Patient Guide

Transcription

Patient Guide

INDICATION
TM
ated forZenatane
the treatment
(Isotretinoin)
of severe recalcitrant
Capsules
e effects
areassociated
indicated with
for the
itstreatment
use, Zenatane
of
nodularsevere
acne who
recalcitrant
are unresponsive
nodular acne.
to
tibiotics.
Because of significant adverse
effects associated with its use,
ZenataneTM should be reserved
for patients with severe nodular
acne who are unresponsive to
conventional therapy, including
systemic antibiotics.
IMPORTANT SAFETY INFORMATION
ZenataneTM must not be used by female patients who are or
may become pregnant. There is an extremely high risk that
severe birth defects will result if pregnancy occurs while
taking ZenataneTM in any amount, even for short periods of time.
Potentially any fetus exposed during pregnancy can be affected. There are no
accurate means for determining whether an exposed fetus has been affected.
Other serious side effects include depression, psychosis, and rarely, suicidal
ideation, suicide attempts and suicide, and aggressive and/or violent behavior;
Pseudotumor Cerebri, pancreatitis, hearing impairment, inflammatory bowel
disease, skeletal changes, hyperostosis, premature epiphyseal closure, vision
impairment, corneal opacities, decreased night vision.
• Verify your insurance and answer
any related questions
Promius Pharma is pleased to bring you some valuable
support tools to help guide you through your commitment
to treatment requirements. We will also introduce you
to a unique pharmacy program—The Promius PromiseTM—
that provides convenient product access as well as
other support services.
• Confirm your iPLEDGETM eligibility
The following tools are enclosed in this folder:
The Promius Promise will
contact you soon in order to:
Patient
Guide
• Automatically apply the
TOOLS TO HELP
ZENATANE co-pay card for
Y O U patients*:
NAVIGATE
eligible
YOUR TREATMENT
– $0 co-pay for commercially
REQUIREMENTS
insured patients
– Save up to $100 per
prescription for cash-paying
patients
• Ship ZENATANE directly to your
home if you are iPLEDGETM eligible
• Remind you to make your next
office appointment if you would
like us to do so
• Contact your doctor’s office and
insurance company, if necessary
• Answer other questions
you may have
There are other ways The Promius
Promise can help. To hear more,
call 1.888.959.7600.
ull Prescribing Information in folder for
other important Warnings and Precautions.
iCan CHECK (Step-By-Step Checklist)
Can help make sure you’ve taken all of the necessary steps
to meet your treatment requirements. With it you can track:
• Any needed tests you must schedule
• The monthly mandated timeframe
to fill your prescription
• Answering any mandatory questions
about treatment requirements
iCan ASK (Q&A)
Can lead you to the right answers. This Q&A is conveniently
organized to provide answers to questions about your
ZENATANETM (Isotretinoin) Capsules prescription, the
treatment requirements, The Promius PromiseTM pharmacy,
and support services.
iCan FIND (Tips & Resources)
Can lead you to additional tips and resource contact
information to help your experience with ZENATANETM
and the treatment process flow smoothly.
See the back of this brochure.
For more information, please see full Prescribing Information in folder for
Boxed Warning, Contraindications, and other important Warnings and Precautions.
INDICATION
ZenataneTM (Isotretinoin) Capsules are indicated for the treatment of severe recalcitrant
nodular acne. Because of significant adverse effects associated with its use, ZenataneTM
should be reserved for patients with severe nodular acne who are unresponsive to
conventional therapy, including systemic antibiotics.
Zenatane must not be used by female patients who are or
may become pregnant. There is an extremely high risk that
severe birth defects will result if pregnancy occurs while
taking Zenatane in any amount, even for short periods of time.
Potentially any fetus exposed during pregnancy can be affected. There are no
accurate means for determining whether an exposed fetus has been affected.
Other serious side effects include depression, psychosis, and rarely, suicidal
ideation, suicide attempts and suicide, and aggressive and/or violent behavior;
Pseudotumor Cerebri, pancreatitis, hearing impairment, inflammatory bowel
disease, skeletal changes, hyperostosis, premature epiphyseal closure, vision
TM
Convenience and
Service – From
Promius Pharma
The Promius PromiseTM will
contact you soon in order to:
• Verify your insurance and answer
any related questions
Promius Pharma is pleased to bring you some valuable
support tools to help guide you through your commitment
