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LORBRENA™ has a once-daily dosing schedule1
|The recommended dose for LORBRENA™ is 100 mg taken orally once daily, with or without food.|
|If a dose reduction is needed, LORBRENA™ is also available as a 25 mg tablet.|
|Not actual size of tablets||
|LORBRENA™ tablets should be swallowed whole.|
|The tablets should not be chewed, crushed or split prior to swallowing.|
|LORBRENA™ is contraindicated in patients taking strong CYP3A inducers.*|
|While taking LORBRENA™, consider alternative medicinal products to strong CYP3A inhibitors with less potential to inhibit CYP3A.*|
*Please refer to the full LORBRENA LPD for recommendations regarding the use of CYP3A4/5 inducers and CYP3A4/5 inhibitors.1
LORBRENA™ is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity.1
Abbreviations: CYP, Cytochrome; LPD, Local Product Document.
LORBRENA™ dose modifications: Hyperlipidemia1
Hyperlipidemia was generally managed with lipid-lowering agents and dose interruptions, with or without dose modifications.2
Patients should have their serum cholesterol and triglycerides monitored:1
LORBRENA™ dose modifications: CNS adverse reactions1
Advise patients to notify their healthcare provider if they experience new or worsening CNS symptoms.1
In some cases, LORBRENA™ needs to be withheld and then the dose reduced.
For Grade 4 adverse reactions, permanently discontinue LORBRENA™.1
CNS adverse reactions experienced with LORBRENA™ include seizures, psychotic effects and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep.1
LORBRENA™ dose modifications: ILD/pneumonitis1
Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis have occurred with LORBRENA™.1
Any Grade treatment–related ILD/Pneumonitis, permanently discontinue LORBRENATM1
Any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis should be promptly evaluated. Symptoms include:1
Immediately withhold LORBRENATM in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENATM for treatment-related ILD/pneumonitis of any severity.
LORBRENA™ dose modifications: AV block1
The recommendations for dose modifications vary according to the degree of AV block.1
LORBRENA™ dose modifications: Other adverse reactions1
Please refer to the LORBRENA™ Local Product Document, Therapy Management package (available from your representative) or medical information for dose recommendations for different grades of adverse reactions.
§ 0.2% experienced Grade 3 AV block and underwent pacemaker placement.
Abbreviations: AV, Atrioventricular; CNS, Central nervous system; ILD, Interstitial lung disease; TRAEs, Treatment-related adverse events.
Adverse events should be reported. Adverse events can be reported to [email protected]
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