JANUARY 14, 2000 • HOUSTON VOICE
SUSTIVA™ (efavirenz) capsules
Patient Information about SUSTIVA*
lor HIV (Human Immunodeficiency Virus) Infection
Generic name: efavirenz (en-FAH-vih-rehnz)
Please read this information before you start taking SUSTIVA. Read it again each time you refill your
prescription, in case there is any new information. Don't treat this leaflet as your only source of information
about SUSTIVA. Always discuss SUSTIVA with your doctor when you start taking your medicine and at
every visit. You should remain under a doctor's care when using SUSTIVA. You should not change or stop
treatment without first talking to your doctor.
What is SUSTTVA?
SUSTIVA is a medicine used to help treat HIV, the virus that causes AIDS (acquired immune deficiency
syndrome). SUSTIVA is a type of HIV drug called a "non-nucleoside reverse transcriptase inhibitor" (NNRTI).
How does SUSTIVA work?
SUSTIVA works by lowering the amount of HIV in the blood (called 'viral load"). SUSTIVA must
be taken wilh other anti-HIV medicines. When taken with other anti-HIV medicines. SUSTIVA has been
shown to reduce viral load and increase the number of CD4 cells (a type of immune cell in blood).
SUSTIVA may not have these effects in every patient.
Does SUSTIVA cure HIV or AIDS?
SUSTIVA is not a cure for HIV or AIDS. People taking SUSTIVA may still develop other infections
associated with HIV Because of this, it is very important that you remain under the care of your doctor.
Does SUSTIVA reduce the risk of passing HIV to others?
SUSTIVA has not been shown to reduce the risk of passing HIV to others. Continue to practice safe sex,
and do not use or share dirty needles.
How should I take SUSTIVA?
• The dose ol SUSTIVA lor adults is 600 mg (three 200 mg capsules, taken together) once a day by moulh
The dose ot SUSTIVA for children may be lower (see Can children take SUSTIVA?
• Take SUSTIVA at the same time each day. You should lake SUSTIVA at bedtime during the first few weeks
or if you have side effects, such as dizziness or trouble concentrating (see What are the possible
side effects of SUSTIVA?
• Swallow SUSTIVA with water, juice, milk or soda. You may take SUSTIVA with or without meals, however,
SUSTIVA should not be taken with a high fat meal
• Do not miss a dose of SUSTIVA. If you forget to take SUSTIVA, take the missed dose right away.
If you do miss a dose, do nol double the next dose. Carry on with your regular dosing schedule.
II you need help in planning the best times to take your medicine, ask your doctor or pharmacist.
• Take the exact amount of SUSTIVA your doctor prescribes. Never change the dose on your own.
Do not stop this medicine unless your doctor tells you to stop.
• When your SUSTIVA supply starts io run low, ge! more from your doctor or pharmacy. This is very
important because the amount of virus in your blood may increase if the medicine is stopped for
even a short time. The virus may develop resistance to SUSTIVA and become harder to treat.
Can children take SUSTTVA?
Yes. children who are able to swallow capsules can take SUSTIVA. Rash may be a serious problem
in some children. Tell your child's doctor right away if you notice rash or any other side effects while your
child is taking SUSTIVA. The dose of SUSTIVA for children may be lower than the dose for adults. Capsules
containing lower doses of SUSTIVA are available. Your child's doctor will determine the right dose based
on your child's weight
Who should not take SUSTIVA?
Do not take SUSTIVA if you are allergic to SUSTIVA or any ot its ingredients.
What other medical problems or conditions should I discuss with my doctor?
Talk to your doctor right away if you:
• Are pregnant or want to become pregnant
• Are breast-feeding
• Have problems with your liver, or have had hepatitis
• Start or change any medicine
• Have side effects while faking SUSTIVA (efavirenz)
• Have a history of mental illness, substance or alcohol abuse
What are the possible side effects of SUSTIVA?