to treatment requirements. We will also introduce you
to a unique pharmacy program—The Promius Promise—
that provides convenient product access as well as
other support services.
Your ZENATANETM
(Isotretinoin) Capsules
prescription is backed by
The Promius PromiseTM—
a convenient pharmacy
and support service that
is designed to bridge your
needs with the needs of
your healthcare provider.
Enroll and get ZENATANETM
delivered directly to
your home!
• Confirm your iPLEDGETM eligibility
The following tools are enclosed in this folder:
• Automatically apply the
ZENATANETM co-pay card for
eligible patients*:
iCan CHECK (Step-By-Step Checklist)
Ask your doctor’s office to
complete and submit your
enrollment form today.
– $0 co-pay for commercially
insured patients
– Save up to $100 per
prescription for cash-paying
patients
• Ship ZENATANETM directly to your
home if you are iPLEDGETM eligible
• Remind you to make your next
office appointment if you would
like us to do so
• Contact your doctor’s office and
insurance company, if necessary
*See rebate card for
eligibility requirements
• Answer other questions
you may have
®
U N L I M I T E D
P O S S I B I L I T I E S
There are other ways The Promius
PromiseTM can help. To hear more,
call 1.888.959.7600.
Can help make sure you’ve taken all of the necessary steps
to meet your treatment requirements. With it you can track:
• Any needed tests you must schedule
•T
he monthly mandated timeframe
to fill your prescription
•A
nswering any mandatory questions
about treatment requirements
iCan ASK (Q&A)
Can lead you to the right answers. This Q&A is conveniently
organized to provide answers to questions about your
ZENATANETM (Isotretinoin) Capsules prescription, the
treatment requirements, The Promius Promise pharmacy,
and support services.
iCan FIND (Tips & Resources)
Can lead you to additional tips and resource contact
information to help your experience with ZENATANE
and the treatment process flow smoothly.
See the back of this brochure.
INDICATION
INDICATION
ZenataneTM (Isotretinoin) Capsules are indicated for the treatment of severe recalcitrant nodular acne. Because of significant
adverse effects associated with its use, ZenataneTM should be reserved for patients with severe nodular acne who are unresponsive
to conventional therapy, including systemic antibiotics.
ZenataneTM (Isotretinoin) Capsules
are indicated for the treatment of
severe recalcitrant nodular acne.
Because of significant adverse
effects associated with its use,
Zenatane should be reserved
for patients with severe nodular
acne who are unresponsive to
conventional therapy, including
ZenataneTM must not be used by female patients who are or may become pregnant. There is an extremely high
risk that severe birth defects will result if pregnancy occurs while taking ZenataneTM in any amount, even for short
periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means
for determining whether an exposed fetus has been affected.
Other serious side effects include depression, psychosis, and rarely, suicidal ideation, suicide attempts and suicide, and
aggressive and/or violent behavior; Pseudotumor Cerebri, pancreatitis, hearing impairment, inflammatory bowel disease, skeletal
changes, hyperostosis, premature epiphyseal closure, vision impairment, corneal opacities, decreased night vision.
iCan
Patient
Guide
FIND
Tips & Resources
TOOLS TO HELP
YOU NAVIGATE
Helpful Tips From Your ZENATANETM
(Isotretinoin) Capsules Toolkit
YOUR TREATMENT
THE FOLLOWING SOURCES
ARE AVAILABLE TO YOU:
REQUIREMENTS
The iCan CHECKLIST reminds you:
f the simple steps you need to follow to keep your
• O
treatment commitments
o mark your calendar for 30 days after stopping
• T
ZENATANETM; this is when you’re able to donate blood
again
Using the iPLEDGETM System
The iPLEDGETM system can be accessed either online or via
the phone: www.ipledgeprogram.com or 1.866.495.0654.
If you have questions, ask your healthcare provider or
contact iPLEDGETM directly.
Try these time-saving tips for
accessing iPLEDGETM:
The Promius PromiseTM:
1.888.959.7600
The iPLEDGETM program:
www.ipledgeprogram.com
or by phone at: 1.866.495.0654
The ZENATANETM website:
www.zenatane.com
• Bookmark the site on your computer
• Save the phone number on your mobile phone
All Roads Lead to Answers
Whether you need information about your ZENATANETM
treatment or The Promius PromiseTM pharmacy service, there
are resources available to you.
Your questions are important, so we want
to be sure you get answers.
©2012 Promius Pharma, LLC. All rights reserved.
ZNT-1212-005
®
U N L I M I T E D
P O S S I B I L I T I E S
INDICATION
