A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Accutane Patient, Information, Instructions - Isotretinoin
Accutane Patient, Information, Instructions - Isotretinoin
PATIENT INFORMATION
MEDICATION GUIDE
Read this Medication Guide every time you get a prescription
or a refill for Accutane (ACK-u-tane). There may be new information. This information
does not take the place of talking with your prescriber (doctor or other health
care provider).
What is the most important information I should know about
Accutane?
Accutane is used to treat a type of severe acne (nodular acne)
that has not been helped by other treatments, including antibiotics. However,
Accutane can cause serious side effects. Before starting Accutane, discuss with
your prescriber how bad your acne is, the possible benefits of Accutane, and
its possible side effects, to decide if Accutane is right for you. Your prescriber
will ask you to read and sign a form or forms indicating you understand some
of the serious risks of Accutane.
Possible serious side effects of taking Accutane include birth
defects and mental disorders.
1. Birth defects. Accutane can cause birth defects (deformed
babies) if taken by a pregnant woman. It can also cause miscarriage (losing
the baby before birth), premature (early) birth, or death of the baby. Do not
take Accutane if you are pregnant or plan to become pregnant while you are taking
Accutane. Do not get pregnant for 1 month after you stop taking Accutane. Also,
if you get pregnant while taking Accutane, stop taking it right away and call
your prescriber.
All females should read the section in this Medication Guide
"What are the important warnings for females taking Accutane?"
2. Mental problems and suicide. Some patients, while
taking Accutane or soon after stopping Accutane, have become depressed or developed
other serious mental problems. Symptoms of these problems include sad, "anxious"
or empty mood, irritability, anger, loss of pleasure or interest in social or
sports activities, sleeping too much or too little, changes in weight or appetite,
school or work performance going down, or trouble concentrating. Some patients
taking Accutane 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. There were reports that some of
these people did not appear depressed. There have been reports of patients on
Accutane becoming aggressive or violent. No one knows if Accutane caused these
behaviors or if they would have happened even if the person did not take Accutane.
All patients should read the section in this Medication Guide
"What are the signs of mental problems?"
For other possible serious side effects of Accutane, see "What
are the possible side effects of Accutane?" in this Medication Guide.
What are the important warnings for females taking Accutane?
You must not become pregnant while taking Accutane, or for
1 month after you stop taking Accutane. Accutane can cause severe birth defects
in babies of women who take it while they are pregnant, even if they take Accutane
for only a short time. There is an extremely high risk that your baby will
be deformed or will die if you are pregnant while taking Accutane. Taking
Accutane also increases the chance of miscarriage and premature births.
Female patients will not get their first prescription for Accutane
unless there is proof they have had 2 negative pregnancy tests. The first test
must be done when your prescriber decides to prescribe Accutane. The second
pregnancy test must be done during the first 5 days of the menstrual period
right before starting Accutane therapy, or as instructed by your prescriber.
Each month of treatment, you must have a negative result from a urine or serum
pregnancy test. Female patients cannot get another prescription for Accutane
unless there is proof that they have had a negative pregnancy test.
A yellow self-adhesive Accutane Qualification Sticker on your
prescription indicates to the pharmacist that you are qualified by your prescriber
to get Accutane.
While you are taking Accutane, you must use effective
birth control. You must use 2 separate effective forms of birth control at
the same time for at least 1 month before starting Accutane, while you take
it, and for 1 month after you stop taking it. You can either discuss effective
birth control methods with your prescriber or go for a free visit to discuss
birth control with another physician or family planning expert. Your prescriber
can arrange this free visit, which will be paid for by the manufacturer.
You must use 2 separate forms of effective birth control because
any method, including birth control pills and sterilization, can fail. There
are only 2 reasons you would not need to use 2 separate methods of effective
birth control:
1. You have had your womb removed by surgery (a hysterectomy).
2. You are absolutely certain you will not have genital-to-genital
sexual contact with a male before, during, and for 1 month after Accutane treatment.
