 What
is Sustiva?
•
Sustiva is an anti-HIV medication. It is in a category
of HIV medicines called non-nucleoside
reverse transcriptase inhibitors (NNRTIs). Sustiva prevents HIV from entering
the nucleus of healthy T-cells. This prevents the cells from producing new virus
and decreases the amount of virus in the body.
•
Sustiva was approved by the U.S. Food and Drug Administration
for the treatment of HIV in 1998. It was originally produced by DuPont Pharmaceuticals
and is now manufactured by Bristol-Myers Squibb for sale in the United States.
In Europe and many other parts of the world, Sustiva has a different brand name:
Stocrin. Stocrin is manufactured by by Merck Sharp and Dohme. Stocrin and Sustiva
are the same drug.
•
Sustiva must be used in combination with other drugs to
treat HIV. It is usually combined with two nucleoside
reverse transcriptase inhibitors (NRTIs).
What
about drug interactions?
•
Sustiva is broken down (metabolized) by the liver, like
many medications used to treat HIV and AIDS. This means that Sustiva can interact
with other medications. Sustiva can lower or raise the levels of other medications
in the body. Similarly, other medications can lower or raise the levels of Sustiva
in the body. While many interactions are not a problem, some can cause your medications
to be less effective or increase the risk of side effects.
•
The following medications should not be taken while you
are being treated with Sustiva: Antibiotics:
Priftin (rifapentine)
Antifungals: Standard doses of Vfend (voriconazole)
Antihistamines:
Hismanal (astemizole)
Antipsychotics: Orap (pimozide)
Acid reflux/heartburn
medications: Propulsid (cisapride)
Heart medications: Vascor (bepridil)
Sedatives:
Versed (midazolam) and Halcion (triazolam)
Antimigraine medications: Wigraine
and Cafergot (ergot medications).
•
All of the available nucleoside reverse transcriptase
inhibitors can be combined safely with Sustiva.
•
Sustiva can reduce the amount of various protease inhibitors
in the bloodstream, including Reyataz (atazanavir), Invirase (saquinavir), Crixivan
(indinavir), Kaletra (lopinavir/ritonavir), and Agenerase and and Lexiva (amprenavir/fosamprenavir).
Sustiva can increase the amount of Viracept (nelfinavir) and Norvir (ritonavir)
in the bloodstream. And when Sustiva and Norvir are combined, Sustiva levels also
increase in the bloodstream. If Sustiva is taken with Reyataz, Invirase, Kaletra,
Crixivan, Agenerase, or Lexiva, their doses may need to be increased or they may
need to be combined with a low dose of Norvir (e.g., 100 mg) to help maintain
necessary drug levels in the bloodstream.
•
Sustiva can interact with some medications used to treat
TB, MAC and other bacterial infections. Rifadin (rifampin) can decrease Sustiva
levels (Sustiva dose should be increased to 800 mg). Sustiva can decrease Mycobutin
(rifabutin) levels (Mycobutin dose should be increased). Sustiva can also decrease
Biaxin (clarithromycin) levels; an alternative to clarithromycin is recommended. •
Sustiva can interact with some medications used to treat
various fungal infections, including candidiasis and cryptococcal meningitis.
If Sustiva is combined with Vfend (voriconazole), the Vfend dose should be increased
to 400mg every 12 hours and the Sustiva dose should be decreased to 300mg once
daily using the older capsule formulation. Sustiva can also decrease levels of
Sporanox (itraconazole); it is recommended that a Sporanox alternative be used
instead. Nizoral (ketoconazole) levels can decrease as well; no dosing recommendations
have been made.
•
Sustiva can decrease blood levels of calcium channel blockers
(used to control blood pressure, regulate heart beats, and manage chest pain).
Examples include Cardizem (diltiazem), Plendil (felodipine), Cardene (nicardipine),
Procardia (nifedipine), Calan (verapamil). Increasing the doses of these medications
may be necessary.
•
Sustiva can interact with oral contraceptives/birth control
pills (ethinyl estradiol). Sustiva increases the amount of ethinyl estradiol in
the bloodstream. No alternative has been recommended.
What
is known about side effects? •
Many patients have dizziness, trouble sleeping, drowsiness,
trouble concentrating, and/or unusual dreams a few hours after starting treatment
with Sustiva. These feeling 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. If
you have these side effects, such as dizziness, it does not mean that you will
also have severe depression, strange thoughts or angry behavior. 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 (recreational) drugs. You should also avoid driving or
operating machinery if you are having these side effects.
•
A small number of patients have had severe depression,
strange thoughts, or angry behavior while taking Sustiva. Some patients have had
thoughts of suicide and a few patients have actually committed suicide. These
problems tend to occur more often in patients with a history of mental illness.
You should contact your doctor immediately if you think you are having these symptoms,
so your doctor can decide whether you should continue to take Sustiva.
•
Rash is another common side effect of Sustiva. These rashes
usually go away without any change in treatment. In a small number of patients,
rash may be serious. If you develop rash, call your doctor as soon as possible.
•
Other possible side effects include tiredness, upset stomach,
vomiting, and diarrhea.
•
Sustiva can cause someone to test positive for marijuana
as a result of testing for elicit drug use. If you are asked to submit urine for
a drug test, you may want to tell the person collecting the sample that you take
Sustiva. This way, the laboratory conducting the test will know to use a more
sensitive test to prevent false-positive results.
•
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.
Important
safety information:
•
Do not take SUSTIVA if you are taking the following
medicines because serious and life-threatening side effects may occur when taken
together: Hismanal®
(astemizole), Vascor® (bepridil), Propulsid® (cisapride), Versed®
(midazolam), Orap® (pimozide), Halcion® (triazolam), or ergot medicines
(for example, Wigraine® and Cafergot®).
•
In addition, SUSTIVA should not be taken with: Vfend®
(voriconazole) since it may lose its effect or may increase the chance of having
side effects from SUSTIVA. Some doses of voriconazole can be taken at the same
time as a lower dose of SUSTIVA, but you must check with your doctor first.
•
SUSTIVA should not be taken with ATRIPLA™ (efavirenz
600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) because it
contains efavirenz, the active ingredient of SUSTIVA. •
Fortovase®, Invirase® (saquinavir mesylate) should
not be used as the only protease inhibitor in combination with SUSTIVA. •
Taking SUSTIVA with St. John's wort (Hypericum perforatum)
is not recommended as it may cause decreased levels of SUSTIVA, increased viral
load, and possible resistance to SUSTIVA or cross-resistance to other anti-HIV
drugs. •
Tell your healthcare provider right away if you have
any side effects or conditions, including the following: Severe
depression, strange thoughts, or angry behavior have been reported by a small
number of patients taking SUSTIVA (efavirenz). 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 SUSTIVA 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. If
you have ever had mental illness or are using drugs or alcohol.
•
Pregnancy:
Women should not become pregnant while taking SUSTIVA. Serious birth defects have
been seen in children of women treated with SUSTIVA during pregnancy. 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, SUSTIVA may pass
through breast milk and cause serious harm to the baby. •
Rash is a common side effect that usually goes away without
any change in your medicines, but may be serious in a small number of patients.
Rash may be a serious problem in some children. •
If you have liver disease, your healthcare provider may
want to do tests to check your liver. •
Seizures have occurred in patients taking SUSTIVA, usually
in those with a history of seizures. If you have ever had seizures, or take medicines
for seizures, your healthcare provider may want to switch you to another medicine
or monitor you. •
Changes in body fat have been seen in some patients taking
anti-HIV medicines. The cause and long-term health effects are not known.
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