AARP The Magazine - February/March 2012

MEDICATION GUIDE
INCIVEK (in-SEE-veck)
(telaprevir)
Film-Coated Tablets
Read this Medication Guide before you
start taking INCIVEKTM and each time you
get a refill. There may be new information.
This information does not take the place of
talking with your healthcare provider about
your medical condition or your treatment.
INCIVEK is taken along with peginterferon
alfa and ribavirin. You should also read those
Medication Guides.
What is the most important information I
should know about INCIVEK?
INCIVEK combination treatment may
cause serious side effects including:
1. Birth defects or death of your unborn
baby. INCIVEK in combination with
peginterferon alfa and ribavirin may cause
birth defects or death of your unborn
baby. If you are pregnant or your sexual
partner is pregnant or plans to become
pregnant, do not take these medicines.
You or your sexual partner should not
become pregnant while taking INCIVEK
with peginterferon alfa and ribavirin and
for 6 months after treatment is over.
If you are a female who can become
pregnant, or you are a female whose
male partner takes these medicines:
t You must have a negative pregnancy test
before starting treatment, each month
during treatment, and for 6 months after
your treatment ends.
t;; You must use 2 forms of effective birth
control during treatment and for the
6 months after treatment with these
medicines. Hormonal forms of birth
control including birth control pills, vaginal
rings, implants, or injections may not work
during treatment with INCIVEK. You could
become pregnant. Talk to your healthcare
provider about other forms of birth control
that may be used during this time. If your
healthcare provider tells you to stop taking
INCIVEK, peginterferon alfa and ribavirin,
you must still use two forms of birth
control for the 6 months after treatment
with these medicines. You may use a
hormonal form of birth control as one of
your two forms of birth control after
2 weeks of stopping INCIVEK.
t If you or your female sexual partner
becomes pregnant while taking INCIVEK,
peginterferon alfa, and ribavirin or within
6 months after you stop taking these
medicines, tell your healthcare provider
right away. You or your healthcare provider
should contact the Ribavirin Pregnancy
Registry by calling 1-800-593-2214.
The Ribavirin Pregnancy Registry collects
information about what happens to
mothers and their babies if the mother
takes ribavirin while she is pregnant.
2. Skin reactions. Mild skin rashes are
common with INCIVEK combination
treatment. Sometimes these skin
rashes and other skin reactions can
become severe and require treatment
in a hospital.
t Call your healthcare provider right
away if you develop any skin changes
with any of the symptoms below. Your
healthcare provider will decide if your
skin changes or symptoms may be a
sign of a serious skin reaction:
° rash, with or without itching
° blisters or skin lesions
° mouth sores or ulcers
° red or inflamed eyes, like
“pink eye” (conjunctivitis)
° swelling of your face
° fever
t;; Your healthcare provider will decide if you
need treatment for your rash or if you need
to stop taking INCIVEK, or any of your
other medicines.
t;; Never stop taking INCIVEK combination
treatment without talking with your
healthcare provider first.
See “What are the possible side effects
of INCIVEK?” for more information about
side effects.
3. Do not take INCIVEK alone to treat
chronic hepatitis C infection. INCIVEK
must be used with peginterferon alfa
and ribavirin to treat chronic
hepatitis C infection.
What is INCIVEK?
INCIVEK is a prescription medicine used with
the medicines peginterferon alfa and ribavirin
to treat chronic (lasting a long time)
hepatitis C genotype 1 infection in adults
with stable liver problems, who have not
been treated before or who have failed
previous treatment.
It is not known if INCIVEK is safe and
effective in children under 18 years of age.
Who should not take INCIVEK?
Do not take INCIVEK if you:
t are pregnant or may become
pregnant. See “What is the most
important information I should know
about INCIVEK?”
t are a man with a sexual partner who
is pregnant.
t take certain medicines. INCIVEK
may cause serious side effects when
taken with certain medicines. Read
the section “What should I tell my
healthcare provider before
taking INCIVEK?”
Talk to your health care provider before
taking INCIVEK if any of the above applies
to you.
What should I tell my healthcare provider
before taking INCIVEK?
Before you take INCIVEK, tell your healthcare
provider if you:
t have certain blood problems, such as low
red blood cell count (anemia)
t have liver problems other than
hepatitis C infection
t have hepatitis B infection
t have Human Immunodeficiency Virus (HIV)
infection or any other problems with your
immune system
t history of gout or high uric acid levels in
your blood
t have had an organ transplant
t plan to have surgery
t have any other medical condition
t are breastfeeding. It is not known if INCIVEK
passes into your breast milk. You and your
healthcare provider should decide if you
will take INCIVEK or breastfeed. You should
not do both.
Tell your healthcare provider about all the
medicines you take, including prescription
and non-prescription medicines, vitamins,
and herbal supplements.
INCIVEK and other medicines can affect each
other. This can cause you to have too much or
not enough INCIVEK or your other medicines
in your body, and cause side effects that can
be serious or life-threatening. Your healthcare
provider may need to change the amount of
medicine you take.
Do not take INCIVEK if you take:
t alfuzosin hydrochloride (Uroxatral®)
t atorvastatin (Lipitor®, Caduet®)
t ergot containing medicines such as
methylergonovine (Methergine®)
t lovastatin (Advicor®, Altoprev®, Mevacor®)
t pimozide (Orap®)
t rifampin (Rifadin®, Rifamate®, Rifater®)
t sildenafil citrate (Revatio®) or tadalafil
(Adcirca®) for the lung problem, pulmonary
artery hypertension (PAH)
t simvastatin (Zocor®, Vytorin®, Simcor®)
t St. John’s wort (Hypericum perforatum) or
products containing St. John’s wort
t triazolam (Halcion®)

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