Page 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Plan B
safely and effectively. See full prescribing information for Plan B.
Plan B (levonorgestrel) tablets, 0.75mg, for oral use
Initial U.S. Approval: 1982
----------------------------INDICATIONS AND USAGE---------------------------
Plan B is a progestin-only emergency contraceptive, indicated for prevention
of pregnancy following unprotected intercourse or a known or suspected
contraceptive failure. Plan B is available only by prescription for women
younger than age 17 years, and available over the counter for women 17 years
and older. Plan B is not intended for routine use as a contraceptive. (1)
----------------------DOSAGE AND ADMINISTRATION-----------------------
The first tablet is taken orally as soon as possible within 72 hours after
unprotected intercourse. The second tablet should be taken 12 hours after the
first dose. Efficacy is better if Plan B is taken as soon as possible after
unprotected intercourse. (2)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
A total of two 0.75 mg tablets taken 12 hours apart as a single course of
treatment (3)
-------------------------------CONTRAINDICATIONS------------------------------
Known or suspected pregnancy. (4)
-----------------------WARNINGS AND PRECAUTIONS----------------------
• Ectopic Pregnancy: Women who become pregnant or complain of lower
abdominal pain after taking Plan B should be evaluated for ectopic
pregnancy. (5.1)
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Ectopic Pregnancy
5.2 Existing pregnancy
5.3 Effect on Menses
5.4 STI/HIV
5.5 Physical Examination and Follow-up
5.6 Fertility Following Discontinuation
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
• Plan B is not effective in terminating an existing pregnancy. (5.2)
• Effect on menses: Plan B may alter the next expected menses. If menses
is delayed beyond 1 week, pregnancy should be considered. (5.3)
• STI/HIV: Plan B does not protect against STI/HIV. (5.4)
------------------------------ADVERSE REACTIONS-------------------------------
The most common adverse reactions (≥ 10%) in the clinical trial included
menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue
(17%), headache (17%), dizziness (11%), and breast tenderness (11%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Barr
Laboratories at 1-800-330-1271 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
------------------------------DRUG INTERACTIONS-------------------------------
Drugs or herbal products that induce certain enzymes, such as
CYP3A4, may decrease the effectiveness of progestin-only pills. (7)
-----------------------USE IN SPECIFIC POPULATIONS------------------------
• Nursing Mothers: Small amounts of progestin pass into the breast milk
of nursing women taking progestin-only pills for long-term
contraception, resulting in detectable steroid levels in infant plasma.
(8.3)
• Plan B is not intended for use in premenarcheal (8.4) or postmenopausal
females (8.5).
• Clinical trials demonstrated a higher pregnancy rate in the Chinese
population. (8.6)
See 17 for PATIENT COUNSELING INFORMATION
Revised: 7/2009
8.5 Geriatric Use
8.6 Race
8.7 Hepatic Impairment
8.8 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
*Sections or subsections omitted from the full prescribing information are not
listed.
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Page 2
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Plan B® is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or
a known or suspected contraceptive failure. To obtain optimal efficacy, the first tablet should be taken as soon as possible within
72 hours of intercourse. The second tablet should be taken 12 hours later.
Plan B is available only by prescription for women younger than age 17 years, and available over the counter for women 17
years and older.
Plan B is not indicated for routine use as a contraceptive.
2 DOSAGE AND ADMINISTRATION
Take one tablet of Plan B orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected
contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. The second tablet
should be taken 12 hours after the first dose. Plan B can be used at any time during the menstrual cycle.
If vomiting occurs within two hours of taking either dose of medication, consideration should be given to repeating the dose.
3 DOSAGE FORMS AND STRENGTHS
Each Plan B tablet is supplied as a white, round tablet containing 0.75 mg of levonorgestrel and is marked with INOR on one
side.
4 CONTRAINDICATIONS
Plan B is contraindicated for use in the case of known or suspected pregnancy.
5 WARNINGS AND PRECAUTIONS
5.1 Ectopic Pregnancy
Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical
studies of routine use of progestin-only contraceptives are ectopic.
A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers,
however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower
abdominal pain after taking Plan B. A follow-up physical or pelvic examination is recommended if there is any doubt
concerning the general health or pregnancy status of any woman after taking Plan B.
5.2 Existing Pregnancy
Plan B is not effective in terminating an existing pregnancy.