ZenataneTM (Isotretinoin) Capsules are indicated for the treatment of severe recalcitrant nodular acne. Because of
significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne
who are unresponsive to conventional therapy, including systemic antibiotics.
INDICATION
significant adverse effects associated with its use, ZenataneTM should be reserved for patients with severe nodular acne
Zenatane must not be used by female patients who are or may become pregnant. There is an extremely high
risk that severe birth defects will result if pregnancy occurs while taking Zenatane in any amount, even for short
periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means for
determining whether an exposed fetus has been affected.
UNDERSTANDING
THE
PROMIUS
PROMISE
aggressive and/or violent behavior; Pseudotumor
Cerebri, pancreatitis,
hearing
impairment, inflammatory
bowel disease,
skeletal changes, hyperostosis, premature epiphyseal closure, vision impairment, corneal opacities, decreased night vision.
aggressive and/or violent behavior; Pseudotumor Cerebri, pancreatitis, hearing impairment, inflammatory bowel disease,
UNDERSTANDING THE PROMIUS PROMISE
Q.What is The Promius Promise?
A. The Promius Promise provided by Promius Pharma
is a unique pharmacy service that can deliver your
ZENATANETM (Isotretinoin) Capsules prescription quickly,
easily, and directly to your home or work and automatically
apply the ZENATANE rebate for eligible patients.*
Q.How do I sign up for The Promius Promise?
A.Once you have been prescribed ZENATANE, ask your
healthcare provider to sign you up. Just give him/her your
address and insurance information and he’ll/she’ll fill out and
fax in the enrollment form. Soon after, The Promius Promise
will contact you, ask a few more simple questions, and
confirm the address where you’d like your prescription sent.
That’s all it takes!
If you did not sign up while at your healthcare provider's
office, don't worry: you can still sign up. Simply fax your
enrollment form to The Promius Promise, 1.855.345.6789,
and they will phone you to follow up with you for the
necessary information.
Q.Can The Promius Promise send my prescription
to me within my prescription window?
A.Yes. Once your information has been verified, The Promius
Promise ships your prescription out by UPS. It tracks the
shipment and handles any delivery issues. Just remember,
an adult’s signature is required to receive the shipment. If
you are under 18, The Promius Promise will work with you
to set up a convenient shipment time when
an adult’s signature can be obtained.
Q.How does The Promius Promise get my
prescription to me so fast?
A.Your ZENATANE prescription gets to you quickly via UPS.
The Promius Promise will automatically process the
prescription and apply the ZENATANE co-pay card for
eligible* patients. That means if you have commercial
insurance, you’ll pay $0. (For cash-paying patients, you’ll
save up to $100 per prescription.) The Promius Promise
will even call you or your healthcare provider’s office
if there’s ever a problem.
Q.Can The Promius Promise
get my prescription to me at work?
A.If you’d rather receive your ZENATANE shipment at work
instead of at home, that can be arranged; as long as there
is an adult to sign for it. If you are under 18, The Promius
Promise will work with you to set up a convenient
shipment time when an adult’s signature can be obtained.
FOR FEMALE PATIENTS
OF CHILD-BEARING POTENTIAL
iCan CHECK
A STEP-BY-STEP TREATMENT CHECKLIST
Q.Can The Promius Promise help get my
ZENATANE prescription at a local pharmacy?
A.Yes, if you prefer to get your prescription at a local
pharmacy, The Promius Promise can help you find
a registered pharmacy in your area with ZENATANE in
stock. You will need to bring your co-pay card with you
when you pick up your prescription.
Q.What if I have questions about
The Promius Promise?
A.You can reach The Promius Promise at 1.888.959.7600.
Use this convenient
checklist to keep
track of your treatment
requirements
We will be happy to answer your questions.
If you have questions about ZENATANE,
contact your healthcare provider
or visit www.zenatane.com.
C
ontact The Promius Promise
at 1.888.959.7600.
A
dditional information can also
be found at www.ipledgeprogram.com
or 1.866.495.0654.
©2012 Promius Pharma, LLC.
All rights reserved. ZNT-1212-006
U N L I M I T E D P O S S I B I L I T I E S
INDICATION
STAYING ON TRACK
1
2
At my first
office visit I:
TALKED to my doctor and
made a treatment plan
HEARD and
NOTES ABOUT MY
TREATMENT REQUIREMENTS:
3
At my next office visit I:
Before my next visit I:
UNDERSTOOD all the
T
OOK a pregnancy test at
counseling about:
a lab/doctor’s office within
the first 5 days of my

