one
The
for me
COMPLERA.
A complete HIV treatment in only 1 pill a day.
COMPLERA is for adults who have never taken
HIV-1 medicines before and have no more than
100,000 copies/mL of virus in their blood.
Ask your healthcare provider if it's the one for you.
Patient model. Pill shown is not actual size.
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
What is COMPLERA?
COMPLERA
®
is a prescription HIV medicine that is used as
a complete regimen 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. COMPLERA contains 3 medicines
rilpivirine, emtricitabine and tenofovir disoproxil fumarate.
It is not known if COMPLERA is safe and effective in children
under the age of 18 years.
COMPLERA
®
does not cure HIV-1 infection or AIDS. To control
HIV-1 infection and decrease HIV-related illnesses you must
keep taking COMPLERA. Avoid doing things that can spread
HIV-1 to others: always practice safer sex and use condoms to
lower the chance of sexual contact with body fl uids; never reuse
or share needles or other items that have body fl uids on them,
do not share personal items that may contain bodily fl uids. Ask
your healthcare provider if you have questions about how to
reduce the risk of passing HIV-1 to others.
IMPORTANT SAFETY INFORMATION
What is the most important information you should know
about COMPLERA?
COMPLERA
®
can cause serious side effects:
·
Build-up of an acid in your blood (lactic acidosis), which
is a serious medical emergency. Symptoms of lactic acidosis
include feeling very weak or tired, unusual (not normal) muscle
pain, trouble breathing, stomach pain with nausea or vomiting,
feeling cold, especially in your arms and legs, feeling dizzy or
lightheaded, and/or a fast or irregular heartbeat.
·
Serious liver problems. The liver may become large
(hepatomegaly) and fatty (steatosis). Symptoms of liver
problems include 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, and/or stomach pain.
·
You may be more likely to get lactic acidosis or serious
liver problems if you are female, very overweight (obese),
or have been taking COMPLERA for a long time. In some
cases, these serious conditions have led to death. Call your
healthcare provider right away if you have any symptoms of
these conditions.
·
Worsening of hepatitis B (HBV) infection. If you also have
HBV and stop taking COMPLERA, your hepatitis may suddenly
get worse. Do not stop taking COMPLERA without fi rst talking
to your healthcare provider, as they will need to monitor your
health. COMPLERA is not approved for the treatment of HBV.
Who should not take COMPLERA?
Do not take COMPLERA if you have ever taken other anti-HIV
medicines. COMPLERA may change the effect of other medicines
and may cause serious side effects. Your healthcare provider
may change your other medicines or change their doses.
Do not
take COMPLERA if you also take these medicines:
·
anti-seizure medicines: carbamazepine (Carbatrol,
Equetro, Tegretol, Tegretol-XR, Teril, Epitol); oxcarbazepine
(Trileptal), phenobarbital (Luminal), phenytoin (Dilantin,
Dilantin-125, Phenytek)
·
anti-tuberculosis medicines: rifabutin (Mycobutin), rifampin
(Rifater, Rifamate, Rimactane, Rifadin) and rifapentine (Priftin)
·
proton pump inhibitors for stomach or intestinal problems:
esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid),
dexlansoprazole (Dexilant), omeprazole (Prilosec), 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 are taking COMPLERA you should not take other HIV
medicines or other medicines containing tenofovir (Viread,
Truvada, Stribild or Atripla); other medicines containing
emtricitabine or lamivudine (Emtriva, Combivir, Epivir, Epivir-HBV,
Epzicom, Trizivir, Atripla, Stribild or Truvada); rilpivirine (Edurant)
or adefovir (Hepsera).
In addition, tell your healthcare provider if you are taking
the following medications because they may interfere with
how COMPLERA works and may cause side effects:
·
certain antacid medicines containing aluminum, magnesium
hydroxide, or calcium carbonate (examples: Rolaids, TUMS).
These medicines must be taken at least 2 hours before or
4 hours after COMPLERA.
·
medicines to block stomach acid including cimetidine
(Tagamet), famotidine (Pepcid), nizatidine (Axid), or
ranitidine HCL (Zantac).
These medicines must be taken at
least 12 hours before or 4 hours after COMPLERA.
·
any of these medicines: clarithromycin (Biaxin); erythromycin
(E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Ilosone), fl uconazole
(Difl ucan), itraconazole (Sporanox), ketoconazole (Nizoral)
methadone (Dolophine); posaconazole (Noxafi l), telithromycin
(Ketek) or voriconazole (Vfend).
·
medicines that are eliminated by the kidneys like acyclovir
(Zovirax), cidofovir (Vistide), ganciclovir (Cytovene IV,
Vitrasert), valacyclovir (Valtrex) and valganciclovir (Valcyte).
These are not all the medicines that may cause problems
if you take COMPLERA. Tell your healthcare provider about
all prescription and nonprescription medicines, vitamins, or
herbal supplements you are taking or plan to take.
Before taking COMPLERA, tell your healthcare provider if you:
·
Have
liver problems, including hepatitis B or C virus
infection, or have abnormal liver tests
·
Have
kidney problems
·
Have ever had a
mental health problem
·
Have
bone problems
·
Are
pregnant or planning to become pregnant. It is not
known if COMPLERA can harm your unborn child
·
Are
breastfeeding: Women with HIV should not breastfeed
because they can pass HIV through their milk to the baby.
Also, COMPLERA may pass through breast milk and could
cause harm to the baby
COMPLERA can cause additional serious side effects:
·
New or worsening kidney problems, including kidney
failure. If you have had kidney problems, or take other
medicines that may cause kidney problems, your healthcare
provider may need to do regular blood tests.
·
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.
·
Changes in liver enzymes: People who have had hepatitis B or
C, or who have had changes in their liver function tests in the
past may have an increased risk for liver problems while taking
COMPLERA. Some people without prior liver disease may also
be at risk. Your healthcare provider may need to check your liver
enzymes before and during treatment with COMPLERA.
·
Bone problems can happen in some people who take
COMPLERA. Bone problems include bone pain, softening
or thinning (which may lead to fractures). Your healthcare
provider may need to do additional tests to check your bones.
·
Changes in body fat can happen in people taking HIV medicine.
·
Changes in your immune system. Your immune system may
get stronger and begin to fi ght infections that have been hidden
in your body for a long time. Tell your healthcare provider if you
start having new symptoms after starting COMPLERA.
The most common side effects reported with COMPLERA are
trouble sleeping (insomnia), abnormal dreams, headache,
dizziness, diarrhea, nausea, rash, tiredness, and depression.
Some side effects also reported include vomiting, stomach pain or
discomfort, skin discoloration (small spots or freckles) and pain.
This is not a complete list of side effects. Tell your healthcare
provider or pharmacist if you notice any side effects while
taking COMPLERA, and call your healthcare provider for
medical advice about side effects.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit http://www.fda.gov/
medwatch or call 1-800-FDA-1088.
Additional Information about taking COMPLERA:
·
Always take COMPLERA exactly as your healthcare
provider tells you to take it.
·
Take COMPLERA with food. Taking COMPLERA with food
is important to help get the right amount of medicine in
your body. (A protein drink does not replace food. If your
healthcare provider stops COMPLERA, make certain you
understand how to take your new medicine and whether you
need to take your new medicine with a meal.)
Stay under the care of your healthcare provider during treatment
with COMPLERA and see your healthcare provider regularly.
Please see Brief Summary of full Prescribing Information with
important warnings on the following pages.
Learn more at www.
COMPLERA.com