Isentress™ – brand name

raltegravir – generic name

Integrase inhibitors work by blocking integrase, a protein that HIV needs to make more copies of itself. This may slow down HIV disease.

Integrase inhibitors work by blocking integrase, a protein that HIV needs to make more copies of itself. This may slow down HIV disease.

The Food and Drug Administration (FDA) has approved Isentress for use in combination with other HIV drugs in HIV+ adults and adolescents who are at least 16 years of age.

Isentress can be used by people who are just starting treatment and have never taken HIV drugs. It can also be used by people who have been on treatment and have HIV that is resistant to other HIV drugs.

Isentress comes in 400 mg tablets.

The dose of Isentress is one 400 mg tablet twice a day.

Isentress can be taken with or without food.

Isentress must be used in combination with other HIV medications to treat HIV.

Isentress should be used with at least one other new HIV drug in people who have been on HIV treatment before. This is important so that at least two new HIV drugs are being started at the same time.

As with all HIV drugs, Isentress should be taken only as prescribed by your doctor. Missing or skipping doses can cause blood levels of Isentress to fall too low and the virus can become resistant to it. This may cause Isentress to stop working.

If you miss a dose of Isentress, you should take it as soon as you remember. If you do not realize that you missed a dose until it is time for your next regularly scheduled dose, skip the missed dose and take the next dose at the regularly scheduled time. Do not take two Isentress tablets at one time.

Isentress may be used by people whose HIV has become resistant to multiple other HIV drugs. Because Isentress fights HIV differently than all other available HIV drugs, there is a good chance that it will work well for people who have drug-resistant HIV.

Isentress is also used by people who are taking HIV drugs for the first time.

In all cases, Isentress should be combined with other HIV drugs.

If your virus develops resistance to Isentress, the drug may stop working or may not work as well for you.

Sometimes taking more than one medication can cause drug interactions. This can cause one or both drugs to not work as well or an increased risk of side effects.

There do not seem to be many drug interactions with Isentress. However, there is an important interaction between Isentress and rifampin and the dose of Isentress needs to be adjusted if these drugs are taken together.

Isentress is not expected to interact with methadone and birth control pills.

There may be interactions between Isentress and other medications that have not yet been found. Be sure your doctor knows about all the medications you are taking (including over-the-counter, prescriptions, street drugs, and herbs), even if you only use them occasionally.

For more information and additional resources to check interactions between the particular drugs you are taking, see The Well Project fact sheet on drug interactions or go to

http://www.hiv-druginteractions.org/
OR
http://hivinsite.ucsf.edu/insite?page=ar-00-02

Isentress is generally well tolerated. If you do experience side effects, they may be temporary and go away as your body adjusts to the medication. If you experience any of the side effects listed below, call your doctor for advice. Do not just stop taking your medication.

• Diarrhea
• Nausea
• Headache
• Fatigue (tiredness)
• Weakness
• Rash
• Skin reactions
• Depression
• Anxiety
• Insomnia (trouble sleeping)

More serious side effects:

• Isentress may cause elevated levels of a muscle enzyme called creatine kinase. Isentress should be used with caution by people who are at an increased risk of muscle problems like myopathy and rhabdomyolysis, which includes people using other drugs that cause these conditions. Contact your health care provider if you experience unexplained muscle pain, tenderness, or weakness.
  

If you experience persistent, unusual, or serious side effects, call your doctor right away.

In the clinical trials conducted for approval of Isentress, only 12% (84 patients) were women. Therefore, very little is known about whether Isentress might act differently in women than it does in men.

Isentress should be used in pregnant women only if the potential benefit outweighs the potential risk to the baby. No studies have been done in pregnant women treated with Isentress.

An Antiretroviral Pregnancy Registry has been established to collect information on pregnant women who take HIV drugs, including Isentress. If you are pregnant and taking Isentress or other HIV drugs, your doctor can register you by calling 1-800-258-4263 or going to www.apregistry.com.

It is not known whether Isentress passes into breast milk. HIV+ women should not breast-feed because their babies could be infected with HIV through the breast milk.

Check with your health care provider about the best treatment options for you and your baby if you are thinking of getting pregnant.

People who are starting HIV treatment for the first time may develop Immune Reconstitution Syndrome or IRS (also called Immune Reconstitution Inflammatory Syndrome or IRIS). IRS can happen as a result of the immune system getting stronger and responding to an HIV-related infection such as Mycobacterium avium infection (MAC), cytomegalovirus (CMV), Pneumocystis jirovecii pneumonia (PCP), or tuberculosis (TB). People may have been treated for these infections in the past or not even know they have them. If you notice any unusual symptoms soon after starting HIV drugs for the first time, let your doctor know right away so you can be evaluated and, if necessary, treated.