ZENATANETM side effects,
menstrual cycle
not donating blood

MONTHLY office visits, to get
UNDERSTOOD counseling
a new prescription every month
about:

Z
ENATANETM
SCHEDULED my next office visit
(Isotretinoin) Capsules
side effects,
not donating blood

N
OT getting pregnant,
getting tested once
a month
OFFICE visits to

get a new prescription
every month
S
CHEDULED my next
office visit
4
5
Between all
my office visits I:
T
OOK pregnancy tests
in a lab or doctor’s office
F
ILLED my ZENATANETM
prescription within SEVEN DAYS
of my negative pregnancy test
6
At my last office visit I:
30 days after my last dose I:
UNDERSTOOD all the
TOOK a pregnancy test in a lab or doctor’s office
counseling about:

Z
ENATANETM side effects,
not getting pregnant, and not
donating blood for 30 days

R
ETURNING to the office
or lab for final pregnancy test
(if any of these things did not
happen, discuss it with your
healthcare provider)
TOOK a pregnancy test
in a lab or doctor’s office
Additional information can be found at
www.ipledgeprogram.com or 1.866.495.0654
For questions about ZENATANETM,
visit www.zenatane.com
INDICATION
INDICATION
UNDERSTANDING
THE
PROMIUS
PROMISE
hearing
bowel disease,
TM
UNDERSTANDING THE PROMIUS PROMISE T M
Q.What is The Promius PromiseTM?
A. The Promius PromiseTM provided by Promius Pharma
apply the ZENATANETM rebate for eligible patients.*
Q.How do I sign up for The Promius PromiseTM?
A.Once you have been prescribed ZENATANETM, ask your
fax in the enrollment form. Soon after, The Promius PromiseTM
enrollment form to The Promius PromiseTM, 1.855.345.6789,
FOR FEMALE PATIENTS
OF CHILD-BEARING POTENTIAL
Q.Can The Promius PromiseTM
iCan CHECK
A.If you’d rather receive your ZENATANETM shipment at work
PromiseTM will work with you to set up a convenient
Q.Can The Promius PromiseTM help get my
ZENATANETM prescription at a local pharmacy?
pharmacy, The Promius PromiseTM can help you find
a registered pharmacy in your area with ZENATANETM in
Use this convenient
checklist to keep
requirements
The Promius PromiseTM?
A.You can reach The Promius PromiseTM at 1.888.959.7600.
TM
PromiseTM ships your prescription out by UPS. It tracks the
you are under 18, The Promius PromiseTM will work with you
Q.How does The Promius PromiseTM get my
A.Your ZENATANETM prescription gets to you quickly via UPS.
The Promius PromiseTM will automatically process the
prescription and apply the ZENATANETM co-pay card for
save up to $100 per prescription.) The Promius PromiseTM
If you have questions about ZENATANETM,
C
ontact The Promius PromiseTM
at 1.888.959.7600.
A
or 1.866.495.0654.
®
INDICATION
INDICATION
UNDERSTANDING
THE
PROMIUS
PROMISE
hearing
bowel disease,
UNDERSTANDING THE PROMIUS PROMISE
Q.What is The Promius Promise?
A. The Promius Promise provided by Promius Pharma
apply the ZENATANE rebate for eligible patients.*
Q.How do I sign up for The Promius Promise?
A.Once you have been prescribed ZENATANE, ask your
fax in the enrollment form. Soon after, The Promius Promise
enrollment form to The Promius Promise, 1.855.345.6789,
Promise ships your prescription out by UPS. It tracks the
you are under 18, The Promius Promise will work with you
Q.How does The Promius Promise get my
A.Your ZENATANE prescription gets to you quickly via UPS.
The Promius Promise will automatically process the
prescription and apply the ZENATANE co-pay card for
save up to $100 per prescription.) The Promius Promise
Q.Can The Promius Promise
A.If you’d rather receive your ZENATANE shipment at work
Promise will work with you to set up a convenient
FOR FEMALE PATIENTS OF
NON CHILD-BEARING POTENTIAL
AND MALE PATIENTS
iCan CHECK
Q.Can The Promius Promise help get my
ZENATANE prescription at a local pharmacy?
pharmacy, The Promius Promise can help you find
a registered pharmacy in your area with ZENATANE in
The Promius Promise?
A.You can reach The Promius Promise at 1.888.959.7600.
Use this convenient
checklist to keep
requirements
If you have questions about ZENATANE,
C
ontact The Promius Promise
at 1.888.959.7600.
A
or 1.866.495.0654.
INDICATION
STAYING ON TRACK
1
NOTES ABOUT MY
TREATMENT REQUIREMENTS:
2
At my first office visit I:
Before my next visit I:
TALKED to my doctor and
F
ILLED my ZENATANETM
made a treatment plan
prescription within 30 days
HEARD and UNDERSTOOD
counseling about:

Z
ENATANETM (Isotretinoin)
Capsules side effects,
not donating blood

OFFICE visits to get a new
prescription every month
3
4
At my next office visit I:
UNDERSTOOD all the counseling about:
(if any of these things did not happen,
discuss it with your healthcare provider)
5
Between all
my office visits I:
F
ILLED my ZENATANETM

ZENATANE
TM
side effects,
prescription within 30 days
not donating blood
At my last office visit I:
UNDERSTOOD all the counseling about:

Z
ENATANETM side effects, not
donating blood for the next 30 days
RECEIVED a new prescription of ZENATANETM
Additional information can be found at
www.ipledgeprogram.com or 1.866.495.0654
For questions about ZENATANETM, visit www.zenatane.com
INDICATION
INDICATION
UNDERSTANDING
THE
PROMIUS
PROMISE
hearing
bowel disease,
TM
A. The Promius PromiseTM provided by Promius Pharma
apply the ZENATANETM rebate for eligible patients.*
A.Once you have been prescribed ZENATANETM, ask your
fax in the enrollment form. Soon after, The Promius PromiseTM
FOR FEMALE PATIENTS OF
NON CHILD-BEARING POTENTIAL
AND MALE PATIENTS
UNDERSTANDING THE PROMIUS PROMISE T M
enrollment form to The Promius PromiseTM, 1.855.345.6789,
Q.Can The Promius PromiseTM get
my prescription to me at work?
iCan CHECK
A.If you’d rather receive your ZENATANETM shipment at work
PromiseTM will work with you to set up a convenient
Q.Can The Promius PromiseTM help get my
ZENATANETM prescription at a local pharmacy?
pharmacy, The Promius PromiseTM can help you find
a registered pharmacy in your area with ZENATANETM in
Use this convenient
checklist to keep
requirements
TM
PromiseTM ships your prescription out by UPS. It tracks the
you are under 18, The Promius PromiseTM will work with you
The Promius PromiseTM will automatically process the
prescription and apply the ZENATANETM co-pay card for
save up to $100 per prescription.) The Promius PromiseTM
C
ontact The Promius PromiseTM
at 1.888.959.7600.
A
or 1.866.495.0654.
®
iCan Ask
PATIENT Q&A Guide
INDICATION
ZenataneTM (Isotretinoin) Capsules are indicated for
the treatment of severe recalcitrant nodular acne.
Because of significant adverse effects associated
with its use, ZenataneTM should be reserved for
patients with severe nodular acne who are
unresponsive to conventional therapy, including
Q
UESTIONS
As you know, the treatment
you’ve been prescribed has certain
requirements you must meet.
Following through on your
commitments may be easier because
of the materials in the ZENATANETM
(Isotretinoin) Capsules Toolkit.
For more information, please see full Prescribing
Information in folder for Boxed Warning, Contraindications,
and other important Warnings and Precautions.
ZenataneTM must not be used by female
patients who are or may become
pregnant. There is an extremely high
risk that severe birth defects will result
if pregnancy occurs while taking ZenataneTM in any
amount, even for short periods of time. Potentially
any fetus exposed during pregnancy can be affected.
There are no accurate means for determining whether
an exposed fetus has been affected.
Other serious side effects include depression, psychosis,
and rarely, suicidal ideation, suicide attempts and
suicide, and aggressive and/or violent behavior;
Pseudotumor Cerebri, pancreatitis, hearing impairment,
inflammatory bowel disease, skeletal changes,
hyperostosis, premature epiphyseal closure, vision
A
NSWERS
This Q&A is conveniently organized
to help you learn more about:
• ISOTRETINOIN and ZENATANETM
• The Promius PromiseTM,
our unique pharmacy service
INDICATION
with its use, ZenataneTM should be reserved for patients
with severe nodular acne who are unresponsive to
conventional therapy, including systemic antibiotics.
UNDERSTANDING ISOTRETINOIN
A N D Z E N A T A N E TM
(I sotretinoi n) Capsul es
You must return to your doctor as directed to make sure you
FOR FEMALE PATIENTS
WHO CAN GET PREGNANT
do not have any signs of serious side effects. Your doctor
may do a blood test to check for serious side effects from
ZENATANETM. Female patients who can get pregnant will take
a pregnancy test each month.1,2
Q.What is isotretinoin and why did my doctor
prescribe it?
If you take too much ZENATANE or overdose, call your
TM
Q.If I am visiting my doctor for a skin problem,
why are we talking about birth control?
doctor or poison control center right away.
The goal is to prevent:
of severe recalcitrant nodular acne. It is used when other
Q.What is my “prescription window?”
treatments, including antibiotics, have not helped. It is a capsule
A. You must pick up your ZENATANETM prescription within a set
that is taken by mouth.1
A. Your ZENATANETM Toolkit offers easy-to-follow
materials that provide:
requirements and progress
• Females who are taking ZENATANETM from getting pregnant
Female patients who can get pregnant must agree to use
• Step-by step guidance in tracking of your treatment
• Answers to questions about ZENATANETM
or The Promius PromiseTM
number of days, known as your “prescription window.”
2 separate forms of effective birth control at the same time
If you are a female who can get pregnant, your prescription
1 month before, while taking, and for 1 month after taking
serious mental health issues—so there is a set of steps called the
window is only 7 days. This means that the time from the day
isotretinoin. You must access the iPLEDGETM system to
iPLEDGE™ Program that must be followed when taking it.
Q.What if I damage or lose these support materials?
when you receive a negative pregnancy test result to the day
answer questions about the program requirements and
when you pick up your ZENATANETM cannot exceed 7 days.
to enter your 2 chosen forms of birth control. You can
This is to make sure you are not pregnant while taking the
access iPLEDGETM at www.ipledgeprogram.com or by calling
medicine. If you do not pick up your prescription by 11:59 pm
1.866.495.0654.1
It can cause serious side effects—including birth defects and
Q:What is ZENATANETM?
A: ZENATANETM is an isotretinoin made available from Promius
Pharma. For more information about ZENATANE , please see
TM
Eastern time on day 7 of your prescription window, (count
the full prescribing information or visit www.zenatane.com.
the day of your pregnancy test as day 1), you must repeat
Q:Are there requirements for taking ZENATANE ?
pregnancy testing and schedule another office visit before
A: You must enroll in iPLEDGE™ and follow all instructions.
you can be issued a new ZENATANE prescription.
TM
The goal of the iPLEDGE™ Program is to prevent pregnancies
TM
If you are male or a female who cannot get pregnant, your
prescription window is 30 days from the time you receive
females from taking ZENATANE .
your prescription from your healthcare provider.
Because of the potential for serious side effects, it’s
important that a woman who can get pregnant does not get
pregnant while on treatment. If you are a female who can get
pregnant, you must agree to use two approved forms of birth
control and take pregnancy tests, before, during, and for one