5.3 Effects on Menses
Some women may experience spotting a few days after taking Plan B. Menstrual bleeding patterns are often irregular among
women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception.
If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy.
5.4 STI/HIV
Plan B does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).
5.5 Physical Examination and Follow-up
A physical examination is not required prior to prescribing Plan B. A follow-up physical or pelvic examination is recommended
if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B.
5.6 Fertility Following Discontinuation
A rapid return of fertility is likely following treatment with Plan B for emergency contraception; therefore, routine contraception
should be continued or initiated as soon as possible following use of Plan B to ensure ongoing prevention of pregnancy.
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical
practice.
A double-blind, controlled clinical trial in 1,955 evaluable women compared the efficacy and safety of Plan B (one 0.75 mg
tablet of levonorgestrel taken within 72 hours of unprotected intercourse, and one tablet taken 12 hours later) to the Yuzpe
regimen (two tablets each containing 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse,
and two tablets taken 12 hours later).
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Page 3
The most common adverse events (>10%) in the clinical trial for women receiving Plan B included menstrual changes (26%),
nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%), and breast tenderness (11%). Table 1
lists those adverse events that were reported in ≥ 5% of Plan B users.
Table 1: Adverse Events in ≥ 5% of Women, by % Frequency
Plan B
Levonorgestrel
N=977 (%)
Nausea 23.1
Abdominal Pain 17.6
Fatigue 16.9
Headache 16.8
Heavier Menstrual Bleeding 13.8
Lighter Menstrual Bleeding 12.5
Dizziness 11.2
Breast Tenderness 10.7
Vomiting 5.6
Diarrhea 5.0
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Plan B. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
Gastrointestinal Disorders
Abdominal Pain, Nausea, Vomiting
General Disorders and Administration Site Conditions
Fatigue
Nervous System Disorders
Dizziness, Headache
Reproductive System and Breast Disorders
Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain
7 DRUG INTERACTIONS
Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma
concentrations of progestins, and may decrease the effectiveness of progestin-only pills. Some drugs or herbal products that may
decrease the effectiveness of progestin-only pills include:
• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s wort
• topiramate
Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-
administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.
Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin-only pills or
the potential for enzyme alterations.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral
progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not
demonstrated significant adverse effects.
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Page 5
Table 2: Pharmacokinetic Parameter Values Following Single Dose Administration of Plan B
(Levonorgestrel) Tablets 0.75 mg to Healthy Female Volunteers under Fasting Conditions
Mean (± SD)
C
max
(ng/mL)
T
max
(h)
CL
(L/h)
V
d
(L)
t
½
(h)
AUC
inf
(ng·hr/mL)
Levonorgestrel
14.1 (7.7)
1.6 ( 0.7) 7.7 (2.7) 260.0 24.4 (5.3) 123.1 (50.1)
C
max
= maximum concentration
T
max
= time to maximum concentration
CL = clearance
V
d
= volume of distribution
t
1/2
= elimination half life
AUC
inf
= area under the drug concentration curve from time 0 to infinity
Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of
Plan B has not been evaluated.
Distribution
The apparent volume of distribution of levonorgestrel is reported to be approximately 1.8 L/kg. It is about 97.5 to 99% protein-
bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin.
Metabolism
Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent,
glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also
present in plasma, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16βhydroxylevonorgestrel.
Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may
differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel
concentrations among users.
Excretion
About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as
glucuronide conjugates.
Specific Populations
Pediatric: This product is not intended for use in the premenarcheal population, and pharmacokinetic data are not available for
this population.
Geriatric: This product is not intended for use in postmenopausal women and pharmacokinetic data are not available for this
population.
Race: No formal studies have evaluated the effect of race on pharmacokinetics of Plan B. However, clinical trials demonstrated
a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of emergency contraception).
The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown [see
USE IN SPECIFIC POPULATIONS (8.6)].
Hepatic Impairment: No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B.
Renal Impairment: No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B.
Drug-Drug Interactions
No formal drug-drug interaction studies were conducted with Plan B [see DRUG INTERACTIONS (7)].
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins. There was no
increase in tumorgenicity following administration of levonorgestrel to rats for 2 years at approximately 5 µg/day, to
dogs for 7 years at up to 0.125 mg/kg/day, or to rhesus monkeys for 10 years at up to 250 µg/kg/day. In another 7
year dog study, administration of levonorgestrel at 0.5 mg/kg/day did increase the number of mammary adenomas in
treated dogs compared to controls. There were no malignancies.
