Selzentry Labeling Includes New Warnings for People With Kidney Problems

By Myles Helfand

June 2, 2010

The CCR5 inhibitor Selzentry (Celsentri, maraviroc) should be used with caution by HIV-positive people with kidney problems, according to a U.S. Food and Drug Administration release. The release provides details on several changes that have just been made to the official drug labeling for Selzentry, all of which have to do with the renal (kidney) issues.

This is all pretty new information. Although it was previously known that some Selzentry dose adjustments were likely needed for people with kidney failure, that's also true of an awful lot of drugs, since the kidneys basically act as the body's filtration system -- and if they stop working, it seriously hurts the body's ability to prevent drug levels from building up dangerously.

The new Selzentry labeling will include a number of specific warnings and other information related to the kidneys, including:

Selzentry should be avoided entirely (if possible) if a person has severe kidney impairment or end-stage renal disease and is taking any drug known to be a "CYP3A inhibitor" or "CYP3A inducer." That CYP3A bit refers to a specific group of human genes that are responsible for helping the body process drugs (among other chemicals). Many drugs we take attempt to speed up (induce) or slow down (inhibit) the job those genes perform. In the case of people on Selzentry who have major kidney problems, could result in a dangerous situation. CYP3A inhibitors and inducers include the HIV medication Sustiva (Stocrin, efavirenz) and most protease inhibitors except for Aptivus (tipranavir). (It's worth noting, incidentally, that Selzentry's drug labeling has long recommended dose adjustments for people taking CYP3A inhibitors or inducers; this update focuses specifically on people with severe kidney damage.)
A Selzentry dose reduction (from 300 mg twice daily to 150 mg twice daily) is recommended for people with severe kidney problems who experience symptoms of postural hypotension, or a sudden drop in blood pressure people may experience when they sit up or stand. The main symptom is a sudden feeling of lightheadedness, although people can sometimes pass out from it.
Research so far suggests that people with mild to moderate kidney impairment don't need to worry about adjusting their Selzentry dose as a result of their kidney problems. Ditto for people with severe kidney impairment who are not taking a CYP3A inhibitor or inducer, provided they also aren't experiencing any of those postural hypotension symptoms.

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