month after ending ZENATANETM therapy.
Q.Why do I need to go to my healthcare provider’s
office every month?
A. Your healthcare provider needs to see if ZENATANETM is
working. He/she will want to see if you are having any
side effects from your ZENATANETM treatment and if you
A.Forms of contraception can fail. Using two forms
will get pregnant.
MALE PATIENTS OR FEMALES
WHO CANNOT GET PREGNANT
Q. How do I take ZENATANETM?
to pick up your written prescription, because ZENATANETM
every month you are on treatment to receive your written
A. Take ZENATANETM exactly as your healthcare provider
prescriptions can only be written for a 30-day supply.
prescription. ZENATANETM is only dispensed in a 30-day
of ZENATANETM at one time. It should be taken twice a day
with a meal and a full glass of liquid. Do not chew or suck on
contact The Promius PromiseTM at 1.888.959.7600
for prompt replacements.
A. Absolutely. The same helpful materials are available
at www.zenatane.com.
Q.Is there anyone I can talk to regarding questions
I might have on the materials I received?
A. For questions regarding the toolkit materials,
please call The Promius PromiseTM at 1.888.959.7600.
A.If you are a male or a female who cannot get pregnant,
you will need to visit your healthcare provider’s office
prescribed it. You will receive no more than a 30-day supply
A. If you need additional copies of any of your materials,
Q.What must males and females
who cannot get pregnant do monthly
to receive a ZENATANETM prescription?
are meeting all of your requirements. You will also need
1,2
• Tips for handling the challenges of therapy more easily
Q.Are any of the these materials available online?
Q.Why two forms of contraception?
of contraception reduces the chance that you
1
in females taking ZENATANETM and to prevent pregnant
TM
Q. Is there any kind of support that can help me
during the treatment process?
A.ZENATANETM has serious side effects, including birth defects.
1
A: Isotretinoin (eye-soh-tret-in-OH-in) is used for the treatment
THE ZENATANE T M TOOLKIT
supply. If you do not pick up your prescription by 11:59 pm
Eastern time on day 30 of your prescription window (count
your office visit as day 1), you will be required to start the
process over again by visiting your healthcare provider.2
the capsule. If you miss a dose, skip that dose. Do not take
two doses to try to make up for it. 1,2
Zenatane must not be used by female
patients who are or may become
pregnant. There is an extremely high
risk that severe birth defects will result
if pregnancy occurs while taking Zenatane in any
amount, even for short periods of time. Potentially
any fetus exposed during pregnancy can be affected.
There are no accurate means for determining whether
an exposed fetus has been affected.
Other serious side effects include depression, psychosis,
and rarely, suicidal ideation, suicide attempts and
suicide, and aggressive and/or violent behavior;
Pseudotumor Cerebri, pancreatitis, hearing impairment,
inflammatory bowel disease, skeletal changes,
hyperostosis, premature epiphyseal closure, vision
INDICATION
TM
Q.Can The Promius PromiseTM get
my prescription to me at work?
A. The Promius PromiseTM from Promius Pharma, the providers
A.If you’d rather receive your ZENATANETM shipment at work instead
of ZENATANETM (Isotretinoin) Capsules is a pharmacy service
that can deliver your ZENATANETM prescription quickly, easily,
and directly to your home or work and automatically apply the
ZENATANETM rebate for eligible patients.*
of at home, that can be arranged—as long as there is an adult
to sign for it. If you are under 18, The Promius PromiseTM will work
with you to set up a convenient shipment time when an adult’s
signature can be obtained.
*See back of rebate card for eligibility requirements.
Q.Can The Promius PromiseTM help get my ZENATANETM
prescription at a local pharmacy?
A.Once you have been prescribed ZENATANETM, ask your healthcare
A.Yes, if you prefer to get your prescription at a local pharmacy,
provider to sign you up. Just give him/her your address and
insurance information to fill out and to fax in the enrollment
form. Soon after, The Promius PromiseTM will contact you, ask a
few more simple questions and confirm the address where you’d
like your prescription sent. That’s all it takes!
A
NSWERS
If you did not sign up while at your healthcare provider’s office:
don’t worry. You can still sign up. Simply fax your
enrollment form to The Promius PromiseTM, 1.855.345.6789;
they will phone you to follow up for all necessary information.
They will be happy to answer your questions.
A. Yes. Once your information has been verified, The Promius
Contact The Promius PromiseTM at 1.888.959.7600.
PromiseTM ships your prescription by UPS. It tracks the shipment
and handles any delivery issues. Just remember, an adult’s
signature is required to receive the shipment. If you are under 18,
The Promius PromiseTM will work with you to set up a convenient
• ISOTRETINOIN and ZENATANE
• The Promius Promise,
our unique pharmacy service
The Promius PromiseTM can help you find a registered pharmacy
in your area with ZENATANETM in stock. You will need to bring
your co-pay card* with you when you pick up your prescription.
Q Can The Promius PromiseTM send my prescription
This Q&A is conveniently organized
to help you learn more about:
Additional information can also be found at
www.ipledgeprogram.com or 1.866.495.0654.
The Promius PromiseTM will automatically process the prescription
and apply the ZENATANETM co-pay card for eligible patients.*
That means if you have commercial insurance, you’ll pay $0. (For cash-paying patients, you’ll save up to $100 per prescription.)
The Promius PromiseTM will even call you or your healthcare
provider’s office if there’s ever a problem.
*See back of rebate card for eligibility requirements.
Q
UESTIONS
As you know, the treatment
you’ve been prescribed has certain
requirements you must meet.
Following through on your
commitments may be easier because
of the materials in the ZENATANETM
(Isotretinoin) Capsules Toolkit.
INDICATION
with its use, Zenatane should be reserved for
patients with severe nodular acne who are
unresponsive to conventional therapy, including
UNDERSTANDING THE PROMIUS PROMISETM
iCan Ask
PATIENT Q&A Guide
®
References: 1. The iPLEDGE Program. Isotretinoin
Educational Kit for Female Patients Who Can Get
Pregnant. Washington, DC: The iPLEDGE Program;
December 2007. 2. The iPLEDGE Program. Patient
Introductory Brochure. Washington, DC: The
iPLEDGE Program; April 2012.
*