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Page 6
Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in vitro mammalian
culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells, and in an in vivo micronucleus assay
in mice.
Fertility: There are no irreversible effects on fertility following cessation of exposures to levonorgestrel or progestins
in general.
14 CLINICAL STUDIES
A double-blind, randomized, multinational controlled clinical trial in 1,955 evaluable women (mean age 27)
compared the efficacy and safety of Plan B (one 0.75 mg tablet of levonorgestrel taken within 72 hours of
unprotected intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets each containing 0.25
mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse, and two additional tablets
taken 12 hours later). After a single act of intercourse occurring anytime during the menstrual cycle, the expected
pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with Plan B.
Emergency contraceptives are not as effective as routine hormonal contraception since their failure rate, while low
based on a single use, would accumulate over time with repeated use [see INDICATIONS AND USAGE (1)].
At the time of expected menses, approximately 74% of women using Plan B had vaginal bleeding similar to their
normal menses, 14% bled more than usual, and 12% bled less than usual. The majority of women (87%) had their
next menstrual period at the expected time or within + 7 days, while 13% had a delay of more than 7 days beyond the
anticipated onset of menses.
16 HOW SUPPLIED/STORAGE AND HANDLING
Plan B (levonorgestrel) tablets, 0.75 mg, are available for a single course of treatment in PVC/aluminum foil blister
packages of two tablets each. The tablet is white, round and marked INOR on one side.
Available as: Unit-of-use NDC 51285-769-93
Store Plan B tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° to
30°C (59° to 86°F) [see USP].
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
• Take Plan B as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive
failure.
• If you vomit within two hours of taking either tablet, immediately contact your healthcare provider to discuss whether to take
another tablet.
• Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking Plan B, in order to be evaluated
for an ectopic pregnancy.
• After taking Plan B, consider the possibility of pregnancy if your period is delayed more than one week beyond the date you
expected your period.
• Do not use Plan B as routine contraception.
• Plan B is not effective in terminating an existing pregnancy.
• Plan B does not protect against HIV-infection (AIDS) and other sexually transmitted diseases/infections.
• For women younger than age 17 years, Plan B is available only by prescription.
Mfg. by Gedeon Richter, Ltd., Budapest, Hungary
for Duramed Pharmaceuticals, Inc.
Subsidiary of Barr Pharmaceuticals, Inc.
Pomona, New York 10970
Phone: 1-800-330-1271 Website: www.go2planb.com
BR- 0038/11001288
Revised July 2009
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
For additional information intended for
healthcare professionals, please see
enclosed Product Information for Plan B
®
.
Emergency
Contraceptive
Plan B
®
Emergency Contraceptive.
Because the unexpected happens.
Important Information About Plan B
®
,
Birth Control & Sexually Transmitted Diseases
From the makers of Plan B
®
, Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc.
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
What is Plan B
®
?
Plan B
®
is emergency contraception that helps prevent pregnancy
after birth control failure or unprotected sex. It is a backup method of
preventing pregnancy and is not to be used routinely.
Plan B
®
can reduce your chance of pregnancy after unprotected sex (if
your regular birth control was used incorrectly or fails, or if you have
had sex without birth control). For example, if you were using a
condom and it broke or slipped, if you did not use your regular birth
control as you should have, or if you did not use any birth control,
Plan B
®
may work for you.
2
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
What Plan B
®
is not.
Plan B
®
will not work if you are already pregnant and will not affect an
existing pregnancy. Plan B
®
should not be used as regular birth
control. It is important to have another reliable source of birth control
that is right for you. Plan B
®
will not protect you from HIV infection (the
virus that causes AIDS) and other sexually transmitted diseases.
3
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
When is the appropriate time to use Plan B
®
?
You can use Plan B
®
after you have had unprotected sex in the last 72
hours (3 days), and you do not want to become pregnant.
Plan B
®
can be used as a backup or emergency method to regular
birth control if, for example,
• Your regular birth control method was used incorrectly or failed
(your partner’s condom broke or slipped)
• You made a mistake with your regular method
• You did not use any birth control method
4
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
When is it not appropriate to use Plan B
®
?
• Plan B
®
should not be used as a regular birth control method. It
does not work as well as most other forms of birth control when
they are used consistently and correctly. Plan B
®
is a backup or
emergency method of contraception.