Many patients have dizziness, trouble sleeping, drowsiness, trouble concentrating, and/or unusual
dreams a few hours after starting treatment with SUSTIVA. These feelings may be less noticeable if you
take SUSTIVA at bedtime. They also tend to go away after you've taken the medicine for a few weeks.
Rarely, patients have more serious side effects that may affect mood or ability to think clearly. These side
effects occur more often in patients with a history of mental illness or substance abuse. Tell your doctor
promptly if any of these side effects continue or if they bother you. There is the possibility that these
symptoms may be more severe if SUSTIVA is used with alcohol or mood altering (street) drugs. You should
avoid driving or operating machinery if you are having these side effects.
One of the most common side effects is rash These rashes usually go away without any change in
Ireatment. In a small number of patients, rash may be serious. If you develop a rash, call your doctor promptly.
Other common side effects include tiredness, upset stomach, vomiting, and diarrhea. However, this
is not a complete lisl of side effects reported with SUSTIVA when taken with other anti-HIV drugs. Do not
rely on this leaflet alone for information about side effects. Your doctor can discuss a more complete list
of side effects with you
Please contact your doctor immediately before stopping SUSTIVA because of side effects. Tell your
doctor or other healthcare provider if you notice any side effects while taking SUSTIVA.
What about birth control, pregnancy, or breast-feeding?
Women should not become pregnant while taking SUSTIVA. Birth defects have been seen in animals
treated with SUSTIVA. It is not known whether this could happen in humans. You should use a condom
or diaphragm in addition to other methods of birth control while taking SUSTIVA. Inform your doctor
immediately if you are pregnant. If you want to become pregnant, talk to your doctor. Do not take SUSTIVA
if you are breast-feeding. Talk to your doctor if you are breast-feeding your baby.
Can I take other medicines with SUSTIVA?
SUSTIVA may change the effect of other medicines (including ones for HIV). Your doctor may change
your medicines or change fheir doses. For this reason, it is very important Io:
• Let all your doctors and pharmacists know that you take SUSTIVA.
• Tell your doctors and pharmacists about all medicines you take. This includes those you buy
over-the-counter and herbal or natural remedies.
Bring all your medicines when you see a doctor or make a lisf of their names, how much you lake,
and how often you take them. This will give your doctor a complete picture of the medicines you use.
Then he or she can decide Ihe best approach for your situation
The following medicines may cause serious and life-threatening side effects when taken with SUSTIVA.
You should not take any of these medicines while taking SUSTIVA:'*
• Hismanal® (astemizole)
• Propulsid® (cisapride)
• Versed® (midazolam)
• Halcion® (triazolam)
• Ergot medications (for example, Wigrame® and Cafergot®)
The following medicines may need to be changed or have their dose changed when taken wilh SUSTIVA-'
• Crixivan® (indinavir)
• Fortovase® (saquinavir)
• Biaxin® (clarithromycin)
How should I keep SUSTIVA?
SUSTIVA is available as 50 mg. 100 mg, and 200 mg capsules.
Keep SUSTIVA at room temperature (77°F) in the buttle given to you by your pharmacist.
The temperature can range from 59°-86°F.
Keep SUSTIVA out of the reach of children
How can I learn more about SUSTIVA?
Talk to your doctor or other healthcare provider if you have questions about either SUSTIVA or HIV,
For additional information you can visit the SUSTIVA website at http://www.sustiva.com.
This medicine was prescribed for your particular condition. Do not use
it for any other condition or give it to anybody else. Keep SUSTIVA out of
the reach of children. If you suspect that more than the prescribed dose
of this medicine has been taken, contact your local poison control center
or emergency room immediately.
•SUSTIVA™ and Ihe SUNBURST LOGO are trademarks
of OuF>ont Pharmaceuticals Company.
Copyright C 1999 DuFtmt Pharmaceuticals Company
"The brands listed are the registered trademarks of their respective
owners and are no! trademarks of DuPont Pharmaceulicals Company.
J) DuPont Pharmaceuticals
Wilmington. OE 19880
Issued September. 1998