Friday, October 28, 2005

New Kaletra Formulation

A notice from the FDA . . .

Today (October 28, 2005) the Food and Drug Administration approved a new formulation of Kaletra. Kaletra (lopinavir/ritonavir) is now available as a film coated tablet (200mg/50mg) that provides advantages over the currently marketed capsule formulation for HIV-1 infected patients. Specifically, the tablet formulation:
  • does not require refrigeration,
  • can be administered without regard to meals
  • does not require dose adjustments for concomitant use with certain NNRTIs and PIs in treatment-naive patients
  • has a decreased pill burden compared to the capsule formulation (2 tablets twice daily or 4 tablets once daily in treatment-naive patients only vs 3 capsules twice daily or 6 capsules once daily in treatment-naive patients
    only)

. . .

The capsule formulation will be phased out over time by the company.

Kaletra is a product of Abbott Laboratories. The original formulation was approved on September 15, 2000.


More information, including a copy of the new package insert, will be available on the FDA's website.

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