• Plan B
®
should not be used if you are already pregnant because it
will not work.
• Plan B
®
should not be used if you are allergic to levonorgestrel or
any other ingredients in Plan B
®
.
5
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
• Plan B
®
does not protect against HIV (the virus that causes AIDS) or
other sexually transmitted diseases (STDs). The best ways to protect
yourself against getting HIV or other STDs are to use a latex condom
correctly with every sexual act or not to have sex at all.
6
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
How does Plan B
®
work?
Plan B
®
is two pills with levonorgestrel, a hormone that has been used
in many birth control pills for over 35 years. Plan B
®
contains a higher
dose of levonorgestrel than birth control pills, but works in a similar
way to prevent pregnancy. It works mainly by stopping the release of
an egg from the ovary. It is possible that Plan B
®
may also work by
preventing fertilization of an egg (the uniting of sperm with the egg)
or by preventing attachment (implantation) to the uterus (womb).
7
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
How can I get the best results from Plan B
®
?
You have only a few days to try to prevent pregnancy after unprotected
sex. The sooner you take Plan B
®
, the better it works. Take the first
Plan B
®
tablet as soon as possible within 72 hours (3 days) after
unprotected sex. Take the second tablet 12 hours later.
How effective is Plan B
®
?
The sooner you take Plan B
®
, the better it will work. Take Plan B
®
as
soon as possible after unprotected sex. If it is taken as soon as
possible within 72 hours (3 days) after unprotected sex, it will
significantly decrease the chance that you will get pregnant. Seven
out of every 8 women who would have gotten pregnant will not
become pregnant.
8
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
How will I know if Plan B
®
worked?
Most women will have their next menstrual period at the expected
time or within a week of the expected time. If your menstrual period
is delayed beyond 1 week, you may be pregnant. You should get a
pregnancy test and follow up with your healthcare professional.
9
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
What if I am already pregnant and use
Plan B
®
?
There is no medical evidence that Plan B
®
would harm a developing
baby. If you take Plan B
®
(accidentally) after you are already pregnant
or it does not work and you become pregnant, it is not likely to cause
any harm to you or your pregnancy. The pregnancy will continue.
Plan B
®
will not work if you are already pregnant.
10
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
What should I do if my menstrual period is
delayed beyond 1 week and I have severe
lower stomach (abdominal) pain?
If you have severe lower stomach (abdominal) pain about 3 to 5 weeks
after taking Plan B
®
, you may have a pregnancy outside the uterus,
which is called a tubal pregnancy. A tubal pregnancy requires
immediate medical treatment, so you should see a healthcare
professional right away.
11
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Can I use Plan B
®
for regular birth control?
No. Plan B
®
should not be used for regular birth control. It is an
emergency or backup method to be used if your regular birth control
fails or is used incorrectly or if you have sex without birth control. You
should protect yourself against STDs and pregnancy every time you
have sex. If you have unprotected sex again after taking Plan B
®
, it will
not help protect you from getting pregnant.
12
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
How often can I use Plan B
®
?
Plan B
®
is meant for emergency protection only, and is not designed
to be used frequently. If you find that you need to use emergency
contraception often, talk to your healthcare professional and learn
about methods of birth control and STD prevention that are right
for you.
13
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Will I experience any side effects from Plan B
®
?
When used as directed, Plan B
®
is safe for women. Some women will
have mild, temporary side effects, such as menstrual changes, nausea,
lower stomach (abdominal) pain, tiredness, headache, dizziness, breast
pain and vomiting. These are similar to the side effects that some
women have when taking regular birth control pills. Some women
taking Plan B
®
will have menstrual changes such as spotting or
bleeding before their next period. Some women may have a heavier
or lighter next period, or a period that is early or late. If your period
is more than a week late, you should get a pregnancy test.
14
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
What warnings should I know about when using
Plan B
®
?
Plan B
®
does not protect against the AIDS virus (HIV) or other
sexually transmitted diseases (STDs).
1515
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Do not use:
• If you are already pregnant (because it will not work)
• If you are allergic to levonogestrel or any of the ingredients in Plan B
®
• For regular birth control
When using this product, you may have:
• Menstrual changes • Headache
• Nausea • Dizziness
•
Lower stomach (abdominal) pain
• Breast pain
• Tiredness • Vomiting
1616
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control
Center right away at 1-800-222-1222.