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MEDICATION GUIDE
ZENATANE (ZEN – a – tān)
(isotretinoin capsules)
Read the Medication Guide that comes with Zenatane before you start taking it and each time you get a prescription. There may be new information. This
information does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about Zenatane?
• Zenatane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
• Because Zenatane can cause birth defects, Zenatane is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE
program.
• Zenatane may cause serious mental health problems.
1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who
are pregnant or who plan to become pregnant must not take Zenatane. Female patients must not get pregnant:
• for one month before starting Zenatane
• while taking Zenatane
• for one month after stopping Zenatane
If you get pregnant while taking Zenatane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy
to:
• FDA MedWatch at 1-800-FDA-1088, and
• the iPLEDGE pregnancy registry at 1-866-495-0654
2. Serious mental health problems. Zenatane may cause:
• depression
• psychosis (seeing or hearing things that are not real)
• suicide. Some patients taking Zenatane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people
tried to end their own lives. And some people have ended their own lives.
Stop Zenatane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression
or psychosis:
• start to feel sad or have crying spells
• lose interest in activities you once enjoyed
• sleep too much or have trouble sleeping
• become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
• have a change in your appetite or body weight
• have trouble concentrating
• withdraw from your friends or family
• feel like you have no energy
• have feelings of worthlessness or guilt
• start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
• start acting on dangerous impulses
• start seeing or hearing things that are not real
After stopping Zenatane, you may also need follow-up mental health care if you had any of these symptoms.
What is Zenatane?
Zenatane is a medicine taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments,
including antibiotics. Zenatane can cause serious side effects (see “What is the most important information I should know about Zenatane?”). Zenatane
can only be:
• prescribed by doctors that are registered in the iPLEDGE program
• dispensed by a pharmacy that is registered with the iPLEDGE program
• given to patients who are registered in the iPLEDGE program and agree to do everything required in the program
What is severe nodular acne?
Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne
can lead to permanent scars.
Who should not take Zenatane?
• Do not take Zenatane if you are pregnant, plan to become pregnant, or become pregnant during Zenatane treatment. Zenatane causes severe birth
defects. See “What is the most important information I should know about Zenatane?”
• Do not take Zenatane if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Zenatane.
What should I tell my doctor before taking Zenatane?
Tell your doctor if you or a family member has any of the following health conditions:
• mental problems
• asthma
• liver disease
• diabetes
• heart disease
• bone loss (osteoporosis) or weak bones
• an eating problem called anorexia nervosa (where people eat too little)
• food or medicine allergies
Tell your doctor if you are pregnant or breast-feeding. Zenatane must not be used by women who are pregnant or breast feeding.
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Zenatane
and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:
• Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Zenatane. Taking both together may increase your chance of
getting side effects.
• Tetracycline antibiotics. Tetracycline antibiotics taken with Zenatane can increase the chances of getting increased pressure in the brain.
• Progestin-only birth control pills (mini-pills). They may not work while you take Zenatane. Ask your doctor or pharmacist if you are not sure what
type you are using.
• Dilantin (phenytoin). This medicine taken with Zenatane may weaken your bones.
• Corticosteroid medicines. These medicines taken with Zenatane may weaken your bones.
• St. John’s Wort. This herbal supplement may make birth control pills work less effectively.
These medicines should not be used with Zenatane unless your doctor tells you it is okay.
Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.
How should I take Zenatane?
• You must take Zenatane exactly as prescribed. You must also follow all the instructions of the iPLEDGE program. Before prescribing Zenatane, your
doctor will:
• explain the iPLEDGE program to you
• have you sign the Patient Information/Informed Consent Form (for all patients). Female patients who can get pregnant must also sign another consent
form.
You will not be prescribed Zenatane if you cannot agree to or follow all the instructions of the iPLEDGE program.
• You will get no more than a 30 day supply of Zenatane at a time. This is to make sure you are following the Zenatane iPLEDGE program. You should
talk with your doctor each month about side effects.
• The amount of Zenatane you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
• Take Zenatane 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your Zenatane capsules whole with a full glass of liquid.
Do not chew or suck on the capsule. Zenatane can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole.
• If you miss a dose, just skip that dose. Do not take 2 doses at the same time.
• If you take too much Zenatane or overdose, call your doctor or poison control center right away.
• Your acne may get worse when you first start taking Zenatane. This should last only a short while. Talk with your doctor if this is a problem for you.
• You must return to your doctor as directed to make sure you don’t have signs of serious side effects. Your doctor may do blood tests to check for serious
side effects from Zenatane. Female patients who can get pregnant will get a pregnancy test each month.
• Female patients who can get pregnant must agree to use two separate forms of effective birth control at the same time one month before, while taking,
and for one month after taking Zenatane. You must access the iPLEDGE system to answer questions about the program requirements and to enter
your two chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1-866-495-0654.
(Continued on other side)
(Continued from previous side)