If you have sex at any time without using 2 forms of effective
birth control, get pregnant, or miss your period, stop using Accutane and call
your prescriber right away.
All patients should read the rest of this Medication Guide.
What are the signs of mental problems?
Tell your prescriber if, to the best of your knowledge, you
or someone in your family has ever had any mental illness, including depression,
suicidal behavior, or psychosis. Psychosis means a loss of contact with reality,
such as hearing voices or seeing things that are not there. Also, tell your
prescriber if you take medicines for any of these problems.
Stop using Accutane and tell your provider right away if you:
· 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 inappropriate
guilt
· Start having thoughts about hurting yourself
or taking your own life (suicidal thoughts)
What is Accutane?
Accutane is used to treat the most severe form of acne (nodular
acne) that cannot be cleared up by any other acne treatments, including antibiotics.
In severe nodular acne, 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. However, because Accutane can have serious side effects,
you should talk with your prescriber about all of the possible treatments for
your acne, and whether Accutane’s possible benefits outweigh its possible risks.
Who should not take Accutane?
· Do not take Accutane if you are pregnant,
plan to become pregnant, or become pregnant during Accutane treatment.
Accutane causes severe birth defects. All females should read the section
"What are the important warnings for females taking Accutane?" for
more information and warnings about Accutane and pregnancy.
· Do not take Accutane unless you completely
understand its possible risks and are willing to follow all of the instructions
in this Medication Guide. Tell your prescriber if you or someone in your family
has had any kind of mental problems, asthma, liver disease, diabetes, heart
disease, osteoporosis (bone loss), weak bones, anorexia nervosa (an eating
disorder where people eat too little), or any other important health problems.
Tell your prescriber about any food or drug allergies you have had in the
past. These problems do not necessarily mean you cannot take Accutane, but
your prescriber needs this information to discuss if Accutane is right for
you.
How should I take Accutane?
· You will get no more than a 30-day supply
of Accutane at a time, to be sure you check in with your prescriber each month
to discuss side effects.
· Your prescription should have a special yellow
self-adhesive sticker attached to it. The sticker is YELLOW. If your prescription
does not have this yellow self-adhesive sticker, call your prescriber. The
pharmacy should not fill your prescription unless it has the yellow self-adhesive
sticker.
· The amount of Accutane you take has been
specially chosen for you and may change during treatment.
· You will take Accutane 2 times a day with
a meal, unless your prescriber tells you otherwise. Swallow your Accutane
capsules with a full glass of liquid. This will help prevent the medication
inside the capsule from irritating the lining of your esophagus (connection
between mouth and stomach). For the same reason, do not chew or suck on the
capsule.
· If you miss a dose, just skip that dose.
Do not take 2 doses the next time.
· You should return to your prescriber as directed
to make sure you don’t have signs of serious side effects. Because some of
Accutane’s serious side effects show up in blood tests, some of these visits
may involve blood tests (monthly visits for female patients should always
include a urine or serum pregnancy test).
What should I avoid while taking Accutane?
· Do not get pregnant while taking Accutane.
See "What is the most important information I should know about Accutane?"
and "What are the important warnings for females taking Accutane?"
· Do not breast feed while taking Accutane
and for 1 month after stopping Accutane. We do not know if Accutane can pass
through your milk and harm the baby.
· Do not give blood while you take Accutane
and for 1 month after stopping Accutane. If someone who is pregnant gets your
donated blood, her baby may be exposed to Accutane and may be born with birth
defects.
· Do not take vitamin A supplements.
Vitamin A in high doses has many of the same side effects as Accutane. Taking
both together may increase your chance of getting side effects.
· Do not have cosmetic procedures to smooth
your skin, including waxing, dermabrasion, or laser procedures, while you
are using Accutane and for at least 6 months after you stop. Accutane
can increase your chance of scarring from these procedures. Check with your
prescriber for advice about when you can have cosmetic procedures.