What are the directions for using Plan B
®
?
Women 17 years of age and older:
• Take the first Plan B
®
tablet as soon as possible within 72 hours (3
days) after unprotected sex.
• Take the second tablet 12 hours after you take the first tablet.
• If you vomit within 2 hours of taking either dose of medication, call a
healthcare professional to find out if you should repeat that dose.
Prescription only for women younger than age 17. If you are younger
than 17, see a healthcare professional.
17
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
What should I do if I have questions about
Plan B
®
?
If you have questions or need more information about this product,
call our toll-free number, 1-800-330-1271, visit our website at
www.go2PlanB.com, or ask a healthcare professional.
Other information
Tablets are enclosed in a blister seal. Do not use if the blister seal
is broken.
Store at room temperature 20–25°C (68–77°F).
You may report side effects to FDA at 1-800-FDA-1088.
1818
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Active ingredient: levonorgestrel 0.75 mg in each tablet
Inactive ingredients: colloidal silicon dioxide, potato starch,
gelatin, magnesium stearate, talc, corn starch, lactose monohydrate
Protect yourself in more ways than one!
If you are sexually active, but you are not ready for a pregnancy, it is
important to use regular pregnancy protection. There are many types
of birth control. Whichever type you choose, it is important to use your
regular birth control method as directed.
This ensures that you have effective
protection against pregnancy
every time you have sex.
1919
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
But things do not always go as planned. For example, if you were
using a condom and it broke or slipped, or if you did not use your
regular birth control as you should have, or if you did not use any
birth control, Plan B
®
may work for you. Plan B
®
is an emergency
contraceptive that helps prevent pregnancy after unprotected sex or
when your birth control fails or is not used correctly.
Remember, Plan B
®
is only for emergency pregnancy prevention.
There are many other products that work for regular birth control that
are available by prescription or over-the-counter.
2020
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
There is also another form of protection to think about when you have
sex: protection against sexually transmitted diseases (STDs). Some
common STDs are HIV/AIDS, chlamydia, genital herpes, gonorrhea,
hepatitis, human papilloma virus (HPV), genital warts, syphilis, and
trichomonas. Some of these STDs can be very serious and can lead to
infertility (inability to have a baby), problems during pregnancy,
chronic illness, and even death.
All sexually active women are at risk of catching STDs because they
may not know that their partner has an STD (the partner
himself may not know). If your partner uses a
latex condom correctly each and every time
you have sex with him, this will help reduce,
but not eliminate, the chance that you will
catch an STD.
2121
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
No other birth control methods will effectively protect you from STDs.
The female condom may give you some STD protection, but it is not
as effective as a male latex condom.
For more information on STDs, call the Centers for Disease Control
and Prevention (CDC) AIDS/STD Hotline. The CDC phone numbers
are 1-800-342-AIDS (2437) for English, 1-800-344-7432 for Spanish, or
1-800-243-7889 for hearing impaired, TDD.
Be sure to protect yourself against pregnancy and STDs by using
some form of birth control plus a latex condom. Of course, not having
sex is the most effective way to prevent pregnancy and stay free of
STDs.
2222
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Plan B
®
is used to prevent pregnancy after unprotected sex.
Plan B
®
should not be used for regular birth control, if you are
already pregnant (because it will not work), or if you are allergic
to levonorgestrel or any of the ingredients in Plan B
®
.
The sooner you take Plan B
®
, the better it will work.
2323
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Plan B
®
does not protect against the AIDS virus (HIV) or other
sexually transmitted diseases (STDs)
Common side effects associated with the use of Plan B
®
include
menstrual changes, nausea, lower stomach (abdominal) pain,
tiredness, headache, dizziness, breast pain and vomiting
.
24
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
1-800-330-1271 www.go2planB.com
®
Mfg. by Gedeon Richter, Ltd., Budapest, Hungary
for Duramed Pharmaceuticals, Inc.
Subsidiary of Barr Pharmaceuticals, Inc.
Pomona, New York 10970
©2009 Duramed Pharmaceuticals, Inc. 12001129 July 2009 Printed in USA
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
DURAMED PHARMACEUTICALS, INC.
CARE
SM
(CONVENIENT ACCESS, RESPONSIBLE EDUCATION) PROGRAM
THE MARKETING, EDUCATION, DISTRIBUTION,
AND MONITORING PROGRAM FOR
PLAN B
®
Introduction
The CARE
SM
(Convenient Access, Responsible Education) Program was carefully
constructed to help ensure that Plan B
®
will be used responsibly and appropriately.
