Dallas Voice (Dallas, Tex.), Vol. 23, No. 30, Ed. 1 Friday, December 8, 2006 Page: 42 of 84
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Important Information
INDICATION: ATRIPLA™ (efavirenz 600 mg/
emtricitabine 200 mg/tenofovir disoproxil
fumarate 300 mg) is a prescription medication
used alone as a complete regimen or with
other medicines to treat HIV infection in adults.
ATRIPLA does not cure HIV or prevent
passing HIV to others. See your healthcare
provider regularly.
IMPORTANT SAFETY INFORMATION:
Contact your healthcare provider right away
if you experience any of the following side
effects or conditions associated with ATRIPLA:
• Nausea, vomiting, unusual muscle pain,
and/or weakness. These may be signs of a
buildup of acid in the blood (lactic acidosis),
which is a serious medical condition.
• Light colored stools, dark colored urine,
and/or if your skin or the whites of your
eyes turn yellow. These may be signs of
serious liver problems.
• If you have HIV and hepatitis B virus (HBV),
your liver disease may suddenly get worse
if you stop taking ATRIPLA. Do not stop
taking ATRIPLA unless directed by your
healthcare provider.
Do not take ATRIPLA if you are taking the
following medicines because serious and
life-threatening side effects may occur when
taken together: Hismanal® (astemizole),
Propulsid® (cisapride), Versed® (midazolam),
Halcion® (triazolam), or ergot derivatives
(for example, Wigraine® and Cafergot®).
In addition, ATRIPLA should not be taken
with: Combivir® (lamivudine/zidovudine),
Emtriva® (emtricitabine), Epivir®or Epivir-HBV®
(lamivudine), Epzicom™ (abacavir sulfate/
lamivudine), Sustiva® (efavirenz), Trizivir®
(abacavir sulfate/lamivudine/zidovudine),
Truvada® (emtricitabine/tenofovir disoproxil
fumarate [DF]), or Viread® (tenofovir DF),
because they contain the same or similar
active ingredients as ATRIPLA.
Vfend® (voriconazole) should not be taken
with ATRIPLA since it may lose its effect or
may increase the chance of having side effects
from ATRIPLA. Fortovase®, Invirase® (saquinavir
mesylate) should not be used as the only
protease inhibitor in combination with ATRIPLA.
Taking ATRIPLA with St. John's wort (Hypericum
perforatum) is not recommended as it may
cause decreased levels of ATRIPLA, increased
viral load, and possible resistance to ATRIPLA
or cross-resistance to other anti-HIV drugs.
This list of medicines is not complete.
Discuss with your healthcare provider all
prescription and nonprescription medicines,
vitamins, and herbal supplements you are
taking or plan to take.
Contact your healthcare provider right away
if you experience any of the following side
effects or conditions:
• Severe depression, strange thoughts,
or angry/abnormal behavior have been
reported by a small number of patients.
Some patients have had thoughts of suicide
and a few have actually committed suicide.
These problems may occur more often in
patients who have had mental illness.
• Dizziness, trouble sleeping or concentrating,
drowsiness, unusual dreams, and/or
hallucinations are common, and tend to go
away after taking ATRIPLA™ (efavirenz 600 mg/
emtricitabine 200 mg/tenofovir disoproxil
fumarate 300 mg) for a few weeks. Symptoms
were severe in a few patients and some
patients discontinued therapy. These symptoms
may become more severe with the use of
alcohol and/or mood-altering (street) drugs.
If you are dizzy, have trouble concentrating,
and/or are drowsy, avoid activities that
may be dangerous, such as driving or
operating machinery.
• Kidney or liver problems. If you have had
kidney or liver problems, including hepatitis
infection or take other medicines that may
cause kidney or liver problems, your healthcare
provider should do regular blood tests.
• Pregnancy: Women should not become
pregnant while taking ATRIPLA. Serious
birth defects have been seen in children of
women treated during pregnancy with one
of the medicines in ATRIPLA. Women must
use a reliable form of barrier contraception,
such as a condom or diaphragm, even if
they also use other methods of birth control.
• Breast-Feeding: Women with HIV should
not breast-feed because they can pass
HIV through their milk to the baby. Also,
ATRIPLA may pass through breast milk
and cause serious harm to the baby.
• Rash is a common side effect that usually
goes away without treatment, but may be
serious in a small number of patients.
• Seizures have occurred in patients taking
a component of ATRIPLA, usually in those
with a history of seizures. If you have ever
had seizures, or take medicine for seizures,
your healthcare provider may want to
monitor you.
• Bone changes. If you have had bone
problems in the past, your healthcare
provider may want to check your bones.
• If you have ever had mental illness or use
illegal drugs or alcohol.
Changes in body fat have been seen in some
people taking anti-HIV medicines. The cause
and long-term health effects are not known.
Common side effects of ATRIPLA include
tiredness, headache, upset stomach,
vomiting, gas, and diarrhea. Skin discoloration
(small spots or freckles) may also happen
with ATRIPLA.
You should take ATRIPLA once daily on an
empty stomach. Taking ATRIPLA at bedtime
may make some side effects less bothersome.
si
If you or someone you know needs help
paying for medicine, call 1-888-4PPA-N0W
(1-888-477-2669). Or go to www.pparx.org
^ Partnership for
S* ' Prescription Assistance
Bristol-Myers Squibb (5 gilead
© 2006 Bristol-Myers Squibb & Gilead Sciences, LLC. All rights reserved.
ATRIPLA and the ATRIPLA logo are trademarks of Bristol-Myers Squibb
6 Gilead Sciences, LLC. EMTRIVA, VIREAD, and TRUVADA are registered
trademarks of Gilead Sciences, Inc. SUSTIVA is a registered trademark of
Bristol-Myers Squibb Pharma Company. All other trademarks are owned
by third parties. SF K0007M/TR0012D October 2006
42 I dallasvoice.com I 12.08.06
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Nash, Tammye. Dallas Voice (Dallas, Tex.), Vol. 23, No. 30, Ed. 1 Friday, December 8, 2006, newspaper, December 8, 2006; Dallas, Texas. (https://texashistory.unt.edu/ark:/67531/metapth238938/m1/42/: accessed April 28, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Special Collections.