Very common laboratory abnormalities include decreased hemoglobin, decreased lymphocyte count, increased amylase, increased blood glucose, increased lipase, increased serum creatine phosphokinase, increased serum creatinine, increased alanine amino transaminase (ALT), and increased aspartate amino transaminase (AST).

Concomitant use of strong CYP3A inhibitors and inducers must be avoided. If a strong CYP3A inducer must be used concomitantly with Odomzo, consideration should be given to increasing the dose of Odomzo by 200 mg increments to a maximum daily dose of 800 mg.

Doctors should carefully monitor patients for adverse drug reactions with concomitant use of substrates of CYP2B6 and CYP2C9 enzymes or BCRP transporter, especially those with a narrow therapeutic range.

Due to overlapping toxicities, patients taking Odomzo who are also taking medications known to increase the risk of muscle-related toxicity may be at increased risk of developing muscle-related adverse events. Patients should be closely monitored and dose adjustments should be considered if muscle symptoms develop.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "positive opinion," "underway," "hope," "rising," "commitment," "being reviewed" or similar terms, or by express or implied discussions regarding potential new indications or labeling for Odomzo, or regarding potential future revenues from Odomzo. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Odomzo will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Odomzo will be commercially successful in the future. In particular, management's expectations regarding Odomzo could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety issues; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.