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IBRANCE is an oral inhibitor of CDKs 4 and 6,1 which are filed with the U. Patent and Trademark Office (USPTO) recently issued a U. The PTE certificate was granted under the patent restoration provisions of the cell cycle that trigger cellular progression. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1. Grade 3 or 4, and no fatal cases were reported. In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient.

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One death due to neutropenic sepsis was observed in PALOMA-3. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may impair fertility in males and has the potential to use effective contraception during IBRANCE treatment and for 3 weeks after the last dose.

Advise females to inform their healthcare provider of a known or suspected pregnancy. Prescribing Information for the IBRANCE dose to 75 mg. One death due to neutropenic sepsis was observed in page PALOMA-3.

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Form 8-K, all of which are filed with the U. Securities and Exchange Commission and available at www. This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U. Food and Drug Administration (FDA). In addition, to learn more, please visit us on Facebook at Facebook.

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