 2017. 4. PARAGARD®
Prescribing Information, Cooper Surgical Inc., January 2018. 5. Trussell, J. Contraception failure in the United States. Contraception. 2011;83:397-404. Available at
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3638209/. Accessed September 9, 2014
5
 Counseling Goals
Ensure That The Patient:
• Understands and commits fully to not becoming pregnant
• Commits to using 2 forms of contraception together simultaneously, consistently,
and correctly. The patient must use 2 forms of effective contraception for at least 1
month prior to initiation of isotretinoin treatment, during isotretinoin treatment,
and for 1 month after discontinuing isotretinoin treatment
• Chooses the forms of contraception that will work best for the patient and that the
patient and the partner will actually use
• If, after counseling, the patient recognizes they will not be able to commit fully to
the iPLEDGE® REMS contraception requirements, encourage the patient to not
take isotretinoin and do not prescribe or if counseling, inform the prescriber
• Commits fully to abstinence, not having any sexual contact with a partner that could
result in pregnancy. This commitment is required 24 hours a day, 7 days a week for 1
month before, during, and for 1 month after the patient stops taking isotretinoin
• Knows when to contact the prescriber for emergency contraception
• Understands the risk of having a child with significant birth defects from exposure
to isotretinoin

Counseling Younger Teens

For younger teens, it is important to stress the following aspects of contraception for
the iPLEDGE REMS during counseling:
• Why it is important to use 2 forms of birth control, 1 primary and 1
secondary, at all times. Younger teens may need more emphasis on this
point to fully understand it and comply.
• Emergency contraception. Younger teens may need more explanation from
you about the need to take immediate action if they have unprotected
sexual contact with a partner that could result in pregnancy or if their
contraception forms fail.
CAUSES
BIRTH DEFECTS

DO NOT GET
PREGNANT

6
Contraception Requirements
Using 2 Forms of Contraception Provides More Protection
Use of 2 iPLEDGE REMS approved forms of contraception (at least 1 of which is a
primary form) simultaneously substantially reduces the risk that a patient will become
pregnant.
In addition, it is not known if hormonal contraceptives are less effective when used with
isotretinoin.3 Because of this possibility and the fact that all contraceptive forms are less than
100% effective, the iPLEDGE REMS requires the additional protection of a second form of
contraception.

Selecting an Effective Primary Form of Contraception

The single most important decision in contraception for the iPLEDGE REMS is selecting a
primary form that the patient can and will use as correctly as possible. Other important factors
to consider in counseling the patient on selecting a primary form include side effects,
contraindications, and the patient’s ability to use it correctly.

All of these factors influence compliance with the iPLEDGE REMS requirements to
prevent pregnancy.

Hormonal Combination Oral Contraceptives as a Primary Form

For a patient who has indicated having difficulty taking oral contraceptives correctly, other
contraception not requiring daily dosing may be a better choice. It is critical that such a
patient choose a form other than daily oral contraceptive agents.

7
 Selecting an Effective Secondary Form of Contraception
There are 2 forms of secondary contraception: barrier and other. Barrier forms
include the diaphragm and cervical cap (both of which must be used with a
spermicide) and the male latex condom (which can be used with or without a
spermicide). The other form is the vaginal sponge, which contains a spermicide. The
most important issue for a secondary form is that it be used correctly each time the
patient has sexual contact (penis-vaginal) with a partner that could result in
pregnancy and that it be in place should the primary form fail.
Help the patient select a secondary form that the patient can fully commit to using
correctly each time they have any sexual contact (penis-vaginal) with a partner that could
result in pregnancy.

Unacceptable Forms of Contraception

The following forms of contraception are not acceptable for the iPLEDGE REMS:
• Progesterone-only “mini-pills”
• Female condoms
• Natural family planning (rhythm method or fertility awareness)
• Breastfeeding
• Withdrawal
• Cervical shield, a silicone disc with a one-way air valve that creates suction to adhere
to the cervix*
Patients currently using these unacceptable forms of contraception must switch to the iPLEDGE
REMS approved forms of contraception.

*A cervical shield should not be confused with a cervical cap, which is an effective secondary form of contraception.

8
Emergency Contraception
The patient should also realize that emergency contraception should not be used on a regular
basis as a replacement for the other contraceptive forms selected.
Abstinence
For this program, all patients who can become pregnant must fully commit
to pregnancy prevention.
Isotretinoin is not recommended for any patient who can become pregnant who cannot
or will not follow the contraceptive requirements of the iPLEDGE® REMS. Abstinence
(committing to not having any sexual contact with a partner that could result in pregnancy)
may be appropriate when it is a lifestyle choice, such as religious practice, and not just a
social circumstance, such as not having a current partner. If, after counseling, a patient who
has sexual contact chooses abstinence, the patient must understand that the patient has
committed to not having any sexual contact with a partner that could result in pregnancy 24
hours a day, 7 days a week for 1 month before, during, and for 1 month after the patient
stops taking isotretinoin.