· Avoid sunlight and ultraviolet lights
as much as possible. Tanning machines use ultraviolet lights. Accutane may
make your skin more sensitive to light.
· Do not use birth control pills that do
not contain estrogen ("minipills"). They may not work while
you take Accutane. Ask your prescriber or pharmacist if you are not sure what
type you are using.
· Talk with your doctor if you plan to take
other drugs or herbal products. This is especially important for patients
using birth control pills and other hormonal types of birth control because
the birth control may not work as effectively if you are taking certain drugs
or herbal products. You should not take the herbal supplement St. John’s Wort
because this herbal supplement may make birth control pills not work as effectively.
· Talk with your doctor if you are currently
taking an oral or injected corticosteroid or anticonvulsant (seizure) medication
prior to using Accutane. These drugs may weaken your bones.
· Do not share Accutane with other people.
It can cause birth defects and other serious health problems.
· Do not take Accutane with antibiotics
unless you talk to your prescriber. For some antibiotics, you may have
to stop taking Accutane until the antibiotic treatment is finished. Use of
both drugs together can increase the chances of getting increased pressure
in the brain.
What are the possible side effects of Accutane? Accutane has
possible serious side effects
· Accutane can cause birth defects, premature
births, and death in babies whose mothers took Accutane while they were
pregnant. See "What is the most important information I should know about
Accutane?" and "What are the important warnings for females taking
Accutane?"
· Serious mental health problems. See
"What is the most important information I should know about Accutane?"
· Serious brain problems. Accutane can
increase the pressure in your brain. This can lead to permanent loss of sight,
or in rare cases, death. Stop taking Accutane and call your prescriber right
away if you get any of these signs of increased brain pressure: bad headache,
blurred vision, dizziness, nausea, or vomiting. Also, some patients taking
Accutane have had seizures (convulsions) or stroke.
· Abdomen (stomach area) 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 Accutane. Stop taking Accutane and call your prescriber
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, or dark urine.
· Bone and muscle problems. Accutane
may affect bones, muscles, and ligaments and cause pain in your joints or
muscles. Tell your prescriber if you plan vigorous physical activity during
treatment with Accutane. Tell your prescriber if you develop pain, particularly
back pain or joint pain. There are reports that some patients have had stunted
growth after taking Accutane for acne as directed. There are also some reports
of broken bones or reduced healing of broken bones after taking Accutane for
acne as directed. No one knows if taking Accutane for acne will affect your
bones. If you have a broken bone, tell your provider that you are taking Accutane.
Muscle weakness with or without pain can be a sign of serious muscle damage.
If this happens, stop taking Accutane and call your prescriber right away.
· Hearing problems. Some people taking
Accutane have developed hearing problems. It is possible that hearing loss
can be permanent. Stop using Accutane and call your prescriber if your hearing
gets worse or if you have ringing in your ears.
· Vision problems. While taking Accutane
you may develop a sudden inability to see in the dark, so driving at night
can be dangerous. This condition usually clears up after you stop taking Accutane,
but it may be permanent. Other serious eye effects can occur. Stop taking
Accutane and call your prescriber right away if you have any problems with
your vision or dryness of the eyes that is painful or constant.
· Lipid (fats and cholesterol in blood)
problems. Many people taking Accutane develop high levels of cholesterol
and other fats in their blood. This can be a serious problem. Return to your
prescriber for blood tests to check your lipids and to get any needed treatment.
These problems generally go away when Accutane treatment is finished.
· Allergic reactions. In some people,
Accutane can cause serious allergic reactions. Stop taking Accutane and get
emergency care right away if you develop hives, a swollen face or mouth, or
have trouble breathing. Stop taking Accutane and call your prescriber if you
develop a fever, rash, or red patches or bruises on your legs.