Plan B
®
is an over-the-counter (OTC) product for women age 17 or older, with a
prescription-only requirement for women younger than age 17. The sales and marketing
plan for Plan B
®
has been designed to limit the availability of this product, to the extent
practical, to pharmacies and clinics, and to educate healthcare professionals and
consumers within the target age groups regarding the responsible use of Plan B
®
. The
need to take Plan B
®
in as timely a manner as possible dictates that any responsible
marketing program not only address healthcare professionals but also include extensive
consumer education. Thus, the CARE
SM
program contains elements that include an
appropriate consumer education component. In addition, the sponsor will work closely
with retail pharmacies and drug wholesalers to ensure that they will carry Plan B
®
, and
that they will understand and follow the prescription age requirement for the dispensing
of the product to women younger than age 17.
The CARE
SM
program is intended to address issues affecting access to Plan B
®
by
providing sources of accurate and responsible information to both healthcare providers
and consumers. It is also designed to provide a framework for pharmacies to ensure
availability of Plan B
®
as an OTC product when sought by knowledgeable consumers
who are 17 years or older. Women younger than age 17 will require a prescription from
their healthcare provider in order to obtain Plan B
®
. The CARE
SM
program is not
July 7, 2009 Confidential Page 1 of 9
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Duramed Pharmaceuticals, Inc
Plan B
®
(Levonorgestrel) Tablets, 0.75 mg
CARE
SM
Program
intended to impact or change those who can lawfully prescribe or dispense Plan B
®
under
prevailing state laws.
Four core elements of CARE
SM
contribute to the achievement of program objectives.
Labeling/Packaging/Informational toll free number (to provide essential information
to consumers in an accessible, easy to understand format. The Plan B
®
packaging is
designed to meet both prescription and OTC requirements.)
Education (to provide information intended to educate physicians, pharmacists,
pharmacy staff, nurse practitioners, and patients. Educational initiatives will focus on
clearly instructing all audiences on the new lower age requirement that women
younger than age 17 obtain a prescription for Plan B
®
.)
Distribution (to ensure that Plan B
®
will be available only to licensed drug
wholesalers, retail operations with pharmacy services and clinics with licensed
healthcare practitioners, and to successfully facilitate the Plan B
®
prescription-only
age requirement. These settings will also provide easy access by the consumer to a
pharmacist or other healthcare professional should questions arise.)
Monitoring (to evaluate the effectiveness of the program by determining if the age
restriction is understood by all audiences and is properly being adhered to.)
I. Labeling/Packaging
The Plan B
®
labeling was developed to provide clear and comprehensive communication
of the key messages outlined above, and to make known additional sources of
information. The Plan B
®
packaging is designed to meet all requirements of both a
prescription and over-the-counter product. The Plan B
®
packaging allows pharmacies to
July 7, 2009 Confidential Page 2 of 9
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Duramed Pharmaceuticals, Inc
Plan B
®
(Levonorgestrel) Tablets, 0.75 mg
CARE
SM
Program
appropriately dispense Plan B
®
as either a prescription or OTC product. The package
also provides educational information to the consumer in a patient friendly format.
Elements of the package are as follows:
The back of the carton includes the Drug Facts as well as a space for the
pharmacy to place the required prescription labeling;
The statement, “Rx only for women younger than age 17” appears on the
Principal Display Panel and “prescription only for women younger than age 17.
If you are younger than age 17, see a healthcare professional” appears on the
Drug Facts panel of the carton;
The inner portion of the carton houses the Plan B
®
tablet and clearly states the
directions for when to take Plan B
®
;
The Plan B
®
Package Insert and an educational booklet designed for the consumer
(Consumer Information Leaflet) will be housed inside the carton;
The toll-free number for the Plan B
®
24-hour Information Line and the Plan B
®
web address are clearly displayed in the Drug Facts panel of the package should
the consumer have additional questions on Plan B
®
.
II. Education
The CARE
SM
Program provides for an intensively educational approach to the
introduction of Plan B
®
as an OTC product to those age 17 years or older. Educational
programs will focus on both healthcare professionals as well as consumers. The
July 7, 2009 Confidential Page 3 of 9
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Duramed Pharmaceuticals, Inc
Plan B
®
(Levonorgestrel) Tablets, 0.75 mg
CARE
SM
Program
consumer advertising is designed to stimulate discussions with healthcare providers. The
program will assist healthcare providers in developing an adequate knowledge base so
that they can provide responsible and accurate counseling to patients.
