Patient Information/Informed Consent About Birth Defects
patients who can get pregnant)
To be completed by the patient (and her parent or
guardian* if patient is under age 18) and signed by her doctor.
Read each item below and initial in the space provided to
show that you understand each item and agree to follow your doctor's
instructions. Do not sign this consent and do not take isotretinoin 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.
1. I understand that there is a very high chance that my
unborn baby could have severe birth defects if I am pregnant or become pregnant
while taking isotretinoin. This can happen with any amount and even if taken
for short periods of time. This is why I must not be pregnant while taking isotretinoin.
2. I understand that I must not get pregnant one month
before, during the entire time of my treatment, and for one month after the end
of my treatment with isotretinoin.
3. I understand that I must avoid sexual intercourse
completely, or I must use two separate, effective forms of birth control
(contraception) at the s ame time. The only exceptions are if I have had surgery
to remove the uterus (a hysterectomy) or both of my ovaries (bilateral oophorectomy), or my doctor has medically confirmed that I am postmenopausal.
4. I understand that hormonal birth control products are
among the most effective forms of birth control. Combination birth control
pills and other hormonal products include skin patches, shots, under-the-skin
implants, vaginal rings, and intrauterine devices (IUDs). Any form of birth
control can fail. That is why I must use two different birth control methods at
the same time, starting one month before, during, and for one month after
stopping therapy every time I have sexual intercourse, even if one of the
methods I choose is hormonal birth control.
5. I understand that the following are effective forms of
- tubal sterilization (tying my tubes)
- partner's vasectomy
- intrauterine device
- hormonal (combination birth control pills, skin patches,
shots, under-the skin implants, or vaginal ring.
- male latex condom with or without spermicide
- diaphragm with spermicide
- cervical cap with spermicide
- vaginal sponge (contains spermicide)
A diaphragm and cervical cap must each be used with
spermicide, a special cream that kills sperm. I understand that at least one of
my two forms of birth control must be a primary method.
6. I will talk with my doctor about any medicines
including herbal products I plan to take during my isotretinoin treatment
because hormonal birth control methods may not work if I am taking certain medicines
or herbal products.
7. I may receive a free birth control counseling session
from a doctor or other family planning expert. My isotretinoin doctor can give
me an isotretinoin Patient Referral Form for this free consultation.
8. I must begin using the birth control methods I have chosen
as described above at least one month before I start taking isotretinoin.
9. I cannot get my first prescription for isotretinoin
unless my doctor has told me that I have two negative pregnancy test results.
The first pregnancy test should be done when my doctor decides to prescribe
isotretinoin. The second pregnancy test must be done in a lab during the first
5 days of my menstrual period right before starting isotretinoin therapy
treatment or as instructed by my doctor. I will then have one pregnancy test;
in a lab.
- every month during treatment
- at the end of treatment
- and 1 month after stopping treatment
I must not start taking isotretinoin until I am sure that
I am not pregnant, have negative results from two pregnancy tests, and the
second test has been done in a lab.
10. I have read and understand the materials my doctor
has provided to me, including The iPLEDGE Program Guide for Isotretinoin for
Female Patients Who Can Get Pregnant, The iPLEDGE Birth Control Workbook and
The iPLEDGE Program Patient Introductory Brochure. My doctor provided me and
asked me to watch a video about birth control and a video about birth defects
I was told about a private counseling line that I may
call for more information about birth control. I have received information on
emergency birth control.
11. I must stop taking isotretinoin right away and call
my doctor if I get pregnant, miss my expected menstrual period, stop using
birth control, or have sexual intercourse without using my two birth control
methods at any time.
12. My doctor provided me information about the purpose
and importance of providing information to the iPLEDGE Program should I become
pregnant while taking isotretinoin or within one month of the last dose. I
understand that if I become pregnant, information about my pregnancy, my
health, and my baby's health may be shared with the makers of isotretinoin,
authorized parties who maintain the iPLEDGE Program for the makers of
isotretinoin, and government health regulatory authorities.
13. I understand that being qualified to receive
isotretinoin in the iPLEDGE Program means that I:
- have had two negative urine or blood pregnancy tests
before receiving the first isotretinoin prescription. The second test must be
done in a lab. I must have a negative result from a urine or blood pregnancy
test done in a lab repeated each month before I receive another isotretinoin
- have chosen and agreed to use two forms of effective
birth control at the same time. At least one method must be a primary form of
birth control, unless I have chosen never to have sexual contact with a male
(abstinence), or I have undergone a hysterectomy. I must use two forms of
birth control for at least one month before I start isotretinoin therapy,
during therapy, and for one month after stopping therapy. I must receive
counseling, repeated on a monthly basis, about birth control and behaviors
associated with an increased risk of pregnancy.
- have signed a Patient Information/Informed Consent About
Birth Defects (for female patients who can get pregnant) that contains warnings
about the chance of possible birth defects if I am pregnant or become pregnant
and my unborn baby is exposed to isotretinoin.
- have been informed of and understand the purpose and
importance of providing information to the iPLEDGE Program should I become
pregnant while taking isotretinoin or within 1 month of the last dose.
- have interacted with the iPLEDGE Program before starting
isotretinoin and on a monthly basis to answer questions on the program
requirements and to enter my two chosen forms of birth control.
My doctor has answered all my questions about
isotretinoin and I understand that it is my responsibility not to get pregnant
one month before, during isotretinoin treatment, or for one month after I stop
taking is otretinoin.
I now authorize my doctor ________________ to begin my
treatment with isotretinoin.
Parent/Guardian Signature (if under age
Please print: Patient Name and
______________________________ Telephone _______________________
I have fully explained to the patient,
__________________, the nature and purpose of the treatment described above and
the risks to females of reproductive potential. I have asked the patient if she
has any questions regarding her treatment with isotretinoin and have answered
those questions to the best of my ability.
Doctor Signature: __________________________________
PLACE THE ORIGINAL SIGNED DOCUMENTS IN THE PATIENT'S
PLEASE PROVIDE A COPY TO THE PATIENT.
Patient Information/Informed Consent (for all patients
To be completed by patient (and parent or guardian if
patient is under age 18) and signed by the doctor.
Read each item below and initial in the space provided if
you understand each item and agree to follow your doctor'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
isotretinoin if there is anything that you do not understand about all the
information you have received about using isotretinoin.
Name) understand that isotretinoin 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.
2. My doctor has told me about my choices for treating my
3. I understand that there are serious side effects that
may happen while I am taking isotretinoin. These have been explained to me.
These side effects include serious birth defects in babies of pregnant
patients. [Note: There is a second Patient Information/Informed Consent About
Birth Defects (for female patients who can get pregnant)].
4. I understand that some patients, while taking
isotretinoin or soon after stopping isotretinoin, have become depressed or
developed other serious mental problems. Symptoms of depression include sad,
“anxious” or empty mood, irritability, acting on dangerous impulses, 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 isotretinoin 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 isotretinoin becoming
aggressive or violent. No one knows if isotretinoin caused these behaviors or
if they would have happened even if the person did not take isotretinoin. Some
people have had other signs of depression while taking isotretinoin (see #7 below).
5. Before I start taking isotretinoin, I agree to tell my
doctor if 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.
6. Before I start taking isotretinoin, I agree to tell my
doctor 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.
7. Once I start taking isotretinoin, I agree to stop
using isotretinoin and tell my doctor right away if any of the following signs
and symptoms of depression or psychosis 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 guilt
- Start having thoughts about hurting myself or taking my
own life (suicidal thoughts)
- Start acting on dangerous impulses
- Start seeing or hearing things that are not real
8. I agree to return to see my doctor every month I take
isotretinoin to get a new prescription for isotretinoin, to check my progress,
and to check for signs of side effects.
9. Isotretinoin will be prescribed just for me - I will
not share isotretinoin with other people because it may cause serious side
effects, including birth defects.
10. I will not give blood while taking isotretinoin or
for one month after I stop taking isotretinoin. I understand that if someone
who is pregnant gets my donated blood, her baby may be exposed to isotretinoin
and may be born with serious birth defects.
11. I have read the The iPLEDGE Program Patient
Introductory Brochure, and other materials my provider provided me containing
important safety information about isotretinoin. I understand all the
information I received.
12. My doctor and I have decided I should take
isotretinoin. I understand that I must be qualified in the iPLEDGE Program to
have my prescription filled each month. I understand that I can stop taking isotretinoin
at any time. I agree to tell my doctor if I stop taking isotretinoin.
I now allow my doctor _______________________ to begin my
treatment with isotretinoin.
Parent/Guardian Signature (if under age
Patient Name (print)__________________________________
- fully explained to the patient,
______________________________, the nature and purpose of isotretinoin treatment,
including its benefits and risks.
- provided the patient with the appropriate educational
materials, The iPLEDGE Program Patient Introductory Brochure and asked the
patient if he/she has any questions regarding his/her treatment with isotretinoin.
- answered those questions to the best of my ability.
PLACE THE ORIGINAL SIGNED DOCUMENTS IN THE PATIENT'S
MEDICAL RECORD. PLEASE PROVIDE A COPY TO THE PATIENT.
(isotretinoin) Capsules USP
Read the Medication Guide that comes with Claravis 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 Claravis ?
- Claravis is used to treat a type of severe acne (nodular
acne) that has not been helped by other treatments, including antibiotics.
- Because Claravis can cause birth defects, Claravis is
only for patients who can understand and agree to carry out all of the
instructions in the iPLEDGE Program.
- Claravis may cause serious mental health problems.
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
Claravis. Female patients must not get pregnant:
- for 1 month before starting Claravis
- while taking Claravis
- for 1 month after stopping Claravis.
If you get pregnant while taking Claravis, s top
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. Claravis may
- psychosis (seeing or hearing things that are not
- suicide. Some patients taking Claravis 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 Claravis 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 Claravis, you may also need follow-up
mental health care if you had any of these symptoms.
What is Claravis ?
Claravis 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. Claravis can cause serious side effects (see
“What is the most important information I should know about Claravis ?”).
Claravis can only be:
- prescribed by doctors that are registered in the iPLEDGE
- dispensed by a pharmacy that is registered with the
- 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 Claravis ?
- Do not take Claravis if you are pregnant, plan to
become pregnant, or become pregnant during Claravis treatment. Claravis causes
severe birth defects. See “What is the most important information I should know
about Claravis ?”
- Do not take Claravis if you are allergic to anything
in it. See the end of this Medication Guide for a complete list of
ingredients in Claravis.
What should I tell my doctor before taking Claravis ?
Tell your doctor if you or a family member has any of
the following health conditions :
- mental problems
- liver disease
- 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 breastfeeding.
Claravis must not be used by women who are pregnant or breastfeeding.
Tell your doctor about all of the medicines you take
including pres cription and nonprescription medicines, vitamins and herbal
supplements. Claravis and certain other medicines can interact with each
other, sometimes causing serious side effects. Especially tell your doctor if
- Vitamin A supplements. Vitamin A in high doses has
many of the same side effects as Claravis. Taking both together may increase
your chance of getting side effects.
- Tetracycline antibiotics. Tetracycline antibiotics
taken with Claravis can increase the chances of getting increased pressure in
- Progestin-only birth control pills (mini-pills ). They may not work while you take Claravis. Ask your doctor or pharmacist if you
are not sure what type you are using.
- Dilantin (phenytoin). This medicine taken with
Claravis may weaken your bones.
- Corticosteroid medicines. These medicines taken
with Claravis 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 Claravisunless
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 Claravis ?
- You must take Claravis exactly as prescribed. You must
also follow all the instructions of the iPLEDGE Program. Before prescribing
Claravis, 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 Claravis 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 Claravis at
a time. This is to make sure you are following the Claravis iPLEDGE Program.
You should talk with your doctor each month about side effects.
- The amount of Claravis you take has been specially chosen
for you. It is based on your body weight, and may change during treatment.
- Take Claravis 2 times a day with a meal, unless your
doctor tells you otherwise. Swallow your Claravis capsules whole with a full
glass of liquid. Do not chew or suck on the capsule. Claravis can hurt the
tube that connects your mouth to your stomach (esophagus) if it is not swallowed
- If you miss a dose, just skip that dose. Do not take 2
doses at the same time.
- If you take too much Claravis or overdose, call your
doctor or poison control center right away.
- Your acne may get worse when you first start taking
Claravis. 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 Claravis. 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 Claravis. 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.
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 Claravis.
If you have sex at any time without using two forms of
effective birth control, get pregnant, or miss your expected period, stop using
Claravis and call your doctor right away.
What should I avoid while taking Claravis ?
- Do not get pregnant while taking Claravis and for
one month after stopping Claravis. See “What is the most important
information I should know about Claravis ?”
- Do not breastfeed while taking Claravis and for
one month after stopping Claravis. We do not know if Claravis can pass through
your milk and harm the baby.
- Do not give blood while you take Claravis and for
one month after stopping Claravis. If someone who is pregnant gets your donated
blood, her baby may be exposed to Claravis and may be born with birth defects.
- Do not take other medicines or herbal products with Claravis unless you talk to your doctor. See “What should I tell my
doctor before taking Claravis ?”
- Do not drive at night until you know if Claravis has
affected your vision. Claravis may decrease your ability to see in the
- Do not have cosmetic procedures to smooth your s kin,
including waxing, dermabrasion, or laser procedures, while you are using
Claravis and for at least 6 months after you stop. Claravis 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. Claravis may make your skin
more sensitive to light.
- Do not share Claravis with other people. It can
cause birth defects and other serious health problems.
What are the possible side effects of Claravis ?
- Claravis 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 Claravis ?”
- Claravis may cause serious mental health problems. See
“What is the most important information I should know about Claravis ?”
- serious brain problems. Claravis can increase the
pressure in your brain. This can lead to permanent loss of eyesight and, in
rare cases, death. Stop taking Claravis and call your doctor right away if you
get any of these signs of increased brain pressure:
- bad headache
- blurred vision
- nausea or vomiting
- seizures (convulsions)
- skin problems. Skin rash can occur in patients
taking Claravis. In some patients a rash can be serious. Stop using Claravis
and call your doctor right away if you develop conjunctivitis (red or inflamed
eyes, like “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 Claravis. Stop taking Claravis and call your doctor if you get:
- severe stomach, chest or bowel pain
- trouble swallowing or painful swallowing
- new or worsening heartburn
- rectal bleeding
- yellowing of your skin or eyes
- dark urine
- bone and muscle problems. Claravis 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 Claravis.
Tell your doctor if you get:
- back pain
- joint pain
- broken bone. Tell all healthcare providers that you take
Claravis if you break a bone.
Stop Claravis and call your doctor right away if you
have muscle weakness. Muscle weakness with or without pain can be a sign of serious
Claravis may stop long bone growth in teenagers who are
- hearing problems. Stop using Claravis 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. Claravis may affect your ability
to see in the dark. This condition usually clears up after you stop taking
Claravis, but it may be permanent. Other serious eye effects can occur. Stop
taking Claravis 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 Claravis and
- lipid (fats and cholesterol in blood) problems. Claravis 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 Claravis treatment
- serious allergic reactions. Stop taking Claravis
and get emergency care right away if you develop hives, a swollen face or
mouth, or have trouble breathing. Stop taking Claravis and call your doctor if
you get a fever, rash, or red patches or bruises on your legs.
- blood sugar problems. Claravis 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 Claravis 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
These are not all of the possible side effects with
Claravis. 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.
How should I store Claravis ?
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- Keep Claravis and all medicines out of the reach of
General Information about Claravis.
Medicines are sometimes prescribed for conditions that
are not mentioned in Medication Guides. Do not use Claravis for a condition for
which it was not prescribed. Do not give Claravis 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 Claravis. If you would like more information, talk with your
doctor. You can ask your doctor or pharmacist for information about Claravis
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 Claravis ?
Active Ingredient: Isotretinoin
Inactive Ingredients : Each capsule contains the
following inactive ingredients: butylated hydroxyanisole, edetate disodium,
gelatin, hydrogenated vegetable oil, polysorbate 80, soybean oil, titanium
dioxide, white wax (beeswax), and vitamin E.
In addition, the 10 mg capsule contains black iron oxide
and FD&C yellow no. 6. The 20 mg capsule contains black iron oxide, red
iron oxide and yellow iron oxide. The 30 mg capsule contains red iron oxide and
yellow iron oxide. The 40 mg capsule contains FD&C yellow no. 6.
The edible imprinting ink contains: 10 mg strength,
D&C red no. 7 calcium lake, FD&C yellow no. 6 aluminum lake, propylene
glycol, shellac glaze, and titanium dioxide; 20 mg strength, ammonium hydroxide,
propylene glycol, shellac glaze, simethicone and titanium dioxide; 30 mg
strength, D&C yellow no. 10 aluminum lake, FD&C blue no.1 aluminum
lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake,
iron oxide black, propylene glycol, and shellac glaze; 40 mg strength, ammonium
hydroxide, iron oxide black, propylene glycol, and shellac glaze.
This Medication Guide has been approved by the U.S. Food
and Drug Administration.