· Signs of other possibly serious problems.
Accutane may cause other problems. Tell your prescriber if you have trouble
breathing (shortness of breath), are fainting, are very thirsty or urinate
a lot, feel weak, have leg swelling, convulsions, slurred speech, problems
moving, or any other serious or unusual problems. Frequent urination and thirst
can be signs of blood sugar problems.
Serious permanent problems do not happen often. However, because
the symptoms listed above may be signs of serious problems, if you get these
symptoms, stop taking Accutane and call your prescriber. If not treated, they
could lead to serious health problems. Even if these problems are treated, they
may not clear up after you stop taking Accutane.
Accutane has less serious possible side effects
The common less serious side effects of Accutane are dry skin,
chapped lips, dry eyes, and dry nose that may lead to nosebleeds. People who
wear contact lenses may have trouble wearing them while taking Accutane and
after therapy. Sometimes, people’s acne may get worse for a while. They should
continue taking Accutane unless told to stop by their prescriber.
These are not all of Accutane’s possible side effects. Your
prescriber or pharmacist can give you more detailed information that is written
for health care professionals.
This Medication Guide is only a summary of some important information
about Accutane. Medicines are sometimes prescribed for purposes other than those
listed in a Medication Guide. If you have any concerns or questions about Accutane,
ask your prescriber. Do not use Accutane for a condition for which it was not
prescribed.
PATIENT INFORMATION/CONSENT (FOR FEMALE PATIENTS CONCERNING
BIRTH DEFECTS)
To be completed by the patient, her parent/guardian* and
signed by her prescriber.
Read each item below and initial in the space provided to show
that you understand each item and agree to follow your prescriber's instructions.
Do not sign this consent and do not take Accutane if there is anything that
you do not understand.
*A parent or guardian of a minor patient (under age 18) must
also read and initial each item before signing the consent. ________________________________________________________________________
(Patient’s Name)
1. I understand that there is a very high risk that my unborn
baby could have severe birth defects if I am pregnant or become pregnant while
taking Accutane in any amount even for short periods of time. This is why I
must not be pregnant while taking Accutane.
Initial: ______
2. I understand that I must not take Accutane (isotretinoin)
if I am pregnant.
Initial: ______
3. I understand that I must not get pregnant during the
entire time of my treatment and for 1 month after the end of my treatment with
Accutane.
Initial: ______
4. I understand that I must avoid sexual intercourse completely,
or I must use 2 separate, effective forms of birth control (contraception) at
the same time. The only exception is if I have had surgery to remove the
womb (a hysterectomy).
Initial: ______
5. I understand that birth control pills and topical/injectable/implantable/insertable
hormonal birth control products are among the most effective forms of birth
control. However, any form of birth control can fail. Therefore, I must use
2 different methods at the same time, every time I have sexual intercourse,
even if 1 of the methods I choose is birth control pills or topical/injectable/implantable/insertable
hormonal birth control.
Initial: ______
6. I will talk with my prescriber about any drugs or herbal
products I plan to take during my Accutane treatment because hormonal birth
control methods (for example, birth control pills) may not work if I am taking
certain drugs or herbal products (for example, St. John’s Wort).
Initial: ______
7. I understand that the following are considered effective
forms of birth control:
Primary: Tubal ligation (tying my tubes), partner’s vasectomy,
birth control pills, topical/injectable/implantable/insertable hormonal birth
control products, and an IUD (intrauterine device).
Secondary: Diaphragms, latex condoms, and cervical caps. Each
must be used with a spermicide, which is a special cream or jelly that kills
sperm.
I understand that at least 1 of my 2 methods of birth control
must be a primary method.
Initial: ______
8. I understand that I may receive a free contraceptive
(birth control) counseling session from a doctor or other family planning expert.
My Accutane prescriber can give me an Accutane Patient Referral Form for this
free consultation.
Initial: ______
9. I understand that I must begin using the birth control
methods I have chosen as described above at least 1 month before I start taking
Accutane.
Initial: ______
10. I understand that I cannot get a prescription for Accutane
unless I have 2 negative pregnancy test results. The first pregnancy test should
be done when my prescriber decides to prescribe Accutane. The second pregnancy
test should be done during the first 5 days of my menstrual period right before
starting Accutane therapy, or as instructed by my prescriber. I will then have
1 pregnancy test every month during my Accutane therapy.
Initial: ______
11. I understand that I should not start taking Accutane until
I am sure that I am not pregnant and have negative results from 2 pregnancy
tests.
Initial: ______
12. I have read and understand the materials my prescriber
has given to me, including the Patient
Product Information, Important Information Concerning Your
Treatment with Accutaneâ (isotretinoin).
My prescriber gave me and asked me to watch the videos about contraception.
I was told about a confidential counseling line that I may call for more information
about birth control. I have received information on emergency contraception
(birth control).
Initial: ______
13. I understand that I must stop taking Accutane right away
and inform my prescriber if I get pregnant, miss my menstrual period, stop using
birth control, or have sexual intercourse without using my 2 birth control methods
at any time.
Initial: ______
14. My prescriber gave me information about the confidential
Accutane Survey and explained to me how important it is to take part in the
Accutane Survey.
Initial: ______
15. I understand that the yellow self-adhesive Accutane Qualification
Sticker on my prescription for
Accutane means that I am qualified to receive an Accutane prescription,
because I:
· have had 2 negative urine or serum pregnancy
tests before receiving the initial Accutane prescription. I must have a negative
result from a urine or serum pregnancy test repeated each month prior to my
receiving each subsequent prescription.
· have selected and committed to use 2 forms
of effective contraception simultaneously, at least 1 of which must be a primary
form, unless absolute abstinence is the chosen method, or I have undergone
a hysterectomy. I must use 2 forms of contraception for at least 1 month prior
to initiation of Accutane therapy, during therapy, and for 1 month after discontinuing
therapy. I must receive counseling, repeated on a monthly basis, about contraception
and behaviors associated with an increased risk of pregnancy.
· have signed a Patient Information/Consent form
that contains warnings about the risk of potential birth defects if I am pregnant
or become pregnant and my unborn baby is exposed to isotretinoin.
· have been informed of the purpose and importance
of participating in the Accutane Survey and given the opportunity to enroll.
Initial: ______
My prescriber has answered all my questions about Accutane
and I understand that it is my responsibility not to get pregnant during Accutane
treatment or for 1 month after I stop taking Accutane.
Initial: ______
I now authorize my prescriber ________________ to begin my
treatment with Accutane.
Patient Signature:________________________________ Date:____________________
Parent/Guardian Signature (if under age 18):____________________ Date:___________
Please print: Patient Name and Address________________________________________
_______________________________________ Telephone _______________________
I have fully explained to the patient, __________________, the nature and purpose
of the treatment described above and the risks to females of childbearing potential.
I have asked the patient if she has any questions regarding her treatment with
Accutane and have answered those questions to the best of my ability.
Prescriber Signature: ______________________________ Date:__________________
INFORMED CONSENT/PATIENT AGREEMENT (FOR ALL PATIENTS):
To be completed by patient (parent or guardian if patient is
under age 18) and signed by the prescriber.
Read each item below and initial in the space provided if you
understand each item and agree to follow your prescriber’s instructions. A parent
or guardian of a patient under age 18 must also read and understand each item
before signing the agreement.
Do not sign this agreement and do not take Accutane if there
is anything that you do not understand about all the information you have received
about using Accutane.
1. I, ____________________________________________________________,
(Patient’s Name)
understand that Accutane is a medicine used to treat severe
nodular acne that cannot be cleared up by any other acne treatments, including
antibiotics. In severe nodular acne, many red, swollen, tender lumps form in
the skin. If untreated, severe nodular acne can lead to permanent scars.