Efforts directed to raising consumer awareness of the product and its appropriate use will
follow appropriate professional education programs. The educational materials will
address not only Plan B
®
but will encourage healthcare professionals to urge users to
adopt routine forms of contraception and avoid reliance on Plan B
®
as their primary form
of birth control.
A. Educational Program to Healthcare Professionals.
Plan B
®
will be introduced and explained to healthcare professionals to raise
awareness and knowledge levels as to this product for emergency contraception.
This program is intended to ensure that healthcare professionals are prepared to
support their patient populations.
Specifically, the new lower prescription age requirement will be emphasized to
healthcare professionals to ensure that they are knowledgeable of the prescription
requirement for women younger than age 17 and that they understand how to
appropriately dispense the Plan B
®
package in both prescription and OTC scenarios.
Programs will include continuing education by certified professionals and
educational materials (including websites and toll free numbers) that can be accessed
easily and at any time. The sponsor will make available to the state boards of
pharmacy Continuing Education programs for pharmacists. The sponsor’s sales
July 7, 2009 Confidential Page 4 of 9
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Duramed Pharmaceuticals, Inc
Plan B
®
(Levonorgestrel) Tablets, 0.75 mg
CARE
SM
Program
representatives
1
will communicate the prescription requirement for women younger
than age 17 as well as the OTC availability of Plan B
®
for those 17 years of age or
older.
B. Educational Campaign to Consumers
1. The campaign is designed to convey critical awareness and educational
messages as well as information about product availability, the time sensitivity
of use, and the age requirements to obtain Plan B
®
as a prescription or OTC
product. The intent will be to make consumers aware of the availability of
emergency contraception, its appropriate use and the need to use it as soon as
possible. Women younger than age 17 will be encouraged to contact their
healthcare professional to learn about emergency contraception, routine forms of
birth control, and sexually transmitted infection (STI)/human immunodeficiency
virus (HIV).
2. The direct to consumer campaign will be designed to target those ages 17 to 44.
i) The language and visuals used will be appropriate and of interest to this
targeted age group. As appropriate, new promotional materials will be
provided to FDA for comment. Promotional materials will be submitted to
the Division of Drug Marketing, Advertising, and Communications via Form
FDA 2253.
ii) Media placements that target audiences younger than age 17 will not be
used.
1
The sponsor’s sales force for female healthcare products, currently consisting of approximately 230 sales
representatives, visit the offices of approximately 30,000 physicians, mostly Obstetricians and
Gynecologists.
July 7, 2009 Confidential Page 5 of 9
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Duramed Pharmaceuticals, Inc
Plan B
®
(Levonorgestrel) Tablets, 0.75 mg
CARE
SM
Program
III. Distribution
The sponsor believes that in the interest of responsible usage (and in recognition of the
circumstances of the need for emergency contraception), Plan B
®
should be available in
those retail pharmacy outlets that typically sell a broad range of OTC medications and
that have pharmacy services staffed with pharmacists (or, in the case of clinics, other
healthcare professionals) during normal business hours to answer questions. Since Plan
B
®
will have a prescription only requirement for women younger than age 17, Duramed
Pharmaceuticals and the third party distributors, wholesaler distribution and chain drug
companies, will only be allowed to distribute Plan B
®
to licensed pharmacies or other
licensed healthcare clinics, as it would be unlawful to distribute a prescription product to
any business that does not have a valid pharmacy license and/or physician license. Since
Plan B
®
has both Rx and OTC labeling, it will be treated as any other Rx product for
distribution purposes; specifically, it would only be distributed to licensed pharmacies or
healthcare clinics. Therefore, Plan B
®
will not be available at gas stations or convenience
stores. Additionally, since Plan B
®
has both Rx and OTC labeling, the pharmacies will
keep the product behind the counter and control it as an Rx product. The pharmacy and
clinic settings will also allow pharmacists and other healthcare providers to properly
restrict OTC access to those age 17 years or older.
IV. Monitoring
The sponsor intends to monitor trends in the use of emergency contraception to evaluate
the effectiveness of the CARE
SM
program and will make adjustments as appropriate.
