This is an international site for VOTUBIA® (everolimus) and is intended for Health Care Professionals in the EU. The information on this site is based on the EU SmPC and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country via www.novartisoncology.com/contactus.

This medicinal product has been authorized under a so-called, conditional approvalTM scheme. This means that further evidence on this medicinal product is awaited. The European Medicines Agency will review new information on the product every year and the EU SmPC will be updated as necessary.

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US Residents | Important Safety Information | EU Summary of Product Characteristics

You hear...

"VOTUBIA® targets an underlying cause of SEGA associated with
TSC, mTOR overactivation"1-4

They hear...

"It shrank."

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VOTUBIA® (everolimus) tablets for patients with SEGA associated with TSC not amenable to surgery

VOTUBIA® is indicated for the treatment of patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.1

The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease-related symptoms, has not been demonstrated.1

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Patients on VOTUBIA®

experienced SEGA volume reduction in a prospective open-label single-arm, Phase II study of 28 patients.1

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Adverse reactions

reported in a Phase II study for the treatment of SEGA and in Phase III studies.

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VOTUBIA® targets mTOR overactivation,

an underlying cause of SEGA associated with TSC.1-4

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VOTUBIA® MOA

Read about the VOTUBIA® mechanism of action.

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Phase II VOTUBIA®
clinical study

Read about the Phase II VOTUBIA® clinical study design.

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Dosing BSA Calculator

Enter your patient's height (in centimeters) and weight (in kilograms) to calculate their body surface area and recommended starting dose.

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  • Click here for information about calculating the starting dose of VOTUBIA®
  • The starting dose may need to be modified based on concomitant medications and hepatic function
    • Click here for more information about concomitant medications, including dose modifications based on some CYP3A4 inhibitors and inducers
    • Click here for more information about hepatic function

References

  1. VOTUBIA® [summary of product characteristics]. Novartis Pharma AG; 2011.
  2. Meikle L, Pollizzi K, Egnor A, et al. Response of a neuronal model of tuberous sclerosis to mammalian target of rapamycin (mTOR) inhibitors: effects on mTORC1 and Akt signaling lead to improved survival and function. J Neurosci. 2008;28:5422-5432.
  3. Crino PB, Nathanson KL, Henske EP. The tuberous sclerosis complex. N Engl J Med. 2006;355:1345-1356.
  4. Yang Q, Guan K-L. Expanding mTOR signaling. Cell Res. 2007;17:666-681.