segunda-feira, julho 10, 2006
Novo Kaletra aprovado pela EMEA
Abbott's New Tablet Formulation of Kaletra (lopinavir/ritonavir) Approved in Europe
- New Formulation of the Leading Protease Inhibitor Reduces Pill Count, Does Not Require Refrigeration -
ABBOTT PARK, Ill., July 03, 2006 /PRNewswire-FirstCall/ -- Abbott announced today that it has received marketing authorization from the European Commission for the tablet formulation of Kaletra(R) (lopinavir/ritonavir), a new, more convenient version of the leading protease inhibitor (PI) prescribed worldwide for the treatment of HIV. The Kaletra tablet allows adult patients to take fewer pills with or without food as part of their treatment regimen while maintaining the same safety and efficacy. In addition, the new formulation does not require refrigeration.
This approval will complement Abbott's efforts to expedite registration filings for the tablet formulation in countries around the world, including in developing countries. To date, Abbott has filed for registration of the new tablet formulation in countries in Africa, Asia and Latin America. Many developing countries require documentation of European approval as part of the filing process for the new tablet formulation. Abbott will be obtaining the necessary documentation and moving forward with the filing process in these countries as rapidly as possible.
"Kaletra is a proven HIV treatment, and this new and more convenient tablet formulation is welcomed by both physicians and patients," said Dr. Martin Fisher, consultant physician in HIV and Genitourinary Medicine, Brighton and Sussex University Hospitals.
The approved tablet formulation of Kaletra is designed to offer patients new benefits not available with the current soft capsules, enhancing the dosing convenience without compromising efficacy.
* Reduced pill count -- though the total daily dose of Kaletra (800 mg lopinavir/200 mg ritonavir) is unchanged, patients will now only need to take four tablets per day, as opposed to six capsules
* Dosing with or without food, providing patients greater flexibility -- the current soft capsule formulation should be taken with food
* No required refrigeration -- unlike the current soft capsule formulation, which requires refrigeration, the new Kaletra tablet can be stored at room temperature
Kaletra was developed using the proprietary Meltrex(TM) melt-extrusion technology, a formulation process resulting in a stable, solid dispersion of Kaletra, translating to fewer pills while maintaining the same amount of lopinavir and ritonavir. A single Kaletra tablet will now be composed of 200 mg lopinavir and 50 mg ritonavir, as compared to 133.3 mg lopinavir and 33.3 mg ritonavir in the previously introduced soft capsule.
"The tablet formulation of Kaletra is another example of Abbott's continued commitment to offering the next step in simple, safe and effective treatments for the HIV community," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott.
The approval of the tablet formulation from the European Commission was based on data from pharmacokinetic studies. The Kaletra tablet submission was filed as a line extension to the EMEA on May 19, 2005. The United States Food and Drug Administration (FDA) approved the Kaletra tablet on October 31, 2005.
Kaletra Tablet Availability
With approval of the more convenient Kaletra tablets in the EU, the vast majority of patients will convert to the tablet formulation. Patients should finish taking their current supply before starting a new prescription, should never take Kaletra tablets and capsules together, and should follow their doctor's directions, exactly as written on the label. Capsules will remain available in special cases where they are needed, including pediatrics.
To assist with the conversion from Kaletra capsules to Kaletra tablets, Abbott is providing educational information to health care providers and the HIV community.
Kaletra Safety Information
Kaletra is currently approved by the EMEA in its capsule formulation, and always used in combination with other anti-HIV medicines to treat people with HIV infection. Kaletra should not be taken by patients who have had an allergic reaction to lopinavir/ritonavir or any of its ingredients, including lopinavir or ritonavir.
Taking certain medications with Kaletra could create the potential for serious side effects that could be life threatening. Kaletra should not be taken with amiodarone, astemizole, cisapride, dihydroergotamine, ergonovine, ergotamine, methylergonovine, midazolam, pimozide, terfenadine or triazolam.
In addition, Kaletra should not be taken with fluticasone propionate, lovastatin, rifampin, simvastatin, or products containing St. John's Wort (Hypericum perforatum). Particular caution should be used when taking Kaletra with sildenafil, tadalafil, or vardenafil. Please consult your local prescribing information for country specific recommendations. Patients should discuss all medicines, including those without a prescription and herbal preparations they are taking or plan to take, with their doctor or pharmacist.
Pancreatitis and liver problems, which can be fatal, have been reported. Patients should tell their doctor if they have had liver disease such as hepatitis. 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 antiretroviral therapy. Some patients receiving Kaletra have had large increases in triglycerides and cholesterol. Varying degrees of cross-resistance among protease inhibitors have been observed.
In Kaletra clinical trials, the most commonly reported side effects of moderate-to-severe intensity were abdominal pain, abnormal bowel movements, diarrhea, feeling weak or tired, headache, nausea and vomiting. Children taking Kaletra may sometimes get a skin rash. This is not a complete list of reported side effects. Kaletra oral solution contains alcohol.
Kaletra does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others.
For more information about Kaletra including the full prescribing information visit http://www.kaletra.com.
For the Summary of Product Characteristics visit http://www.emea.eu.int/.