REMS File

Kaletra Oral Solution

Brand NameKaletra Oral Solution
Generic Namelopinavir and ritonavir
Marketed byAbbott Laboratories
NDA/BLA HolderAbbott
NDA/BLA NumberNDA 21-251/S-023, NDA 21-906/S-014
NDA/BLA Approval Date11/15/2000, 10/28/2005
StatusApproved
Review ClassificationPriority
REMS Approval Date4/6/2009
Class REMSNo
REMS Source Documenthttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM144244.pdf
Boxed Warning?No
Boxed WarningN/A
IndicationKALETRA is an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1)
Route of AdministrationOral Tablets
Mechanism of ActionLopinavir, an inhibitor of the HIV-1 protease, prevents cleavage of the Gag-Pol polyprotein, resulting in the production of immature, non-infectious viral particles.
RisksCardiac arrhythmias, Drug-Drug Interactions
Risks (MedGuide Language)
  • Interactions with other medicines. It is important to know the medicines that should not be taken with KALETRA. Read the section \\\"What should I tell my doctor before taking KALETRA?\\\"

  • Changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an EKG (electrocardiogram) and can lead to serious heart problems. Your risk for these problems may be higher if you:
    • already have a history of abnormal heart rhythm or other types of heart disease
    • take other medicines that can affect your heart rhythm while you take KALETRA.
Approved Labelinghttp://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s029,021906s022lbl.pdf
Medication Guide?Yes
Medication Guidehttp://www.fda.gov/downloads/Drugs/DrugSafety/UCM143461.pdf
Medication Guide Version2009
Communication Plan?No
Communication PlanN/A
Elements to Assure Safe Use?No
Elements to Assure Safe UseN/A
Implementation System?No
Implementation SystemN/A
Assessment ProgramYes
Assessment Program Timeline1st FDAAA assessment: October 2010 (18 months from initial REMS approval) 2nd FDAAA assessment: April 2012 (3 years from initial REMS approval) 3rd FDAAA assessment: April 2016 (7 years from initial REMS approval)
Branded ProgramNo
Program DescriptionN/A
Link to Branded ProgramN/A
Deemed/ApprovedApproved
Approval Lettershttp://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021906ltr.pdf

Sources

REMS Document: from FDA Approved REMS
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Approval Letters: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Approved Labeling: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

Medication Guide: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)

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