IMPORTANT INFORMATION ABOUT SUSTIVA®
(efavirenz)
INDICATION:
SUSTIVA® (efavirenz) is a prescription medicine used in combination
with other medicines to treat people who are infected with the human immunodeficiency
virus type 1 (HIV-1).
SUSTIVA does not cure HIV and has not been shown to prevent passing HIV to others.
See your healthcare provider regularly.
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: Vascor® (bepridil),
Propulsid® (cisapride),
Versed® (midazolam), Orap® (pimozide), Halcion® (triazolam), or ergot medicines (for example,Wigraine® and Cafergot®).
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.
SUSTIVA should not be taken with ATRIPLA® (efavirenz 600 mg / emtricitabine
200 mg/tenofovir disoproxil fumarate 300mg) because it contains efavirenz, the
active ingredient in SUSTIVA.
If you are taking SUSTIVA with
REYATAZ® (atazanavir sulfate), your
REYATAZ may need to be replaced if this is not the first time you are receiving
treatment for your HIV infection. Other drugs that may also need to be replaced
include
Fortovase® (saquinavir),
Invirase® (saquinavir),
Biaxin® (clarithromycin),
Carbatrol® (carbamazepine),
Tegretol® (carbamazepine),
Noxafil® (posaconazole) and
Sporonox® (itraconazole).
SUSTIVA and Vfend® (voriconazole)
must not be taken together at standard
doses. Some doses of voriconazole can be taken at the same time as a lower dose
of SUSTIVA, but you must check with your healthcare provider first.
These are not all the medicines that may cause problems if you take SUSTIVA® (efavirenz).
Discuss with your healthcare provider all prescription and nonprescription medicines,
vitamins, and herbal supplements you are taking or plan to take.
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. 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, and/or
unusual dreams, 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® (efavirenz) and for 12 weeks after stopping SUSTIVA.
Serious birth defects have been seen in children of women treated with SUSTIVA during
pregnancy. Therefore, 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.
- Liver problems: Some patients taking SUSTIVA have experienced serious liver problems including liver failure resulting in transplantation or death.
Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection,
but there have also been reports in patients without any existing 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.
Other common side effects of SUSTIVA® (efavirenz) taken with
other anti-HIV medicines include: tiredness, upset stomach, vomiting, and diarrhea.
Some patients taking SUSTIVA have experienced increased levels of lipids (cholesterol
and triglycerides) in the blood.
You should take SUSTIVA on
an empty stomach, preferably
at bedtime, which may make some side effects less bothersome.
Full Prescribing Information
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