SELZENTRY� (sell-ZEN-tree)
Tablets(maraviroc)
�
Read
the Medication Guide that comes with SELZENTRY before you start taking it and
each
time you get a refill. There may
be new information. This information does not take the place of
talking with your doctor about your
medical condition or treatment.
�
What is the most important information i should know about SELZENTRY?
Liver problems
Liver problems (liver toxicity) have happened in
patients taking SELZENTRY. An allergic
reaction may happen before liver
problems occur. Stop taking SELZENTRY and call your doctor
right away if you get any of the
following symptoms:
� an
itchy rash on your body (allergic reaction)
� Your
skin or eyes look yellow and/or dark (tea-colored) urine
� vomiting
and/or upper right stomach area (abdominal) pain
You
should see your doctor right away but continue taking SELZENTRY if you have any
of the
following other symptoms: nausea,
fever, flu-like symptoms, fatigue
�
What is SELZENTRY?
SELZENTRY
is an anti-HIV medicine called a CCR5 antagonist. HIV (Human
Immunodeficiency
Virus) is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
SELZENTRY
is used with other anti-HIV medicines in adults with CCR5-tropic HIV-1
infection
who are already taking anti-HIV medicines and
the medicines are not controlling their HIV
infection.
� SELZENTRY
will not cure HIV infection.
� People
taking SELZENTRY may still develop infections, including opportunistic
infections or other
conditions that happen with HIV infection.
� It
is very important that you stay under the care of your doctor during treatment
with
SELZENTRY.
� The
long-term effects of SELZENTRY are not known at this time.
� SELZENTRY
has not been studied in children less than 16 years of age.
�
Does SELZENTRY lower the risk of passing HIV to other
people?
No, SELZENTRY does not lower the risk of passing HIV to
other people through sexual
contact, sharing needles, or being
exposed to your blood.
� Continue to practice safer sex.
� Use
latex or polyurethane condoms or other barrier methods to lower the chance of
sexual contact with any body
fluids. This includes semen from a man, vaginal secretions
from a woman, or blood.
� Never
re-use or share needles.
� Ask
your doctor if you have any questions about safer sex or how to prevent passing
HIV
to other people.
�
How does SELZENTRY work?
HIV
enters cells in your blood by attaching itself to structures on the surface of
the cell called
receptors. SELZENTRY blocks a specific
receptor called CCR5 that CCR5-tropic HIV-1 uses to
enter CD4 or T-cells in your
blood. Your doctor will do a blood test to see if you have been
infected with CCR5-tropic HIV-1
before prescribing SELZENTRY for you.
� When
used with other anti-HIV medicines, SELZENTRY may:
� reduce the amount of HIV in your blood.
This is called �viral load�.
� increase
the number of white blood cells called T (CD4) cells.
Both
of these may keep your immune system healthy, so it can help fight infection.
SELZENTRY
does not work in all patients with CCR5-tropic HIV-1 infection.
�
What should I tell my doctor before taking SELZENTRY?
Tell your doctor about all of your medical conditions,
including if you:
� have
any allergies
� have
liver problems including a history of hepatitis B or C
� have
heart problems
� have
kidney problems
� have
low blood pressure or take medicines to lower blood pressure
� are pregnant or planning to become
pregnant. It is not known if SELZENTRY may harm
your unborn baby. If you take
SELZENTRY while you are pregnant, talk to your doctor
about how you can be included in
the Antiretroviral Pregnancy Registry.
� are breast-feeding or planning to
breast-feed. It is recommended that HIV-positive women
should not breastfeed their babies.
This is because of the chance of passing HIV to your
baby. Talk with your doctor about
the best way to feed your baby.
�
Tell your doctor about all the medicines you take,
including prescription and non-prescription
medicines, vitamins and herbal
supplements. Certain other medicines may affect the levels of
SELZENTRY in your blood. Your
doctor may need to change your dose of SELZENTRY when
you take it with certain medicines.
�
Do not take products that contain St. John�s Wort
(hypericum perforatum). St. John�s
Wort may lower the levels of SELZENTRY in your blood so that
it will not work to treat
your CCR5-tropic HIV infection.
Know the medicines you take. Keep
a list of your medicines. Show the list to your doctor and
pharmacist when you get a
new medicine.
�
How should I take SELZENTRY?
Take SELZENTRY exactly as prescribed by your doctor. SELZENTRY
comes in 150 mg
and 300 mg tablets. Your doctor will prescribe
the dose that is right for you.
� Take SELZENTRY twice a day.
� Swallow
SELZENTRY tablets whole. Do not chew the tablets.
� Take
SELZENTRY tablets with or without food.
� Always
take SELZENTRY with the other anti-HIV drugs prescribed by your doctor.
�
Do not change your dose or stop taking SELZENTRY or your
other anti-HIV medicines
without first talking with your doctor.
� If
you take too much SELZENTRY, call your doctor or the poison control center
right away.
� If
you forget to take SELZENTRY, take the next dose of SELZENTRY as soon as
possible
and then take your next scheduled dose at its
regular time. If it is less than 6 hours before
your next dose, do not take the
missed dose. Wait and take the next dose at the regular time.
Do
not take a double dose to make up for a missed dose.
� It
is very important to take all your anti-HIV medicines as prescribed and at the
same time
each day. This can help your
medicines work better. It also lowers the chance that your
medicines will stop working to fight
HIV (drug resistance).
� When
your SELZENTRY supply starts to run low, ask your doctor or pharmacist for a
refill.
This
is very important because the amount of virus in your blood may increase and
SELZENTRY
could stop working if it is stopped for even a short period of time.
�
What are the possible side effects of SELZENTRY?
When SELZENTRY has been given with other anti-HIV drugs,
there have been serious side
effects including:
� Liver problems. See
�What is the most important information I should know about
SELZENTRY?�
� Heart problems including heart
attack
� Low blood pressure when standing up
(postural hypotension). Low
blood pressure when
standing up can cause dizziness or
fainting. Do not drive a car or operate heavy machinery
if you have dizziness while taking SELZENTRY.
� Changes in your immune system. A condition called Immune
Reconstitution Syndrome can
happen when you start taking HIV
medicines. Your immune system may get stronger and
could begin to fight infections
that have been hidden in your body such as pneumonia, herpes
virus or tuberculosis. Tell your
doctor if you develop new symptoms after starting your HIV
medicines.
� Possible chance of infection or cancer. SELZENTRY
affects other immune system cells
and therefore may possibly increase your
chance for getting other infections or cancer,
although there is no evidence from
the clinical trials of an increase in serious infections or
cancer.
�
The most common side effects of SELZENTRY include cough,
fever, colds, rash, muscle and
joint pain, stomach pain,
dizziness. Tell your doctor about any side effect that bothers you or
does not go away.
These
are not all of the side effects with SELZENTRY. For more information, ask your
doctor or
pharmacist.
�
How should I store SELZENTRY?
� Store
SELZENTRY tablets at room temperature from 59◦F
to 86◦ (15◦Cto
30◦C)] .
� Safely
throw away medicine that is out of date or that you no longer need.
� Keep SELZENTRY and all medicines
out of the reach of children.