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FDA Approves Lopinavir/Ritonavir Tablet Formulation for HIV Patients

ABBOTT PARK, Ill., Oct. 31 /PRNewswire-FirstCall/ -- Abbott announced today that it has received U.S. Food and Drug Administration (FDA) approval for a new tablet formulation of its HIV protease inhibitor (PI) Kaletra(R) (lopinavir/ritonavir), which will allow adult patients to take fewer pills with or without food as part of their treatment regimen. Additionally, there will be no refrigeration requirements for the tablets. These benefits were not available with the old Kaletra capsules. The standard daily doses of new Kaletra tablets and capsules provide similar drug levels in the blood.

Kaletra is the number one prescribed PI for the treatment of HIV worldwide and has been taken by hundreds of thousands of patients since the drug was introduced in 2000. According to the updated guidelines released by a panel convened by the U.S. Department of Health and Human Services in October 2005, Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents, "Kaletra, in combination with zidovudine and lamivudine or emtricitabine, are recommended as the preferred PI-based regimens for the treatment of patients new to HIV therapy."

"Physicians strive to provide patients with medications that are effective against the virus and meet patient requests for simpler treatment regimens," said Calvin Cohen, M.D., research director, Community Research Initiative of New England and Harvard Vanguard Medical Associates, Boston. "Kaletra tablets respond to physician and patient needs by combining the new benefits of fewer pills per day, without food or refrigeration restrictions, with a drug that has a well-established clinical track record."

The FDA approval of the Kaletra tablet formulation was based on data from pharmacokinetic studies in 141 non-HIV infected, healthy individuals. The studies demonstrated that Kaletra tablets provide similar drug levels in the blood to the capsule formulation. In these studies, Kaletra tablets were generally well tolerated.

Kaletra tablet benefits include:
* Fewer tablets per dose as part of a treatment regimen in adults. While the total daily dose of Kaletra (800 mg lopinavir/200 mg ritonavir) is unchanged, the number of Kaletra pills adult patients need to take is reduced from six capsules to four tablets per day.

* Kaletra tablets can be taken with or without food.

* Kaletra tablets do not need to be refrigerated before or after dispensing. Exposure to high humidity outside the original container for longer than two weeks is not recommended.

"Abbott has a long history of innovative science in HIV and bringing forward improved treatment options for patients," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "With the new Kaletra tablet, we are providing patients with a more convenient version of the number one prescribed protease inhibitor for the treatment of HIV."

Abbott developed new Kaletra tablets using proprietary melt-extrusion technology (Meltrex(TM)), which enables a stable, solid dispersion of Kaletra within a tablet that provides similar drug levels in the blood relative to the capsules. The new Kaletra tablets each contain 200 mg lopinavir and 50 mg ritonavir and the old capsules each contain 133.3 mg lopinavir and 33.3 mg ritonavir. The film-coated tablets are similar in size to the capsules. The color of the new Kaletra tablets in the U.S. is yellow. The old Kaletra capsules are orange.

Kaletra capsules were initially approved for twice-daily administration. In April 2005, the FDA also approved capsules for once-daily administration in adult patients with no prior antiretroviral treatment.

Kaletra Tablet Availability
Kaletra tablets will be available at pharmacies across the country in the next few weeks. Abbott is planning for a full conversion from capsules to tablets to reduce the potential for patient and pharmacist confusion between the two formulations by March 2006. Patients should finish taking their current supply before starting a new prescription. Patients should never take Kaletra tablets and capsules together, and follow the directions from their doctor, exactly as written on the label.

To assist with the transition from Kaletra capsules to Kaletra tablets, Abbott is providing educational information with the HIV community and healthcare providers. More information is available at www.kaletra.com and 1-866-KALETRA.

Kaletra Indication and Safety Information Kaletra (lopinavir/ritonavir) is always used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Kaletra is a combination of two medicines. They are lopinavir and ritonavir. Kaletra is a type of medicine called an HIV protease (PRO-tee-ase) inhibitor. Kaletra is for adults and for children age six months and older.

Once-daily dosing of Kaletra in combination with other anti-HIV medicines is not recommended for people with previous HIV treatment and has not been evaluated in children.

Important Safety Information
Kaletra does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others.

Kaletra should not be taken if you have had an allergic reaction to Kaletra or any of its ingredients, including lopinavir or ritonavir.

Taking Kaletra with certain drugs can cause serious problems or death. Kaletra should not be taken with dihydro.ergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot(R), Migranal(R), D.H.E. 45(R), Ergotrate Maleate, and Methergine, as well as Halcion(R), Hismanal(R), Orap(R), Propulsid(R), Seldane(R) or Versed(R).

Kaletra should also not be taken with rifampin, also known as ..Rimactane(R), Rifadin(R), Rifater(R), or Rifamate(R), Flonase(R), Mevacor(R), Zocor(R) or products containing St. John's wort (Hypericum perforatum). Once-daily Kaletra should not be taken with Agenerase(R), Sustiva(R), Viracept(R), Viramune(R), Dilantin(R), Phenobarbital or Tegretol(R).

Particular caution should be used when taking Viagra(R), Cialis(R) or Levitra(R), since the interaction with Kaletra may result in an increase in their related side effects. Discuss all medicines, including those without a prescription and herbal products you are taking or plan to take, with your doctor or pharmacist.

Pancreatitis and liver problems, which can be fatal, have been reported in patients receiving Kaletra. Tell your doctor if you have nausea, vomiting, or abdominal pain, which may be signs of pancreatitis, or if you have or have had liver disease such as hepatitis B or C. In patients taking protease inhibitors, increased bleeding (in patients with hemophilia) and diabetes/high blood sugar have occurred.

Changes in body fat have been seen in some patients receiving anti- retroviral therapy. The cause and long-term health effects of these conditions are not known at this time. Some patients receiving Kaletra have had large increases in triglycerides and cholesterol. Varying degrees of cross-resistance among protease inhibitors have been observed.

The most commonly reported side effects of moderate severity are: abdominal pain, abnormal bowel movements, diarrhea, feeling weak or tired, headache, and nausea. Children taking Kaletra may sometimes get a skin rash. This is not a complete list of reported side effects.

Diarrhea may be more common in patients taking Kaletra capsules once-daily compared to the twice-daily dose (57 percent vs. 35 percent of mild to severe events and possibly related to the drug; and 16 percent vs. 5 percent of at least moderate severity and possibly related to the drug as found in a clinical study). Kaletra oral solution contains alcohol. Exposure of this product to high humidity outside the original container for longer than two weeks is not recommended.

Source: Abbott Laboratories

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