What is the most important information I should know about Sustiva?

• Treatment with Sustiva has been associated with the development of serious psychiatric side effects including severe depression, suicidal thoughts, aggressive behavior, paranoid reactions, manic reactions. Contact your doctor immediately if you develop any new or worsening psychiatric symptoms.
• Use caution when driving, operating machinery, or performing other hazardous activities. Sustiva may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
• Avoid alcohol or use it with caution while taking Sustiva. Alcohol may increase dizziness and drowsiness while taking this medication.
• Sustiva is not a cure for HIV or AIDS, and you can still transmit the virus to others during therapy with the medication. Follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles.

What is Sustiva?

• Sustiva is an antiviral medication. It is in a category of HIV medicines called non-nucleoside reverse transcriptase inhibitors. Sustiva inhibits the reproduction of HIV in the body.
• Sustiva is used to treat the human immunodeficiency virus (HIV), which causes the acquired immunodeficiency syndrome (AIDS). Sustiva is not a cure for HIV or AIDS.
• Sustiva may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Sustiva?

• Sustiva may cause serious and/ or life-threatening side effects if taken with certain other medications including the following: cisapride (Propulsid), astemizole (Hismanal), terfenadine (Seldane), midazolam (Versed), triazolam (Halcion), ergotamine (Ergostat, Ergomar, and others), dihydroergotamine (D.H.E. 45), and others. Do not take any other medicines during treatment with Sustiva without first talking to your doctor.
• Before taking Sustiva, tell your doctor if you have
  • liver disease;
  • a history of mental illness or depression; or
  • high blood levels of cholesterol or triglycerides (types of fat in the blood).
• You may not be able to take Sustiva, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Sustiva is in the FDA pregnancy category D. This means that Sustiva is known to be harmful to an unborn baby. Do not use Sustiva without first talking to your doctor if you are pregnant or could become pregnant during treatment. Discuss with your doctor the appropriate use of birth control during treatment with Sustiva if necessary.
• Sustiva passes into breast milk and it is not known whether it will affect a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast feed their babies.

How should I take Sustiva?

• Take Sustiva exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Sustiva can be taken with or without food. Do not take Sustiva with a high fat meal.
• Taking Sustiva at bedtime may help to minimize side effects.
• It is important to take Sustiva regularly to get the most benefit.
• Treatment of HIV/ AIDS almost always requires the use of two or more drugs. If you need to stop taking one of the medicines you are taking for HIV, you should stop all of them until you can talk to your doctor.
• Your doctor may want you to have blood tests or other medical evaluations during treatment with Sustiva to monitor progress and side effects.
• Store Sustiva at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless your doctor directs otherwise.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of an Sustiva overdose may include confusion, poor coordination, headache, numbness or tingling, tremor, dizziness, muscle cramps, and seizures.

What should I avoid while taking Sustiva?

• Use caution when driving, operating machinery, or performing other hazardous activities. Sustiva may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
• Avoid alcohol or use it with caution while taking Sustiva. Alcohol may increase dizziness and drowsiness while taking this medication.
• Follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles. Sustiva is not a cure for HIV or AIDS, and you can still transmit the virus to others during therapy with this medication.

What are the possible side effects of Sustiva?

• Treatment with Sustiva has been associated with the development of serious psychiatric side effects including severe depression, suicidal thoughts, aggressive behavior, paranoid reactions, manic reactions. Contact your doctor immediately if you develop any new or worsening psychiatric symptoms.
• If you experience any of the following serious side effects, stop taking Sustiva and seek emergency medical attention or notify your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
  • a rash.
• Other, less serious side effects may be more likely to occur. Continue taking Sustiva and talk to your doctor if you experience
  • dizziness;
  • drowsiness;
  • insomnia;
  • abnormal dreams;
  • impaired concentration;
  • agitation or nervousness;
  • headache;
  • mild nausea, vomiting, or diarrhea; or
  • changes in body fat (e.g., increased fat in the upper back, neck, breast, and trunk and loss of fat from the legs, arms, and face).
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Sustiva?

• Sustiva may cause serious and/ or life-threatening side effects if taken with certain other medications including the following: cisapride (Propulsid), astemizole (Hismanal), terfenadine (Seldane), midazolam (Versed), triazolam (Halcion), ergotamine (Ergostat, Ergomar, and others), dihydroergotamine (D.H.E. 45), and others. Do not take any other medicines during treatment with Sustiva without first talking to your doctor.
• Before taking Sustiva, tell your doctor if you are taking
  • indinavir (Crixivan);
  • ritonavir (Norvir);
  • saquinavir (Invirase, Fortovase);
  • warfarin (Coumadin);
  • clarithromycin (Biaxin);
  • rifabutin (Mycobutin); or
  • rifampin (Rifadin, Rimactane).
• You may not be able to take Sustiva, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Sustiva. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.