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Interaction Between Reyataz & Prilosec
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Jan 12, 2005
BMS Virology has sent a Customer Clinical Advisory Letter to healthcare providers regarding new PK data concerning the coadministration of REYATAZ and Norvir with presecription-strength (40 mg) Prilosec (omeprazole, AstraZeneca), a proton-pump inhibitor (PPI), for HIV-infected patients with gastrointestinal disease. The data reviewed in the letter support the recommendation in the current REYATAZ Package Insert that REYATAZ and PPIs NOT be coadministered.
The letter states:
- DO NOT COADMINISTER REYATAZ OR REYATAZ/RTV with omeprazole due to the reduction in atazanavir exposure levels. This recommendationis consistent with the current Reyataz US Package Insert.
- It is not known whether the over-the-counter dose of omeprazole (20 mg once daily) would produce similar results; therefore, coadministration is not recommended.
- Increasing the REYATAZ/RTV dose to 400/100 in combination with omeprazole DID NOT result in REYATAZ exposures comparable to those observed with a regimen of REYATAZ/RTV 300,100 without omeprazole.
- Simultaneous administration of 8 ounces of cola given in an effort to decrease gastric PH did not appear to affect this reduction.
As part of a post-approval commitment, the FDA requested that the interaction of REYATAZ with PPIs be studied. The FDA is aware that BMS has sent the Customer Clinical Advisory letter.
Coadministration of REYATAZ with PPIs is expected to decrease REYATAZ plasma concentrations & reduce its therapeutic effect. Therefore, for HIV-infected patients with gastrointestinal disease, PPIs should NOT be coadministered with REYATAZ. As stated earlier, this information is in the REYATAZ Package Insert.
There may be alternatives to using PPIs, including H2-Receptor antagonists & antacids, as stated in the REYATAZ Package Insert:
- H2-Receptor antagonists: Reduced plasma concentrations of atazanavir are expected if H2-Receptor antagonisys are administered with REYATAZ. This may result in loss of therapeutic effect & development of resistance. To lessen the effect of H2-Receptor antagonists on REYATAZ exposure, it is recommended that H2-Receptor antagonists (eg- Pepcid or Tagamet or Zantac) and REYATAZ be administered as fas apart as possible, preferably 12 hours apart.
- ANTACIDS: reduced plasma concentrations of atazanavir are expected if antacids, including buffered medications, are administered with REYATAZ. REYATAZ should be administered 2 hours before or one hour after these medications.
Investigations regarding the potential drug interaction between REYATAZ & H2-Receptor antagonists when coadministered are ongoing.
If you have any questions about this new information or require additional medical information, please contact the Virology Medical Services Dept at BMS at 1-800-426-7644 (select option 3).
Sincerely,
Sally L. Hodder, MD
Vice president, Virology Medical Affairs
Bristol-Myers Squibb Company
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