PALIO Date: 7.30.13 · Client: Gilead · Product: Complera · File Name: 9731_pgitvd_Digest__updtd_gab_HIV_Positive.indd
· Trim: 5.5" x 8.5" · Bleed: 5.75" x 8.75" · Live: 5" x 8"
PALIO Date: 7.30.13 · Client: Gilead · Product: Complera · File Name: 9731_pgitvd_Digest__updtd_gab_HIV_Positive.indd
· Trim: 5.5" x 8.5" · Bleed: 5.75" x 8.75" · Live: 5" x 8"
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HIV Positive
HIV Positive
Brief Summary of full Prescribing Information
COMPLERA
®
(kom-PLEH-rah)
(emtricitabine, rilpivirine, tenofovir disoproxil
fumarate) tablets
Brief summary of full Prescribing Information. For
more information, please see the full Prescribing
Information including Patient Information.
What is COMPLERA?
·
COMPLERA is a prescription HIV (Human
Immunode ciency Virus) medicine that is used to
treat HIV-1 in adults
who have never taken HIV medicines before, and
who have an amount of HIV in their blood
(this is called `viral load') that is no more than
100,000 copies/mL. Your healthcare provider will
measure your viral load.
(HIV is the virus that causes AIDS (Acquired
Immunode ciency Syndrome)).
·
COMPLERA contains 3 medicines rilpivirine,
emtricitabine, tenofovir disoproxil fumarate
combined in one tablet. It is a complete regimen to
treat HIV-1 infection and should not be used with
other HIV medicines.
·
It is not known if COMPLERA is safe and effective in
children under the age of 18 years old.
·
COMPLERA does not cure HIV infection or AIDS.
You must stay on continuous therapy to control HIV
infection and decrease HIV-related illnesses.
·
Ask your healthcare provider if you have any
questions about how to prevent passing HIV to other
people. Do not share or re-use needles or other injection
equipment, and do not share personal items that can
have blood or body uids on them, like toothbrushes and
razor blades. Always practice safer sex by using a latex
or polyurethane condom to lower the chance of sexual
contact with semen, vaginal uids or blood.
What is the most important information I should know
about COMPLERA?
COMPLERA can cause serious side effects, including:
·
Build-up of an acid in your blood (lactic acidosis).
Lactic acidosis can happen in some people who take
COMPLERA or similar (nucleoside analogs) medicines.
Lactic acidosis is a serious medical emergency that can
lead to death. Lactic acidosis can be hard to identify
early, because the symptoms could seem like symptoms
of other health problems.
Call your healthcare provider
right away if you get any of the following symptoms
which could be signs of lactic acidosis:
feel very weak or tired
have unusual (not normal) muscle pain
have trouble breathing
have stomach pain with nausea (feeling sick to your
stomach) or vomiting
feel cold, especially in your arms and legs
feel dizzy or lightheaded
have a fast or irregular heartbeat
·
Severe liver problems. Severe liver problems can
happen in people who take COMPLERA. In some
cases, these liver problems can lead to death. Your
liver may become large (hepatomegaly) and you
may develop fat in your liver (steatosis).
Call your
healthcare provider right away if you get any of the
following symptoms of liver problems:
your skin or the white part of your eyes turns
yellow (jaundice)
dark "tea-colored" urine
light-colored bowel movements (stools)
loss of appetite for several days or longer
nausea
stomach pain
·
You may be more likely to get lactic acidosis or
severe liver problems if you are female, very
overweight (obese), or have been taking COMPLERA
for a long time.
·
Worsening of Hepatitis B infection. If you have
hepatitis B virus (HBV) infection and take COMPLERA,
your HBV may get worse ( are-up) if you stop taking
COMPLERA. A " are-up" is when your HBV infection
suddenly returns in a worse way than before. COMPLERA
is not approved for the treatment of HBV, so you must
discuss your HBV with your healthcare provider.
Do not let your COMPLERA run out. Re ll your
prescription or talk to your healthcare provider before
your COMPLERA is all gone.
Do not stop taking COMPLERA without rst talking to
your healthcare provider.
If you stop taking COMPLERA, your healthcare
provider will need to check your health often and do
blood tests regularly to check your HBV infection.
Tell your healthcare provider about any new or
unusual symptoms you may have after you stop
taking COMPLERA.
Who should not take COMPLERA?
Do not take COMPLERA if:
·
your HIV infection has been previously treated with
HIV medicines.
