cluding laboratory terms, were fatigue, sepsis, gastrointestinal hemorrhage, pneumonia, diarrhea, febrile neutropenia, edema, dyspnea, nausea, vomiting, abdominal pain and renal insufficiency.
About AML
AML is the most common acute leukemia in adults; it accounts for approximately 25% of all adult leukemias worldwide, with the highest incidence rates occurring in the US, Europe and Australia. It also has the lowest survival rate of all adult leukemias.
AML prevents white blood cells from maturing, causing an accumulation of "blasts," which do not allow room for the normal blood cells. Mutations in specific genes are found in many cases of AML, and genetic testing for mutations in newly diagnosed AML patients can help to determine prognosis and potential treatment strategies.
About advanced SM
In advanced SM, the uncontrolled growth of neoplastic mast cells causes organ damage (e.g., liver dysfunction), low blood counts and weight loss. Patients also suffer from debilitating systemic symptoms such as pruritus (severe itching of the skin) caused by mast cells releasing inflammatory mediators, such as histamine, into the blood.
The uncontrolled proliferation of mast cells is caused in many people by a KIT gene mutation-the most common mutation, encoding the D816V substitution, occurs in approximately 90% of patients. The KIT gene mutation results in activation of the KIT enzyme, which triggers the abnormal proliferation and survival of mast cells.
About Rydapt® (midostaurin)
Rydapt(midostaurin) is an oral, multi-targeted inhibitor of multiple kinases, including FLT3 and KIT, which help regulate many essential cell processes, interrupting cancer cells' ability to grow and multiply.
Rydapt is available in 25mg capsules.
In AML, the recommended dosage for Rydapt is 50 mg orally twice daily on days 8 to 21 each cycle of induction therapy and on days 8 to 21 each cycle of consolidation therapy.
For a description of the experience with single-agent treatment beyond induction and consolidation, healthcare professionals should refer to the Clinical Studies section of the Prescribing Information.
In advanced SM, the recommended dosage for Rydapt is 100mg orally twice daily.
Rydapt Important Safety Information
Patients who are allergic to midostaurin or any of the ingredients in Rydapt should not take Rydapt. If a patient taking Rydapt develops signs of an allergic reaction, they should seek medical help immediately. Signs of an allergic reaction include trouble breathing, flushing, chest pain, throat tightness, and swelling of lips, mouth or throat.
Rydapt should be not be used during pregnancy since Rydapt may harm an unborn baby. Pregnancy testing should be conducted for women who might become pregnant. Effective birth control should be used during treatment and for at least four months after stopping Rydapt. If a patient becomes pregnant or thinks she may be, the patient should tell their doctor right away. Women should not breastfeed during treatment with Rydapt and for at least four months after the final dose. Men taking Rydapt who have female partners that are able to become pregnant should use effective birth control during his treatment with Rydapt and for at least four months after the last Rydapt dose. Rydapt may cause fertility problems in women and men, which may affect their ability to have children.
Rydapt may cause lung problems that may lead to death. Patients on Rydapt who develop a new or worsening cough, shortness of b |
