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SUSTIVA (efavirenz) Capsule Instruction for Use Video

US FULL PRESCRIBING INFORMATION patientinformation
INSTRUCTIONS FOR USE

INDICATION
SUSTIVA® (efavirenz) is a prescription medicine used with other antiretroviral medicines to help treat HIV-1 infection in adults and children 3 months or older and who weigh at least 3.5 kg (7 lbs 12 oz).

SUSTIVA does not cure HIV or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections.

See your healthcare provider regularly while taking SUSTIVA.


IMPORTANT SAFETY INFORMATION

What are the possible side effects of SUSTIVA (efavirenz)?

  • Severe depression, strange thoughts, or angry 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, and/or unusual dreams are common side effects. These side effects may be reduced if you take SUSTIVA at bedtime on an empty stomach; they tend to go away after taking SUSTIVA for a few weeks. Tell your healthcare provider right away if any of these side effects continue or if they bother you. These symptoms may be more severe if SUSTIVA is used with 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.
  • Rash is a common side effect that usually goes away without any change in treatment. Rash may be serious in a small number of patients. Rash occurs more commonly in children and may be a serious problem. If a rash develops, call the healthcare provider right away.
  • Other common side effects include: tiredness, upset stomach, vomiting, and diarrhea. Some patients taking SUSTIVA have experienced increased levels of lipids (cholesterol and triglycerides) in the blood.
  • Changes in body fat have been seen in some patients taking anti-HIV medicines. Increase of fat in the upper back and neck, breasts, and around the trunk may happen. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects are not known.
  • 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 while you take SUSTIVA or may switch you to another medicine.

This is not a complete list of side effects. Tell your healthcare provider or pharmacist if you notice any side effects while taking SUSTIVA.

Who should not take SUSTIVA® (efavirenz) ?

  • Do not take SUSTIVA if you are allergic to efavirenz or any of the ingredients.

What should I avoid while taking SUSTIVA?

  • Women should not become pregnant while taking SUSTIVA and for 12 weeks after stopping it. 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, while on SUSTIVA and for 12 weeks after stopping SUSTIVA. Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because SUSTIVA may make these contraceptives ineffective.
  • Women with HIV should not breast-feed because they can pass HIV or may pass SUSTIVA through their milk to the baby. It is not known if SUSTIVA can be passed to your baby in your breast milk and whether SUSTIVA could harm your baby.
  • Avoid alcohol or other medicines causing similar side effects (such as drowsiness) when taking SUSTIVA because they may increase those side effects.
  • Do not take any other medicines without checking with your doctor.

Before using SUSTIVA, tell your doctor if you:

  • Have problems with your liver or have hepatitis.
  • Have ever had mental illness or are using drugs or alcohol.
  • Have ever had seizures or take medicines for seizures. Seizures have occurred in patients taking SUSTIVA, 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 switch you to another medicine or monitor you.

What important information should I know about taking other medicines with SUSTIVA (efavirenz)?

SUSTIVA may change the effect of other medicines, including ones for HIV, and cause serious side effects. Your doctor may change your other medicines or change their doses.

MEDICINES YOU SHOULD NOT TAKE WITH SUSTIVA (efavirenz)

  • Do not take SUSTIVA with
    St. John’s wort (Hypericum perforatum) or products containing St. John’s wort, as it may cause decreased levels of SUSTIVA, increased viral load, and possible resistance to SUSTIVA or cross-resistance to other anti-HIV drugs.
  • 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®).
  • SUSTIVA (efavirenz) should not be taken with ATRIPLA® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) unless your doctor tells you to.
  • 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 Sporanox® (itraconazole), and Victrelis® (boceprevir).
  • 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.

Please refer to the Patient Information for a list of medicines that may require a change in the dose of either SUSTIVA or the other medicine.

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.

You should take SUSTIVA on an empty stomach, preferably at bedtime, which may make some side effects less bothersome.

US Full Prescribing Information

CD4+ cell: A type of white blood cell that fights infection and can be attacked by HIV. May also be called a T-cell.
Viral load: How much virus is in a sample of blood; usually measured as the number of copies of HIV RNA per milliliter of blood. It may be used to judge how well your treatment is working.
Drug resistance: Antiretroviral medicines work by helping to slow replication of the virus.1 When HIV becomes resistant to a medicine, this means that the virus has mutated (or changed form) and its replication may no longer be controlled by that medicine.1
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