Monitoring will be accomplished in several ways, with information gathered from both
healthcare professionals and consumers.
Monitoring actual use of Plan B
®
is complex due to the difficulties inherent in identifying
July 7, 2009 Confidential Page 6 of 9
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Duramed Pharmaceuticals, Inc
Plan B
®
(Levonorgestrel) Tablets, 0.75 mg
CARE
SM
Program
those who have purchased the product and in gathering useful, generalizable information.
Consequently, the monitoring component will rely on a variety of sources intended to
provide trend data, observational data, and signals of program effectiveness and potential
problems. Monitoring components may include the following:
1. A market research survey or surveys of a subset of healthcare professionals (e.g.
OB/GYN, family practice, pharmacists, nurses, family planning and health clinic
personnel) to determine:
• Whether the prescription requirement for women younger than age 17 is
understood and is being adhered to at the point of purchase
• Attitudes toward and experience with patients’ usage of Plan B
®
• Trends among emergency contraception users within their patient
population (especially source of awareness, repeat use, use instead of
more effective forms of contraception, incidence of STIs, etc.)
• Nature of interactions with Plan B
®
users (Does the contact with the
healthcare professional occur prior to product usage? after usage? Are
the women in search of contraceptive counseling? What types of side
effects are being seen in use?)
• Areas where additional information is needed in the marketplace, as
identified by the questions raised by the users
2. Gathering data from actual users of Plan B
®
is difficult because the number of
users will be relatively small and because the decision to use emergency
contraception is a private and emotional one. Women choosing to use the product
are expected to wish to remain anonymous and are entitled to maintain their
privacy. Nevertheless, the sponsor may work with a variety of sources in an
July 7, 2009 Confidential Page 7 of 9
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Duramed Pharmaceuticals, Inc
Plan B
®
(Levonorgestrel) Tablets, 0.75 mg
CARE
SM
Program
effort to obtain and analyze consumer data in accordance with HIPAA regulations
to assess the effectiveness of the CARE
SM
program elements.
3. Monitoring compliance of the Plan B
®
prescription age requirement can be
somewhat complex because there will be no documented information on the
purchasers of Plan B
®
who were old enough to obtain it as an OTC product. The
sponsor intends to monitor the level of comprehension of the prescription age
requirement particularly at the pharmacy level, where the age of consumers must
be assessed at the point of purchase. The following program will provide accurate
information directly related to accessing compliance:
Point of Purchase Monitoring Program:
The sponsor will continue to conduct a “Point-of-Purchase Monitoring
Program”, which intends to track how Plan B
®
is being sold at the time of
purchase. Due to the challenges of obtaining specific purchase data on an
OTC product and respecting consumer privacy, this program will include
anonymous shoppers who will be directed to visit locations where Plan B
®
is available and purchase the product. These transactions will be
documented and analyzed to determine the level of comprehension of the
Plan B
®
prescription age requirement and how it is handled at the point of
purchase. The shoppers in this program will be 15 to 16 years old. Parental
consent will be obtained for the shoppers as they will be under the age of 18
years. Locations for this program will be selected based on areas where
Plan B
®
use is high, and will be in different regions of the US to provide a
national representation of the findings. These findings would provide
concrete information on how the prescription age requirement for Plan B
®
is
being addressed at the pharmacy and if it is properly being followed. The
Sponsor will use these findings to identify areas where more education on
July 7, 2009 Confidential Page 8 of 9
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Duramed Pharmaceuticals, Inc
Plan B
®
(Levonorgestrel) Tablets, 0.75 mg
CARE
SM
Program
the prescription age restriction is needed and will focus their efforts on
improving the level of understanding among pharmacists and the pharmacy
staff. Findings from the study will be communicated to the pharmacy, and
the corporate office, if appropriate, since education and retraining will be the
first course of remedial action. In the case of repeat violators, the violator’s
State Board of Pharmacy will be notified. The Point-of-Purchase
Monitoring Program will be conducted annually.
V. Reporting
The sponsor will continue to provide FDA a monitoring report with the available results
from the above monitoring activities, including the point of purchase monitoring, on an
annual basis, with submission of the report within 60 calendar days after the interval date.
Any change in reporting period will be requested by the sponsor and agreed to by FDA.
Duramed Pharmaceuticals, Inc.
July 2009
July 7, 2009 Confidential Page 9 of 9
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda