Download ABSORICA Patient Brochure

To learn about Gold
Medalist Kelly Clark’s
ABSORICA journey,
turn to page 14!
What you need to know
about ABSORICA®
A guide to the only isotretinoin
therapy that is approved to be
taken without regard to food1
Before ABSORICA treatment
5 months after ABSORICA treatment
Actual patient photographs courtesy of Mark Seraly, MD.
Save money on your ABSORICA
prescription. Use your A-PLU$
discount card located in the
back pocket of this brochure
ABSORICA is a retinoid indicated for the treatment of severe
recalcitrant nodular acne (SRNA) in patients 12 years of age and older.1
For more information, please see
PATIENT COUNSELING INFORMATION
(Section 17) at the end of the
full Prescribing Information.
W I T H
L I D O S E™ T E C H N O L O G Y
About ABSORICA
(isotretinoin) capsules
ABSORICA is used to treat the most severe form of
acne, called severe recalcitrant nodular acne (SRNA)
(in patients 12 years of age and older), that has not been
helped by any other treatments, including antibiotics.
SRNA is when many red, swollen, tender lumps form in
the skin. They can be the size of pencil erasers or larger.
If left untreated, SRNA can lead to permanent scars.2
ABSORICA medication is taken by mouth in two divided
doses (follow your prescriber’s directions). ABSORICA
capsules contain the active ingredient isotretinoin, and
is the only oral medication with this ingredient that can
be taken with or without food.1
ABSORICA is for both male and female patients. It is only
for females who are not pregnant or are not
planning to become pregnant, because it can cause
severe birth defects. ABSORICA is only prescribed to
patients registered in the iPLEDGE™ Program who can
understand and agree to follow and carry out all the
program instructions. Your prescriber will explain the
program to you. You may also learn about the iPLEDGE™
Program online at www.ipledgeprogram.com.1,2
IMPORTANT SAFETY INFORMATION
WARNING: CAUSES BIRTH DEFECTS
Pregnancy Category X
• ABSORICA 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 ABSORICA in any
amount, even for short periods of time.
• Potentially any fetus exposed during pregnancy can
be affected.
• There are no accurate means of determining whether
an exposed fetus has been affected.
2
• Birth defects which have been documented following isotretinoin
exposure include abnormalities of the face, eyes, ears, skull,
central nervous system, cardiovascular system, and thymus and
parathyroid glands. Cases of IQ scores less than 85 with or without
other abnormalities have been reported. There is an increased risk of
spontaneous abortion and premature births have been reported.
• Documented external abnormalities include: skull abnormality; ear
abnormalities (including anotia, micropinna, small or absent external
auditory canals); eye abnormalities (including microphthalmia); facial
dysmorphia; cleft palate. Documented internal abnormalities include:
CNS abnormalities (including cerebral abnormalities, cerebellar
malformation, hydrocephalus, microcephaly, cranial nerve deficit);
cardiovascular abnormalities; thymus gland abnormality; parathyroid
hormone deficiency. In some cases death has occurred with certain
abnormalities previously noted.
• If pregnancy does occur during the treatment of a female patient who
is taking ABSORICA, ABSORICA must be discontinued immediately and
she should be referred to an Obstetrician-Gynecologist experienced
in reproductive toxicity for further evaluation and counseling.
Special Prescribing Requirements
• Because of the risk of teratogenicity and to minimize fetal exposure,
ABSORICA is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS) called iPLEDGETM. Under
iPLEDGETM, prescribers, patients, pharmacies, and distributors must
enroll and be registered in the program.
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
3
W I T H
L I D O S E™ T E C H N O L O G Y
About acne
What causes acne?
A combination of 3 factors occurs in the body, causing
acne to form3:
• Too much of a skin oil called sebum is made
• There are too many dead skin cells
• There is a buildup of bacteria
Hair
Dead Skin Cells
Skin Surface
Oil
(Sebum)
Oil-Producing Gland
Hair Follicle
During puberty, the body begins to make more
hormones. Some of these hormones, called androgens,
cause the oil glands in the skin to get bigger and make
more sebum.3
Normally, sebum helps remove old skin cells and
keeps your skin soft. The sebum flows up and out of
the oil gland through a pore, or small opening to the
skin surface.3,4
When you have acne, a pore has become blocked with
too much sebum and too many dead skin cells. Once
the pore clogs, bacteria start to build up. The bacteria
can cause redness, swelling, and infection underneath
the surface of the skin. This leads to acne lesions, which
can be anywhere from mild to very severe.3,4
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
4
When you have severe inflammatory acne, it is common
to have nodules. These are large, painful lumps deep
beneath the surface of the skin. Nodules can be the size of
pencil erasers, or larger, and can be hard to treat.3,6
What makes some people more prone to
having acne?
Some people may think that dirt, greasy foods, and
chocolate make you more likely to have acne. This is
simply not true. Acne does tend to run in families. If any
of your family members had acne, then you are more
likely to have it. For women, the menstrual cycle and
pregnancy can cause hormonal changes that make
acne worse.3
How is acne treated?
There are many ways to treat acne. Some medications
are applied to the skin; others are taken by mouth.
Different treatments work for different people,
depending on how severe their acne is.5
ABSORICA capsules contain isotretinoin, which is used
to treat people with SRNA that has not improved with
other treatments, including antibiotics. This is why your
prescriber has recommended ABSORICA for you.2
ABSORICA (isotretinoin) capsules are
different from the other medications
with isotretinoin
It is a medication that does not need to be taken
with food.1,2 (For more information on food and
ABSORICA, please see the section, “Taking ABSORICA
(isotretinoin) capsules with or without food” on
page 8 of this brochure.)
Be sure to visit the Web site
at www.absorica.com for
more information.
W I T H
5
L I D O S E™ T E C H N O L O G Y
Visit absorica.com
How do ABSORICA (isotretinoin)
capsules work?
ABSORICA (isotretinoin) capsules
reduce sebum in severe recalcitrant
(difficult-to-treat) nodular acne1,3,5
Hair
Skin Surface
REDUCES
Dead Skin Cells
REDUCES
Oil (Sebum)
SHRINKS
Oil-Producing Gland
Hair Follicle
ABSORICA treats acne where it starts. It reduces the
amount of sebum the skin produces by shrinking the
oil glands. When less sebum is made, fewer bacteria
grow. The pores have less chance of clogging and
forming acne.
ABSORICA capsules also reduce the
number of dead skin cells7
If you recall, too many dead skin cells (caused by too
much sebum) also cause pores to clog. ABSORICA helps
your skin shed the dead cells.
ABSORICA capsules are different
ABSORICA is different from other isotretinoin
medications. Each ABSORICA (isotretinoin) capsule
is created using Lidose™ Technology.8 With this
technology, the body is able to absorb the medication
without food. Once the medication is properly
absorbed, it can then work to help clear up your acne.9
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
6
In helping to treat your acne, ABSORICA
(isotretinoin) capsules may cause
other side effects2
• Your acne may get worse when you first start taking
ABSORICA. This should last only a short while. Talk
with your prescriber if this is a problem for you
• Common, less serious side effects of ABSORICA
include dry skin, chapped lips, dry eyes, and dry nose
that may lead to nosebleeds. Call your prescriber if you
have any side effects that bother you or that do not
go away
• People who wear contact lenses may have trouble
wearing them while taking ABSORICA and for a while
after therapy has stopped. Consider avoiding contact
lenses during treatment
• ABSORICA may cause serious mental health problems
such as depression, psychosis (seeing or hearing things
that are not real), and, rarely, suicidal thoughts and
aggressive and/or violent behaviors. Call your prescriber
right away if you notice any signs of these problems
• ABSORICA may cause serious brain problems, skin
problems, stomach area (abdomen) problems, bone
and muscle problems, hearing problems, vision
problems, blood sugar problems, and decreased red
and white blood cells. These are not all of the possible
side effects with ABSORICA. Your prescriber or
pharmacist can give you more detailed information
or see the full prescribing information
W I T H
7
L I D O S E™ T E C H N O L O G Y
Visit absorica.com
Taking ABSORICA (isotretinoin)
capsules with or without food
How does food affect other
isotretinoin medications?
Food is a very important part of other isotretinoin
acne treatments. Food affects how these medications
are taken up by the body. Without food, other
isotretinoin pills and capsules may not be absorbed
well by your body.10
Most of these medications are absorbed best when they
are taken with a high-fat meal.10
How does food affect how you take your
ABSORICA medication?1
You may take ABSORICA with a meal or without a meal.
ABSORICA capsules are specially designed so that they do
not need to be taken with a high-fat meal to be effective.
Therefore, it’s important to make sure your pharmacist
does not substitute ABSORICA capsules for any other
brand. ABSORICA is not interchangeable with generic
products of Accutane® (isotretinoin) capsules.
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
8
Why are ABSORICA (isotretinoin)
capsules different?
Typical isotretinoin treatments need to be taken
with a high-fat meal to be effective.1,9 Only a very
small percentage of people take them with a highfat meal; most people either forget or don’t normally
eat high-fat meals. This could prevent the medication
from working as well as it should.11 This is not a problem
with ABSORICA.
ABSORICA is an isotretinoin medication made with a
special capsule technology called Lidose™. Scientists
designed Lidose™ so that the body can absorb some
medicines without a high-fat meal.8
Tests with ABSORICA show that a person’s body will
absorb this medicine well, even in the fasting state.
Skipping meals is not recommended, but it is good
to know that you can be flexible with your eating
habits, if necessary, with ABSORICA.1
With ABSORICA, you don’t have to change your usual
eating habits and you don’t have to schedule your meals
so that they match the time you take your medication.
ABSORICA capsules now come in 25- and 35-mg
strengths. These strengths allow your doctor to more
accurately tailor your dose based on your weight.
ABSORICA capsules are the only isotretinoin acne
treatment to offer 6 dosage strengths.
ABSORICA fits your lifestyle while helping to clear up
your severe acne.
W I T H
9
L I D O S E™ T E C H N O L O G Y
Visit absorica.com
Taking ABSORICA
(isotretinoin) capsules
Your ABSORICA prescription
You will receive no more than a 30-day supply of
ABSORICA (isotretinoin) capsules at a time. This is
because of the iPLEDGE™ Program requirements.
The dose of ABSORICA that you will take has been
specifically chosen for you by your prescriber. The
amount of medicine you need is based on your weight
and other factors. It is recommended that ABSORICA be
taken twice a day.1,2
How to take your ABSORICA medication
Take ABSORICA in two divided doses. Be sure to swallow
your ABSORICA capsules whole with a full glass of liquid.
Do not chew or suck on the capsules. ABSORICA can
hurt the tube that connects your mouth to your
stomach (esophagus) if it is not swallowed whole.2
IF YOU MISS A DOSE, JUST SKIP THAT DOSE. Do not
take 2 doses at the same time. If you take too much
ABSORICA, or overdose, call your prescriber or the
Poison Control Center (1-800-222-1222) right away.2
Actual patient
photographs
courtesy of
Dr Scott A. Smith,
FAOCD, FASMS.
Before ABSORICA treatment
5 months after ABSORICA treatment
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
10
With ABSORICA (isotretinoin) capsules,
what you eat and when you eat is up to you
You do not have to change your usual eating style with
ABSORICA. You can eat healthy foods, such as foods with
little or no fat, while taking this medication.1
With ABSORICA, you are not limited to only eating a
high-fat meal with each dose. You can continue to enjoy
whatever diet you decide is best for you, whether it
involves high-fat, low-fat, or no-fat foods.
Getting your ABSORICA capsules is easy
Ask your health care provider about PARTNERx SHIP™.
This program offers the convenience of fast, easy, and
free delivery of ABSORICA right to your door.
W I T H
11
L I D O S E™ T E C H N O L O G Y
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What factors can affect the
success of ABSORICA treatment?
Isotretinoin, the active ingredient in ABSORICA
(isotretinoin) capsules, has successfully helped to clear
up severe cases of nodular (inflamed) acne after other
treatments have failed.6,12,13 Patients often have no
recurrence of their acne after using ABSORICA.7
Factors that affect the success of treatment
with ABSORICA (isotretinoin) capsules include:
• Appropriate patient selection
ABSORICA is for patients with severe recalcitrant
(difficult-to-treat) nodular acne that has not been
helped by other treatments, including antibiotics.2
• Age
ABSORICA is for patients who are 12 years of age
and older. ABSORICA has not been studied in
younger patients.1
• Dosage of ABSORICA capsules
Your prescriber will determine the best dose of
ABSORICA for you based on your weight and how
you respond to treatment. Your prescriber may
change your dose during treatment. Regardless
of the dose, you should take ABSORICA twice
a day, and your ABSORICA treatment may last
15 to 20 weeks.1,2
Actual patient
photographs
courtesy of
Dr Scott A. Smith,
FAOCD, FASMS.
Before ABSORICA treatment
5 months after ABSORICA treatment
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
12
• Food
Remember, you may take ABSORICA without regard to
meals. You may choose foods based on your usual eating
habits.1,2 The foods need not be high fat.
• Staying on track with your therapy
It’s important to follow all of your prescriber’s
instructions for your treatment to be most successful.
Take ABSORICA medication regularly twice a day,
don’t miss doses, and continue taking ABSORICA for
15 to 20 weeks. You must also follow all requirements
of the iPLEDGE™ Program.1,2
• Family support
Having support from your family is important.
You will need support, both as you begin therapy
and as you continue it for the full course of
15 to 20 weeks of your prescription.2 Your family
and friends can help you keep a positive attitude.
Actual patient
photographs
courtesy of
Melissa L.F.
Knuckles, MD.
Before ABSORICA treatment
5 months after ABSORICA treatment
W I T H
13
L I D O S E™ T E C H N O L O G Y
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Kelly Clark—
A champion’s ABSORICA journey
Kelly Clark is widely regarded as one of the most
accomplished and respected snowboarders in the
world. She is the most successful female snowboarder
in the history of the sport and, with over 70 career
wins, she has the most snowboarding wins among
women and men. At 32 years of age, she remains at the
top of her field and shows no signs of slowing down.
Kelly is a true champion.
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
14
Kelly’s experience with SRNA
Kelly first developed acne as a teenager, as do many
people, but as her peers’ skin began to clear, Kelly saw no
relief and she actually found her acne becoming more
inflamed, red, and painful. When her acne persisted
into her adult years, Kelly feared “severe acne was just
something I would have to live with.”
W I T H
15
L I D O S E™ T E C H N O L O G Y
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Kelly’s treatment with ABSORICA
After discussing the challenges of living with severe
acne and past treatment attempts, Kelly and her
dermatologist decided that isotretinoin would
be an appropriate therapy. Given her lifestyle as a
professional athlete, Kelly was concerned about the
dietary requirements of standard isotretinoins. Not
only could she not commit to routinely scheduled
meals, but the necessary high-fat foods were not
feasible in light of her training diet. Her doctor
explained that ABSORICA capsules were different
because their effectiveness was not dependent on
food intake.1 Together, Kelly and her dermatologist
decided that ABSORICA was the right isotretinoin
treatment for her.
Kelly also found the PARTNERx SHIP program to be
a good fit for her busy schedule because it offers
express delivery of the medication and worked with
her travel schedule.
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
16
Kelly’s ABSORICA success story
Kelly began to see a noticeable improvement in her skin
within weeks of starting ABSORICA. Her skin was clearer
and her pain from her lesions was reduced. During her
5-month treatment regimen, she remained committed
to close monitoring and regular screening. After
completing treatment, the results spoke for themselves.
“My friends and teammates kept telling
me how great my skin looked, which
I’d never heard before.”
IMPORTANT SAFETY INFORMATION
ABSORICA may cause serious
mental health problems.
See pages 18-22 for
more information.
W I T H
17
L I D O S E™ T E C H N O L O G Y
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Safety information for ABSORICA
(isotretinoin) capsules
Isotretinoin medication causes
birth defects2
There is a very high risk of birth defects (deformed
babies) if a pregnant woman takes medication that
contains isotretinoin. There are additional risks to
pregnant women taking isotretinoin, including
premature (early) birth, miscarriage (loss of the baby),
and stillbirth (death of the baby).
Female patients must not get pregnant:
• For 1 month before starting ABSORICA treatment
• While taking ABSORICA treatment
• For 1 month after stopping ABSORICA treatment
For female patients, stop using ABSORICA
(isotretinoin) capsules and call your
prescriber right away if you2:
• Have sex at any time without using 2 forms of the
iPLEDGE™ Program accepted birth control methods
• Get pregnant
• Miss your expected period
Do not drive at night until you know if
ABSORICA (isotretinoin) capsules have
affected your vision
ABSORICA may decrease your ability to see in the dark,
so night driving may be more difficult.2
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
18
What are the possible side effects
of ABSORICA (isotretinoin) capsules?
Serious mental health problems2
ABSORICA may cause depression, psychosis (seeing
or hearing things that are not real), and suicide. Some
patients taking ABSORICA 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 ABSORICA treatment and call your prescriber 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 ABSORICA capsules,
you may need to see a mental
health care professional if
you experienced any of
these symptoms.
19
W I T H
L I D O S E™ T E C H N O L O G Y
Visit absorica.com
Safety information for ABSORICA
(isotretinoin) capsules
Serious brain problems2
ABSORICA (isotretinoin) capsules can increase the
pressure in your brain. This can lead to permanent loss of
eyesight and, in rare cases, death. Stop taking ABSORICA
and call your prescriber right away if you have any of
these signs of increased brain pressure:
• Bad headache
• Blurred vision
• Dizziness
• Nausea or vomiting
• Seizures (convulsions)
• Stroke
Skin problems2
Skin rash can occur in patients taking ABSORICA.
In some patients, a rash can be serious. Stop using
ABSORICA and call your prescriber right away if you
develop conjunctivitis (red or inflamed eyes, like
“pink eye”); a rash with a fever; blisters on your legs,
arms, or face, and/or sores in your mouth, throat,
nose, or eyes; or if your skin begins to peel.
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
20
Additional possible side effects
of ABSORICA (isotretinoin) capsules
Stomach area (abdomen) problems2
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 ABSORICA. Stop taking ABSORICA and call your
prescriber if you have
• Severe stomach, chest, or bowel pain
• Trouble swallowing or painful swallowing
• New or worsening heartburn
• Diarrhea
• Bleeding from the rectum
• Yellowing of your skin or eyes
• Dark urine
Bone and muscle problems2
ABSORICA may affect bones, muscles, and ligaments
and cause pain in your joints or muscles. Tell your
prescriber if you plan to engage in hard physical activity,
including sports, during treatment with ABSORICA. Tell
your prescriber if you have back pain, joint pain, or a
broken bone. Tell your prescriber, or any other health
care providers, that you take ABSORICA if you break
a bone.
Stop ABSORICA treatment and call your prescriber
right away if you have muscle weakness. Muscle
weakness, with or without pain, can be a sign of
serious muscle damage.
ABSORICA may stop long
bone growth in teenagers
who are still growing.
W I T H
21
L I D O S E™ T E C H N O L O G Y
Visit absorica.com
Safety information for ABSORICA
(isotretinoin) capsules
Hearing problems2
Stop ABSORICA treatment and call your prescriber if
your hearing gets worse or if you have ringing in your
ears. Your hearing loss may be permanent.
Vision problems2
ABSORICA may affect your ability to see in the dark.
This condition usually clears up after you stop taking
ABSORICA, but it may be permanent. Other serious eye
effects can occur. Stop taking ABSORICA and call your
prescriber 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 during and after ABSORICA treatment.
Lipid (fats and cholesterol in blood) problems2
ABSORICA can raise the level of fats and cholesterol
in your blood. This can be a serious problem. Return to
your prescriber for blood tests to check your lipid levels
and to get any needed treatment. These problems
associated with fats or cholesterol while taking ABSORICA
usually go away when ABSORICA treatment is finished.
Blood sugar problems2
ABSORICA may cause blood sugar problems, including
diabetes. Tell your prescriber if you are very thirsty or
urinate a lot.
Decreased red and white blood cells2
Call your prescriber if you have trouble breathing,
if you faint, or feel weak.
These are not all of the possible side effects with
ABSORICA (isotretinoin) capsules. Please see the
enclosed Package Insert in pocket for more information.
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
22
What should I tell my prescriber before
taking ABSORICA (isotretinoin) capsules?
Tell your prescriber if you or a family
member has any of the following
health conditions2:
• 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), and food or medicine allergies
Tell your prescriber if you are pregnant
or breastfeeding. ABSORICA (isotretinoin)
capsules must not be used by women who
are pregnant or breastfeeding.2
Tell your prescriber about all of the
medications you take, including prescription
and nonprescription medications, vitamins,
and herbal supplements.2
ABSORICA (isotretinoin) capsules and certain other
medications can interact with each other, sometimes
causing serious side effects. Especially tell your prescriber
if you take2:
• Vitamin A supplements
• Tetracycline antibiotics
• Progestin-only birth control pills (minipills)
• Dilantin (phenytoin)
• Corticosteroid medicines
• St. John’s wort
These medications should not be used with ABSORICA
(isotretinoin) capsules, unless your prescriber tells
you it is okay.2
Know the medications you take. Keep a list of them to
show to your prescriber and
pharmacist. Do not take any
new medication without
talking with your prescriber.2
W I T H
23
L I D O S E™ T E C H N O L O G Y
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What should I avoid while taking
ABSORICA (isotretinoin) capsules?2
• Do not get pregnant while taking ABSORICA and for
1 month after stopping treatment
• Do not breastfeed while taking ABSORICA and for
•
•
1 month after stopping treatment
— It is not known if ABSORICA can pass through breast
milk and harm a baby
Do not donate blood while taking ABSORICA and for
1 month after stopping treatment
— If a pregnant woman gets your donated blood, her
baby may be exposed to ABSORICA and may be born
with birth defects
Do not take other medications or herbal supplements
while taking ABSORICA, unless allowed by your prescriber
• Do not drive at night until you know if ABSORICA
•
•
has affected your vision
— ABSORICA may decrease your ability to see in the dark
Avoid sunlight and ultraviolet lights as much as possible
— Tanning machines use ultraviolet lights. ABSORICA
may make your skin more sensitive to light
Do not share ABSORICA with other people
— It can cause birth defects and other serious
health problems
— Each treatment is individualized for each patient,
as determined by a licensed prescriber
During treatment with ABSORICA (isotretinoin)
capsules and for 6 months after treatment2
• Do not have cosmetic procedures to smooth your skin
— This includes waxing, dermabrasion, and laser procedures
— ABSORICA can increase your chance of scarring from
these procedures. Check with your prescriber for advice
about when you can have cosmetic procedures
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
24
Instructions for taking ABSORICA
(isotretinoin) capsules
You must take ABSORICA (isotretinoin) capsules exactly
as directed by your prescriber. You must also follow
all the instructions of the iPLEDGE™ Program. Before
prescribing ABSORICA to you, your prescriber will2
• 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
Your prescriber will not prescribe ABSORICA if you
cannot agree to or follow all the instructions of the
iPLEDGE™ Program.2
Your prescriber will have you return to the office monthly
to make sure you don’t have any signs of serious side
effects, and may prescribe blood tests. Female patients
who can get pregnant will also be given a monthly
pregnancy test. At each visit, you should talk with your
prescriber about any side effects you may have.1,2
Store ABSORICA at 68° to 77°F (20° to 25°C) and protect
from light. Keep ABSORICA and all medicines out of
the reach of children.2
For male patients taking ABSORICA
(isotretinoin) capsules who are in a
sexual relationship with a woman
who may get pregnant
Use 2 methods of iPLEDGE™ Program accepted birth
control during treatment with ABSORICA and for 1 month
after stopping treatment.
ABSORICA is found in semen of male patients in very
small quantities. The relationship between isotretinoin
in semen and birth defects
is unknown.2
W I T H
25
L I D O S E™ T E C H N O L O G Y
Visit absorica.com
Additional instructions for females
taking ABSORICA (isotretinoin)
capsules who can get pregnant
This information applies to patients who
are able to get pregnant. This includes
• Women who have menstrual periods
• Young women who have not started having
menstrual periods
• Women who have had a tubal sterilization (women
who have had their tubes tied can still get pregnant)
This information does not apply to the
following patients:
• Males
• Women who have stopped having periods for
12 months in a row (menopause) and are confirmed
by a prescriber as being in menopause
• Women who have had their ovaries or uterus
removed by surgery
Because ABSORICA (isotretinoin) capsules
cause birth defects1,2
It is critical for female patients not to get pregnant while
taking ABSORICA. Abstinence means that you will not
have sex or sexual contact with any male for 24 hours a
day, 7 days a week. This may be difficult to do, especially
if you are used to having sex.
If you cannot commit to continuous abstinence from sex
with a male, you should use 2 forms of effective birth
control while you are taking ABSORICA and for 1 month
after finishing your therapy.
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
26
Getting started
• You must choose 2 separate forms of effective birth
control because any single form (including sterilization
and birth control pills) can fail. You may either discuss
effective forms of birth control with your prescriber or
discuss birth control with another prescriber or family
planning expert at a free visit. Your prescriber can
arrange this free visit, which will be paid for by
the makers of ABSORICA (isotretinoin) capsules1,2
• Get a pregnancy test administered by your prescriber.
Results from this test must be negative1
• Start using 2 methods of iPLEDGE™ Program accepted
birth control together for 30 days before your next
appointment with your prescriber1
• Get a second pregnancy test at a CLIA (Clinical
Laboratory Improvement Amendments)–certified
laboratory, which your prescriber can recommend.
The results from this test must be negative1
• Sign 2 consent forms for treatment
• Get a prescription from your prescriber for your first
2
30-day supply of ABSORICA2
• Before you fill the prescription, answer questions to
show that you understand the iPLEDGE™ Program
and pregnancy prevention. Your prescriber will
explain the iPLEDGE™ Program requirements.
You may also learn about iPLEDGE™ online at
www.ipledgeprogram.com2
• Continue using 2 forms of effective birth control
together throughout your ABSORICA treatment2
• Begin your first 30-day prescription of ABSORICA and
make sure to schedule your next appointment with your
prescriber. Take ABSORICA
exactly as prescribed.
