**Criteria for Use: Raltegravir (Isentress^TM^)**

**VHA Pharmacy Benefits Management Service and the Medical Advisory
Panel**

*The following recommendations are based on current medical evidence.
The content of the document is dynamic and will be revised as new
clinical data become available. The purpose of this document is to
assist practitioners in clinical decision making, to standardize and
improve the quality of patient care, and to promote cost-effective drug
prescribing. The clinician, however, must make the ultimate judgment
regarding the propriety of any course of treatment in light on
individual patient situations*

Refer to the Raltegravir Monograph at
[www.pbm.va.gov](http://www.pbm.va.gov/) or
[http://vaww.pbm.va.gov](http://vaww.pbm.va.gov/)

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| **FDA APPROVED INDICATION FOR USE**                                   |
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| Raltegravir is indicated in combination with other antiretroviral     |
| agents for treatment of HIV-1 in treatment-experienced adult patients |
| who have evidence of viral replication and HIV-1strains resistant to  |
| multiple antiretroviral agents.                                       |
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| **EXCLUSION CRITERION (If selected, patient is NOT eligible)**        |
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| ⁪HIV-2                                                                 |
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| **INCLUSION CRITERIA (All must be selected for patient to be          |
| eligible)**                                                           |
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| ⁪Treatment-experienced patient (defined as 3 class experience with at  |
| least one protease inhibitor failure)                                 |
|                                                                       |
| ⁪Evidence of virologic failure (documented by a viral load \>1,000     |
| copies/mL) or intolerant to an individual agent within current        |
| antiretroviral regimen                                                |
|                                                                       |
| ⁪Able to construct a multi-drug regimen that includes, preferably, at  |
| least one additional active antiretroviral drug (if available) in     |
| addition to raltegravir                                               |
|                                                                       |
| ⁪Under the care of an experienced HIV practitioner                     |
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| **DOSAGE AND ADMINISTRATION (Refer to PI for dosage recommendations   |
| in organ dysfunction)**                                               |
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| 400mg orally twice daily without regard to food.                      |
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| **RECOMMENDED MONITORING**                                            |
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| In addition to standard monitoring in a patient receiving             |
| antiretrovirals, the following is recommended:                        |
|                                                                       |
| 1)  Baseline and periodic monitoring of LFTs, particularly in         |
|     patients with pre-existing liver dysfunction or co-infected with  |
|     viral hepatitis B or C.                                           |
|                                                                       |
| 2)  Baseline and periodic monitoring of CPK, particularly in patients |
|     receiving other medications associated with elevations of CPK.    |
|                                                                       |
| -Because of the risk of myopathy or rhabdomyolysis, caution should be |
| used when prescribing raltegravir with other medications that can     |
| cause these conditions.                                               |
|                                                                       |
| -Potential risk for malignancy                                        |
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| **ISSUES FOR CONSIDERATION**                                          |
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| Caution should be used when co-administering raltegravir with         |
| inducers of UGT1A1 (e.g., rifampin, phenytoin, phenobarbital) due to  |
| reduced plasma concentrations of raltegravir.                         |
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