A patient who switches contraception choices during treatment from abstinence to

two forms of iPLEDGE approved contraception is required to wait for 30 days while
consistently using 2 forms of birth control before continuing treatment. The patient
will be required to have a negative pregnancy test, which starts the 30-day wait
period. When the 30-day wait period is over, the patient will need to have negative
pregnancy test, complete the comprehension questions and be confirmed by the
prescriber before continuing treatment.

One of the most common reasons that patients become pregnant is that they engage in having
sexual activity contact with a partner that could result in pregnancy when they planned to be
abstinent.

9
 About The Referral Form
The Contraception Referral Form, brought in to you by this patient, has been filled out in
part by the prescriber. Please fill out the rest of the form at the conclusion of your
counseling session and fax or mail the copy back to the prescriber, keeping a copy for
your own records.

Reimbursement Form
Also in the back pocket is a reimbursement form for contraceptive counseling services.
The iPLEDGE® REMS provides reimbursement for 1 contraception counseling session for
patients who have been prescribed isotretinoin. Please complete the form and fax it to 1-
866-495-0660.

Reporting a Pregnancy
If you become aware of a pregnancy in a patient taking isotretinoin, please report the
pregnancy to the iPLEDGE REMS by calling 1-866-495-0654 and choosing the option to
“Report a Pregnancy.”
Please remind any patient who is pregnant to contact the doctor/prescriber who prescribed
the isotretinoin.

REFERENCES
1. Lammer EJ, Chen DT, Hoar RM, et al. Retinoic acid embryopathy. N Engl J Med. 1985;313:837–841.
2. Gideon K, Avner M, Shear N. Generic isotretinoin: a new risk for unborn children. CMAJ. 2004;170:1567–1568.
3. Isotretinoin Prescribing Information.

1
ISOTRETINOIN CONTRACEPTION E COUNSELING REFERRAL FORM
Prescriber: Please complete the top of this form which should be taken
to the contraception counselor by the patient or sent in advance for
patients being referred for contraception counseling

Patient , _ iPLEDGE® REMS ID#

is considering treatment with isotretinoin. I am referring the
h patient for counseling to help choose the 2 forms of
contraception before receiving
g the first prescription.

n
The patient had a negative (serum/urine) pregnancy test on _

Isotretinoin Prescriber’s Name _ _

Address _ _
Telephone - _- Fax - -
Isotretinoin Prescriber’s _
Signature Date

RECORD OF CO N
TRACEPTION COUNSELING
Contraception Counselor:
• Please review the Contraception Counseling Guide
(www.ipledgeprogram.com/#/main/resources) for details on the iPLEDGE REMS
contraception requirements
• Complete this form and fax or mail back to isotretinoin prescriber
• Once form is completed, please copy this completed form and provide to the patient
I have provided the following for your patient _
Comprehensive contraception counseling
Information about emergency contraception
The patient has:
Chosen 2 forms of contraception
Committed to abstain from any sexual contact (penis-vaginal) with a partner who could get the patient pregnant
and is not planning to use 2 forms of contraception. I informed the patient that it is not recommended for the
patients who have had sexual contact (penis-vaginal) with a partner who could get the patient pregnant.
The patient has not yet decided upon the forms of contraception to be used.

Primary Form _
Secondary or Second Primary Form _
I have prescribed the selected contraception.
Yes No (Please comment below)
I have counseled the patient and patient agrees to complying with
t the contraceptive requirements of the iPLEDGE REMS.
Yes No (Please comment below)

Name _
Address _
Telephone _
Specialty (circle
c one): OB-GYN Fam Prac IM RN LPN Other
Contraception Counselor’s Signature _
Date _

_
Once Form is Completed, Please Copy this Completed Form and Provide to the Patient

Please see accompanying complete product information, including boxed

CONTRAINDICATIONS
R AND WARNINGS, CONTRAINDICATIONS,
R www.ipledgeprogram.com 1-866-495-0654
WARNINGS, PRECAUTIONS, AND
ADVERSE REACTIONS
©2 1 6
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www.ipledgeprogram.com
11-866-495-0654
www.ipledgeprogram.com
1-866-495-0654