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Sustiva (Efavirenz)
Sustiva Tablet

Articles on Sustiva
Full US Prescribing Inormation

Patient Information

What is Sustiva?
What is known about side effects?
What about drug interactions?
Important safety information
www.sustiva.com


Articles on Sustiva


Does Nevirapine Lower Viral Load More than Efavirenz?
1-7-2011

Switching from Efavirenz to Etravirine Reduces Central Nervous System Side Effects
8-20-2010

The SENSE Trial: Etravirine (ETR) shows fewer Neuropsychiatric Adverse Events than Efavirenz (EFV) in Treatment-na´ve HIV-1 Infected Patients
7-23-2010

SWITCH-EE Study: A Randomized Cross-over Study to Compare Etravirine and Efavirenz treatment
7-23-2010

Switching to Atripla« (EFV/FTC/TDF) from ABC/3TC FDC (Kivexa«/Epzicom«) + Efavirenz (EFV) Improves Lipid Levels Towards NCEP Recommendations: Primary Endpoint Results of a 24-week Randomised Study
7-23-2010

Efavirenz (Sustiva) Label Updated with New Information about Adverse Events and Drug Interactions
4-16-2010

Bristol-Myers-Squibb Begins Enhanced Co-Pay Assistance for Atazanavir (Reyataz) and Efavirenz (Sustiva)
1-5-2010

Experimental NNRTI Rilpivirine (TMC278) Shows Efficacy Comparable to Efavirenz (Sustiva) at 96 Weeks, but with Fewer Side Effects
12-08-2009

Raltegravir Demonstrates Durable Efficacy Through 96 Weeks: Results from STARTMRK, A Phase III Study of Raltegravir-based vs. Efavirenz-based Therapy in Treatment-Na´ve HIV+ Patients

9-15-2009


At 96 Weeks, Raltegravir (Isentress) Is as Effective as Efavirenz (Sustiva) in Suppressing HIV Viral Load and Improving Immune Function
9-15-2009

Long-term Study Finds No Link between Maternal Use of Antiretroviral Therapy -- including Efavirenz (Sustiva) -- and Birth Defects
4-28-2009

Bristol-Myers Squibb Announces Copayment Assistance Programs for Atazanavir (Reyataz), Efavirenz (Sustiva), and Atripla
4-28-2009

NRTI Backbone Choice Affects Durability of Efavirenz- or Nevirapine-based HAART in Treatment-naive HIV patients

4-12-2009


Does Efavirenz (Sustiva) Cause Lipid Accumulation in the Liver?
2-18-2009

Effect of Efavirenz on the Pharmacokinetics of Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
11-05-2008

Comparison of Etravirine Resistance and Efavirenz/Nevirapine Resistance among HIV-1 Infected Patients Who Experienced Virologic Failure with NNRTI-based Antiretroviral Therapy
11-05-2008


Low Doses of CCR5 Antagonist Vicriviroc Do Not Suppress HIV as well as Efavirenz (Sustiva) in Treatment-naive Patients; New Study Underway
10-14-2008


Individual Genetic Variations, Rather than Race/Ethnicity, Best Predict Efavirenz (Sustiva) Side Effects
10-14-2008


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.