You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family
planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Zenatane.
If you have sex at any time without using two forms of effective birth control, get pregnant, or miss your expected period, stop using Zenatane
and call your doctor right away.
What should I avoid while taking Zenatane?
• Do not get pregnant while taking Zenatane and for one month after stopping Zenatane. See “What is the most important information I should know
about Zenatane?”
• Do not breast feed while taking Zenatane and for one month after stopping Zenatane. We do not know if Zenatane can pass through your milk and
harm the baby.
• Do not give blood while you take Zenatane and for one month after stopping Zenatane. If someone who is pregnant gets your donated blood, her baby
may be exposed to Zenatane and may be born with birth defects.
• Do not take other medicines or herbal products with Zenatane unless you talk to your doctor. See “What should I tell my doctor before taking
Zenatane?”
• Do not drive at night until you know if Zenatane has affected your vision. Isotretinoin may decrease your ability to see in the dark.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Zenatane and
for at least 6 months after you stop. Zenatane can increase your chance of scarring from these procedures. Check with your doctor for advice about
when you can have cosmetic procedures.
• Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Zenatane may make your skin more sensitive to
light.
• Do not share Zenatane with other people. It can cause birth defects and other serious health problems.
What are the possible side effects of Zenatane?
• Zenatane can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.
See “What is the most important information I should know about Zenatane?”
• Zenatane may cause serious mental health problems. See “What is the most important information I should know about Zenatane?”
• serious brain problems. Zenatane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop
taking Zenatane and call your doctor right away if you get any of these signs of increased brain pressure:
• bad headache
• blurred vision
• dizziness
• nausea or vomiting
• seizures (convulsions)
• stroke
• skin problems. Skin rash can occur in patients taking Zenatane. In some patients a rash can be serious. Stop using Zenatane and call your doctor right
away if you develop conjunctivitis (red or inflamed eyes, lik “pink eye”), a rash with a fever, blisters on legs, arms or face and/or sores in your mouth,
throat, nose, eyes, or if your skin begins to peel.
• stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver,
pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even
after you stop taking Zenatane. Stop taking Zenatane and call your doctor if you get:
• severe stomach, chest or bowel pain
• trouble swallowing or painful swallowing
• new or worsening heartburn
• diarrhea
• rectal bleeding
• yellowing of your skin or eyes
• dark urine
• bone and muscle problems. Zenatane may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your doctor if you plan
hard physical activity during treatment with Zenatane. Tell your doctor if you get:
• back pain
• joint pain
• broken bone. Tell all healthcare providers that you take Zenatane if you break a bone.
Stop Zenatane and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle
damage.
Zenatane may stop long bone growth in teenagers who are still growing.
• hearing problems. Stop using Zenatane and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be
permanent.
• vision problems. Zenatane may affect your ability to see in the dark. This condition usually clears up after you stop taking Zenatane, but it may be
permanent. Other serious eye effects can occur. Stop taking Zenatane and call your doctor right away if you have any problems with your vision or
dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking Zenatane and after treatment.
• lipid (fats and cholesterol in blood) problems. Zenatane can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return
to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Zenatane treatment is
finished.
• serious allergic reactions. Stop taking isotretinoin and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble
breathing. Stop taking Zenatane and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
• blood sugar problems. Zenatane may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
• decreased red and white blood cells. Call your doctor if you have trouble breathing, faint, or feel weak.
• The common, less serious side effects of Zenatane are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor
if you get any side effect that bothers you or that does not go away.
These are not all of the possible side effects with Zenatane. Your doctor or pharmacist can give you more detailed information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Dr. Reddys at 1-866-733-3952.
How should I store Zenatane?
• Store at 68° to 77°F (20° to 25°C). Protect from light.
• Keep Zenatane and all medicines out of the reach of children.
General Information about Zenatane
Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Zenatane for a condition for which it was
not prescribed. Do not give Zenatane to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Zenatane. If you would like more information, talk with your doctor. You can
ask your doctor or pharmacist for information about Zenatane that is written for healthcare professionals.
You can also call iPLEDGE program at 1-866-495-0654 or visit www.ipledgeprogram.com.
What are the ingredients in Zenatane?
Active Ingredient: isotretinoin
Inactive Ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined
soybean oil and white wax. Gelatin capsules contain gelatin, glycerin, methylparaben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow
No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333)
containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode
black S-1-27794 containing iron oxide black, N-butyl alcohol, propylene glycol, industrial methylene spirit and shellac.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Dilantin is a registered trademark of Warner-Lambert Company LLC.
To reorder additional Medication Guides contact Dr. Reddy’s Customer Service at 1-866-733-3952.
Rx Only
Manufactured by:
Cipla Limited
Kurkumbh Village
Pune – 413 802 INDIA
Manufactured for:
Dr. Reddy’s Laboratories Limited
Bachupally – 500 090 INDIA
Issued: 0113

Patient Guide

Transcription

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