IF YOU MISS A DOSE,
SKIP IT. DO NOT TAKE
W I T H LI D O S E T E CH N O LO G Y
2 DOSES TOGETHER2
™
27
Visit absorica.com
Additional instructions for taking
ABSORICA (isotretinoin) capsules if
you can get pregnant
Each month of your therapy with ABSORICA
(isotretinoin) capsules
• Continue using 2 methods of iPLEDGE™ Program
accepted birth control together2
• Get a pregnancy test performed at a CLIA-certified
laboratory. The test results must be negative2
• Get a prescription from your prescriber for your next
30-day supply of ABSORICA2
• Answer questions to show that you understand
the iPLEDGE™ Program requirements and
pregnancy prevention2
• Begin your next 30-day prescription of ABSORICA and
make sure to schedule your next appointment. Take
ABSORICA exactly as prescribed. IF YOU MISS A DOSE,
SKIP IT. DO NOT TAKE 2 DOSES TOGETHER2
After your final prescription is finished
• Get a pregnancy test administered by your prescriber
• Answer questions to show that you understand
1
the iPLEDGE™ Program requirements and
pregnancy prevention2
• Continue using 2 methods of iPLEDGE™ Program
accepted birth control together for 30 more days2
• Get a final pregnancy test administered by your
prescriber 30 days after your last dose of ABSORICA1
• DO NOT donate blood for 1 month after your last dose
of ABSORICA2
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
28
References
1. ABSORICA [prescribing information]. Jacksonville, FL: Ranbaxy Laboratories Inc.;
September 2015.
2. ABSORICA Medication Guide. Jacksonville, FL: Ranbaxy Laboratories Inc.;
September 2015.
3. Acne Mayo Clinic Web site: http://www.mayoclinic.org/diseases-conditions/acne/
basics/causes/con-20020580. Accessed December 10, 2015.
4. Acne. MedlinePlus Medical Encyclopedia Web site. http://www.nlm.nih.gov/
medlineplus/ency/article/000873.htm. Accessed September 24, 2014.
5. Questions and answers about acne. National Institute of Arthritis and
Musculoskeletal and Skin Diseases Web site. http://www.niams.nih.gov/
health_info/acne/. Accessed September 24, 2014.
6. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne with
13-cis-retinoic acid: evaluation of sebum production and the clinical response
in a multiple-dose trial. J Am Acad Dermatol. 1980;3(6):602-611.
7. Del Rosso JQ. Face to face with oral isotretinoin: a closer look at the spectrum
of therapeutic outcomes and why some patients need repeated courses.
J Clin Aesthet Dermatol. 2012;5(11):17-24.
8. Vanderbist F, Servais C, Baudier P, (2008). U.S. Patent No. 7,435,427.
Washington, DC: U.S. Patent and Trademark Office.
9. Del Rosso JQ. Status report on oral isotretinoin in the management of acne
vulgaris: why all the discussion about drug absorption and relapse rates?
Curr Derm Rep. 2013;2(3):177-180.
10. Sotret [prescribing information]. Jacksonville, FL: Ranbaxy Laboratories Inc.;
February 2010.
11. Zeichner J. On dosage and diet: isotretinoin 101. Pract Dermatol. January 2014:4647.
12. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and
conglobate acne with13-cis-retinoic acid. N Engl J Med. 1979;300(7):329-333.
13. Jones H, Blanc D, Cunliffe WJ. 13-cis retinoic acid and acne. Lancet.
1980;2(8203):1048-1049.
ABSORICA and PARTNER x SHIP are trademarks of Ranbaxy Laboratories Inc.
All other trademarks are property of their respective owners.
W I T H
29
L I D O S E™ T E C H N O L O G Y
Visit absorica.com
IMPORTANT SAFETY INFORMATION
• ABSORICA is used to treat a type of severe recalcitrant nodular acne
that has not been helped by other treatments, including antibiotics.
• Because ABSORICA can cause birth defects, ABSORICA is only for
patients who can understand and agree to carry out all of the
requirements of the iPLEDGETM Program.
• ABSORICA may cause serious mental health problems.
For more information, please see PATIENT COUNSELING INFORMATION
(Section 17) at the end of the full Prescribing Information.
For more product information, please visit www.absorica.com.
W I TH
L I D O S E™ T E C H N O L O G Y
If you experience any Adverse Events you are encouraged to report
them to the Drug Safety Department at 1-800-406-7984 or email
[email protected]. You can also report to the FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Ranbaxy Laboratories Inc.
Jacksonville, FL 32257
Copyright © 2015 Ranbaxy Laboratories Inc, a SUN PHARMA company.
Printed in USA
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