·
you are taking any of the following medicines:
anti-seizure medicines: carbamazepine (Carbatrol,
Equetro, Tegretol, Tegretol-XR, Teril, Epitol);
oxcarbazepine (Trileptal); phenobarbital (Luminal);
phenytoin (Dilantin, Dilantin-125, Phenytek)
anti-tuberculosis (anti-TB) medicines: rifabutin
(Mycobutin); rifampin (Rifater, Rifamate, Rimactane,
Rifadin); rifapentine (Priftin)
proton pump inhibitor (PPI) medicine for certain
stomach or intestinal problems: esomeprazole (Nexium,
Vimovo); lansoprazole (Prevacid); dexlansoprazole
(Dexilant); omeprazole (Prilosec, Zegerid); pantoprazole
sodium (Protonix); rabeprazole (Aciphex)
more than 1 dose of the steroid medicine
dexamethasone or dexamethasone sodium phosphate
St. John's wort (Hypericum perforatum)
·
If you take COMPLERA, you should not take:
Other medicines that contain tenofovir (Atripla,
Stribild, Truvada, Viread)
Other medicines that contain emtricitabine or
lamivudine (Combivir, Emtriva, Epivir or Epivir-HBV,
Epzicom, Trizivir, Atripla, Truvada, Stribild)
rilpivirine (Edurant)
adefovir (Hepsera)
What should I tell my healthcare provider before
taking COMPLERA?
Before you take COMPLERA, tell your healthcare
provider if you:
·
have or had liver problems, including hepatitis B or C
virus infection, kidney problems, mental health problem
or bone problems
·
are pregnant or plan to become pregnant. It is not
known if COMPLERA can harm your unborn child.
Pregnancy Registry. There is a pregnancy registry for
women who take antiviral medicines during pregnancy.
The purpose of this registry is to collect information about
the health of you and your baby. Talk to your healthcare
provider about how you can take part in this registry.
·
are breast-feeding or plan to breast-feed. You should
not breastfeed if you have HIV because of the risk
of passing HIV to your baby. Do not breastfeed if you
are taking COMPLERA. At least two of the medicines
contained in COMPLERA can be passed to your baby
in your breast milk. We do not know whether this could
harm your baby. Talk to your healthcare provider about
the best way to feed your baby.
Tell your healthcare provider about all the medicines
you take, including prescription and nonprescription
medicines, vitamins, and herbal supplements.
·
COMPLERA may affect the way other medicines work,
and other medicines may affect how COMPLERA
works, and may cause serious side effects. If you
take certain medicines with COMPLERA, the amount of
COMPLERA in your body may be too low and it may not
work to help control your HIV infection. The HIV virus in
your body may become resistant to COMPLERA or other
HIV medicines that are like it.
Especially tell your healthcare provider if you take:
·
an antacid medicine that contains aluminum,
magnesium hydroxide, or calcium carbonate. If you take
an antacid during treatment with COMPLERA, take the
antacid
at least 2 hours before or at least 4 hours
after you take COMPLERA.
·
a medicine to block the acid in your stomach, including
cimetidine (Tagamet), famotidine (Pepcid), nizatidine
(Axid), or ranitidine hydrochloride (Zantac). If you
take one of these medicines during treatment with
COMPLERA, take the acid blocker
at least 12 hours
before or at least 4 hours after you take COMPLERA.
·
any of these medicines (if taken by mouth or injection):
clarithromycin (Biaxin)
erythromycin (E-Mycin, Eryc, Ery-Tab, PCE,
Pediazole, Ilosone)
uconazole (Di ucan)
itraconazole (Sporanox)
ketoconazole (Nizoral)
methadone (Dolophine)
posaconazole (Noxa l)
telithromycin (Ketek)
voriconazole (Vfend)
·
medicines that are eliminated by the kidney, including
acyclovir (Zovirax), cidofovir (Vistide), ganciclovir
(Cytovene IV, Vitrasert), valacyclovir (Valtrex), and
valganciclovir (Valcyte)
What are the possible side effects of COMPLERA?
COMPLERA can cause serious side effects, including:
·
See "What is the most important information I should
know about COMPLERA?"
·
New or worse kidney problems, including kidney
failure, can happen in some people who take
COMPLERA. Your healthcare provider should do blood
tests to check your kidneys before starting treatment
with COMPLERA. If you have had kidney problems in
the past or need to take another medicine that can
cause kidney problems, your healthcare provider may
need to do blood tests to check your kidneys during your
treatment with COMPLERA.
·
Depression or mood changes. Tell your healthcare
provider right away if you have any of the
following symptoms:
feeling sad or hopeless
feeling anxious or restless
have thoughts of hurting yourself (suicide) or have
tried to hurt yourself