Initials: ______
2. My prescriber has told me about my choices for treating
my acne. Initials: ______
3. I understand that there are serious side effects that
may happen while I am taking Accutane. These have been explained to me. These
side effects include serious birth defects in babies of pregnant females. (Note:
There is a second Informed Consent form for female patients concerning birth
defects.)
Initials: ______
4. I understand that some patients, while taking Accutane
or soon after stopping Accutane, have become depressed or developed other serious
mental problems. Symptoms of these problems include sad, "anxious"
or empty mood, irritability, anger, loss of pleasure or interest in social or
sports activities, sleeping too much or too little, changes in weight or appetite,
school or work performance going down, or trouble concentrating. Some patients
taking Accutane 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. There were reports that some of
these people did not appear depressed. There have been reports of patients on
Accutane becoming aggressive or violent. No one knows if Accutane caused these
behaviors or if they would have happened even if the person did not take Accutane.
Some people have had other signs of depression while taking Accutane (see #7
below).
Initials: ______
5. Before I start taking Accutane, I agree to tell my prescriber
if, to the best of my knowledge, I have ever had symptoms of depression
(see #7 below), been psychotic, attempted suicide, had any other mental problems,
or take medicine for any of these problems. Being psychotic means having a loss
of contact with reality, such as hearing voices or seeing things that are not
there.
Initials: ______
6. Before I start taking Accutane, I agree to tell my prescriber
if, to the best of my knowledge, anyone in my family has ever had symptoms of
depression, been psychotic, attempted suicide, or had any other serious mental
problems.
Initials: ______
7. Once I start taking Accutane, I agree to stop using Accutane
and tell my prescriber right away if any of the following happen. I:
· Start to feel sad or have crying spells
· Lose interest in activities I 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 my appetite or body weight
· Have trouble concentrating
· Withdraw from my friends or family
· Feel like I have no energy
· Have feelings of worthlessness or inappropriate
guilt
· Start having thoughts about hurting myself
or taking my own life (suicidal thoughts) Initials: ______
8. I agree to return to see my prescriber every
month I take Accutane to get a new prescription for Accutane, to check my progress,
and to check for signs of side effects.
Initials: ______
9. Accutane will be prescribed just for me—I will not share
Accutane with other people because it may cause serious side effects, including
birth defects.
Initials: ______
10. I will not give blood while taking Accutane or for 1 month
after I stop taking Accutane. I understand that if someone who is pregnant gets
my donated blood, her baby may be exposed to Accutane and may be born with serious
birth defects.
Initials: ______
11. I have read the Patient Product Information, Important
Information Concerning Your Treatment with Accutaneâ
(isotretinoin), and other materials my provider gave me containing important
safety information about Accutane. I understand all the information I received.
Initials: ______
12. My prescriber and I have decided I should take Accutane.
I understand that each of my Accutane prescriptions must have a yellow self-adhesive
Accutane Qualification Sticker on it. I understand that I can stop taking Accutane
at any time. I agree to tell my prescriber if I stop taking Accutane.
Initials: ______
I now authorize my prescriber ___________________________ to
begin my treatment with Accutane.
Patient Signature: __________________________________________
Date: _________
Parent/Guardian Signature (if under age 18): _____________________ Date: _________
Patient Name (print) ___________________________________
Patient Address ____________________________________ Telephone (___.___.___)
____________________________________
I have:
· fully explained to the patient, __________________,
the nature and purpose of Accutane treatment, including its benefits and risks
· given the patient the appropriate educational
materials, Be Smart, Be Safe, Be Sure, for Accutane and asked the patient
if he/she has any questions regarding his/her treatment with Accutane
· answered those questions to the best of my
ability
· placed the yellow self-adhesive Accutane Qualification
Sticker on the prescription.
Prescriber Signature: ___________________________________ Date:______________
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